Here’s Why Mesoblast Stock Rose Over 18% Today – The Motley Fool

What happened

Shares of Mesoblast (NASDAQ:MESO) rose as much as 18.1% today after the company announced its experimental stem cell treatment, remestemcel-L, will be available under an expanded-access protocol for children with COVID-19 in the United States.

More specifically, the company filed the protocol with the Food and Drug Administration to treat individuals between the ages of two months and 17 years old suffering from multisystem inflammatory syndrome (MIS-C). It could signify a major step in the availability of the drug candidate to treat severe cases of COVID-19 that don't require mechanical ventilator support, which doctors are increasingly avoiding.

At the close on Monday, the small-cap stock had settled to a 9.1% gain.

Image source: Getty Images.

Mesoblast is conducting a 300-patient placebo-controlled study of remestemcel-L as a treatment for acute respiratory distress syndrome (ARDS) in COVID-19 patients who require ventilator support. If promising results from a 12-patient study are replicated in the larger patient population, then the cell therapy could become an important tool for doctors across the globe.

There's just one major issue for the Australian biopharma, which turns out to be great news for the overall trajectory of the coronavirus pandemic: Doctors have learned that placing COVID-19 patients on ventilators increases the fatality rate of the disease. In other words, ventilators are increasingly being avoided at this point in the health crisis, which appears to be reducing the fatality rate.

That observation could significantly reduce the need for remestemcel-L as it's being used in the ongoing 300-patient study -- unless Mesoblast can expand the use of the experimental cell therapy in severe cases of COVID-19 that don't require ventilator support. The science around the immune-system-modulating effects of remestemcel-L supports its use in such cases, but today's news is the first step (albeit a small and early one) in that direction.

The announcement of an expanded-access protocol for remestemcel-L in children with MIS-C will expand the use of the cell therapy in treating severe cases of COVID-19 -- even those that don't involve mechanical ventilators. If Mesoblast can prove its experimental therapy is safe and effective in reducing the severity of the immune response resulting from the viral infection, then remestemcel-L could emerge as one of the most important non-vaccine treatments in the health crisis.

First things first, of course: The company must deliver successful results in the ongoing 300-patient study of COVID-19 associated ARDS requiring ventilator support. If successful, then it will help to prove the safety and efficacy of the cell therapy in reducing severe immune responses. Those results would also make it easier to persuade regulators and doctors to expand the drug's use in severe cases that don't require mechanical ventilators.

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Here's Why Mesoblast Stock Rose Over 18% Today - The Motley Fool

Eucalyptus necklace and other unproven Covid-19 cures raise alarm in Indonesia – The Straits Times

JAKARTA - A minister touted a necklace made of eucalyptus, while researchers, including from the national intelligence agency, announced the discovery of a combination of drugs and cutting-edge stem cell therapies.

These were among a litany of claims of Covid-19 cures in Indonesia that havealarmed doctors andthe consumer protection foundation.

The Indonesian Consumers Foundation (YLKI), in a letter earlier this month to State Secretary Pratikno, expressed concerns over plans to produce anti-coronavirus medicines that had not passed clinical trials. The State Secretary is a key aide to President Joko Widodo and is involved in the day-to-day running of the government.

In Indonesia, the Food and Drug Monitoring Agency (BPOM), the equivalent ofthe United States Food and Drug Administration, conducts extensive clinical trials to ensure the safety and efficacy of any proposed new drug.

Last month, researchers at Airlangga University in East Java province and the State Intelligence Agency (BIN) announced the discovery of five combinations of drugs to fight Covid-19,as well as two types of stem cell therapies that reportedly inhibit the coronavirus that causes Covid-19.

The announcement was criticised by doctors, who were also perplexed by the involvement of an intelligence agency in a medical endeavour.

Responding to the joint announcement by BIN and the university, Dr Pandu Riono, who teaches at the University of Indonesia's medical school, issued a reminder that public safety should remain paramount even during an emergency situation such as a pandemic.

He also appealed to government agencies to operate within their respective spheres and never to ignore science.

YLKIchairman Tulus Abadi noted that many of the claims of Covid-19 cures increasingly being circulatedwere, in fact, "unlicensed and whose effectiveness has not been scientifically proven".

"BPOM must increase monitoring and warn the parties making such claims that they are not based on required clinical trials. Even if the claim was made by a minister," he said.

Last week, Agriculture Minister Syahrul Yasin Limpo announced that his ministry would begin mass producing an anti-Covid-19 necklace made of eucalyptus in August. He claimed that it could kill 80 per cent of the virus in a patient in just half an hour.

A few days later, the ministry's research and development head, Mr Fadjry Djufry, backtracked, saying that the products - which includedhand-held inhalers and roll-ons - were merely for aromatherapy.

He said they would not be labelled as anti-viral, although they could treat known Covid-19 symptoms such as shortness of breath.

In a recent webinar involving medical doctors, Dr Lucia Rizka Andalusia, the drug registration director at BPOM, said the agency would not close the door to creativity in efforts to find and use effective herbaltraditional medicines against Covid-19, but emphasised that it must ensure safety.

But the chairman of the independent Indonesian Doctors Council,Dr Sukman Tulus, issued a warning to his colleagues.

Administering drugs, herbal medicines and traditional healing substances that are "not yet licensed and do not have clear standards would amount to a breach of professional duty and even a breach of law" for medical doctors, he said.

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Eucalyptus necklace and other unproven Covid-19 cures raise alarm in Indonesia - The Straits Times

Global Organ Preservation Market Future Demand (COVID 19 Impact Analysis) & Growth Analysis with Forecast up to 2027 – Cole of Duty

Global Organ Preservation Market By Preservation Solution (Citrate, Collins, Viaspan, Renograf, UW Solution, Custodial HTK, Perfadex, Hypothermosol, HBS Solution, Lifor, Sirna Transport Solution, Others), Technique (SCS, Hypothermic Machine Perfusion, Normothermic Machine Perfusion), Organ Type (Kidneys, Liver, Lung, Heart, Others), End User (Organ Banks, Hospitals & Clinics, Others), Country (U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa), Industry Trends and Forecast to 2027

Data Bridge Market Research has added an exhaustive research study of the Global Organ Preservation Market detailing every single market driver and intricately analyzing the business vertical. The research report has abilities to raise as the most significant market worldwide as it has remained playing a remarkable role in establishing progressive impacts on the universal economy. The Research report presents a complete assessment of the Market and contains a future trend, current growth factors, attentive opinions, facts, and industry-validated market data. Some are thekey players taken under coverage for this study arePARAGONIX TECHNOLOGIES INC., 21st Century Medicine, ESSENTIAL PHARMACEUTICALS LLC, Lifeline Scientific, Dr. Franz Khler Chemie GmbH, Preservation Solutions Inc, OrganOx Limited, XVIVO Perfusion.

Market Analysis and Insights of Organ Preservation

Organ preservation marketis analysed by Data Bridge Market Research, wherein we have accounted for the market to witness a potential growth rate of 7.98% in the forecasted period of 2020 to 2027, resulting in the market reaching a cap of USD 386.55 million by the end of the forecasted period. Various innovations and advancements witnessed across the organ transplantation and preservation market are expected to be the major driving factors for organ preservation market in the forecasted period of 2020 to 2027.

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The major players covered in the organ preservation market report are PARAGONIX TECHNOLOGIES INC., 21st Century Medicine, ESSENTIAL PHARMACEUTICALS LLC, Lifeline Scientific, Dr. Franz Khler Chemie GmbH, Preservation Solutions Inc, OrganOx Limited, XVIVO Perfusion, TransMedics, Inc., Bridge to Life Ltd., Organ Recovery Systems, BioLifeSolutions Inc., IGL among other domestic and global players. Market share data is available for global, North America, Europe, Asia-Pacific (APAC), South America and Middle East and Africa (MEA) separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Organ preservation is the process of storing and preserving the organs donated for transplantation. This preservation process involves flushing the organ with specific preservation solution dependent on the requirements and storing them on the basis of different techniques as required by the organ. Due to the different of distance or time between the organ donation and organ transplantation procedure, there is a need for carrying out this preservation procedure helping doctors sustain the organ over a longer period of time.

Increasing incidences of organ failures occurring worldwide amid high growth of geriatric population, along with the various regional authorities providing favourable regulations, organizing initiatives and creating awareness programs to increase the volume of organ donations and organ transplantation procedures worldwide; these factors are the major growth factors for organ preservation market in the forecasted period of 2020 to 2027.

Large-scale costs associated with the organ transplantation procedure restricts the procedure consumers to a smaller consumer base, while the lack of appropriate donors as well as the alternative modes of organ transplantation available such as the development of organs with the help of stem cell procedures are the factors expected to restrict the markets growth in the above-mentioned forecasted period.

This organ preservation market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on Data Bridge Market Research organ preservation market contact us for anAnalyst Brief, our team will help you take an informed market decision to achieve market growth.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Organ preservation market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for organ preservation market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the organ preservation market. The data is available for historic period 2010 to 2018.

Global Organ Preservation Market Scope and Market Size

Organ preservation market is segmented on the basis of preservation solution, technique, organ type and end user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

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Organ Preservation Market Country Level Analysis

Organ preservation market is analysed and market size insights and trends are provided by country, preservation solution, technique, organ type and end user as referenced above.

The countries covered in organ preservation market report are U.S., Canada and Mexico in North America, Germany, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe in Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Brazil, Argentina and Rest of South America as part of South America South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa (MEA) as a part of Middle East and Africa (MEA).

Asia-Pacific is expected to witness growth at the highest rate in the forecasted period of 2020 to 2027, as the volume of organs being donated in the region along with the favourable regulations presented by the authorities on enhancing the organ transplantation procedures are the major factors behind this growth rate. North America will hold the largest market share due to the high volume of organ transplants taking place in the region, along with the large-scale advancements of technology for carrying out these procedures.

The country section of the organ preservation market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Table of Contents-Snapshot Executive Summary Chapter 1 Industry Overview Chapter 2 Industry Competition by Manufacturers Chapter 3 Industry Production Market Share by Regions Chapter 4 Industry Consumption by Regions Chapter 5 Industry Production, Revenue, Price Trend by Type Chapter 6 Industry Analysis by Applications Chapter 7 Company Profiles and Key Figures in Industry Business Chapter 8 Industry Manufacturing Cost Analysis Chapter 9 Marketing Channel, Distributors and Customers Chapter 10 Market Dynamics Chapter 11 Industry Forecast Chapter 12 Research Findings and Conclusion Chapter 13 Methodology and Data Source

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Competitive Landscape and Organ Preservation Market Share Analysis

Organ preservation market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to organ preservation market.

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Global Organ Preservation Market Future Demand (COVID 19 Impact Analysis) & Growth Analysis with Forecast up to 2027 - Cole of Duty

Hammond police officer jumps at chance to donate stem cells – The Times of Northwest Indiana

The grandmother of a local boy fighting cancer explained a swab would be taken from their mouths and sent off for analysis. If they were determined to be a match for someone in need, they would be notified.

Its hard to get a match, Seles said. But if you do, they ask, 'Would you be interested in following through?'"

Seles and his wife both signed up, but so far Courtney Seles hasnt received a call.

Adam learned in summer 2019 that he was a match and the recipient would need a donation within just four to six weeks.

He traveled with his father, Nathan Seles, 58, to Grand Rapids for a physical and blood draw. While they were at the facility, staff worked to ensure Seles was comfortable and wanted to follow through with the donation process.

At one point, he looked over and saw his father was crying, he said.

It means a lot to him, Seles said of his dad. Hes dealt with cancer a few times. It means a lot to him that I can do something.

Seles began the injections at home with the help of his mother-in-law, a nurse, he said.

Medical staff warned he could feel pain in the back or legs, because the medication being injected allows stem cells to pass from the bone marrow into the blood stream.

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Hammond police officer jumps at chance to donate stem cells - The Times of Northwest Indiana

Joint Study by Sunway University and Harvard Medical School Shows Gene Therapy Can Advance Cancer Treatment – QS WOW News

Sunway Universitys Professor Jeff Tan Kuan Onn of the Department of Biological Sciences and Professor Poh Chit Laa from the Centre for Virus and Vaccine Research, along with their research collaborators from Harvard Medical Schools Center for Stem Cell Therapeutics and Imaging (USA) as well as University of Tennessee Health Science Centre (USA) have completed a study that has demonstrated the efficacy of molecular gene therapy as a new strategy for cancer treatment.

The research could potentially contribute to shorter treatment time for cancers, reduce treatment costs and minimize the adverse effects of current chemo-drugs in cancer patients such as susceptibilities toward microbial infections, hair loss, and other side effects of chemo-drugs that drastically affect the quality of life of cancer patients undergoing therapy.

Principal Investigator Professor Jeff Tan explained, Currently, chemo-drugs are relatively ineffective against cancer cells that have developed drug-resistance resulting in the need for high doses of chemo-drugs or a combination of chemo-drugs to be administered to patients with cancer cells. Chemo-drug resistant cancer cells also can spread quickly and that drastically reduce the survival rate of cancer patients.

Our research utilizes molecular gene therapy which is the introduction of genetic materials into cancer cells to promote the sensitivity of cancer cells to chemo-drugs. By genetically engineering the cancer cells, we find that we can induce the cancer cells to produce activated pro-death and tumor suppressor proteins that cause cell death and growth arrests in cancer cells. The weakened cancer cells can then be killed relatively easily by the administration of chemo-drugs in smaller doses. Ultimately, the research could contribute to increasing the survival rates of cancer patients undergoing cancer treatments he added.

Co-Investigator Professor Poh Chit Laa said that the effectiveness of the strategy has been demonstrated in mice implanted with human breast cancer cells. In the mice that were treated with the gene therapy, the tumors obtained from the treated mice showed significant tumor cell death and the tumors were 20 times smaller and 32 times lighter in volume and weight, respectively, when compared to the tumors obtained from the untreated mice. The results indicated that gene therapy was able to shrink the tumors significantly, even without treatment with chemo-drugs. Small doses of market-available anti-cancer drugs could then be used to kill the cancer cells effectively. We hope to see our research contribute to better survival rates of cancer patients, and minimize the side-effects associated with anti-cancer drugs, said Professor Poh.

We are currently working on investigations to optimize the delivery of the gene therapy and anti-cancer drugs to human tumors with hopes that this will result in tangible clinical outcomes, said Professor Jeff Tan.

The research project was recently published in the peer-review Journal of Cancer Research and Clinical Oncology. Collaborators for the research include Lee Yong Hoi, Pang Siew Wai and Samson Eugin Simon from the Department of Biological Sciences, Sunway University; Esther Revai Lechtich and Khalid Shah, of the Center for Stem Cell Therapeutics and Imaging, Brigham and Womens Hospital, Harvard Medical School (USA); Suriyan Ponnusamy and Ramesh Narayanan from the Department of Medicine, Centre of Cancer Drug Discovery, College of Medicine, University of Tennessee Health Science Centre (USA).

The research is a result of a collaboration agreement between Harvard Medical School and Sunway University aimed at developing new cancer therapies targeting drug-resistant cancer cells. In 2016, Professor Jeff Tan visited Harvard University on the Jeffrey Cheah Travel Grant which enabled him to better understand how cancer research projects are conducted as well as examining experimental models used to study cancer biology at Harvard University, Massachusetts General Hospital (MGH), a hospital affiliated with Harvard Medical School, and the Dana-Farber Cancer Institute.

To read the jointly published article: https://link.springer.com/article/10.1007/s00432-020-03231-9

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Joint Study by Sunway University and Harvard Medical School Shows Gene Therapy Can Advance Cancer Treatment - QS WOW News

Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical Announce FDA and Health Canada Approval of INQOVI (Decitabine and Cedazuridine)…

INQOVI is the first and only orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML),1 two blood malignancies.

Approval was based on data from the ASCERTAIN phase 3 study and supporting phase 1 and 2 clinical studies. The ASCERTAIN phase 3 study evaluated the five-day, decitabine exposure equivalence between oral INQOVI and intravenous decitabine. The safety and efficacy of INQOVI was also assessed in the clinical studies.

The review and approval of INQOVI was conducted under the ORBIS initiative from the FDA Oncology Center of Excellence (OCE) with simultaneous submission and regulatory review in the U.S., Canada, and Australia. The FDA also reviewed the NDA under Priority Review status. INQOVI is not currently approved in Australia. INQOVI was formerly named ASTX727, its experimental compound code.

Intravenous or subcutaneous administered hypomethylating agents have been the cornerstone for the treatment of patients with MDS and CMML since the mid-2000s, said Guillermo Garcia-Manero, MD, Professor and Chief of Section of Myelodysplastic Syndromes, Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas, and Principal Investigator of the ASCERTAIN clinical study. The FDAs approval of INQOVI builds on the proven therapeutic utility of hypomethylating agents in these diseases and offers a new orally administered option that offers patients an alternative to five consecutive days of IV infusions every month during a treatment period that can extend to several months.

Until now, patients with intermediate and high-risk MDS and CMML have not had an approved, orally administered hypomethylating agent option for treatment of their disease, said Mohammad Azab, MD, president and chief medical officer of Astex Pharmaceuticals, Inc. The INQOVI clinical program was designed to deliver an oral alternative to IV decitabine based on comparative decitabine exposure data in the clinical trials, and to assess INQOVIs safety and efficacy profile. As part of the ORBIS project initiative of FDA and Health Canada we were able to share and address information requests simultaneously with both agencies resulting in a more efficient review and completion of assessment in a timely manner. The outcome is expedited availability of this important oral alternative to patients in both countries, added Dr. Azab. We greatly appreciate the FDAs priority review and Health Canadas review of the INQOVI NDA / NDS under Project ORBIS and the approval of a new therapeutic option for patients with these diseases.

INQOVI is an orally administered, fixed-dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine,2 an inhibitor of cytidine deaminase.3 By inhibiting cytidine deaminase in the gut and the liver, INQOVI is designed to allow for oral delivery of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine (geometric mean ratio of the 5-day cumulative decitabine area-under-the-curve following 5 consecutive once daily doses of INQOVI compared to that of intravenous decitabine was 99% (90% CI: 93, 106).1 The phase 1 and phase 2 clinical study results have been published in Lancet Haematology4 and Blood,5 respectively. The phase 3 ASCERTAIN study data was presented at the American Society of Hematology (ASH) Meeting in Orlando, Florida, in December 2019 by Dr. Garcia-Manero.6

Astexs parent company, Otsuka Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd. previously announced that, subject to regulatory approvals, commercialization of oral INQOVI in the U.S. and Canada will be conducted by Taiho Oncology, Inc. and Taiho Pharma Canada, Inc. respectively.

Our partnership with Astex is a demonstration of the commitment that Taiho Oncology has to bringing new therapeutic options to patients with cancer, said Tim Whitten, president and chief executive officer of Taiho Oncology, Inc. The approval of INQOVI makes the possibility of at-home hypomethylating agent treatment of intermediate and high-risk MDS and CMML a reality, enabling patients to take their medication from the convenience and comfort of their home. This is especially significant during the COVID-19 pandemic, allowing patients to potentially reduce the number of office visits needed for current IV treatment administration. We look forward to working with all healthcare professionals to help deliver the first new oral HMA treatment alternative for patients with intermediate and high-risk MDS and CMML in nearly fifteen years.

About INQOVI (See https://www.inqovi.com)

INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.1

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Myelosuppression: Fatal and serious myelosuppression can occur with INQOVI. Based on laboratory values, new or worsening thrombocytopenia occurred in 82% of patients, with Grade 3 or 4 occurring in 76%. Neutropenia occurred in 73% of patients, with Grade 3 or 4 occurring in 71%. Anemia occurred in 71% of patients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients, with Grade 3 or 4 occurring in 32%.

Fatal and serious infectious complications can occur with INQOVI. Pneumonia occurred in 21% of patients, with Grade 3 or 4 occurring in 15%. Sepsis occurred in 14% of patients, with Grade 3 or 4 occurring in 11%. Fatal pneumonia occurred in 1% of patients, fatal sepsis in 1%, and fatal septic shock in 1%.

Obtain complete blood cell counts prior to initiation of INQOVI, prior to each cycle, and as clinically indicated to monitor response and toxicity. Administer growth factors, and antiinfective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.

Embryo-Fetal Toxicity: INQOVI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise patients to use effective contraception during treatment with INQOVI and for 6 months (females) or 3 months (males) after last dose.

ADVERSE REACTIONS

Serious adverse reactions in > 5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and one case each of cerebral hemorrhage and sudden death.

The most common adverse reactions ( 20%) were fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased. The most common Grade 3 or 4 laboratory abnormalities (>50%) were leukocytes decreased, platelet count decreased, neutrophil count decreased, and hemoglobin decreased.

USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with INQOVI and for at least 2 weeks after the last dose.

Renal Impairment: No dosage modification of INQOVI is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] of 30 to 89 mL/min based on Cockcroft-Gault). Due to the potential for increased adverse reactions, monitor patients with moderate renal impairment (CLcr 30 to 59 mL/min) frequently for adverse reactions. INQOVI has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min) or end-stage renal disease (ESRD: CLcr <15 mL/min).

Please see the accompanying Full Prescribing Information.

https://www.inqovi.com/pi

To view the FDA Press Release, please see the following link.

https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-myelodysplastic-syndromes-mds-can-be-taken-home

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. U.S. incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.7,8 The prevalence has been estimated to be from 60,000 to 170,000 in the U.S.9 MDS may evolve into acute myeloid leukemia (AML) in one-third of patients.10 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML.

CMML is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. The incidence of CMML in the U.S. is approximately 1,100 new cases per year,11 and CMML may transform into AML in 15% to 30% of patients.12 The hypomethylating agents decitabine and azacitidine are effective treatment modalities and are FDA-approved for the treatment of intermediate and high-risk MDS and CMML. These agents are administered by IV infusion, or by large-volume subcutaneous injections.

About Astex, Taiho, and Otsuka

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer. Astex is developing a proprietary pipeline of novel therapies and has multiple partnered products in development under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

Taiho Oncology, Inc., is a subsidiary of Taiho Pharmaceutical Co., Ltd. and an indirect subsidiary of Otsuka Holdings Co., Ltd. Taiho has established a world-class clinical development organization that works urgently to develop innovative cancer treatments and has built a commercial business in the U.S. Taiho has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents.

Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: Otsukapeople creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, Inc. please visit: https://www.astx.com

For more information about Otsuka Pharmaceutical, please visit: https://www.otsuka.co.jp/en/

For more information about Taiho Pharmaceutical, please visit: https://www.taihooncology.com/

References

CDEC-PM-US-0125

View source version on businesswire.com: https://www.businesswire.com/news/home/20200707005938/en/

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Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical Announce FDA and Health Canada Approval of INQOVI (Decitabine and Cedazuridine)...

Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market 2020:Key market Insights, Drivers and Restraints, Opportunities and Challenges,…

Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Research Report

Los Angeles, United States, July 8th, 2020, The report on the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market is comprehensively prepared with main focus on the competitive landscape, geographical growth, segmentation, and market dynamics, including drivers, restraints, and opportunities. It sheds light on key production, revenue, and consumption trends so that players could improve their sales and growth in the Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market. It offers a detailed analysis of the competition and leading companies of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. Here, it concentrates on the recent developments, sales, market value, production, gross margin, and other important factors of the business of top players operating in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market.

With deep quantitative and qualitative analysis, the report provides encyclopedic and accurate research study on important aspects of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. It brings to light key factors affecting the growth of different segments and regions in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. It also offers SWOT, Porters Five Forces, and PESTLE analysis to thoroughly examine the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. It gives a detailed study on manufacturing cost, upstream and downstream buyers, distributors, marketing strategy, and marketing channel development trends of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. Furthermore, it provides strategic bits of advice and recommendations for players to ensure success in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market.

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Some of the Important Key player operating in this Report are: , Orange County Hair Restoration Center, Hair Sciences Center of Colorado, Anderson Center for Hair, Evolution Hair Loss Institute, Savola Aesthetic Dermatology Center, Virginia Surgical Center, Hair Transplant Institute of Miami, Colorado Surgical Center & Hair Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies

Segmental Analysis

The report has classified the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies manufacturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Railway Signaling System industry.

Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Segmentation by Product

, Platelet Rich Plasma Injections, Stem Cell Therapy Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies

Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Segmentation by Application

Dermatology Clinics, Hospitals

Regions and Countries

The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

Key Questions Answered

What is the size and CAGR of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market?

Which are the leading segments of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market?

What are the key driving factors of the most profitable regional market?

What is the nature of competition in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market?

How will the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market advance in the coming years?

What are the main strategies adopted in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market?

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Table of Contents

1 Report Overview 1.1 Study Scope 1.2 Key Market Segments 1.3 Players Covered: Ranking by Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue 1.4 Market Analysis by Type 1.4.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size Growth Rate by Type: 2020 VS 2026 1.4.2 Platelet Rich Plasma Injections 1.4.3 Stem Cell Therapy 1.5 Market by Application 1.5.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Share by Application: 2020 VS 2026 1.5.2 Dermatology Clinics 1.5.3 Hospitals 1.6 Coronavirus Disease 2019 (Covid-19): Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Industry Impact 1.6.1 How the Covid-19 is Affecting the Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Industry

1.6.1.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business Impact Assessment Covid-19

1.6.1.2 Supply Chain Challenges

1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products 1.6.2 Market Trends and Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Potential Opportunities in the COVID-19 Landscape 1.6.3 Measures / Proposal against Covid-19

1.6.3.1 Government Measures to Combat Covid-19 Impact

1.6.3.2 Proposal for Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players to Combat Covid-19 Impact 1.7 Study Objectives 1.8 Years Considered 2 Global Growth Trends by Regions 2.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Perspective (2015-2026) 2.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Growth Trends by Regions 2.2.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Regions: 2015 VS 2020 VS 2026 2.2.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Historic Market Share by Regions (2015-2020) 2.2.3 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Regions (2021-2026) 2.3 Industry Trends and Growth Strategy 2.3.1 Market Top Trends 2.3.2 Market Drivers 2.3.3 Market Challenges 2.3.4 Porters Five Forces Analysis 2.3.5 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Growth Strategy 2.3.6 Primary Interviews with Key Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players (Opinion Leaders) 3 Competition Landscape by Key Players 3.1 Global Top Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players by Market Size 3.1.1 Global Top Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players by Revenue (2015-2020) 3.1.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue Market Share by Players (2015-2020) 3.1.3 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Share by Company Type (Tier 1, Tier 2 and Tier 3) 3.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Concentration Ratio 3.2.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Concentration Ratio (CR5 and HHI) 3.2.2 Global Top 10 and Top 5 Companies by Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue in 2019 3.3 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players Head office and Area Served 3.4 Key Players Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Product Solution and Service 3.5 Date of Enter into Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market 3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026) 4.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Historic Market Size by Type (2015-2020) 4.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Type (2021-2026) 5 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Breakdown Data by Application (2015-2026) 5.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 5.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Application (2021-2026) 6 North America 6.1 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020) 6.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in North America (2019-2020) 6.3 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020) 6.4 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 7 Europe 7.1 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020) 7.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Europe (2019-2020) 7.3 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020) 7.4 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 8 China 8.1 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020) 8.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in China (2019-2020) 8.3 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020) 8.4 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 9 Japan 9.1 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020) 9.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Japan (2019-2020) 9.3 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020) 9.4 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 10 Southeast Asia 10.1 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020) 10.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Southeast Asia (2019-2020) 10.3 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020) 10.4 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 11 India 11.1 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020) 11.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in India (2019-2020) 11.3 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020) 11.4 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 12 Central & South America 12.1 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020) 12.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Central & South America (2019-2020) 12.3 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020) 12.4 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 13 Key Players Profiles 13.1 Orange County Hair Restoration Center 13.1.1 Orange County Hair Restoration Center Company Details 13.1.2 Orange County Hair Restoration Center Business Overview and Its Total Revenue 13.1.3 Orange County Hair Restoration Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction 13.1.4 Orange County Hair Restoration Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)) 13.1.5 Orange County Hair Restoration Center Recent Development 13.2 Hair Sciences Center of Colorado 13.2.1 Hair Sciences Center of Colorado Company Details 13.2.2 Hair Sciences Center of Colorado Business Overview and Its Total Revenue 13.2.3 Hair Sciences Center of Colorado Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction 13.2.4 Hair Sciences Center of Colorado Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020) 13.2.5 Hair Sciences Center of Colorado Recent Development 13.3 Anderson Center for Hair 13.3.1 Anderson Center for Hair Company Details 13.3.2 Anderson Center for Hair Business Overview and Its Total Revenue 13.3.3 Anderson Center for Hair Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction 13.3.4 Anderson Center for Hair Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020) 13.3.5 Anderson Center for Hair Recent Development 13.4 Evolution Hair Loss Institute 13.4.1 Evolution Hair Loss Institute Company Details 13.4.2 Evolution Hair Loss Institute Business Overview and Its Total Revenue 13.4.3 Evolution Hair Loss Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction 13.4.4 Evolution Hair Loss Institute Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020) 13.4.5 Evolution Hair Loss Institute Recent Development 13.5 Savola Aesthetic Dermatology Center 13.5.1 Savola Aesthetic Dermatology Center Company Details 13.5.2 Savola Aesthetic Dermatology Center Business Overview and Its Total Revenue 13.5.3 Savola Aesthetic Dermatology Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction 13.5.4 Savola Aesthetic Dermatology Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020) 13.5.5 Savola Aesthetic Dermatology Center Recent Development 13.6 Virginia Surgical Center 13.6.1 Virginia Surgical Center Company Details 13.6.2 Virginia Surgical Center Business Overview and Its Total Revenue 13.6.3 Virginia Surgical Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction 13.6.4 Virginia Surgical Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020) 13.6.5 Virginia Surgical Center Recent Development 13.7 Hair Transplant Institute of Miami 13.7.1 Hair Transplant Institute of Miami Company Details 13.7.2 Hair Transplant Institute of Miami Business Overview and Its Total Revenue 13.7.3 Hair Transplant Institute of Miami Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction 13.7.4 Hair Transplant Institute of Miami Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020) 13.7.5 Hair Transplant Institute of Miami Recent Development 13.8 Colorado Surgical Center & Hair Institute 13.8.1 Colorado Surgical Center & Hair Institute Company Details 13.8.2 Colorado Surgical Center & Hair Institute Business Overview and Its Total Revenue 13.8.3 Colorado Surgical Center & Hair Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction 13.8.4 Colorado Surgical Center & Hair Institute Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020) 13.8.5 Colorado Surgical Center & Hair Institute Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix 15.1 Research Methodology 15.1.1 Methodology/Research Approach 15.1.2 Data Source 15.2 Disclaimer 15.3 Author Details

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Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market 2020:Key market Insights, Drivers and Restraints, Opportunities and Challenges,...

Canine Arthritis Treatment Global Projection: 2020 Opportunities, Key Players, Competitive and Regional Analysis by Forecast 2025 – 3rd Watch News

Global Canine Arthritis Treatment Market Research Report Cover Covid-19 Impact

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Canine Arthritis Treatment Market Segmentation:

Segmentation by Type:

Non-steroidal anti-inflammatory Medications (NSAIDs) Opioids Stem Cell Therapy Allogeneic Stem Cells Autologous Stem Cells

Segmentation by Application:

Retail Pharmacies Veterinary Hospitals and Clinics E-commerce Drug Stores

By Region

North America (USA, Canada, Mexico)

Europe (UK, France, Germany, Russia, Rest of Europe)

Asia-Pacific (China, South Korea, India, Japan, Rest of Asia-Pacific)

LAMEA, Latin America, Middle East, Africa

Canine Arthritis Treatment Market Key Players:

Norbrook Laboratories Limited Zoetis Inc. Vetoquinol S.A. Aratana Therapeutics Inc. Elanco (Eli Lilly and Company) Dechra Pharmaceuticals Plc. Bayer AG VetStem Biopharma Boehringer Ingelheim

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Gene Therapy for Age-related Macular Degeneration Market Size : Industry Growth, Competitive Analysis, Future Prospects and Forecast 2025 – Jewish…

A report on Gene Therapy for Age-related Macular Degeneration market compiled by Brand Essence Market Research provides a succinct analysis regarding the values and trends existing in the current business scenario. The study also offers a brief summary of market valuation, market size, regional outlook and profit estimations of the industry. Furthermore, the report examines the competitive sphere and growth strategies of leading players in the Gene Therapy for Age-related Macular Degeneration market.

In 2018, the GlobalGene Therapy for Age-related Macular Degeneration Marketsize was xx million US$ and it is expected to reach xx million US$ by the end of 2025, with a CAGR of xx% during 2019-2025.

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Key playersof the Gene Therapy for Age-related Macular Degeneration market are RetroSense Therapeutics, REGENXBIO, AGTC

Gene Therapy for Age-related Macular Degeneration Market Segmentation:

Product Type: Subretinal,Intravitreal,Unspecified

Application: Monotherapy,Combination Therapy

Region Coverage (Regional Production, Demand & Forecast by Countries etc.): North America (U.S., Canada, Mexico) Europe (Germany, U.K., France, Italy, Russia, Spain etc.) Asia-Pacific (China, India, Japan, Southeast Asia etc.) South America (Brazil, Argentina etc.) Middle East & Africa (Saudi Arabia, South Africa etc.)

Table of Contents

1 Report Overview 1.1 Study Scope 1.2 Key Market Segments 1.3 Players Covered 1.4 Market Analysis by Type 1.4.1 Global Gene Therapy for Age-related Macular Degeneration Market Size Growth Rate by Type (2014-2025) 1.4.2 Topical Products 1.4.3 Botulinum 1.4.4 Dermal Fillers 1.4.5 Chemical Peels 1.4.6 Microabrasion Equipment 1.4.7 Laser Surfacing Treatments 1.5 Market by Application 1.5.1 Global Gene Therapy for Age-related Macular Degeneration Market Share by Application (2014-2025) 1.5.2 Hospitals 1.5.3 Dermatology Clinics 1.6 Study Objectives 1.7 Years Considered

2 Global Growth Trends 2.1 Gene Therapy for Age-related Macular Degeneration Market Size 2.2 Gene Therapy for Age-related Macular Degeneration Growth Trends by Regions 2.2.1 Gene Therapy for Age-related Macular Degeneration Market Size by Regions (2014-2025) 2.2.2 Gene Therapy for Age-related Macular Degeneration Market Share by Regions (2014-2019) 2.3 Industry Trends 2.3.1 Market Top Trends 2.3.2 Market Drivers 2.3.3 Market Opportunities

3 Market Share by Key Players 3.1 Gene Therapy for Age-related Macular Degeneration Market Size by Manufacturers 3.1.1 Global Gene Therapy for Age-related Macular Degeneration Revenue by Manufacturers (2014-2019) 3.1.2 Global Gene Therapy for Age-related Macular Degeneration Revenue Market Share by Manufacturers (2014-2019) 3.1.3 Global Gene Therapy for Age-related Macular Degeneration Market Concentration Ratio (CR5 and HHI) 3.2 Gene Therapy for Age-related Macular Degeneration Key Players Head office and Area Served 3.3 Key Players Gene Therapy for Age-related Macular Degeneration Product/Solution/Service 3.4 Date of Enter into Gene Therapy for Age-related Macular Degeneration Market 3.5 Mergers & Acquisitions, Expansion Plans

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Gene Therapy for Age-related Macular Degeneration Market Size : Industry Growth, Competitive Analysis, Future Prospects and Forecast 2025 - Jewish...

Autolus: Progress Developing Next Generation Car-T Therapies Ought To Lift Share Price – Seeking Alpha

Investment Thesis

Autolus share price performance since IPO. Source: TradingView.

Autolus (AUTL), a developer of next-generation programmed T cell therapies, has taken some time to come to the boil but its treatments are now showing significant signs of promise.

The company has endured a number of frustrating setbacks (which I will discuss below) which led to its share price retreating to a price of $4, and although it has now recovered to trade at $14.9 at time of writing, that is some way below the highs of $48 achieved in late 2018.

With its recent issues resolved and a pivotal trial now in progress of a candidate that has delivered best-in-class data, and another candidate also outperforming on efficacy and targeting the large DLBCL market, I am forecasting potentially strong share price growth for Autolus over the next 12-18 months. Further positive news flow can push the company's shares back into the $30-50 range, in my view.

Chimeric Antigen Receptor ("CAR") T-cell therapy is a hugely promising field of treatment for certain types of cancers which involves extracting immune cells from patients (autologous CAR-T), or from a healthy donor (allogeneic CAR-T), and re-engineering them, adding receptors which allow the T-cells to locate previously undetectable cancerous cells and destroy them, once they are infused back into the patient's body.

The complex nature of the treatment, however, has seen development limited by high toxicities, such as cytokine release syndrome ("CRS") which can cause patient mortality, prohibitive manufacturing costs, length of time taken to extract, re-engineer and return T-cells to the patients' body, and the fact that currently, CAR-T therapy is restricted to hematological cancers only.

To date, only 2 CAR-T therapies - Gilead's (GILD) Yescarta and Novartis' Kymriah - have been approved, both for relapsed/refractory Diffuse Large B-Cell Lymphoma ("DLBCL"). Sales of both have largely disappointed, with Kymriah earning $278m of revenues in 2019, and Yescarta earning $456m. A third treatment, Bristol-Myers Squibb's (NYSE:BMY) Liso-cel, also looks set for approval in DLBCL by the FDA in November.

Autolus is attempting to address the limitations and risks that are restricting the advancement of CAR-T therapies with its proprietary cell programming technologies, including pattern recognition for enhanced selectivity (of unhealthy cells over healthy ones), controlled activity (modulating T-cell activity in the event of dangerous side-effects), enhanced activity (delivery of cytokine signals without administration of actual cytokines), and the targeting of more than one type of B-cell antigen at once, thereby minimising the possibility of relapse due to single antigen loss.

The company has now progressed its AUTO1 candidate into a pivotal trial for acute lymphoblastic lymphoma ("ALL"), after a small data sample from a phase 1 trial suggested that AUTO-1 had a potentially stronger efficacy profile, and comparable safety profile to current-standard-of-care Blinatumomab (brand name Blincyto, marketed by Amgen (NASDAQ:AMGN), 2019 sales of $312m).

Meanwhile, Autolus is targeting the much larger DLBCL market with AUTO3, which again, early small data samples have suggested may present a better safety and efficacy profile to both Kymriah and Yescarta. Additionally, Autolus intends to explore the possibility of treating patients in an outpatient setting, which is inaccessible to Kymriah and Yescarta but represents 80% of a $4bn market, the company says.

This is a bold strategy, but with cash and cash equivalents at the end of Q120 totalling $243.3 million, Autolus anticipates its runway will last until 2022, which sets the company up to fully enrol and complete its AUTO1 pivotal trial by H121, potentially securing approval before FY21, and to potentially progress AUTO3 into a pivotal trial, should results from its phase 1 study, due to complete before the end of FY20, impress.

As such, this could be a good time for investors to be opening a position in Autolus, with no further dilution expected in the near term, and plenty of catalysts to look forward to, not just from AUTO1 and 3, but from a pre-clinical portfolio of (at the present time) 4 further promising treatments.

In the rest of this article I will provide more detail on the company and its candidates, and explore the pros and cons of an investment in Autolus.

Autolus is based in the United Kingdom and was spun out of University College London ("UCL") in 2014 (according to its Q120 10Q), with whom it has an ongoing exclusive licensing arrangement to certain technology rights in the field of cancer therapy and diagnosis. UCL has been responsible for conducting the company's phase 1 trials of candidate AUTO1, has received a series of upfront payments and share issuances in exchange for use of its technologies, and will receive further milestone payments of up to ~$100m, as well as royalty payments from sales of any of Autolus' candidates that use its in-licensed patent rights.

The company is led by CEO and Chairman Dr. Christian Itin, who has served as Chairman and CEO of numerous biotech companies, notably Micromet Inc., a T-cell pioneer acquired by Amgen in 2012 for $1.2bn in cash. Autolus' Chief Medical Officer is Vijay Reddy Peddareddigari, who has held leadership roles at Janssen Oncology and GlaxoSmithKline (NYSE:GSK), specialising in early to mid-stage clinical development.

Autolus IPOd in June 2018, raising $156.5m via the sale of 10,147,059 American Depositary Shares ("ADS") representing the same number of ordinary shares, at a price of $17. In April 2019, the company raised a further $108.8m selling 4,830,000 ADS at a price of $24.

Autolus subsequently ran into issues as delays to a planned new manufacturing site in the UK, licensed from a taxpayer-funded Cell and Gene Therapy Catapult, put a 5-month hold on clinical development, and the company decided to halt trials of candidate AUTO2, targeting multiple myeloma, citing under-performance relative to competing candidates being developed by bluebird bio (BLUE), Celgene, and Johnson & Johnson (JNJ). This resulted in Autolus's share price declining 91% from a November 2018 high of $48, to just $4. The company completed its final fundraising at a price of $11 in Jan 2020, raising $74m.

I would not necessarily lay too much blame at Autolus' door for this unfortunate sequence of events, which was further complicated by a large stake in the company held by the collapsed investment firm Woodford Investment Mgmt - a previously strong supporter of UK biotech firms - which has now been offloaded. Some 64 institutional firms now hold stakes in Autolus, totalling ~33% of all of the company's shares.

Whilst it is disappointing that the company withdrew AUTO2 from development, it is also unsurprising - large Pharma concern Gilead also withdrew a CAR-T candidate from this over-crowded field - and speaks to the significant end-value of developing a successful therapy.

Autolus was ultimately right, in my view, to divert its efforts and funding to more promising candidates. Regarding manufacturing, in addition to its UK manufacturing facility, Autolus plans to lease a fully-scaled commercial site for cell process in Rockville, Maryland, US, with a capacity of 5,000 patients per annum.

The pivotal trial of candidate AUTO1 will also partially take place in the US, which I view as a positive sign, since it will give the company more credibility within what will become its most important market, and give the company the opportunity to restore its reputation in full public view.

The ongoing development of AUTO1 appears to be favourable for the company. There are no approved CAR T therapies for ALL, which is a relatively rare disease, with 8,400 cases diagnosed worldwide each year according to estimates.

The FDA has awarded Autolus an orphan drug designation for AUTO1, which targets the antigen CD19, and has been engineered to have a fast target binding off-rate, which essentially means that it does not over-activate the programmed T-cells, thereby reducing toxicity whilst increasing persistence, theoretically resulting in the destruction of more of the target cancer cells.

So far, the data has borne out the theory. Autolus' ALLCAR Phase 1 study dosed 19 patients, with none so far experiencing higher than grade 3 CRS. 3 patients with a high leukemia burden experienced grade 3 neurotoxicity, but this was resolved swiftly with the application of steroids.

AUTO1 phase 1 preliminary data vs. standard of care. Source: company presentation.

In terms of clinical activity, as we can see above AUTO1's 87% complete response and event-free survival rates are double that of Blincyto, albeit from a far smaller sample of patients.

The pivotal study, AUTO1-AL1, in adult ALL will enrol 100 relapsed or refractory patients, with the primary endpoint being overall complete response rate, and is on track to complete by the end of 2021.

Although this would not necessarily be a lucrative market for Autolus, much more importantly, a trial win and approval would represent a coup for the company given the paucity of approved CAR-T therapies, mark it out as an acquisition target, and generate more excitement around its other candidates, which would likely have a profound effect on the share price.

DLBCL is the most common form of Non Hodgkin Lymphoma, with ~24,000 patients diagnosed with the disease every year. The third line setting is around 4x larger than ALL - approximately 10,000 patients.

Although Kymriah and Yescarta are approved treatments in this space, achieving relatively high overall response rates of between 70-80%, only around 35% of these patients achieve durable complete response rates, whilst the toxicity of the treatments, which includes high rates of CRS (13-22% of patients) and severe neurotoxicity (12-28%), means that patients must be intensively managed, limiting the use of CAR-T outside of the in-patient setting.

AUTO3 has been designed with a dual target approach, simultaneously targeting antigen receptors CD19 and CD22, which Autolus believes may reduce the probability of relapse due to antigen loss, whilst the addition of pembrolizumab to the treatment regime mediates the probability of PD1/PDL1 related CAR-T cell exhaustion.

AUTO3 comparison with Yescarta, Kymriah / liso-cel. Source. company presentation.

As we can see above AUTO3 - in its phase 1/2 ALEXANDER study - involving 23 patients to date - has shown a complete response rate which compares favourably with Yescarta, Kymriah, and liso-cel, whilst its safety profile shows clear out-performance at the recommended phase 2 dose level. All 9 of the complete responses observed were ongoing at the median follow-up period of 3 months.

The positive safety data opens up the possibility of AUTO-3 being used as an outpatient therapy in non-academic hospitals and community oncology clinics - where 80% of third-line and second-line DLBCL patients are currently treated - Autolus believes, opening up the market opportunity for the company to an estimated size of $4bn.

Autolus expects to make a decision in Q320 as to whether to progress AUTO3 into a pivotal trial, providing a short-term price catalyst for investors that ought to be positive, based on the strong safety and efficacy data shown during the ALEXANDER study. There is undoubtedly evidence that AUTO3 can progress CAR-T therapy treatment to a new level of convenience for patients, and Autolus has added a 20 person outpatient cohort to the ALEXANDER trial as an additional feasibility test.

A failure to make further progress with AUTO3 (into a pivotal trial) would be costly for Autolus, both financially and reputationally, but the evidence to date suggests that progress into a pivotal trial in a key market is the most likely next step.

Even if AUTO3 were to face further setbacks, it would not necessarily be a disastrous outcome for Autolus in the long term, since the company's technology platforms have delivered numerous other candidates and ought to continue to do so given the promise of the candidates developed to date.

Autolus current pipeline. Source: company website.

The breadth of the indications that Autolus is developing therapies for is impressive, and importantly, the company is developing not only autologous therapies, like AUTO1 and AUTO3, but also allogeneic candidates, which use cells from donor patients - often referred to as "off-the-shelf" CAR-T therapies, due to the added convenience and shorter turnaround times associated with allogeneic techniques.

Autolus "toolkit" and candidates. Source: company presentation.

AUTO4 is a treatment for peripheral T cell lymphoma that has differentiated targets and is currently progressing through a clinical trial in the UK, which has been impacted by COVID-19, management revealed on its Q120 earnings call, but has shown signs of strong efficacy, achieving a complete metabolic response in a 57-year-old patient. Auto 6 targets the solid tumor environment with a potentially enhanced safety profile and has demonstrated in both in vivo and in vitro environments.

What stands out about Autolus for me is its innovative and differentiated technologies, which have allowed the company to reach the point where it stands a good chance of being able to progress CAR-T therapy beyond its current limitations.

Already, there are signs that the first approved CAR-T therapies - Yescarta and Kymriah - look set to be challenged by new and improved therapies that can overcome the safety and toxicity issues that require patients to be intensively managed throughout their treatment programme, ensuring that CAR-T is currently not viewed as a potential first or even second-line therapy, but as a last resort treatment.

As described above, the early signs are that Autolus can potentially secure approval - albeit in the small ALL market - as a treatment for relapsed or refractory patients, and that this could be achievable before the end of 2021.

AUTO3 targets an area of higher unmet need and an approval in this market - which is some way off and can be considered only a 50/50 likelihood at best - would be a significant coup for the company and mark Autolus out as one of the most prominent CAR-T companies outside of big Pharma, bringing the prospect of acquisition into play. When we think about Gilead's recent $4.7bn acquisition of Forty Seven and its anti-CD47 technology, or Novartis acquisition of The Medicines Company for $9.7bn, that is certainly an enticing prospect for Autolus investors.

Where I have doubts about Autolus is in the company's logistical management. Its well-documented manufacturing issues that caused significant delays to its clinical development programmes were unwelcome, and the fact that its operations span 2 different continents suggests that the company has not quite established a satisfactory modus operandi, which may create problems managing larger scale clinical trials or even in selecting which of its promising candidates to progress, and how.

Targeting the outpatient setting with AUTO3 is an interesting approach that could open the floodgates for CAR-T as a more flexible and reliable treatment. But at the same time, I believe the company's core focus needs to be on generating satisfactory trial results - if its candidates generate results sufficient to be considered for an outpatients regime, so much the better, but the efficacy and safety results are of more importance at this stage.

Although the share price nosedived in 2020, Autolus has raised the funds it needs to guide at least 2 of its candidates through pivotal trials. At $31m in Q120, $22.5m in Q119, and $146m in FY19, the company's cash burn is very high, and if its current later stage trials are not successful, I can see the management having trouble raising further funds in the future.

Autolus upcoming clinical data points, Source: company presentation.

Much rests on the news flow in the remainder of 2020 and during 2021. The most important of these, in my view, will be the decision on whether to progress AUTO3 into a pivotal trial - slated to be made in Q3, which will signify a major progressive milestone for the company, put it in the spotlight, and generate significant excitement which will lead to boost in the share price. The caveat here is the company's withdrawal of AUTO2, targeting multiple myeloma from a competitive field.

Overall, however, Autolus scores highly amongst CAR-T developers on the strength of its data and its progressive, differentiated approach which has been proven to work, albeit in a limited patient sample size. With its share price woes seemingly behind it, and provided it can handle the logistical side of its operations, even fair-to-middling progress, i.e. an ALL trail win, or another pivotal trial initiation most likely for AUTO3, ought to continue the upward share trend and secure a return to at least the early post-IPO price of $26, with a multitude of impactful price catalysts due in 2020 and 2021.

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Disclosure: I/we have no positions in any stocks mentioned, but may initiate a long position in AUTL over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Autolus: Progress Developing Next Generation Car-T Therapies Ought To Lift Share Price - Seeking Alpha