Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia – BioSpace

BOSTON--(BUSINESS WIRE)-- Follica, Inc. (Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions, today announced positive feedback from a meeting with the U.S. Food and Drug Administration (FDA) as the company prepares to advance its lead program into Phase 3 development following a successful safety and efficacy optimization study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

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Follicas approach, which is designed to stimulate the growth of new follicles and new hair, is being developed as a potential new option for the millions of people seeking treatments to grow new hair. (Graphic: Business Wire)

Follica plans to launch its Phase 3 program this year. Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the U.S. alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimization study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal program, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimization study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimization study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, M.D., who isolated and characterized the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr. Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic Alopecia Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About Follica Follica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions. Founded by PureTech (LSE:PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimized parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimization study in 2019, and its Phase 3 program in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal program. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

1 Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85Olsen EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug 29Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia - BioSpace

Current and Future Trend of Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market by 2026 – Cole of Duty

Los Angeles United States: QY Research always aims at offering its clients an in-depth analysis and the best research material of the various market. This new report on the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market is committed to fulfilling the requirements of the clients by giving them thorough insights into the market. An exclusive data offered in this report is collected by research and industry experts.

Key Manufacturers operating in the 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

The global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market report covers scope and product overview to define the key terms and offers detailed information about market dynamics to the readers. This is followed by the regional outlook and segmental analysis. The report also consists of the facts and key values of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market in terms of sales and volume, revenue, and growth rate.

One of the important factors in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market report is the competitive analysis. The report covers all the key parameters such as product innovation, market strategies of the key players, market share, revenue generation, latest research and development, and market expert views.

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global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market by Segment Type: Platelet Rich Plasma Injections, Stem Cell Therapy

global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market by Application: Dermatology Clinics, Hospitals

Some of the important factors such as marketing strategy, industrial chain, factor analysis, cost analysis, distributors and sourcing strategy are included in this report which makes it an exclusive one. The aim of QY Research is to offer a comprehensive report. The report on global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market report is compiled by industry experts and properly examined which will highlight the key information required by the clients.

Regional Analysis

A section of the report has given comprehensive information about regional analysis. It provides a market outlook and sets the forecast within the context of the overall global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. QY Research has segmented the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market into major geographical regions such as North America, South America, Europe, Asia Pacific, and the Middle East and Africa. Potential new entrants wishing to target only high growth areas are also included in this informative section of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market.

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Major Points from Table of Content:

Chapter One: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Overview

Chapter Two: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market Competition by application, by Players/Suppliers, and by Type

Chapter Three: North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Four: Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Five: Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Six: China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Seven: India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Eight: Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Nine: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market industrial cost analysis

Chapter Ten: Downstream buyers, industrial chain and sourcing strategy

Chapter Eleven: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market Sales data and suppliers profiles/players

Chapter Twelve: Market effect factor analysis

Chapter Thirteen: Traders/Distributors, marketing strategy analysis

Chapter Fourteen: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market forecast (2020-2026) analysis

Chapter Fifteen: Conclusion and research findings

Chapter Sixteen: Annexure/Appendix

About Us

QY Research is a leading global market research and consulting company. Established in 2007 in Beijing, China, QY Research focuses on management consulting, database and seminar services, IPO consulting, industry chain research and custom research to help our clients in providing non-linear revenue model and make them successful. We are globally recognized for our expansive portfolio of services.

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Current and Future Trend of Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market by 2026 - Cole of Duty

Are competitive sports doing you more harm than good? – Starts at 60

Im one of those people who played some form of sport, mainly soccer (or football, depending on where you live) and squash, from the age of five to 52. However, over the last 12 years, due to my right knee giving out, Ive had to find alternative ways to maintain my fitness. Ive tried a variety of therapies for bone-on-bone osteoarthritis including stem cell therapy, platelet-rich plasma (PRP) therapy, and numerous pharmaceutical and natural therapies. Ive also had multiple injections directly into the joint.

Although many of the above therapies have given me significant relief, over the last three months the pain in my right knee has been unbearable to the point where my quality of life was being affected substantially. At the end of last month, I had a total knee replacement.

The knee still remains quite painful, but the pain is going away by the minute and Im able to be quite mobile on crutches and with physiotherapy. Its important with any joint replacement to do as much prehab and rehab as possible without going overboard. Pain is the bodys way of saying youve had enough.

The reason Im writing this article is that Im well aware that many people in my age group have worn out one or a number of their joints. Orthopaedic surgeons often say you will know when you need your joint replaced and thats when theyre happy to do the procedure. I certainly knew it was time, being unable to walk downstairs without significant discomfort. Not to mention, the thought of walking up three flights of stairs was untenable. It hurt when I rolled over in bed.

From my experience, people shouldnt be playing soccer into their 50s, let alone their 60s. Around 12 years ago I had to resuscitate a 61-year-old man who suffered a cardiac arrest 20 minutes into a soccer match. My knee finally caved in one month after this incident and both examples made me seriously consider my choice of sport. But I loved soccer and squash, including the mateship and the enormous stress relief of purely playing a game with your mates and I still miss both of those activities to this day. However, I now believe that people should stop playing competitive sport after the age of 35. Instead, opt for alternative exercises like light walking or strength-building moves.

IMPORTANT LEGAL INFO This article is of a general nature and FYI only, because it doesnt take into account your personal health requirements or existing medical conditions. That means its not personalised health advice and shouldnt be relied upon as if it is. Before making a health-related decision, you should work out if the info is appropriate for your situation and get professional medical advice.

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Are competitive sports doing you more harm than good? - Starts at 60

Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with…

Company Announcement

Copenhagen, Denmark; June 4, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV daratumumab, which is given over several hours. Patients currently on daratumumab IV will have the choice to switch to the SC formulation. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab. With consistent efficacy, and greater convenience for patients and health care providers with dosing time reduced from hours to just minutes and fewer infusion-related reactions, this formulation provides significant benefits for patients, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

About the COLUMBA (MMY3012) studyThe Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: SC daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) studyThe Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), has been approved in the U.S. for the treatment of adult patients with certain multiple myeloma indications. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 DARZALEX Prescribing information, April 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf Last accessed April 20202 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed October 20193 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20204 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.5Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.6 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.7 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974

Company Announcement no. 24CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with...

Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia – Business Wire

BOSTON--(BUSINESS WIRE)--Follica, Inc. (Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions, today announced positive feedback from a meeting with the U.S. Food and Drug Administration (FDA) as the company prepares to advance its lead program into Phase 3 development following a successful safety and efficacy optimization study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

Follica plans to launch its Phase 3 program this year. Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the U.S. alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimization study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal program, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimization study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimization study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, M.D., who isolated and characterized the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr. Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic AlopeciaAndrogenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About FollicaFollica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions. Founded by PureTech (LSE:PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimized parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimization study in 2019, and its Phase 3 program in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal program. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

1 Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85Olsen EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug 29Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia - Business Wire

Global Stem Cell Characterization Kits Market : Analysis and In-depth Study on Market Size Trends, Emerging Growth Factors and Forecasts to 2029 – The…

Stem cells are biological cells that can be converted into specific type of cells as per the bodys requirement. Stem cells are of two types, i.e., adult stem cells and embryonic stem cells. Stem cells can be used to treat various diseases such as cancer, neurodegenerative disorder, cardiovascular disorder and tissue regeneration. Stem cell characterization is the initial step for stem cell research. Stem cell characterization is a challenging and also an evolving process. Stem cell characterization kits are used for identification of stem cell biology markers. In stem cell characterization, stem cell biology marker profiles differ based on their species, maturity and site of origin. Stem cell characterization kit is required to understand the utility of the stem cells in downstream experiments and to confirm the pluripotency of the stem cell.Request Free Sample Report-https://www.factmr.com/connectus/sample?flag=S&rep_id=2691

Based on type of stem cell, the stem cell characterization kits market is segmented into:Stem Cell Characterization Kits for Adult Stem CellsStem Cell Characterization Kits for Induced Pluripotent Stem CellsStem Cell Characterization Kits for Mesenchymal Stem CellsStem Cell Characterization Kits for Neural Stem CellsStem Cell Characterization Kits for Hematopoietic Stem CellsStem Cell Characterization Kits for Umbilical Cord Stem CellsStem Cell Characterization Kits for Human Embryonic Stem CellsBased on application, the stem cell characterization kits market is segmented into:ResearchDrug Discovery & DevelopmentRegenerative MedicineBased on end user, the stem cell characterization kits market is segmented into:Biopharmaceutical CompaniesContract Research OrganizationsAcademics and Research InstitutesBiotechnology CompaniesHave Any Query? Ask our Industry Experts-https://www.factmr.com/connectus/sample?flag=AE&rep_id=2691

Examples of some of the key participants in the stem cell characterization kits market identified across the value chain include Merck KGaA, Celprogen, Inc., Creative Bioarray, Thermo Fisher Scientific Inc., BD Biosciences, R&D Systems, Inc., System Biosciences, Cosmo Bio USA, BioCat GmbH, and DS Pharma Biomedical Co., Ltd.Pertinent aspects this study on the Stem Cell Characterization Kits market tries to answer exhaustively are: What is the forecast size (revenue/volumes) of the most lucrative regional market? What is the share of the dominant product/technology segment in the Stem Cell Characterization Kits market? What regions are likely to witness sizable investments in research and development funding? What are Covid 19 implication on Stem Cell Characterization Kits market and learn how businesses can respond, manage and mitigate the risks? Which countries will be the next destination for industry leaders in order to tap new revenue streams? Which new regulations might cause disruption in industry sentiments in near future? Which is the share of the dominant end user? Which region is expected to rise at the most dominant growth rate? Which technologies will have massive impact of new avenues in the Stem Cell Characterization Kits market? Which key end-use industry trends are expected to shape the growth prospects of the Stem Cell Characterization Kits market? What factors will promote new entrants in the Stem Cell Characterization Kits market? What is the degree of fragmentation in the Stem Cell Characterization Kits market, and will it increase in coming years?Why Choose Fact.MR?

Fact.MR follows a multi- disciplinary approach to extract information about various industries. Our analysts perform thorough primary and secondary research to gather data associated with the market. With modern industrial and digitalization tools, we provide avant-garde business ideas to our clients. We address clients living in across parts of the world with our 24/7 service availability.

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Global Stem Cell Characterization Kits Market : Analysis and In-depth Study on Market Size Trends, Emerging Growth Factors and Forecasts to 2029 - The...

Mesoblast (NASDAQ:MESO) Stock Rating Lowered by Zacks Investment Research – MarketBeat

Mesoblast (NASDAQ:MESO) was downgraded by Zacks Investment Research from a "buy" rating to a "hold" rating in a report released on Wednesday, Zacks.com reports.

According to Zacks, "Mesoblast Limited is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast's allogeneic, 'off-the-shelf' cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions. "

A number of other brokerages have also recently weighed in on MESO. ValuEngine upgraded Mesoblast from a "hold" rating to a "buy" rating in a report on Thursday, April 2nd. Maxim Group started coverage on Mesoblast in a research note on Friday, May 29th. They issued a "buy" rating and a $16.00 price objective for the company. LADENBURG THALM/SH SH upped their target price on shares of Mesoblast from $13.00 to $15.25 and gave the stock a "buy" rating in a research note on Thursday, May 28th. TheStreet raised shares of Mesoblast from a "d+" rating to a "c-" rating in a report on Friday, May 22nd. Finally, HC Wainwright reiterated a "buy" rating and set a $21.00 price target (up previously from $14.00) on shares of Mesoblast in a report on Thursday, May 28th. Two research analysts have rated the stock with a hold rating and seven have issued a buy rating to the company. The company has an average rating of "Buy" and a consensus target price of $14.91.

Our Technical Analysis Guide will give you the insight into todays fast-moving markets. Its designed to give you a head start in learning the basics of various TA tools and techniques.

NASDAQ:MESO opened at $13.39 on Wednesday. The company has a market capitalization of $1.49 billion, a P/E ratio of -20.92 and a beta of 3.53. The company has a quick ratio of 1.21, a current ratio of 1.21 and a debt-to-equity ratio of 0.15. Mesoblast has a 52 week low of $3.12 and a 52 week high of $20.57. The stock's fifty day moving average is $10.75 and its two-hundred day moving average is $8.08.

Mesoblast (NASDAQ:MESO) last announced its earnings results on Wednesday, May 27th. The company reported ($0.14) earnings per share (EPS) for the quarter, meeting analysts' consensus estimates of ($0.14). Mesoblast had a negative return on equity of 13.60% and a negative net margin of 197.65%. The company had revenue of $12.20 million for the quarter, compared to analyst estimates of $9.38 million. Sell-side analysts anticipate that Mesoblast will post -0.57 earnings per share for the current fiscal year.

Institutional investors and hedge funds have recently added to or reduced their stakes in the business. Tobias Financial Advisors Inc. acquired a new stake in Mesoblast during the 4th quarter worth $191,000. Wilbanks Smith & Thomas Asset Management LLC boosted its stake in shares of Mesoblast by 6.0% during the fourth quarter. Wilbanks Smith & Thomas Asset Management LLC now owns 25,025 shares of the company's stock worth $184,000 after buying an additional 1,425 shares during the period. Ingalls & Snyder LLC acquired a new stake in shares of Mesoblast during the first quarter worth about $53,000. Aperio Group LLC purchased a new position in shares of Mesoblast during the first quarter worth about $81,000. Finally, Cetera Advisor Networks LLC acquired a new position in Mesoblast in the 1st quarter valued at about $44,000. 2.12% of the stock is currently owned by institutional investors.

Mesoblast Company Profile

Mesoblast Limited, a biopharmaceutical company, develops and commercializes allogeneic cellular medicines. Its proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage adult stem cells. The company's products under the Phase III clinical trials include MSC-100-IV for steroid refractory acute graft versus host disease; MPC-150-IM for advanced heart failure; and MPC-06-ID for chronic low back pain due to degenerative disc disease.

Further Reading: Hedge Funds Explained

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This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest and most accurate reporting. This story was reviewed by MarketBeat's editorial team prior to publication. Please send any questions or comments about this story to [emailprotected]

13 Stocks Institutional Investors Won't Stop Buying

University endowments, pension funds, sovereign wealth funds, hedge funds and other institutional investors have recently been pouring money into a a group of 13 elite stocks.

These institutional investors don't get easily swayed by hot stocks that are popular with retail investors. You probably won't see a Tesla or a SnapChat in this group, because institutional investors know that these "popular kid" stocks almost always aren't great investments. However, you will find some incredibly solid companies on this list backed by real earnings and real fundamentals.

In order to identify these stocks, we had to comb through every 13D and 13F filing that institutional investors have filed with the SEC in the last quarter. After reviewing more than 5,000 filings, we have identified 13 companies that institutional investors have been buying left. Big money investors are pouring hundreds of millions of dollars into these stocks.

View the "13 Stocks Institutional Investors Won't Stop Buying".

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Mesoblast (NASDAQ:MESO) Stock Rating Lowered by Zacks Investment Research - MarketBeat

Some types of prostate cancer may not be as aggressive as originally thought – Mirage News

UCLA

Dr. Amar Kishan

FINDINGS

Researchers at the UCLA Jonsson Comprehensive Cancer Center analyzed gene-expression patterns in the most aggressive prostate cancer grade group known as Gleason grade group 5 and found that this grade of cancer can actually be subdivided into four subtypes with distinct differences. The findings may affect how people are treated for the disease.

One subtype, which accounts for about 15% of the grade group 5 cancers, has highly aggressive features and is associated with much worse outcomes than the other subtypes. Another, which makes up about 20% of the tumors, appears to be much less aggressive and may not require intensified and aggressive treatments. Traditionally, all tumors in Gleason grade group 5 have been treated in the same way.

BACKGROUND

Prostate cancer is the leading solid-tumor cancer among men in the United States and a major cause of morbidity globally. While early-stage, localized prostate cancer is curable, current treatments dont always work for everyone. To find out why standard treatment may work for some and not others, the UCLA researchers looked at tumors in the Gleason grade group 5 subset of prostate cancer. These tumors are at the highest risk to fail standard treatment, leading to metastasis and death. The researchers thought that studying the gene expression the unique signature of each cancer cell in these tumors might provide insight into how to make treatments more personalized for each patient.

METHOD

The researchers first analyzed data from more than 2,100 Gleason grade group 5 tumors, looking at how the genetic blueprints differed among the tumors. They identified distinct clusters of subgroups and validated their findings by analyzing an additional cohort of more than 1,900 Gleason grade group 5 prostate cancers.

IMPACT

By using the genetic information from tumors in men with prostate cancer, physicians hope to one day create more personalized treatments based on the actual characteristics of the cancer. This information will help optimize quality of life and avoid overtreating subgroups of men who may not need aggressive treatments.

AUTHORS

The studys lead author is Dr. Amar Kishan, an assistant professor of radiation oncology at the David Geffen School of Medicine at UCLA and a researcher at the UCLA Jonsson Comprehensive Cancer Center. The co-senior authors are Dr. Joanne Weidhaas, a professor of radiation oncology and director of translational research at the Geffen School of Medicine, and Paul Boutros, a professor of urology and human genetics and director of cancer data science for the Jonsson Cancer Center. Boutros is also a member of the UCLA Institute of Urologic Oncology and the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at UCLA. Other UCLA authors include David Elashoff, Dr. Rob Reiter and Dr. Matthew Rettig.

JOURNAL

The study was published in the journal European Urology.

FUNDING

The research was funded in part by an award from the American Society for Radiation Oncology and the Prostate Cancer Foundation, the Radiological Society of North America, and the National Institutes of Health.

Link:
Some types of prostate cancer may not be as aggressive as originally thought - Mirage News

Stem Cell Therapy Market Comprehensive Analysis, Growth Forecast From 2019 To 2025 – Cole of Duty

The Stem Cell Therapy Market report has been evaluated with respect to vital aspects such as Industry Strategies, Evolving Technology, Growth rate, Key Companies, Business Competitors, and Forecast till 2025. Substantial details highlighting the importance of the most significant sectors of this business are included in the study.

The Stem Cell Therapy Market is anticipated to record its name in the billion-dollar space within seven years, by exceeding revenue of US$ 15 billion by 2025, with an anticipated CAGR of 10.2% through 2025.

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The Stem Cell Therapy Market report delivers a concise analysis pertaining to the competitive landscape of this industry. All the vital information with regards to this parameter have been covered in the report in a systematic manner. The overall summary has been included after conducting a detailed analysis of the driving parameters, the factors that may hamper the market growth, as well as the growth prospects that this business space has in the future.

Market Segmentation:

Know about Market growth in New Research and its Top growing factors by Key Companies like

Astellas Pharma Inc, Capricor Therapeutics, Cellectis, Cellular Dynamics, Celyad, CESCA Therapeutic, DiscGenics, Gamida Cell, Mesoblast Ltd, Novadip Biosciences, OxStem, ReNeuron Group plc, Takeda Pharmaceuticals

Comprehensive Review of Market Growth, Applications, and Future Prospects

The Regional Evaluation Ensures

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The Stem Cell Therapy Market research report presents a detailed outline of Stem Cell Therapy Market this is mainly inclusive of the generic market definitions, the numerous segmentations, as well as the application landscape. The report outlines a detailed examination of the industry vendors from a regional and global perspective.

An exhaustive brief of the various forecast trends and demand till the year 2025 has been given in the report. The study is inclusive of information pertaining to the numerous firms that form a part of the competitive terrain of this business sphere. Also, the report contains, in exclusive detail, information on the many innovations in this sector, technologies adopted, and also many other factors impacting the product demand.

Report Growth Drivers

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The Stem Cell Therapy Market Report Includes

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Stem Cell Therapy Market Comprehensive Analysis, Growth Forecast From 2019 To 2025 - Cole of Duty

(2020-2026) Stem Cell Manufacturing Market Research, Growth Opportunities, Analysis and Forecasts Report | Thermo Fisher Scientific, Merck Group),…

Stem Cell Manufacturing Industry Amid Global COVID-19 (Coronavirus) Crisis: Report Hive Viewpoint

The Stem Cell Manufacturing market report [6 Years Forecast 2020-2026] focuses on the COVID19 Outbreak Impact analysis of key points influencing the growth of the market. The intelligence report prepared contains details on the leading players of the Global Stem Cell Manufacturing Market, along with various depending aspects related and associated with the market. Profile the Top Key Players of Stem Cell Manufacturing, with sales, revenue and global market share of Stem Cell Manufacturing are analyzed emphatically by landscape contrast and speak to info. Upstream raw materials and instrumentation and downstream demand analysis is additionally administrated. The Stem Cell Manufacturing market business development trends and selling channels square measure analyzed. Stem Cell Manufacturing industry research report enriched on worldwide competition by topmost prime manufactures which providing information such as Company Profiles, Gross, Gross Margin, Capacity, Product Picture and Specification, Production, Price, Cost, Revenue and contact information.

The Stem Cell Manufacturing industry profile also contains descriptions of the leading topmost manufactures/players like (Thermo Fisher Scientific (US), Merck Group (Germany), Becton, Dickinson and Company (US), Bio-Rad Laboratories (US), Miltenyi Biotec (Germany), Takara Bio Group (Japan), STEMCELL Technologies (Canada), Pharmicell (South Korea), Osiris Therapeutics (US), Anterogen (South Korea), Cellular Dynamics International (US), MEDIPOST (South Korea), Lonza Group (Switzerland), Holostem Terapie Avanzate (Italy), Pluristem Therapeutics (Israel)) which including Capacity, Production, Price, Revenue, Cost, Gross, Gross Margin, Growth Rate, Import, Export, Market Share and Technological Developments. COVID-19 can affect the global economy in three main ways: by directly affecting Production and Demand, By Creating Supply Chain and Stem Cell Manufacturing Market Disruption, and by its financial impact on firms and financial markets.

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The report additionally reviews the market key drivers, restraints, growth signs, challenges, market dynamics, aggressive landscape, and different key aspects related to the global Stem Cell Manufacturing market. The report presents a top to bottom illumination of the markets past, current, and future status. It offers an analysis of emerging market sectors and development opportunities in the market. Market structure is described by analyzing the segments such as product type, application, end-users, key regions, and key companies. Further, the report gives in detailed information about the players on the basis of type, financial position, price, growth strategies, product portfolio, and regional presence of the players in the market.

Vital data enclosed in the report:

Product development and innovations relevant to the Stem Cell Manufacturing market Region and country-wise assessment of the different segments and sub-segments of the Stem Cell Manufacturing market and the COVID-19 pandemic impact on each segment Investment scenario in different regional markets post in the current market landscape Pricing strategies and structure adopted by various players in the Stem Cell Manufacturing market Raw material suppliers, vendors, and manufacturers in the Stem Cell Manufacturing market

The scope of the Report:

The report segments the global Stem Cell Manufacturing market on the basis of application, type, service, technology, and region. Each chapter under this segmentation allows readers to grasp the nitty-gritties of the market. A magnified look at the segment-based analysis is aimed at giving the readers a closer look at the opportunities and threats in the market. It also address political scenarios that are expected to impact the market in both small and big ways.The report on the global Stem Cell Manufacturing market examines changing regulatory scenario to make accurate projections about potential investments. It also evaluates the risk for new entrants and the intensity of the competitive rivalry.

The report includes a detailed segmentation study of the global Stem Cell Manufacturing market, where all of the segments are analyzed in terms of market growth, share, growth rate, and other vital factors. It also provides the attractiveness index of segments so that players can be informed about lucrative revenue pockets of the global Stem Cell Manufacturing market. The extensive evaluation of segments provided in the report will help you to direct your investments, strategies, and teams to focus on the right areas of the global Stem Cell Manufacturing market.

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, shipments, revenue (Million USD), price, and market share and growth rate for each application.

HSCs, MSCs, iPSCs, ESCs, Instruments, Media, Consumables

On the basis of product type, this report displays the shipments, revenue (Million USD), price, and market share and growth rate of each type.

Research, Target Identification, Therapy (Autologous, Allogeneic), Cell Banks

Regional Spectrum:

Research contains regional segmentation which describes the regional aspects of the global Stem Cell Manufacturing market. It explains the framework that is expected to affect the entire market. It covers the scenario of the market and anticipates its impact on the market. Main region market conditions are assessed with respect to the product price, profit, capacity, production, supply, demand, and market growth rate and forecast, etc.

Market Size Segmentation by Region & Countries (Customizable):

North America

Europe

Asia-Pacific

South America

Center East and Africa

United States, Canada and Mexico

Germany, France, UK, Russia and Italy

China, Japan, Korea, India and Southeast Asia

Brazil, Argentina, Colombia

Saudi Arabia, UAE, Egypt, Nigeria and South Africa

Our exploration specialists acutely ascertain the significant aspects of the global Stem Cell Manufacturing market report. It also provides an in-depth valuation in regards to the future advancements relying on the past data and present circumstance of Stem Cell Manufacturing market situation. In this Stem Cell Manufacturing report, we have investigated the principals, players in the market, geological regions, product type, and market end-client applications. The global Stem Cell Manufacturing report comprises of primary and secondary data which is exemplified in the form of pie outlines, Stem Cell Manufacturing tables, analytical figures, and reference diagrams. The Stem Cell Manufacturing report is presented in an efficient way that involves basic dialect, basic Stem Cell Manufacturing outline, agreements, and certain facts as per solace and comprehension.

Important Features that are under offering & key highlights of the report:

Detailed overview of Stem Cell Manufacturing market Changing market dynamics of the industry In-depth market segmentation by Type, Application etc Historical, current and projected market size in terms of volume and value Recent industry trends and developments Competitive landscape of Stem Cell Manufacturing market Strategies of key players and product offerings Potential and niche segments/regions exhibiting promising growth A neutral perspective towards Stem Cell Manufacturing market performance Market players information to sustain and enhance their footprint

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Table of Content

1 Introduction 9

1.1 Industry Definition and Research Scope 91.1.1 Industry Definition 91.1.2 Research Scope 101.2 Research Methodology 131.2.1 Overview of Market Research Methodology 131.2.2 Market Assumption 141.2.3 Secondary Data 141.2.4 Primary Data 141.2.5 Data Filtration and Model Design 161.2.6 Market Size/Share Estimation 171.2.7 Research Limitations 181.3 Executive Summary 19

2 Market Overview and Dynamics 21

2.1 Market Size and Forecast 212.2 Major Growth Drivers 222.3 Market Restraints and Challenges 272.4 Emerging Opportunities and Market Trends 302.5 Porters Fiver Forces Analysis 34

3 Segmentation of Global Market by Offering 38

3.1 Market Overview by Offering 383.2 Software 403.3 Service 493.3.1 Professional Services 513.3.2 Managed Services 52

4 Segmentation of Global Market by Application 53

4.1 Market Overview by Application 534.2 Research, Target Identification, Therapy (Autologous, Allogeneic), Cell Banks

5 Segmentation of Global Market by Deployment 61

5.1 Market Overview by Deployment 61

6 Segmentation of Global Market by Industrial Vertical 66

6.1 Market Overview by Industrial Vertical 66

7 Segmentation of Global Market by End User 77

7.1 Market Overview by End User 777.2 HSCs, MSCs, iPSCs, ESCs, Instruments, Media, Consumables

8 Segmentation of Global Market by Region 82

8.1 Geographic Market Overview 2019-2030 828.2 North America Market 2019-2030 by Country 868.2.1 Overview of North America Market 868.2.2 U.S. 908.2.3 Canada 948.2.4 Mexico 968.3 European Market 2019-2030 by Country 988.3.1 Overview of European Market 988.3.2 Germany 1028.3.3 UK 1048.3.4 France 1068.3.5 Spain 1088.3.6 Italy 1108.3.7 Russia 1128.3.8 Rest of European Market 1148.4 Asia-Pacific Market 2019-2030 by Country 1168.4.1 Overview of Asia-Pacific Market 1168.4.2 Japan 1208.4.3 China 1238.4.4 Australia 1258.4.5 India 1278.4.6 South Korea 1298.4.7 Rest of APAC Region 1318.5 South America Market 2019-2030 by Country 1338.5.1 Argentina 1368.5.2 Brazil 1388.5.3 Chile 1408.5.4 Rest of South America Market 1428.6 Rest of World Market 2019-2030 by Country 1438.6.1 UAE 1468.6.2 Saudi Arabia 1488.6.3 South Africa 1508.6.4 Other National Markets 152

9 Competitive Landscape 153

9.1 Overview of Key Vendors 1539.2 New Product Launch, Partnership, Investment, and M&A 1569.3 Company Profiles 158Thermo Fisher Scientific (US), Merck Group (Germany), Becton, Dickinson and Company (US), Bio-Rad Laboratories (US), Miltenyi Biotec (Germany), Takara Bio Group (Japan), STEMCELL Technologies (Canada), Pharmicell (South Korea), Osiris Therapeutics (US), Anterogen (South Korea), Cellular Dynamics International (US), MEDIPOST (South Korea), Lonza Group (Switzerland), Holostem Terapie Avanzate (Italy), Pluristem Therapeutics (Israel)

10 Investing in Global Market: Risk Assessment and Management 177

10.1 Risk Evaluation of Global Market 17710.2 Critical Success Factors (CSFs) 180

Related Reports and Products 183

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(2020-2026) Stem Cell Manufacturing Market Research, Growth Opportunities, Analysis and Forecasts Report | Thermo Fisher Scientific, Merck Group),...