--FDA Grants Pre-BLA Meeting Request and Rolling BLA Submission after Review of HOPE-2 and HOPE-2 OLE 3-Year Results--SAN DIEGO, June 11, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the successful completion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) on next steps for the Biologics License Application (BLA) submission with its lead asset, CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). Additionally, Deramiocel has been selected as the proposed International Nonproprietary Name (INN) for CAP-1002 by the World Health Organization.
Read more from the original source:
Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA...
- Todos Medical Announces Commercial Launch of Todos Branded COVID-19 qPCR Test Kits in the United States [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Sanofi : Information concerning the total number of voting rights and shares - July 2020 [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Neurocrine Biosciences and Voyager Therapeutics Present New Long-Term Three-Year Data Demonstrating that One-Time Treatment with an Investigational... [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Harrow Health to Attend Lake Street’s Virtual 4th Annual (BIG4) Conference September 17, 2020 [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumumab) in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients... [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Zealand Pharma increases its share capital as a consequence of exercise of employee warrants [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Surface Oncology to Participate in the H.C. Wainwright Global Healthcare Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Artelo Biosciences to Present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15th [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Adamas presents new post-hoc data analysis for GOCOVRI® in Parkinson’s disease patients with dyskinesia at the 2020 Movement Disorder Society... [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Axiom Presenting and Exhibiting at SCDM 2020 Virtual Conference September 13-16, 2020 [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Avadel to Present at H.C. Wainwright 22nd Annual Global Investment Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- imber Pharmaceuticals to Present at H.C. Wainwright 22nd Annual Global Investment Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- AnaptysBio to Present at the 2020 Cantor Global Virtual Healthcare Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Resverlogix Provides Update Regarding Extension of its Filing Calendar [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Timber Pharmaceuticals to Present at H.C. Wainwright 22nd Annual Global Investment Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Adamas Announces New Employment Inducement Grant [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Cassava Sciences to Hold Conference Call on Monday, September 14, 2020 at 8:30 am ET [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- Keros Therapeutics Presents Results from Preclinical Studies Investigating KER-012 at the American Society for Bone and Mineral Research 2020 Annual... [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
- electroCore Provides Business Update and Select Financial Guidance [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- PMV Pharma Granted FDA Fast Track Designation of PC14586 for the Treatment of Advanced Cancer Patients that have Tumors with a p53 Y220C Mutation [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Arbutus to Participate in Virtual Fireside Chat at H.C. Wainwright Hepatitis B Virus (HBV) Mini-Conference [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Novavax Appoints Leadership Team to Advance NanoFlu through Regulatory Licensure [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- STEM Animal Health Appoints New President and CEO [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- GenMark Diagnostics Provides Preliminary Financial Results for Third Quarter 2020 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Indus Holdings, Inc. Pre-Announces Record Q3 2020 Revenues in Excess of $14 Million, ~15% EBITDA Margins, and Positive Operating Income [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Todos Medical Reports $2.0 Million in Revenue for the Third Quarter of 2020 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Monthly information regarding the total number of voting rights and total number of shares of the Company as of September 30, 2020 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Telo Genomics Announces that Positive Results of Smoldering Multiple Myeloma Study Selected for Online Publication Within ASH 2020 Proceedings [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Motus GI Hosting Key Opinion Leader Call on Improving Endoscopy Outcomes with the Pure-Vu® System [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Stabilization measures taken [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Better Choice Announces Closing of Expanded Series F Financing and Acceleration of Asian Expansion [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- CohBar’s CEO to Participate on the Emerging Companies Panel at the Targeting Metabesity Conference [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Abeona Therapeutics’ Board of Directors Forms Special Committee to Oversee Operations, Develop Strategic Direction and Leadership Plan [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Acacia Pharma announces BYFAVO™ (remimazolam), its Newly Approved Product for Procedural Sedation, Clears Final Hurdle on Path to Commercial Launch... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Tauriga Sciences Inc. Officially Approved to Operate as a U.S. Government Vendor [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Arcutis Biotherapeutics Announces Closing of Public Offering and Concurrent Private Placement of Common Stock [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- SetPoint Medical Receives FDA Breakthrough Device Designation for its Novel Bioelectronic Platform [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Tauriga Sciences Inc. Secures $135,000 in Inventory Factoring Capital to Support its Accelerating Revenue Growth [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Derm-Biome Pharmaceuticals, Inc. Reports Positive Results from a Preclinical Study In Psoriasis [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- GenMark Diagnostics’ ePlex® Respiratory Pathogen Panel 2 (RP2) Receives EUA from FDA [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Enzo Biochem to Report Fourth Quarter and Fiscal Year 2020 Financial Results on Tuesday, October 13 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Caladrius Biosciences Opens Study of CLBS119 to Repair COVID-19-Induced Lung Damage [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- XORTX Receives Positive Feedback from FDA on COVID-19 Related Acute Kidney Injury [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Mustang Bio Announces MB-105 Data Selected for Presentation at the Virtual 27th Annual Prostate Cancer Foundation Scientific Retreat [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Syneos Health Wins Society for Clinical Research Sites Eagle Award for Fourth Consecutive Year [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Zynerba Pharmaceuticals Announces the Acceptance of Two Posters at the Virtual Joint 49th Annual Child Neurology Society & 16th International... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Celldex Therapeutics Initiates Phase 1b Study of CDX-0159 in Chronic Spontaneous Urticaria [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Selecta Biosciences and IGAN Biosciences Enter into Research License and Option Agreement to Study Selecta’s ImmTOR™ Immune Tolerance Platform in... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- BioCorRx Partners with Truusight Health to Integrate Recovery Program Into Self-Funded Health Plans [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Susan Hirsch Joins Agenus’ Board of Directors [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- C4 Therapeutics Announces Closing of Initial Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Orphan Drug Dehydrated Alcohol Injection [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Larimar Therapeutics Announces Formation of Scientific Advisory Board [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- PCI Biotech: Employee share option scheme [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Rafarma Approves Issuance of Majority of Voting Shares to Board Chairman Ilya Shpurov [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- American Gene Technologies to Present at 2020 Virtual Cell & Gene Meeting on the Mesa [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Zynerba Pharmaceuticals Announces Oral Presentations at the Virtual American Academy of Child and Adolescent Psychiatry (AACAP) 2020 Annual Meeting [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Generex Subsidiary NuGenerex Immuno-Oncology Announces Publication of a Review Article on Cancer Vaccines Highlighting AE37 (Ii-Key-HER2)... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- AnaptysBio Reports Positive Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab in Moderate-to-Severe Generalized Pustular Psoriasis (GPP) [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Recent Peer-Reviewed Publication Supports Immunotherapy for the Treatment of Food Allergies [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Aligos Therapeutics Presents Coronavirus Therapeutic Screening Assay Development at ISIRV-AVG Conference [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- FibroGenesis Named Top 20 Most Innovative Companies of 2020 and Lands at the #2 Spot on Global Smart Leaders Magazine List [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Catalyst Pharmaceuticals Announces Issuance of U.S. Patent for Firdapse® [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Oyster Point Pharma Announces Board of Directors Leadership Changes and New Appointment as the Company Advances into Next Phase of Growth [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Novo Nordisk raises sales and operating profit outlook for 2020 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- X4 Pharmaceuticals Announces Fast Track Designation Granted by the FDA to Mavorixafor for the Treatment of WHIM Syndrome [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Enlivex: After Expedited Review, Israeli Ministry of Health Authorizes Initiation of Phase II Clinical Trial Evaluating Allocetra in COVID-19 Severe... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- CorMedix to Participate in BIO Investor Forum Digital [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Eton Pharmaceuticals Submits New Drug Application to the FDA for Topiramate Oral Solution (ET-101) [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- PRA Health Sciences selected by BARDA to be a member of its exclusive Clinical Studies Network [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- SpringWorks Therapeutics Announces Proposed Public Offering of Common Stock [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- VYNE Therapeutics Announces ZILXI™ (minocycline) topical foam, 1.5% is Available in Pharmacies Nationwide Today, October 1st [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- CytomX Therapeutics Announces the Planned Retirement of Chief Scientific Officer, W. Michael Kavanaugh, M.D. [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Hyloris appoints Dr. Dietmar Aichhorn as Chief Operating Officer [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Caladrius Biosciences to Present at the BIO Investor Forum Digital [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
- Athira Pharma Announces Initiation of Patient Dosing for the LIFT-AD Study, a Phase 2/3 Clinical Trial to Evaluate ATH-1017 for Treatment of... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]