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What Is An RMAT? List of RMAT Designations (50)

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To date, 50 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 155 requests and issued 59, which means that several are not yet public knowledge.

Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.

Thus far, only two companies (Abeona Therapeutics and Athersys) have received two RMAT designations from the U.S. FDA.

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Evotec Achieves Milestone within iPSC-Based Neuroscience Partnership with BMS

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Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry.

HAMBURG, GERMANY / January 5, 2021 — Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced that the Company has received a US $6 million payment from Bristol Myers Squibb Company (NYSE: BMY) within the companies’ iPSC-based neuroscience partnership. The payment follows Bristol Myers Squibb’s decision to add another drug discovery project to the partnership’s portfolio. [Read more…]

Spinogenix Secures DOD Grant To Study Lead Compound in hiPSCs from Patients with ALS

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Spinogenix Announces Grant by U.S. Department of Defense to Advance Novel Drug Candidate in Amyotrophic Lateral Sclerosis (ALS)

SAN DIEGO, Calif., Jan. 05, 2021 — Spinogenix, Inc. a preclinical-stage biopharmaceutical company developing novel small molecule drugs for neurological conditions, today announced that it will be collaborating with Dr. Rita Sattler at the Barrow Neurological Institute and Dr. Justin Ichida at the USC Keck School of Medicine on a grant awarded from the U.S. Department of Defense’s (“DOD”) Congressionally Directed Medical Research Programs (“CDMRP”) to evaluate its lead development candidate in ALS. [Read more…]

FDA Grants RMAT Designation for Cook MyoSite’s Investigational Autologous Muscle Derived Cells for Urinary Sphincter Repair

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December 17, 2020, PITTSBURGH — Cook MyoSite, a biotechnology firm based in Pittsburgh, Pennsylvania, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Cook MyoSite’s investigational product, Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR), for treatment of women with persistent or recurrent stress urinary incontinence (SUI) following surgical treatment. [Read more…]

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