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The Daily Biotech Pulse: FDA Orphan Drug Tags For Neurocrine, Editas Candidates; Sale of BridgeBio's PRV; RMAT Designation For PolarityTE's Product
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PolarityTE Shares Jump After FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for SkinTE

By Ragothaman Srinivasan

The U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to PolarityTE’s (NASDAQ:PTE)  SkinTE under the its open investigational new drug application (IND). 

 

PolarityTE has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA), currently pursuing the first of two pivotal studies on SkinTE® needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication.

 

Richard Hague, Chief Executive Officer, commented : ”FDA granting our request for an RMAT designation for SkinTE validates not only the strength of the preliminary clinical evidence we have developed to date but also demonstrates the seriousness of the conditions that we seek to treat and the substantial nature of the unmet needs among the patient populations that we aim to serve.”

 

Regenerative Medicine Advanced Therapy (RMAT) designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine products, including human cellular and tissue-based therapies. The RMAT designation provides the benefits of intensive FDA guidance on efficient drug development.

 

PolarityTE Shares are trading high 48 percent at $0.22

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Dive Deeper:
The Daily Biotech Pulse: FDA Orphan Drug Tags For Neurocrine, Editas Candidates; Sale of BridgeBio's PRV; RMAT Designation For PolarityTE's Product
Here's a roundup of top developments in the biotech space over the last 24 hours:
Stealth BioTherapeutics Shares Rally following FDA Orphan Drug Designation To Elamipretide For Duchenne muscular dystrophy (DMD)
Stealth BioTherapeutics Corp (NASDAQ: MITO) received Orphan Drug Designation to Elamipretide from the United States Food and Drug Administration (FDA)…
Has Clearmind Developed A Psychedelics-Based Drug That Can Treat Alcoholism? The FDA Is Interested
On Wednesday, May 18, Clearmind Medicine Inc. (OTC Pink: CMNDF) will meet with the Center for Drug Evaluation and Research…
Salarius Pharmaceuticals Successfully Completes pre-IND Meeting with FDA for SP-3164
Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX) successfully completed the pre-IND (Investigational New Drug) meeting process with the U.S. Food and Drug Administration…
One subscription that gives you access to news from hundreds of sites
FDA Clears Regulus Therapeutics' IND for RGLS8429 In Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Regulus Therapeutics Inc. (NASDAQ: RGLS) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug…
FDA Accepts IND for Cue Biopharma's CUE-102 in the treatment of Wilms' Tumor 1 (WT1)
Cue Biopharma, Inc. (NASDAQ: CUE) received the U.S. Food and Drug Administration (FDA) acceptance of the Investigational New Drug (IND) application…
Get all your news in one place