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Sarepta Therapeutics obtained traditional FDA approval for ambulatory DMD patients and accelerated approval for non-ambulatory DMD patients with a confirmed mutation in the DMD gene on the 20th of ...
The FDA’s shift on Elevidys sends a message: boldness, scientific rigor and urgency are essential in confronting rare ...
Certain Sarepta Therapeutics Inc. insiders were accused in a stockholder lawsuit of reaping a combined $6.2 million selling ...
Sarepta is facing a number of issues currently, including platform-level safety concerns, management credibility issues, etc.
The debt refinancing follows the firm's recent trouble with the FDA and efforts to refocus its pipeline priorities, preserve resources, and meet financial obligations.
Sarepta Therapeutics Inc. landed a deal with investors to restructure around $700 million of debt, giving the company a ...
Good morning. We've got a meaty issue for you today. In particular, I urge you to spend some time with Jason Mast's story. It ...
A refinancing deal will delay the maturity of $700 million in debt until 2030, allowing the company to “fully fund” its ...
After deaths and FDA setbacks, Sarepta abandoned LGMD gene therapy, leaving families desperate and patients without ...
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Stocktwits on MSNCiti Believes FDA May Closely Watch Sarepta’s Safeguards For Gene Therapy In Non-Ambulatory DMD Patients
Citi said on Wednesday that the U.S. Food and Drug Administration may take a “more comprehensive look” at the level of ...
The CDMO will be cutting 350 jobs at its Baltimore gene therapy site after a major client’s demand shift, less than a year ...
Catalent is laying off 350 employees in its gene therapy manufacturing division in Baltimore “due to an unexpected shift in ...
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