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FDA Delays Decision on Sarepta's Highly Anticipated Gene Therapy, Shares Tumble.

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Source: STAT
FDA Delays Decision on Sarepta's Highly Anticipated Gene Therapy, Shares Tumble.
Photo: STAT
TL;DR

The FDA has delayed its decision on the approval of Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy by one month, with a new decision expected by June 22. The FDA is also considering granting accelerated approval for the therapy, but only for 4- and 5-year-old patients, rather than all Duchenne patients who could still walk as requested by Sarepta.

Topics:businesshealthcare#accelerated-approval#duchenne-muscular-dystrophy#fda#gene-therapy#healthcare#sarepta-therapeutics
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  1. FDA delays decision on Sarepta's gene therapy for Duchenne  STAT
  2. UPDATE: FDA needs more time for Sarepta's DMD gene therapy—spurring a deja vu of Exondys 51  FierceBiotech
  3. SRPT Stock Tumbles On A Hold-Up For Its Highly Anticipated Gene Therapy  Investor's Business Daily
  4. Sarepta says FDA may limit gene therapy nod to smaller population, shares fall  Reuters
  5. Why Shares of Sarepta Therapeutics Are Dropping Wednesday  The Motley Fool

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