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