Sarepta Therapeutics Inc. and Elevidys Shipments
- Sarepta Therapeutics refused FDA request to stop Elevidys shipments.
- FDA reported three patient deaths linked to gene therapy Elevidys.
- Deaths included two teenage boys with Duchenne muscular dystrophy and a 51-year-old trial participant for limb-girdle muscular dystrophy.
- All deceased patients suffered from acute liver failure after receiving the therapy.
Company Response and Current Situation
- FDA officials met with Sarepta to request a voluntary pause in shipments of Elevidys.
- Sarepta declined, citing no new safety signals among remaining patients who can walk.
- In June, Sarepta had already halted shipments to non-ambulatory patients, accounting for 85% of treated boys.
Regulatory Review and Market Impact
- FDA Commissioner stated the agency is assessing whether Elevidys should remain on the market.
- Recent death of a trial participant with a similar therapy, SRP-9004, raises safety concerns.
- Analyst suggests risks of complete market removal of Elevidys are heightened.
Stock Market Reaction
- Share prices for Sarepta dropped over 30% following the news of the deaths.
- Concerns over patient hesitancy regarding Elevidys and investor trust due to lack of disclosure on the LGMD death.
https://www.zerohedge.com/markets/sarepta-refuses-fda-request-halt-elevidys-after-three-deaths
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