Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular dystrophy patients.
Sarepta Therapeutics' Brutal Week Continues With Bad News Out Of Europe Shares are down another double-digit percentage after bad news continued piling on for gene therapy Elevidys.
Friday's pre-market session: top gainers and losers Let's have a look at what is happening on the US markets before the opening bell on Friday. Below you can find the top gainers and losers in today's pre-market session.
Elevidys Halt Sparks Analyst Downgrades—Sarepta Races To Revise Label Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and valuation cuts.
FDA Names Biotech Veteran George Tidmarsh To Lead Drug Evaluation Division George Tidmarsh appointed to lead FDA drug review division amid staffing cuts and scrutiny over accelerated approvals and drug advertising rules.
Sarepta Tumbles On The 'Painful' Decision To Stop Selling Elevidys Sarepta stock toppled Tuesday after the company said it would voluntarily stop all shipments of Elevidys.
Sarepta Reverses Course, Pauses Elevidys Shipments Amid FDA Safety Review Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the fourth quarter.
Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.
Sarepta Topples, Again, After Refusing The FDA's Request To Pull Elevidys The company is setting up for a showdown with the FDA over its approved gene therapy, Elevidys.
Get insights into the top gainers and losers of Monday's pre-market session. As we await the opening of the US market on Monday, let's delve into the pre-market session and discover the top gainers and losers shaping the early market sentiment.
Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.
GlucoTrack, Sarepta, TNF Pharma Dominate Weekly Retail Health Care Buzz — Here’s Why GlucoTrack repurchased over 90% of its Series A warrants, while Sarepta disclosed a third patient death, suspended Elevidys shipments, and added a black-box warning amid FDA scrutiny.
