Sarepta FDA Scrutiny Intensifies

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Sarepta, FDA and Gene

FDA Scrutiny Intensifies as Sarepta Gene Therapy Faces Dire Setbacks

The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death. This marks a heightened scrutiny following previous deaths linked to the therapy.

The Associated Press on MSN · 2d

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators

Reuters · 2d

Sarepta falls after gene therapy maker pauses Elevidys shipments in US

Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the United States.

pharmaphorum3d

Sarepta resists as FDA seeks pause on Elevidys use

Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...

Zacks.com on MSN3d

SRPT Down After Third Death in Muscular Dystrophy Gene Therapy Program

Sarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.

Sarepta Therapeutics cuts Durham jobs amid mass layoffs, FDA scrutiny

A Massachusetts biotechnology company is laying off 21 employees in Durham amid a broader restructuring and pressure from federal regulators.

Benzinga.com29d

Did The FDA Make A Mistake? Sarepta's Elevidys Approval Under Scrutiny

FDA confirms two fatal cases of liver failure in DMD patients treated with Elevidys HC Wainwright reiterates Sell rating on Sarepta, with a $10 price target Tim Melvin’s system has spotted 10X ...

Hosted on MSN1mon

Sarepta crashes after second death linked to Roche-partnered Elevidys - MSN

FDA may face scrutiny This latest incident casts a shadow over Elevidys, Sarepta’s flagship therapy, and may increase scrutiny of the U.S. Food and Drug Administration’s decision to approve ...

FiercePharma1y

Even after primary miss, Sarepta to seek wider Elevidys approval

On the 10-meter distance test, the drug was associated with a 0.42-second improvement versus placebo, Sarepta said. Related Most expensive drugs in the US in 2023 ...

The Victoria Advocate4mon

Sarepta’s Gene Therapy Under Scrutiny After Patient Death

Sarepta says more than 800 patients have received the treatment The company plans to update prescribing information after this case WEDNESDAY, March 19, 2025 (HealthDay News) -- A patient has died ...

FierceBiotech2y

In a U-turn, FDA orders AdComm for Sarepta's DMD gene therapy

Rather, Sarepta’s understanding is that the U-turn results from a reorganization at the FDA, the creation of the “super office” OTP—the Office of Therapeutic Products—and a desire to ...

The Washington Post1mon

Biotech links second patient death to drug for Duchenne muscular ...

Biotech firm Sarepta Therapeutics said that a second patient died after receiving its gene therapy to treat Duchenne muscular dystrophy, the latest drug to draw scrutiny after winning fast ...

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