Sarepta’s Elevidys Safety Concerns Open Major Opportunity for Solid Biosciences’ (SLDB) SGT-003 in Duchenne Therapy

Solid Biosciences Inc. (NASDAQ:SLDB) is one of the stocks that will double in 2026. On December 4, Needham analyst Gil Blum ...

Sarepta a new outperform at Wedbush as selloff overdone

Wedbush upgrades Sarepta Therapeutics, citing overdone selloff and potential upside as FDA could re-approval Elevidys for non ...

Breakthrough genetic therapies can save lives, but many cost millions for single dose

A new class of life-saving drugs is helping children who once had no hope. But some carry a price tag of millions for a ...
Becker's Hospital Review

After patient deaths, FDA to trim gene therapy’s approval

The FDA said Nov. 14 it will place its most prominent safety warning on Elevidys, a gene therapy for Duchenne muscular dystrophy, after two fatal cases of acute liver injury. Officials have reported ...
Benzinga.com

Sarepta Secures FDA Nod For Elevidys Study To Reduce Liver Injury Risk

The U.S. Food and Drug Administration (FDA) on Tuesday approved dosing in Sarepta Therapeutics Inc.’s (NASDAQ: SRPT) Cohort 8 of ENDEAVOR (Study 9001-103). • SRPT shares are advancing steadily. Get ...
Business Wire

Sarepta Announces Approval to Begin ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with Duchenne

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA ...
SF Weekly

FDA Limits Duchenne Gene Therapy After Two Teens Die of Liver Failure

MONDAY, Nov. 17, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is tightening restrictions on a gene therapy used to treat Duchenne muscular dystrophy after two teenagers died ...
Morningstar

Sarepta Announces Approval to Begin ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with Duchenne

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to begin before the end of the year The enhanced ...

Capricor Therapeutics: Shares Soaring After DMD Study Win - Ball Now In FDA's Court

Capricor Therapeutics, Inc. soars 450% on positive HOPE-3 DMD results. Discover market impact, growth potential, and risks.
Stocktwits on MSN

Sarepta Wins FDA Approval To Begin Study On Reducing Liver Injury Risk With Elevidys

Sarepta Therapeutics, Inc. (SRPT) on Tuesday said that the U.S. Food and Drug Administration (FDA) has approved dosing in a study cohort to evaluate the use of an immunosuppressive regimen as part of ...
Nasdaq

FDA Restricts Use of Sarepta's Gene Therapy, Adds Safety Warnings

Sarepta Therapeutics SRPT announced that the FDA has approved significant changes to the label of Elevidys, its one-shot gene therapy for Duchenne muscular dystrophy (DMD). The revised labeling not ...
WFMZ-TV

FDA Limits Duchenne Gene Therapy After Two Teens Die of Liver Failure

The FDA now limits Elevidys to walking boys ages 4 and up after two teens died from liver failure The therapy will now carry a boxed warning for serious liver injury, liver failure and death Doctors ...