NewsFinale
  • Home
  • News
  • Local News
  • Business
  • Health
  • Finance
  • Celeb Lifestyle
  • Crime
  • Entertainment
  • Advertise Here
Gleammour AquaFresh
NewsFinale
  • Home
  • News
  • Local News
  • Business
  • Health
  • Finance
  • Celeb Lifestyle
  • Crime
  • Entertainment
  • Advertise Here
Home Local News Sarepta’s Stock Drops Again as Company Halts Gene Therapy Under FDA’s Direction

Sarepta’s Stock Drops Again as Company Halts Gene Therapy Under FDA’s Direction

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Up next
Inside Ghislaine Maxwell and Jeffrey Epstein's twisted love affair
A Look Into the Complicated Relationship Between Ghislaine Maxwell and Jeffrey Epstein
Published on 22 July 2025
Author
NewsFinale Journal
Share and Follow
FacebookXRedditPinterestWhatsApp


WASHINGTON – Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths.

The decision, announced late Monday, comes just days after the company rebuffed FDA regulators in an extremely unusual decision that alarmed investors and analysts.

Sarepta CEO Doug Ingram said the company seeks a “productive and positive” relationship with FDA and that “maintaining that productive working relationship required this temporary suspension.”

The Cambridge, Massachusetts-based company said it would “ temporarily pause all shipments” of its gene therapy Elevidys for muscular dystrophy at the close of business Tuesday.

It’s the latest in a series of highly irregular moves that have rocked company shares for weeks and forced it to lay off hundreds of staffers.

Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy, the fatal muscle-wasting disease that affects boys and young men, resulting in early death. The one-time treatment was initially approved for boys age 4 and younger who could still walk. Last year, FDA expanded approval to older patients who are no longer able to walk.

The therapy was already under FDA scrutiny after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. Then the company last week disclosed a third death with a different therapy: a 51-year-old patient who was enrolled in a company trial for a another form of muscular dystrophy.

FDA responded by asking the company to immediately halt all shipments of Elevidys.

Wall Street analysts said the company made the right move.

Defying the FDA would have “irreparably damaged the company’s relationship with FDA under the current leadership and administration,” TD Cowen analyst Ritu Baral told investors in a note Tuesday.

Baral estimated the pause in distribution would last three to six months.

The FDA has the authority to pull drugs from the market, but the process can take months or even years. Instead, the agency usually makes an informal request and companies almost always comply. Even in the rare cases when drugmakers haven’t cooperated, the FDA has prevailed after public hearings and appeals.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.

Share and Follow
FacebookXRedditPinterestWhatsApp
You May Also Like
Two more ramps opening at I-74, I-57 interchange in Champaign
  • Local News

Champaign Traffic Eases: I-74 and I-57 Interchange Welcomes Two New Ramp Openings

CHAMPAIGN, Ill. (WCIA) — Early Thursday morning marks the opening of two…
  • NewsFinale Journal
  • November 20, 2025
Trump signs bill to release Jeffrey Epstein case files after fighting it for months
  • Local News

Trump Approves Bill Releasing Jeffrey Epstein Case Files After Prolonged Opposition

WASHINGTON (AP) — President Donald Trump has signed a new law on…
  • NewsFinale Journal
  • November 20, 2025
A night bus from Cambodia's top tourist destination plunges off a bridge, killing 13 passengers
  • Local News

Tragedy Strikes as Night Bus from Cambodia’s Premier Tourist Spot Plummets Off Bridge, Resulting in 13 Fatalities

PHNOM PENH – In a tragic incident on Thursday, a passenger bus…
  • NewsFinale Journal
  • November 20, 2025
Philippine court convicts former mayor of human trafficking
  • Local News

Former Philippine Mayor Found Guilty in Human Trafficking Case

MANILA – In a landmark decision, a court in the Philippines has…
  • NewsFinale Journal
  • November 20, 2025
Where Dolly Parton plans to open first-ever travel center
  • Local News

Dolly Parton Unveils Plans for Her Debut Travel Center: Find Out Where!

CORNERSVILLE, Tenn. (WKRN) — In an exciting development for Cornersville, Dolly Parton…
  • NewsFinale Journal
  • November 19, 2025
$20,000 reward offered for information on S.C. man wanted for murder
  • Local News

Massive $20,000 Reward Announced for Leads on South Carolina Murder Suspect

CHESTER COUNTY, S.C. – In a concerted effort to bring a fugitive…
  • NewsFinale Journal
  • November 19, 2025
Jets cornerback Kris Boyd breathing on his own after Manhattan shooting, Instagram post says
  • Local News

Jets Cornerback Kris Boyd Miraculously Recovering Post-Manhattan Shooting: Breathes Independently, Instagram Update Reveals

FLORHAM PARK, N.J. (AP) — New York Jets cornerback Kris Boyd updated…
  • NewsFinale Journal
  • November 19, 2025
Tampa nonprofit launches free grocery shopping experience for families
  • Local News

Revolutionizing Aid: Tampa Nonprofit Introduces Free Grocery Shopping for Families in Need

TAMPA, Fla. (WFLA) — The Tampa Bay Fashion Foundation (TBFF), a local…
  • NewsFinale Journal
  • November 19, 2025
IDF strikes Hamas 'terrorist targets' across Gaza following reported ceasefire violation
  • US

IDF Targets Hamas Sites in Gaza After Ceasefire Breach

Israel’s military announced on Wednesday that it had initiated strikes on Hamas…
  • NewsFinale Journal
  • November 20, 2025
Paris wax museum unveils new Diana figure in ‘revenge dress,’ decades after her death in the city
  • Local News

Paris Wax Museum Honors Princess Diana with Iconic ‘Revenge Dress’ Figure, Celebrating Her Legacy Decades After Her Untimely Death

PARIS – In an homage to Princess Diana, a Parisian wax museum…
  • NewsFinale Journal
  • November 20, 2025
Dad killed by ex and new boyfriend days after divorce: Cops
  • Crime

Tragic Incident: Man Fatally Attacked by Ex-Wife and Partner Shortly After Divorce, Police Report

Insets, left to right: Michael Hogue (Boone County Sheriff’s Office), Kevin Nikel…
  • NewsFinale Journal
  • November 20, 2025
This photo provided by Gianluca Masi shows the interstellar comet 3I/Atlas as it streaks through space, 190 million miles from Earth, on Wednesday, Nov. 19, 2025. The image was taken from Manciano, Italy. (Gianluca Masi via AP)
  • AU

Detailed Images Capture Interstellar Comet as It Passes by Mars

NASA has recently shared striking close-up images of an interstellar comet that…
  • NewsFinale Journal
  • November 20, 2025
NewsFinale Journal
  • Home
  • Terms and Conditions
  • Sitemap
  • DMCA
  • Advertise Here
  • Donate
Go to mobile version