Internewscast Journal
  • Home
  • US News
  • Local News
  • Health
  • People
  • Guest Post
  • Support Our Cause
Internewscast Journal
  • Home
  • US News
  • Local News
  • Health
  • People
  • Guest Post
  • Support Our Cause
Home Local news Sarepta Stocks Drop as Gene Therapy Halted Following FDA’s Request
  • Local news

Sarepta Stocks Drop as Gene Therapy Halted Following FDA’s Request

    Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
    Up next
    Tragic Fighter Jet Crash in Bangladesh Claims 27 Lives
    Published on 22 July 2025
    Author
    Internewscast
    Tags
    • again,
    • bows,
    • Business,
    • Doug Ingram,
    • drugmaker,
    • fda,
    • gene,
    • health,
    • pause,
    • Pressure,
    • Sarepta,
    • Shares,
    • slide,
    • therapy
    Share this @internewscast.com
    FacebookXRedditPinterest

    WASHINGTON – The stock value of Sarepta Therapeutics continued on a downward trend Tuesday after the firm declared it would adhere to a request from the Food and Drug Administration to halt the distribution of its gene therapy in response to multiple patient fatalities.

    This decision, revealed late Monday, follows closely on the heels of a rare and contentious refusal by the company to align with FDA regulators, a move that unsettled both investors and analysts.

    Sarepta’s CEO, Doug Ingram, stated that the company is aiming for a “productive and positive” engagement with the FDA and noted that continuing this constructive working relationship necessitated the temporary halt in shipments.

    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 this @internewscast.com
    FacebookXRedditPinterest
    You May Also Like
    TRAFFIC ALERT: I-75 closed in Marion after dump truck strikes CR-320 overpass
    • Local news

    TRAFFIC UPDATE: I-75 Shut Down in Marion Due to Dump Truck Colliding with CR-320 Overpass

    MARION COUNTY, Fla. – An overpass was hit by a dump truck…
    • Internewscast
    • September 24, 2025
    The Latest: 2 detainees killed and another critically injured after shooting at ICE facility
    • Local news

    Breaking News: Two Detainees Dead, One in Critical Condition Following Shooting at ICE Facility

    A gunman using a rifle launched an attack from a nearby rooftop…
    • Internewscast
    • September 24, 2025
    Ohio, 6-7, Bop and Mogging are slang words: Here's what they mean
    • Local news

    Ohio, 6-7, Bop, and Mogging: Understanding These Slang Terms

    [WATCH: In the video player above, see which words Americans have the…
    • Internewscast
    • September 24, 2025
    What did Jimmy Kimmel say during his first show after suspension?
    • Local news

    What were Jimmy Kimmel’s remarks on his first show following his suspension?

    Jimmy Kimmel made his comeback as the host of his late-night show…
    • Internewscast
    • September 24, 2025
    44 malnourished dogs seized from suspected puppy mill in East Texas
    • Local news

    Authorities Rescue 44 Undernourished Dogs from Alleged Puppy Breeding Operation in East Texas

    TROUP, Texas (KETK)– 44 dogs were seized from an East Texas property…
    • Internewscast
    • September 24, 2025
    A trio of space weather satellites blast off together to study the sun’s violent side
    • Local news

    Three Satellites Launch to Investigate the Sun’s Turbulent Weather

    CAPE CANAVERAL, Fla. – A group of space weather satellites launched into…
    • Internewscast
    • September 24, 2025
    For the first time in nearly six decades, a Syrian president steps up to speak at the UN
    • Local news

    Syrian President Addresses the UN After Almost 60 Years

    TANZANIA – In a momentous shift after many years, Syria’s leader delivered…
    • Internewscast
    • September 24, 2025
    Menard County records batches of mosquitoes positive for West Nile Virus
    • Local news

    West Nile Virus Detected in Mosquitoes in Menard County

    MENARD COUNTY, Ill. (WCIA) — Menard County is the latest in Illinois…
    • Internewscast
    • September 24, 2025

    Study by Vanderbilt University Medical Center Shows Autism Diagnoses in Tennessee Have Doubled Over the Past Decade

    NASHVILLE, Tenn. (WKRN) — Research conducted at Vanderbilt University Medical Center has…
    • Internewscast
    • September 24, 2025
    Three detainees were shot at Dallas ICE facility
    • Local news

    Three Inmates Injured by Gunfire at Dallas ICE Center

    IE 11 is not supported. For an optimal experience visit our site…
    • Internewscast
    • September 24, 2025
    What we know about the Dallas ICE facility shooter
    • Local news

    Latest Updates on the Dallas ICE Facility Shooting Incident

    A 29-year-old man from Texas opened fire at an Immigration and Customs…
    • Internewscast
    • September 25, 2025
    Bullets fly as firefighters battle blaze at metal recycling facility
    • Local news

    Firefighters confront blaze with gunfire at metal recycling plant

    CLEVELAND (WJW) Firefighters contended with a substantial industrial fire on Monday at…
    • Internewscast
    • September 24, 2025
    America's 'Tylenol town' which has become hub of autism controversy
    • News

    America’s ‘Tylenol town’ embroiled in autism debate

    Summit, New Jersey, a wealthy commuter town about 40 minutes from Manhattan,…
    • Internewscast
    • September 25, 2025
    Revealed: Brits' biggest obsessions... from Prince Harry and William's feud to a pint at the pub
    • Royals

    Uncovering UK’s Top Fascinations: Royal Family Dramas to Pub Nights

    • Internewscast
    • September 25, 2025
    Motive of shooter who officials say opened fire at Dallas ICE facility remains unclear
    • Local news

    Dallas ICE Facility Shooting: Authorities Still Investigating Shooter’s Intent

    DALLAS – The reasons behind the attack at a U.S. Immigration and…
    • Internewscast
    • September 25, 2025
    Tommy Fleetwood's manager wife Clare, 57, makes rare appearance at Ryder Cup... after admitting 23-year age-gap criticism makes her 'paranoid'
    • Sport

    Tommy Fleetwood’s Wife Clare, 57, Makes a Rare Appearance at Ryder Cup: Opens Up About 23-Year Age Gap Concerns

    Clare Fleetwood recently attended the Ryder Cup to show her support for…
    • Internewscast
    • September 25, 2025
    Internewscast Journal
    • Home
    • Privacy Policy
    • DMCA Notice
    • Terms and Conditions
    • Guest Post
    • Support Our Cause
    Copyright 2023. All Right Reserverd.