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
    4-year-old attacked by mountain lion at Olympic National Park
    • Local news

    Mountain Lion Attacks 4-Year-Old at Olympic National Park

    PORT ANGELES, Washington (WJW) A 4-year-old child was taken to the hospital…
    • Internewscast
    • July 22, 2025
    DOJ: Habba successor 'removed' after NJ court ousting from top prosecutor role
    • Local news

    DOJ: New Jersey Court Dismisses Top Prosecutor – Successor Removed from Position

    Top Justice Department officials on Tuesday announced that a deputy to Alina…
    • Internewscast
    • July 23, 2025
    Trump admin rehashes 2016 election and Malcolm-Jamal Warner drowns: Morning Rundown
    • Local news

    Trump Administration Revisits 2016 Election and Malcolm-Jamal Warner Incident: Morning Brief

    Donald Trump and his administration are revisiting past issues amidst the controversy…
    • Internewscast
    • July 22, 2025
    House beefs up security funds for lawmakers
    • Local news

    House Increases Security Budget for Lawmakers

    House leaders are beefing up security measures and funding for members of…
    • Internewscast
    • July 22, 2025
    FKA twigs drops lawsuit against ex Shia LaBeouf that alleged sexual and physical abuse
    • Local news

    FKA twigs Withdraws Legal Action Against Ex Shia LaBeouf Over Allegations of Abuse

    Singer FKA twigs has dropped a lawsuit she filed against her ex…
    • Internewscast
    • July 22, 2025
    Murdoch is not 'a buddy' to president: Trump's lawyer
    • Local news

    Trump’s Lawyer Clarifies: Murdoch Isn’t a ‘Friend’ to the President

    () President Donald Trump’s attorney said Rupert Murdoch is “not really treating…
    • Internewscast
    • July 23, 2025
    Beyoncé dedicates her website to Malcolm-Jamal Warner as tributes pour in after actor's death
    • Local news

    Beyoncé Honors Malcolm-Jamal Warner on Her Website Amid Outpouring of Tributes After His Passing

    Beyoncé has featured a dedication to Malcolm-Jamal Warner, the “Cosby Show” actor…
    • Internewscast
    • July 22, 2025
    Space industry urges Congress not to ax satellite collisions system
    • Local news

    Democrats Face Fundraising Challenges as Republicans Maintain Financial Edge

    () New campaign finance numbers show the Republican National Committee has a…
    • Internewscast
    • July 22, 2025
    Reports: Largest immigration facility in U.S. to be at Fort Bliss
    • Local news

    Reports Indicate Fort Bliss to Host the Largest U.S. Immigration Facility

    EL PASO, Texas (KTSM) — The federal government is moving forward with…
    • Internewscast
    • July 22, 2025
    Republican legislators call on IL governor to participate in federal school choice program
    • Local news

    GOP Lawmakers Urge Illinois Governor to Join National School Choice Initiative

    SPRINGFIELD, Ill. (WCIA) — The One Big Beautiful Bill may bring back…
    • Internewscast
    • July 22, 2025
    Marion County teen sentenced to 40 years in prison for 2023 triple homicide
    • Local news

    Marion County Teen Receives 40-Year Sentence for 2023 Triple Homicide

    OCALA, Fla. – One of three teenagers accused in a triple homicide…
    • Internewscast
    • July 22, 2025
    FBI warns of government impersonation scams using spoofed FBI phone number
    • Local news

    FBI Alerts Public to Scams Involving Fake FBI Phone Numbers and Government Impersonation

    SOUTH CAROLINA () – The FBI is warning the public about a…
    • Internewscast
    • July 22, 2025
    Opening statements begin in Ksoo's murder trial
    • US

    The murder trial for Ksoo starts with opening statements

    Hakeem Robinson, popularly known as Ksoo, is set to face trial for…
    • Internewscast
    • July 23, 2025
    Felon who allegedly barreled car through LA nightclub crowd faces 37 attempted murder charges
    • US

    Man Accused of Driving Through Los Angeles Nightclub Crowd Faces 37 Attempted Murder Charges

    A convicted felon who allegedly drove his car through a crowd of…
    • Internewscast
    • July 23, 2025

    DCLM Daily Manna 23 July 2025 — Abraham’s Faith

    DCLM Daily Manna 23 July 2025 Devotional by Pastor W. F. Kumuyi…
    • Internewscast
    • July 23, 2025

    Kevin De Bruyne and Scott McTominay Showcase Napoli’s Striking 2025/26 Kits

    Napoli have officially unveiled their home and away kits for the 2025/26…
    • Internewscast
    • July 23, 2025
    Internewscast Journal
    • Home
    • Privacy Policy
    • DMCA Notice
    • Terms and Conditions
    • Guest Post
    • Support Our Cause
    Copyright 2023. All Right Reserverd.