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712,186 Results for "sarepta therapeutics inc".
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Podcasts
Sarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon Whiplash, PDUFAs in Cardio
Sarepta will update Elevidys’ label after a patient died following treatment; the FDA issues flu vaccine recommendations without advisor input; Trump CDC nominee Dave Weldon pulled at last minute; and FDA decisions expected for Alnylam’s Amvuttra in ATTR-CM and Milestone’s etripamil in tachycardia.
March 19, 2025
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2 min read
·
Heather McKenzie
Gene Therapy
Sarepta Shares Crash 22% After Patient on DMD Gene Therapy Elevidys Dies
After a patient taking the Duchenne muscular dystrophy gene therapy Elevydis died of liver injury, Sarepta will update the label to reflect the safety signal.
March 18, 2025
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2 min read
·
Tristan Manalac
Accelerated approval
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
January 15, 2025
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2 min read
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Tristan Manalac
Earnings
Sarepta Previews Q4 Findings, Touts Elevidys Earnings Beat
Sarepta Therapeutics’ Duchenne muscular dystrophy therapy Elevidys handily beat analysts’ expectations in the fourth quarter of 2024, reflecting the biotech’s “world-class” execution, according to BMO Capital Markets analysts.
January 14, 2025
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2 min read
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Tristan Manalac
Duchenne muscular dystrophy
Sarepta’s Recent Elevidys Presentations Leave Duchenne Community Wanting
With Sarepta’s gene therapy Elevidys now available to a majority of Duchenne muscular dystrophy patients, experts express cautious optimism while emphasizing the need for further data.
October 28, 2024
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6 min read
·
Heather McKenzie
Duchenne muscular dystrophy
Sarepta’s Duchenne Gene Therapy Placed on Hold in Europe Pending Death Investigation
The European Medicines Agency asked for three clinical trials to be placed on hold until the exact cause of death of a US teenager, who suffered acute liver failure after receiving Elevidys, can be precisely determined.
April 3, 2025
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1 min read
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Dan Samorodnitsky
Editorial
Sarepta, Biotech’s Regulatory Go-Getter, Signs Standout Rare Disease Deal
Not exactly known for its dealmaking, Sarepta Therapeutics has thrown down a massive wad of cash to work with Arrowhead Pharmaceuticals on RNAi-based medicines.
December 4, 2024
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3 min read
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Annalee Armstrong
Press Releases
Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - March 31, 2025
April 1, 2025
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2 min read
Duchenne muscular dystrophy
Regenxbio Gears Up to Challenge Sarepta in DMD as Gene Therapy Advances to Pivotal Studies
Regenxbio is pushing its Duchenne muscular dystrophy gene therapy into pivotal development, with a BLA planned for 2026—potentially posing a threat to Sarepta’s Elevidys.
November 19, 2024
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2 min read
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Tristan Manalac
Press Releases
Sarepta Therapeutics to Announce Fourth Quarter and Full-Year 2024 Financial Results
February 13, 2025
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1 min read
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