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780,003 Results for "sarepta therapeutics formerly known as avi biopharma inc".
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Regulatory
FDA Imposes Boxed Warning, Narrows Patient Pool for Sarepta’s Duchenne Gene Therapy Elevidys
Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed with the gene therapy.
November 17, 2025
·
1 min read
·
Tristan Manalac
Gene therapy
Sarepta’s Not Done With Gene Therapy Yet as LGMD Asset Yields Promising Data
Despite announcing a broad pivot to siRNA earlier this year, Sarepta is following through with an investigational gene therapy: its limb-girdle muscular dystrophy candidate. But the treatment’s path forward, analysts say, is highly uncertain.
October 15, 2025
·
6 min read
·
Tristan Manalac
Duchenne muscular dystrophy
Sarepta’s DMD Exon-Skippers Fail Confirmatory Study, Stock Craters
Sarepta nevertheless plans to push for full FDA approval of Vyondys 53 and Amondys 45 based on what it said are “encouraging trends” in efficacy.
November 4, 2025
·
2 min read
·
Tristan Manalac
Gene therapy
Doctors Still Prescribing Sarepta’s DMD Gene Therapy After Safety Concerns
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record.
September 16, 2025
·
3 min read
·
Annalee Armstrong
Duchenne muscular dystrophy
UPDATE: Second Patient Dies After Receiving Sarepta’s DMD Gene Therapy Elevidys
Sarepta’s shares crashed 41% in premarket trading Monday morning to $21.01 after the biotech reported a second death from acute liver failure, a known side effect of adeno-associated virus-based gene therapies.
June 16, 2025
·
3 min read
·
Tristan Manalac
Gene therapy
FDA’s Second Platform Designation Goes to Krystal After Sarepta Withdrawal
After the FDA revoked Sarepta Therapeutics’ platform designation in July, Krystal Biotech is “poised to be the first major beneficiary” of this program, according to analysts at William Blair.
October 15, 2025
·
2 min read
·
Tristan Manalac
Gene therapy
Sarepta’s Woes Put the Stalwart AAV Under a Harsh Light
In the wake of multiple patient deaths from liver injuries related to Sarepta Therapeutics’ AAV gene therapy platform, some in the sector are looking for ways to improve the current technology, while others are eager to move on.
August 11, 2025
·
7 min read
·
Dan Samorodnitsky
C-suite
Caught In Sarepta ‘Downdraft,’ Arrowhead Becomes RNAi Knight in Shining Armor
Sarepta’s troubles had nothing to do with Arrowhead’s assets, and yet both companies have seen their stock prices decline this past month.
BioSpace
caught up with Arrowhead’s Chris Anzalone to talk about the biotech’s role as an RNAi pipeline savior.
August 12, 2025
·
7 min read
·
Annalee Armstrong
Gene therapy
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an anonymous senior FDA official. Given Elevidys’ full approval, however, experts told
BioSpace
this path would set up a length legal battle between the regulator and Sarepta Therapeutics.
July 25, 2025
·
4 min read
·
Tristan Manalac
Press Releases
Arrowhead Pharmaceuticals Earns $200 Million Milestone Payment from Sarepta Therapeutics
November 24, 2025
·
4 min read
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