Sarepta Therapeutics, Inc.

NEWS
Its capacity to produce AAV (Adeno Associated Virus) materials at large-scale will support Genethon and Sarepta’s project to take micro-dystrophin to clinical trials this year
It can be a bit difficult to predict exactly what the big stories out of the JP Morgan Healthcare Conference are going to be. There’s no telling if some surprise deal will take the air out of the room, but here’s a look at some of the top presentations.
Sarepta Therapeutics and Roche inked a licensing deal that gives Roche exclusive commercial rights to SRP-9001, Sarepta’s investigation gene therapy for Duchenne muscular dystrophy, outside the U.S.
FDA
The agency is requiring Sarepta to conduct a confirmatory trial, which Sarepta says will conclude by 2024.
It was another busy week for clinical trials. Here’s a look.
There are high hopes for more M&A in the industry for the remainder of the year. Here’s a look at the 10 top takeover targets.
Although a definite blow to Sarepta, this may have negative implications for other companies working to develop therapies for DMD. This includes Wave Life Sciences and Solid Biosciences.
The regulatory agency expressed concern regarding the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides, Sarepta said.
Wrapping up the month of August, there are technically four PDUFA dates on the calendar, although one was approved two months early and another may be delayed as the U.S. Food and Drug Administration reevaluates its policies regarding opioid pain medications. Here’s a look.
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