12 month delay for Roche (read Sarepta too).
Their Gene Therapy P2 now scheduled to complete at end of 2023.
Can we read anything into this? The Murdoch Institute combination trial research with ATL1102 may be of interest to Sarepta and Roche.
https://www.fiercebiotech.com/biote...event-ms-trials-becoming-casualty-ukraine-war“When it comes to clinical trials, things rarely go to plan. Just ask Roche, which revealed today that it has pushed back the regulatory timeline for its Duchenne muscular dystrophy (DMD) treatment by a year. In addition, the Big Pharma noted that the conflict in Ukraine has thrown its multiple sclerosis trials into disarray.
Roche had already bet big bucks on its DMD pipeline, stumping up $1 billion in 2019 to
buy the ex-U.S. rights to the investigational drug SRP-9001. Despite facing a phase 2 trial
failure in 2021, as of February Roche had been expecting to ask for approvalin 2023.
But the company’s latest earnings presentation, published today, noted the submission date as 2024.
RBC analyst Brian Abrahams pointed out that Roche’s filing guidance reflects the company's plans in Europe—where it owns the rights— and not necessarily Sarepta’s plans for the U.S.
“We had the opportunity to speak with Sarepta's management this morning, and importantly, they said this does not reflect any changes to the expected timelines for the [phase 3] EMBARK readout or new FDA regulatory requirements,” Abrahams said in a note. “We continue to expect [phase 3] data around mid-2023.”
In an earnings call with investors, Roche Pharmaceuticals' CEO Bill Anderson discussed the phase 3 DMD trial, saying “We hope to have it accrued this year, which means it’s a 12-month endpoint, which would mean we would have a final result from the phase 3 by the end of 2023.”
