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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: li3511 who wrote (63280)11/4/2025 3:12:45 PM
From: Olecranon1 Recommendation

Recommended By
jhcimmu

  Read Replies (2) of 63311
 
I’ve been maybe Sarepta’s biggest permabull. This really puts a hitch in my giddyup. Once we got past the initial FDA shenanigans with Elevidys, I saw a much clearer path forward than this and clearly had too much faith that the Amondys45/Vyondys53 accelerated approval would sail cleanly through the confirmatory trial.

I wonder just how much rope the current FDA will give Sarepta. Worst case, they may even revisit Exondys 51 which was fully approved in 2016, but is also a PMO and so may attract new suspicion. Maybe not likely, but I’m going to continue looking over my shoulder.

I’ve also been of a mind that Elevidys was now in the clear, and recent months have been consistent with that. But one more death, no matter how attenuated the connection to Elevidis, and things could get ugly there as well.
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