SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?


To: li3511 who wrote (63280)11/4/2025 3:12:45 PM
From: Olecranon1 Recommendation

Recommended By
jhcimmu

  Read Replies (2) | Respond to of 63312
 
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.



To: li3511 who wrote (63280)11/5/2025 1:45:28 AM
From: ghettogoulash2 Recommendations

Recommended By
jhcimmu
Olecranon

  Read Replies (1) | Respond to of 63312
 
Indeed, this will be a tough sell to Prasad & Co. Then again, it's gonna take some big balls to withdraw these therapies from patients. I think we see $10 again. I sold 3/4 of my position at $19, bought some back in the $15s, and will be averaging down from there if I am right. The semiconductor/AI sector, which seems to be about 90% of the market these days, is showing signs of rolling over on these absurd valuations, which unfortunately will take everything else with it.

Reinstatement of Elevidys is taking longer than I expected; guidance for flat revenue next quarter is a surprise. As for the PMOs, I was not at all surprised by the trial results. I have been dreading that readout. However, it would seem that Elevidys is expected to supplant those therapies anyway except in certain cases, most notably, non-ambulatory patients and others ineligible for gene therapy. As an investor, I am in no hurry to reinstate non-ambulatory to Elevidys' label. Too much risk. Unless of course those patients are demanding the drug.