Perhaps I was a little too glib in my first statement regarding SRPT risks.
Just to put some flesh on the bones:
- ELEVIDYS is SRPT’s current and future revenue elephant. ELEVIDYS has already received accelerated approval and RFKJr cannot revoke that approval by caveat. But the confirmatory trial is due to readout in late 2025. In the event that it doesn’t confirm, that would be a huge blow, however unlikely.
- But even with approval, the advisory committee, currently being reconstituted, could narrow CMS payment guidelines, which would obviously hit its mostly pediatric population very hard.
- ELEVIDIS is already approved in Japan and is expected to be approved in Europe in the near term, which generates revenues insulated from RFKJr. regardless of any tinkering with CMS payments
- Meanwhile, as Stockdoc has pointed out, Prasad recently said that HHS is not going after ELEVIDIS since it has prior approval: “I heard that new guy at FDA that spooked everyone (Prasad) about SRPT was interviewed by Goldman Sachs yesterday and was point blank asked if FDA was going to pull Elevydis approval. He stated that was not going to happen and that the FDA is looking forward and not going to revisit prior approvals.”
- It’s theoretically possible thar RFKJr could go after SRPTs PMO triumvirate, which is still contributing 1/3 of SRPT’s revenue and profit. But being less expensive, with a longer marketing history, and a prior approval, PMO also seems off the table for attack.
So yes, there are risks, but the recent haircut in share price is consistent with an already executed narrowing of CMS guidelines for Elevidis, rather than some discounted future possibility. |
