Replies to post #245433 on Biotech Values

[DewDiligence]

VKTX—I think this may have the best risk:reward in the biotech universe right now because their molecule is similar to that of MDGL's and is thus de-risked to the extent that a novel molecular entity can be.

I don’t follow VKTX closely; however, there is controversy about just how much MDGL’s NASH compound has been de-risked.

Apparently, MDGL changed the endpoints in its phase-3 NASH trial in midstream. The company says the changes had the FDA’s blessing, but the new endpoints are not consistent with the FDA’s published guidance on what histological improvements a NASH candidate must show to be considered for an accelerated approval.

If the FDA ends up rejecting MDGL’s NASH NDA it’s unclear what effect that would have on VKTX, but it’s not crazy to be concerned that VKTX might incur a steep sell-off.

[dewophile]

Results for the GLP-1/GIP agonist coming before end of Q12023. I was mostly thinking about this as a sideshow but analysts are weirdly excited about it?

One of the few PFE calls I listened to last year was dominated by analysts asking about their oral GLP-1 agonists (interestingly they had 2 they were progressing at the time one with more favorable pK amd the other slightly more advamced IIRC)
I think it’s just the sheer size of the commercial opportunity. Analysts are talking 15-25B in annual sales for LLY’s dual agonist and it can’t even be dosed orally