Latest From Joseph Haas
Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.
Follow-up Phase IIa data shows strong antifibrotic and NASH-resolution effects for Akero’s efruxifermin, an FGF21 analog. Analysts are calling the drug potentially best in class.
The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.
With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?
With a complete response letter for wet AMD drug abicipar, AbbVie is expected to move on from the drug acquired with Allergan. Molecular Partners now seems inclined to focus on IO, virology.
Also, deals involving Immunomic, Replicate, Biocon, DKSH, Genor, G1, Daiichi Sankyo, Esperion, Alteogen, Gelesis, China Medical System Holdings, Sosei and EverInsight.