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Joseph Haas
Latest From Joseph Haas
No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection
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.
Akero Histology Data Could Be Best In Class For NASH
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.
Intercept CRL Likely About OCA-Specific Concerns, Not NASH Endpoints
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.
Intercept’s CRL Just Continues Upheaval In NASH
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?
AbbVie Expected To Ditch Abicipar After US FDA Setback
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.
Asia Deal Watch: Betta Will Bring Two Agenus Oncology Candidates To Its Market Area
Also, deals involving Immunomic, Replicate, Biocon, DKSH, Genor, G1, Daiichi Sankyo, Esperion, Alteogen, Gelesis, China Medical System Holdings, Sosei and EverInsight.