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Latest From Verastem, Inc.
Yakult's Japan Duvelisib Decision Casts New Shadow Over Shrinking Pharma Ops
Yakult’s decision to pull an approval application for duvelisib in Japan came shortly after a FDA advisory committee said it would re-evaluate the safety and efficacy of the PI3K inhibitor four years since its approval. The developments cast a new shadow over Yakult’s already-suffering pharmaceutical business.
Finance Watch: Q1 Biopharma IPOs Shrink To A Fraction Of 2021 Total
Public Company Edition: Only nine drug developers went public in the US, raising $807m in the first quarter, versus 32 IPOs raising $5.2bn in Q1 of last year. Also, MoonLake closed its SPAC merger, Sanofi priced €650m in sustainability-linked bonds in €1.5bn note sale, and Kaleido will cease operations.
‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals
Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.
Did MEI/Kyowa Kirin Beat The PI3K Tolerability Trap?
PI3K-delta inhibitors have often suffered from safety and tolerability issues, but Phase II data show higher efficacy and lower discontinuation rates for zandelisib than others in the class.
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