Drug Development, Protocols

Protocols: Clovis surges as FDA rules out a panel review for rucaparib; suffering Tokai will now consider all options

Shares of Clovis Oncology surged 13% today on the news that the FDA won’t be holding a panel review for its PARP inhibitor rucaparib. That’s a positive sign for its regulatory prospects. It’s also likely spurred a big sigh of relief at Clovis, which was pummeled during its review of roci not long ago. Rucaparib is one of several late-stage PARP inhibitors angling for a near-term approval. Clovis has a February 23 PDUFA date, but has the potential to score an early approval.

Last month Tokai Pharmaceuticals $TKAI was blasted by the late-stage failure of its lead drug, galeterone. And now it says it’s open to just about anything; including a sale, reverse merger as it includes a review of its remaining strategic alternatives. Wedbush PacGrow has been brought in to advise the company and see what can be salvaged.

Israel’s BioLineRx $BLRX has inked a collaboration with Genentech on several Phase Ib studies that will combine BioLineRx’s BL-8040 with Atezolizumab, Genentech’s anti-PDL1 cancer immunotherapy, in multiple cancer indications.

In addition to bankrolling the diabetes startup AnTolRx (which I wrote about here), Pfizer is also investing in a Pitt spinout dubbed Western Oncolytics. The company has been working at the preclinical stage with a viral approach to attacking cancer cells.


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RAPS Regulatory Convergence 2017