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.

Get Endpoints News in your inbox

Newsletters for those who discover, develop, and market drugs. Enjoy the news with the story intact — entire articles in your inbox, no clicks required. Join 12,000+ biopharma pros who read Endpoints News every day. Free subscription.


Subscribe to Endpoints

John Carroll, Editor and Co-Founder

We produce two daily newsletters designed to give you a complete picture of what's important in biopharma.

Early Edition is a skimmable digest of original sources you need to see by ~7:15a ET, and our Main Edition is the daily chronicle of biotech, with every story inside the email ~11:55a ET.
2x/weekdays. Privacy policy