Clovis Oncology Inc. (NASDAQ: CLVS) was down about 5% Tuesday and was down even more Wednesday after the Oncologic Drugs Advisory Committee voted against its lung cancer drug. The committee recommended that the FDA wait to see results from TIGER-3, Clovis’s ongoing Phase 3 trial, before making a decision on approval of the treatment. As a result analysts piled into the stock, and 24/7 Wall St. has put together a few different views surrounding this FDA decision.
Looking ahead, the FDA set a target action date of June 28, 2016 under the Prescription Drug User Fee Act (PDUFA). The TIGER-3 trial, Clovis’ confirmatory randomized, controlled Phase 3 study for rociletinib is ongoing, with patient enrollment expected to complete in late 2018.
Janney commented on the decision:
Today’s Advisory Committee was more focused than we anticipated on the shortcomings in Clovis’s data set. The panel vote recommended 12-to-1 to wait for TIGER-3 data (expected YE18 at the earliest), we expect to result in a CRL and thus we are pushing roci’ out to a 2020 launch. The panel members were uncomfortable with determining if the agent’s toxicities and dose-dependence were adequately demonstrated by the data at hand. Our fair value is reduced to $24 (from $50) and we remain Buy rated ahead of an expected rucaparib NDA filing this quarter in ovarian cancer.
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