Shares of Onyx ($ONXX) slid 6% this morning on the news that it will have to settle for a standard review of its closely-watched cancer drug carfilzomib after failing to win an accelerated review. Onyx issued a release yesterday saying that regulators had turned down its bid for the inside regulatory track after concluding that the biotech had not completed the necessary trials.
That leaves Onyx on track to learn the fate of its multiple myeloma program by July 27, four months after they would have found out under the accelerated review process. The news clearly disappointed investors, but at least a few analysts believe that the longer review process will still lead to a positive conclusion.
"We are surprised by the FDA's timeline, but remain confident that carfilzomib will be approved and recommend purchase of Onyx on weakness," noted Gene Mack, an analyst with Mizuho Securities, according to a Bloomberg report. Onyx acquired carfilzomib when it bought out Proteolix in an $851 million deal.
"Our goal remains to make this promising new therapy available to patients with relapsed and refractory multiple myeloma as quickly as possible," said Ted W. Love, M.D., executive vice president, research and development and technical operations at Onyx. "We are committed to working with the agency to address the comments outlined in the letter."
- read the press release
- here's the story from Bloomberg
Special Report: Carfilzomib - 10 promising late-stage cancer drugs
Onyx wraps NDA for blockbuster cancer drug hopeful carfilzomib
Onyx Pharma shares soar on report of its hunt for options, acquirers