Onyx Pharma (ONXX) Shares Surge as FDA Panel Sees Benefit to Kyprolis Use
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Shares of Onyx Pharma (Nasdaq: ONXX) are set to open Thursday's trading session up more than 38 percent following news late Wednesday the FDA's Oncologic Drugs Advisory Committee offered a positive benefit-risk opinion on the company's Kyprolis.
The ODAC determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent, Kyprolis should show a benefit.
The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.
Onyx's Exec VP of R&D and Technical Operations, Ted Love, said, "ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma. Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review."
Onyx shares last traded at $61.90.
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The ODAC determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent, Kyprolis should show a benefit.
The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.
Onyx's Exec VP of R&D and Technical Operations, Ted Love, said, "ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma. Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review."
Onyx shares last traded at $61.90.
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