Onyx (ONXX) Shares Falling as FDA Grants Standard Review to NDA for Carfilzomib
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Shares of Onyx Pharma (Nasdaq: ONXX) are down nearly 9 percent in Monday morning's pre-market trading session following a press release late last night.
The company announced the U.S. FDA has granted Standard Review designation to the NDA for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the NDA is July 27, 2012.
Onyx had been hoping for a faster review for the product.
The FDA advised Onyx that recent Oncology Drug Advisory Committee recommendations specify a preference for Phase 3 trials for the accelerated approval pathway. Based on its preliminary review and ongoing assessment of the application, the FDA outlined potential review issues including whether the application is sufficient to support an FDA conclusion that the data provided within the NDA meets accelerated approval criteria and whether the benefit and risk are appropriately balanced, given that the application is based on a single-arm study.
With more than a half hour left in the pre-market trading session, Onyx shares last traded at $37.08.
The company announced the U.S. FDA has granted Standard Review designation to the NDA for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the NDA is July 27, 2012.
Onyx had been hoping for a faster review for the product.
The FDA advised Onyx that recent Oncology Drug Advisory Committee recommendations specify a preference for Phase 3 trials for the accelerated approval pathway. Based on its preliminary review and ongoing assessment of the application, the FDA outlined potential review issues including whether the application is sufficient to support an FDA conclusion that the data provided within the NDA meets accelerated approval criteria and whether the benefit and risk are appropriately balanced, given that the application is based on a single-arm study.
With more than a half hour left in the pre-market trading session, Onyx shares last traded at $37.08.
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