Jefferies Maintains Buy on Onyx Pharma After FDA Acceptance of NDA Filing

Jefferies & Company has published a research report on Onyx Pharmaceuticals

after the FDA accepted the company's carfilzomib NDA filing, which was expected. In the report, Jefferies writes, "Before market open Tues, Nov 29, ONXX announced FDA has accepted its NDA filing for accelerated approval for carfilzomib in relapsed and refractory multiple myeloma which is largely based on the positive results for the single-arm open label carfilzomib PIIb 003-A1. While the timely acceptance is an incremental for positive for ONXX, we note FDA has yet to grant a 6-month priority review with a possibility of a 10-month standard review. Given FDA typically informs the NDA applicant of priority review designation by ~Day 60 from NDA filing or when FDA informs on NDA acceptance (in this case), we believe ONXX may be trying to convince the FDA on the unmet medical needs of its NDA application." Jefferies maintains its Buy rating and $50 price target on Onyx Pharmaceuticals, which is currently trading up $1.08 from yesterday's $42.80 closing price.