Onyx Faces FDA Delay Music (ONXX)
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) is delaying its New Drug Application filing with the FDA for carfilzomib. The delay is based on a recent meeting with the FDA’s Chemistry, Manufacturing and Controls review division where it requested additional information related to commercial-scale manufacturing of carfilzomib.
The company had previously expected to make its application by the end of this year for accelerated approval of carfilzomib. The new target date for its NDA filing for accelerated FDA approval “could occur as early as mid-year 2011.” In short, this is a half-year delay by the sound of it. Maybe more.
While trying to lessen fears, Onyx noted that the clinical profile of carfilzomib has not changed and it further noted that no new safety signals have been observed. It further stated, “The Phase 3 trials are on schedule and actively enrolling patients, and this change is not expected to impact any of the carfilzomib trials or other development plans.”
The company “observed minor variations that are believed to be primarily related to equipment temperature variances.” The complete data set from the Phase 2b 003-A1 clinical trial of carfilzomib in patients with relapsed and refractory multiple myeloma, along with new data on carfilzomib from additional studies, will be presented at the American Society of Hematology Annual Meeting in December 2010.
Delays are rarely a good thing. That is being confirmed in the after-hours session of trading. While the stock rose 4.25 to $27.50 today, the after-hours session right after 5:00 PM EST has shares trading down 7.1% at $25.55. The 52-week trading range is $19.54 to $33.48.
JON C. OGG
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