Baird Reiterates a 'Neutral' on Onyx Pharmaceuticals (ONXX); Carfil Pathway Remains High-Risk, Regardless of Brentuximab Panel Outcome

July 12, 2011 2:54 PM EDT
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Baird reiterates a 'Neutral' on Onyx Pharmaceuticals (NASDAQ: ONXX), PT $32.

Baird analyst said, "ONXX shares are weak today presumably on read-through from FDA's recently posted AdCom documents for SGEN's brentuximab, which similar to carfilzomib, is seeking accelerated approval based on a single-arm trial. While we understand the temptation, we urge investors not to read too far into Thursday's brentuximab panel outcome, as significant dissimilarities exist between these cases. Regardless, we remain cautious on ONXX shares based on what we continue to believe is a high-risk carfilzomib strategy."

"What remain relevant are FDA's viewpoints on accelerated approval; and we're still apprehensive on that. In the documents, FDA reiterated its discomfort with single-arm trials, indicating they are only appropriate for rare diseases, or if the agent demonstrates a high level of activity. To that end, we remain unconvinced that carfil satisfies FDA's high bar for accelerated approval. We remain more comfortable on the sidelines."

For more ratings news on Onyx Pharmaceuticals click here and for the rating history of Onyx Pharmaceuticals click here.

Shares of Onyx Pharmaceuticals closed at $35.73 yesterday.


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Robert W Baird