Is The FDA Panel Vote On Puma Biotech Likely To Lead To Actual Approval?

Shares of Puma Biotechnology Inc PBYI hit a new 52-week high of $80.00 Thursday morning after the company confirmed that the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee voted 12–4 to recommend approval of PB272 (neratinib) for the treatment of early stage breast cancer.

12–4, But No Definitive Approval ... Yet

Following the vote, Credit Suisse's Alethia Young maintained an Outperform rating on Puma's stock with a price target boosted from $58 to $90, although the company's announcement doesn't yet imply the approval of neratinib. The analyst did state that the FDA's vote of 12–4 in favor of approval now increases the odds of ultimate approval from 75 percent to 100 percent.

According to Young, the key debate among the panel surrounded what is the right subset of patients that see benefits from neratinib and limiting eligibility of neratinib use for patients that had completed adjuvant treatment less than two years with Herceptin.

"We only model use in HR+ patients, so even if the label is limited to that subgroup we don't see significant downside from that," Young explained. "We would be cautious to assume that there was a healthy debate around the trial amendments and statistics, but overall it seemed that the concerns were manageable."

Finally, the analyst suggested that the next major catalyst for Puma's stock is the full data presentation Roche's APHINITY study, which "looks at extended adjuvant use of Herceptin and Perjeta for a year."

At time of publication, shares of Puma Bio were up 3.4 percent at $77.50.

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