Puma Biotechnology Inc (NASDAQ:PBYI) jolted as much as 80% higher on Monday morning on news that the U.S. Food & Drug Administration posted a seemingly positive review of Puma’s breast cancer drug, neratinib, ahead of an official vote Wednesday. PBYI then settled back to “just” 60% gains a few hours into the trading day.
The FDA asked a few questions and raised a few concerns, notably, “tolerability of neratinib in this patient population is a concern given the frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea.”
Specifically, 95% of patients in clinical trials suffered from diarrhea, with 40% of those suffering the grade 3 form of the side effect.
However, on the whole, PBYI investors seemed pleased with what the FDA did (and didn’t) ask, taking the review as an encouraging sign ahead of the company’s Oncologic Drugs Advisory Committee meeting, scheduled for Wednesday.
Neratinib (PB272) is being tested for the extended adjuvant treatment of HER2-positive early stage breast cancer. The drug is meant for patients who have already received Herceptin.
The FDA preview said that the primary analysis “showed an improvement with neratinib,” and that despite changes made to the clinical trial, the results of sensitivity analyses “appear to be generally similar to the primary analysis results, supporting an effect of neratinib.”
The results are receiving a warm welcome from PBYI stock longs, who have suffered a roughly 80% decline from 2014 highs even after today’s boffo gains.
The company has been a hotbed of volatility thanks to its dependence on this single candidate — Puma Biotechnology is pre-revenue, and has been incurring increasingly larger net losses over the past few years. Specifically, red ink of about $55 million in 2013 has ballooned to losses of $276 million last year.
As of this writing, Robert Martin did not hold a position in any of the aforementioned securities.