Puma Biotechnology Inc (NASDAQ: PBYI) is having an overwhelmingly strong start to the trading session this morning. So strong, in fact, that the stock has already seen 2 volatility halts. The gains are ultimately the result of the FDA review of neratinib, which seems to support the potential approval of the treatment. As a result, investors became excited, sending the stock skyward and prompting our partners at Trade Ideas to alert us to the gains. At the moment (9:58), PBYI is trading at $55.00 per share after a gain of $17.20 per share (45.50%) thus far today.
PBYI Gains On FDA Review
As mentioned above, the FDA recently reviewed Puma Biotechnology’s neratinib. Today, the results of that review were released, which proved to be overwhelmingly positive. In the review, the FDA waged no serious concerns, nor dropped any major landmines.
In fact, in the review, the FDA pretty much concluded that the efficacy of the treatment supported the its potential approval. In a key paragraph from the review text, the FDA had the following to offer with regard to PBYI neratinib:
“The applicant conducted a multicenter, randomized, double-blind, placebo-controlled study of neratinib versus placebo in women with early-stage HER2-overexpressed/amplified breast cancer after adjuvant treatment with trastuzumab. There were several major unplanned amendments made to the trial impacting enrollment, the number of iDFS events observed, and the period of patient follow up. The primary analysis showed an improvement with neratinib with an absolute difference in iDFS of 2.8% after a 2-year follow-up [stratified HR: 0.66 (0.49, 0.90); p value: 0.008 ]. Despite the unplanned amendments and potential uncertainty introduced with respect to the magnitude of neratinib effect, based on the sensitivity analyses conducted, the results appear to be generally similar to the primary analysis results, supporting an effect of neratinib. The tolerability of neratinib in this patient population is a concern given the frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea. In Study 3004, nearly all patients experienced any Grade diarrhea and 40% of patients experienced Grade 3 diarrhea. Results from the ongoing Phase 2 Study 6201 suggest that antidiarrheal prophylaxis decreases the incidence and severity of diarrhea.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on PBYI. In particular, we’re interested in the ongoing application surrounding bringing neratinib to the market, one which seems as though it’s going overwhelmingly well. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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