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Shares of Puma Biotechnology Inc (NASDAQ:PBYI) soared higher by more than 70 percent on Monday after the U.S. Food and Drug Administration posted briefing documents ahead of the regulatory body's review of Puma's PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer, which is scheduled for Wednesday.
The FDA's Oncologic Drugs Advisory Committee is an independent panel of experts that evaluates data relating to the safety and efficacy of investigational cancer treatments. The committee then makes its recommendations to the FDA although these comments are not binding in the FDA's ultimate decision-making process.
The FDA's report spans more than 150 pages and may be difficult for average investors to decipher. The main conclusion from the report was that the company's study showed statistically significant improvement in patients who were treated with neratinib versus a placebo.
The Street's biotechnology expert Adam Feuerstein tweeted following the release that the report was void of any "landmines" at represents a "win for bulls."
Multiple Trading Halts
Shares of Puma opened for trading on Monday at $39.00 and started spiking higher on heavy volume at around 9:52 a.m. ET. After gaining 9 percent, the stock was halted on a circuit breaker within one minute.Once traders and investors had time to review the FDA report, the stock resumed trading within minutes but was halted at around 9:58 on a second circuit breaker after gaining 45.5 percent.
Shares resumed at 10:03 and continued higher before halted yet again on a third circuit breaker at 10:10 after gaining 83.5 percent on the day.
Shares resumed trading at 10:27 and were last seen trading at $57.19, up 52.25 percent on the day.
Related Links:Here's What Analysts Are Asking Puma Biotech Following Roche's Positive Perjeta ResultsPuma Biotechnology Shares Plunge On Plans To Modify Neratinib European MAA, Competitor Roche's Perjeta Win_____Image Credit: By Think-pink - Own work, CC BY 3.0, via Wikimedia CommonsCrypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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