neratinib

Puma Biotechnology Inc (NASDAQ: PBYI) could face a setback in the launch of its breast cancer drug neratinib, as the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, relayed a "negative trend vote" after a meeting with the biotech company. ...

Shares of Puma Biotechnology Inc (NASDAQ: PBYI), a development stage biotech company focusing on cancer treatment, are down over 25 percent in pre-market trading. What You Need to Know Puma Biotech announced Tuesday afternoon the Committee for Medicinal Products for Human Use of the European...

The U.S. Food and Drug Administration on Monday approved Puma Biotechnology Inc (NASDAQ: PBYI)'s NERLYNX (neratinib), formerly known as PB272, for the treatment of breast cancer. Neratinib is the first anti-HER2 treatment to gain the FDA's approval for extended adjuvant therapy for early-...

June was event-filled as far as the PDUFA calendar was concerned. The month ushered in good tidings for the biotech sector, as most applications for approval pending before the FDA were favorably viewed. The iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) has been up 11.70 percent thus...

Shares of Puma Biotechnology Inc (NASDAQ: 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...

Puma Biotechnology Inc (NASDAQ: PBYI) investors got some major vindication Wednesday when the FDA’s Oncologic Drugs Advisory Committee voted 12–4 to recommend approval of neratinib for treatment of patients with early-stage HER2-positive breast cancer. Puma had plenty of doubters and...

Puma Biotechnology Inc (NASDAQ: PBYI) traders are eagerly-anticipating the end of the trading halt for Puma on Wednesday after the company received a positive recommendation for approval of neratinib from the FDA’s Oncologic Drugs Advisory Committee. The advisory committee voted 12-4 to...

Puma Biotechnology Inc (NASDAQ: PBYI) shares skyrocketed 39.1 percent in Monday’s trading session after the FDA’s review of breast cancer drug candidate neratinib released on Monday was relatively benign. However, even after the big Monday move, JPMorgan said the options market is...

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...

RBC Capital says the commercial opportunity for Puma Biotechnology Inc (NASDAQ: PBYI)’s breast cancer drug neratinib in the extended adjuvant setting should be “considered as eliminated,” given Roche Holding Ltd. (ADR) (OTC: RHHBY)’s positive top-line data for Perjeta....

Shares of Puma Biotechnology Inc (NASDAQ: PBYI) plunged more than 25 percent following plans to modify the summary of product characteristics (SmPC) in its European Marketing Authorization Application (MAA) for its breast cancer drug neratinib. Timeline, Pipeline The company now plans to restrict...

Puma Biotechnology Inc (NYSE: PBYI) shares were down a whopping 21.73 percent on about 5 times its average volume. The plunge has come after a decent bump up last week since a recent low of $34.60 reached November 4. Abstract Steps Up Safety Worries The immediate catalyst that sent the stock on a...

Stock futures pointed to a lower open following premarket data revealing that the U.S. economy and job market are improving faster and stronger than expected. Selling began at the bell and continued for the entire day as major indices failed to hold on to any rallying gains. Investors and...