Forbe's Herper says Ad Comm thumbs up on Puma's neratinib not a sure thing; shares ahead 36% [Seeking Alpha]
Puma Biotechnology Inc (PBYI)
Last puma biotechnology inc earnings: 2/20 04:07 pm
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Source: Seeking Alpha
Puma Biotechnology ( PBYI ) has been up big all day on more than a 10x surge in volume as investors like what they see in the briefing documents ahead of Wednesday's advisory committee review of neratinib for the treatment of HER2+ breast cancer. Forbe's Matthew Herper agrees that the docs "don't look as bad as bears expected" but a positive vote is not a slam dunk. There are two significant "deal-killers" that the committee will address: the high rate of diarrhea and the number of changes made to the study that affected the statistical validity of the data. Apparently, the results were so concerning that the agency advised the company not to file a new NDA when it approached the regulator about doing so. Mr. Herper says the opinion of statistical expert Ralph D'Agostino will be a major factor. Provision Policy analyst Michael McCaughen says the odds of the committee backing approval are a "coin flip." Source: The Fly Previously: Briefing docs out for Ad Comm review
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PBYI
News
- Do Puma Biotechnology's (NASDAQ:PBYI) Earnings Warrant Your Attention? [Yahoo! Finance]Yahoo! Finance
- Puma Biotech cleared to trial Takeda-partnered breast cancer therapy in U.S. [Seeking Alpha]Seeking Alpha
- Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer [Yahoo! Finance]Yahoo! Finance
- Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast CancerBusiness Wire
- Puma Biotechnology, Inc. (NASDAQ: PBYI) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
PBYI
Earnings
- 2/29/24 - Miss
PBYI
Analyst Actions
- 2/13/24 - HC Wainwright
PBYI
Sec Filings
- 3/19/24 - Form 4
- 3/19/24 - Form 8-K
- 2/29/24 - Form 10-K
- PBYI's page on the SEC website