Puma Biotechnology Inc (NASDAQ: PBYI) is having an overwhelmingly rough start to the trading session in the pre-market hours this morning, and for good reason. The company released results from a key clinical trial, leading to fears that the candidate will not make it to market approval. Of course, as a result of these fears, investors are driving the stock into the ground. Today, we’ll talk about the results, what we’re seeing from PBYI, and what we’ll be watching for ahead.
PBYI Falls Hard On Clinical Results
In a press release issued early this morning, Puma Biotechnology announced bad news surrounding a key clinical trial. According to the announcement, the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated issues with the company.
According to the release, the CHMP informed PBYI that it is seeing a negative trend vote after meeting with the company yesterday to discuss the Market Authorisation Application surrounding the company’s neratinib. Neratinib is designed for the extended adjuvant treatment of early-stage HER2-positive breast cancer.
Unfortunately for PBYI and its investors, the negative trend that was announced means that it is highly unlikely that the CHMP will provide a positive opinion surrounding the application. While the vote doesn’t take place until February, this is proving to be a major cause for concern among investors, as it should be.
In their communication with Puma Biotechnology, the EMA pointed out one major concern. According to the CHMP, the benefit-risk assessment is negative. This is due to the fact that the results are based on evidence from a single pivotal trial, and the 2- and5-year invasive disease-free survival benefits observed to date may lack sufficient clinical relevance.
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