Can Bristol-Myers rebound today?
Shares of Bristol-Myers Squibb fell over 6% yesterday following a downgrade by BMO Capital Markets after the company reported weak clinical trial data for its closely watched non-small cell lung cancer drug nivolumab. Nivolumab is part of a new class of drugs being studied by a host of pharma heavyweights known as PD-1 inhibitors, or programmed death inhibitors. Broadly, PD-1 inhibitors are believed to help the immune system recognize tumor cells and thus boost a person's immune reaction.
Yesterday, we learned, per data released for the upcoming American Society for Clinical Oncology meeting, that nivolumab in combination with Yervoy only reduced tumor burden for 22% of patients receiving the treatment. However, nearly half of patients receiving the combo therapy experienced an adverse event, with many discontinuing the trial altogether. In short, these aren't great data for lung cancer, and the high adverse event rate is worrisome.
Looking ahead, Bristol-Myers still plans on filing for regulatory approval for the combo as a third-line lung cancer therapy, but these data don't bode particularly well for its prospects. As a reminder, nivolumab is also being studied as a treatment for melanoma and renal cancer, giving the drug other shots at a potential regulatory approval down the road.
What's my take? I thought Bristol-Myers was fairly priced prior to this sell-off. After this data release and subsequent drop, I am thus considering entering the stock at these levels. My reasoning is simple. Bristol-Myers offers a dividend of nearly 3%, it has a strong clinical pipeline, and top-notch management. Clinical failures are part and parcel of the health care sector, and price swings can create attractive entry points.
Kamada Ltd. falling on mixed trial data
Shares of Israel-based Kamada are down over 27% on heavy volume in premarket this morning after the company released preliminary top-line results for its pivotal clinical trial for its inhaled Alpha-1 Antitrypsin therapy for the treatment of Alpha-1 Antitrypsin Deficiency, or AAT. What you need to understand is that the drug did not achieve its primary endpoint of time to the first moderate or severe exacerbation event at one year. The company did note that the secondary endpoint "frequency of severe exacerbation" was approximately 50% lower in the AAT group compared to placebo.
Despite stressing the importance of the secondary endpoint in its press release, I think you would be wise to sidestep Kamada for the time being. The drug's failure to perform better than placebo for the primary endpoint will likely be a sticking point for regulators, meaning the drug's chances of approval are likely diminished.
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