Jefferies sees ‘bearish view’ on Alkermes depression drug into panel vote

An FDA Advisory Committee will convene on November 1 to review Alkermes’s ALKS-5461, a treatment for depression, Jefferies analyst Biren Amin tells investors in a research note. The analyst believes consensus currently has a “bearish view” on ALKS-5461. As such, any favorable read-through of the briefing documents on Tuesday could see Alkermes shares up 10%-15%, with another 10%-15% upside on a favorable vote, Amin contends. A negative outcome could lead shares to decline by up to 10% in total, says the analyst. He believes Alkermes is focused on comparing the treatment effect by averaging the last three weeks and comparing the change to baseline versus the placebo group as the analysis was conducted in Forward-5 on a prospective basis. Amin, however, has issues with this methodology, saying in a short-term trial the FDA and the Panel may want to see a consistent treatment effect over placebo across several weeks. The trial clearly missed on weeks three, five and end of treatment, and the p-value was driven by week four, Amin writes. He keeps a Hold rating on Alkermes with a $43 price target.
https://thefly.com/landingPageNews.php?id=2812483