Alkermes sinks again on official US rejection

The writing had been on the wall for Alkermes’ depression project ALKS 5461 since a negative US advisory committee vote in November. But the FDA’s official rejection, just after the markets closed on Friday, still sent the company’s stock down as much as 4% this morning. Perhaps the reality is sinking in for investors: even Alkermes appears to have given up on ALKS 5461, though a phase IIIb trial is continuing. Stifel analysts noted that it was unclear whether the FDA had signed off on this study, and the company said an upcoming meeting with the US regulator would determine whether the project had a future. Meanwhile, the group’s schizophrenia candidate ALKS 3831 might get the go-ahead, but its commercial prospects look dim after pivotal data showed that it led to weight gain, a side effect it was designed to avoid. This means that, apart from an early immuno-oncology asset, Alkermes’ main hopes still lie with its marketed products, the alcohol and opioid addiction therapy Vivitrol and the antipsychotic Aristada. However, sales of the former are slowing, and it is unclear whether the product’s revenues will hit sellside consensus of $610m by 2024.