- Alkermes (NASDAQ:ALKS +31.6%) jumps out of the blocks on double normal volume this morning in response to its successful Phase 3 study, FORWARD-5, of ALKS 5461 in major depressive disorder (MDD).
- JPMorgan: believes ALKS 5461 approvable in U.S. based on FORWARD-5 results and totality of overall study data and could be worth $18/share in incremental value.
- Goldman Sachs: reintroduced ALKS 5461 into valuation model assuming peak sales at over $700M. Sees a chance that the FDA will request another Phase 3 study to confirm results (two earlier Phase 3s, FORWARD-3 and FORWARD-4, failed). ALKS price target raised to $48 (16% downside risk) from $35.
- Leerink: ALKS 5461 has "reasonable chance" of FDA approval. Price target raised to $70 (23% upside) from $57.
- Cowen & Co.: rates stock Outperform. Price target under review.
- The success of FORWARD-5 surprised many analysts since two other Phase 3's, FORWARD-3 and FORWARD-4, failed based on the same primary endpoint due to a higher-than-expected placebo effect. Enrollment was increased in FORWARD-5 to compensate.
- Previously: Alkermes +50%; announces positive topline results from 5461 depression drug (Oct. 20)