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Fly News Breaks for May 24, 2016
ALKS
May 24, 2016 | 06:30 EDT
Leerink analyst Paul Matteis points out that Alkermes will present and hold a webcast discussing full data from its FORWARD3 and FORWARD4 studies of ALKS5461 in treatment-resistant depression at the American Society of Clinical Psychopharmacology meeting, which starts on May 30 and runs until June 3. The analyst remains cautious on the drug after FORWARD3 and FORWARD4 missed their primary endpoints. He points out, however, that management has remained optimistic that FORWARD4 provides clear evidence of efficacy for the 2:2 dose. While much needs to be learned about the data from the two failed studies, regulatory precedent in depression, most recently with Otsuka/Lundbeck's Rexulti, suggests that mixed/positive data packages could enable FDA approval, Matteis tells investors in a research note. Rexulti, which was approved by the FDA in June 2015, was very close in Phase 2, succeeded in one large Phase 3 and showed a strong trend in another Phase 3, which is encouraging for Alkermes should the FORWARD5 study be a "clear win," Matteis contends. Unlike ALKS5461, however, Rexulti's dataset did not include a pivotal study that was a clear failure, like FORWARD3, the analyst cautions. Matteis reiterates an Outperform rating on Alkermes with a $58 price target. The shares closed yesterday down 10c to $42.88.