Needham analyst Ami Fadia notes results from study 403 for lumateprone in mixed features reported by Intra-Cellular demonstrated strong efficacy on both the primary and secondary endpoints across the entire study population as well as the sub-populations of MDD and bipolar depression patients with mixed features. Further, there were no safety concerns. While the firm has been skeptical on the regulatory path to approval in mixed features, Needham notes that the placebo adjusted change in MADRS score at week 6 of -5.7 was better than what it had expected. More importantly, the firm believes these data also incrementally increase its confidence in the potential for lumateprone to demonstrate positive data in MDD. Needham maintains the 40% POS for the mixed features indication, but believes the positive move in the stock makes sense and reiterates a Buy rating on the shares with a price target of $66.
Published first on TheFly
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