Flagship Pioneering startups Valo Health and Montai Therapeutics announced a merger on Nov. 11. The combined company will keep the Valo name and be led by Valo CEO Brian Alexander. It plans to combine Valo’s AI-enabled human-biology and predictive-chemistry capabilities with Montai’s chemistry platform and immunology and inflammation pipeline. Deal terms were not disclosed.
Johnson & Johnson said on Nov. 10 that its second Phase 3 study of Caplyta (lumateperone) for manic episodes associated with bipolar I disorder met its primary and key secondary endpoints. Over three weeks, Caplyta improved mania scores more than placebo; improvement was reported as early as Day 3.
In the second trial, 43.9% of Caplyta recipients achieved at least a 50% reduction in mania symptoms, versus 23.7% on placebo. Together with results from the first positive Phase 3 study, the findings support J&J’s planned U.S. regulatory submission. Caplyta is not yet approved for bipolar mania.
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