Sage Therapeutics, Inc. already is on shaky ground with investors after Zurzuvae (zuranolone) was approved in the US last year for postpartum depression, but not for the larger indication of major depressive disorder. So, when the company reported on 17 April that the next big multi-indication asset in its pipeline, dalzanemdor (SAGE-718), failed in the first of four clinical trials expected to read out in 2024, its stock price dropped sharply.
Key Takeaways
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Sage’s dalzanemdor failed in the first of four Phase II trial readouts planned this year, showing no difference versus placebo in mild cognitive impairment (MCI) in Parkinson’s disease patients.
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External expectations are low for Phase II readouts in mid- and late-2024 for the drug in MCI in Huntington’s and Alzheimer’s diseases
Dalzanemdor did not just miss the primary endpoint in the Phase II PRECEDENT trial in the treatment of mild cognitive impairment (MCI) in Parkinson’s disease, but it showed no difference versus placebo on Westchester Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test scores at day 42. Sage fell 19.6% to close at $12
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