Cingulate shares plans to resubmit its ADHD candidate CTx-1301 to the FDA, following a CRL tied to CMC information requests
News|Articles|September 30, 2026
September 2026 in Review: Updates on the Psychiatric Treatment Pipeline, FDA News
Author(s)Leah Kuntz
Check out our pipeline updates from September!
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Take a look at this month’s developments in the psychiatric treatment pipeline. We compiled a recap of the latest news here, just in case you missed any of the updates.
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Alkermes launches a phase 2 trial of oral orexin-2 agonist ALKS 7290 to boost antidepressant response in major depressive disorder, assessing safety and symptom relief.
Sabirnetug phase 2 Alzheimer trial misses cognitive endpoint despite lowering amyloid, prompting Acumen to halt development and open-label extension plans.
Neflamapimod misses its main DLB endpoint, but biomarker and subgroup signals suggest IL-1β pathway impact and may justify a phase 3 trial.
In the second positive phase 3 trial of lumateperone (Caplyta) for bipolar mania, participants saw improved manic symptoms vs placebo as early as day 3.
Lipocine has dosed the first participant in BLOOM, their phase 3 study evaluating LPCN 1154 (oral brexanolone) for postpartum depression.
Compass Pathways has completed its submission of an NDA to the FDA for COMP360 psilocybin for treatment-resistant depression.
GLP-1 drugs enter psychiatry, curbing antipsychotic weight gain while raising new questions about addiction, mood, eating disorders, and culture.
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