- Axsome Therapeutics (AXSM +19.5%) has announced new data from its GEMINI Phase 3 trial of AXS-05 in patients with major depressive disorder, demonstrating significant improvement in patient-reported outcomes of depression, as measured by the QIDS-SR-16 total score when compared to placebo. Data were presented at the 33rd Congress of the European College of Neuropsychopharmacology.
- Clinical response demonstrated in 53% of patients with AXS-05 compared to 33% for placebo
- Significant improvement on the Patient Global Impression of Improvement demonstrated, with 47% of patients reporting their depression being “very much” or “much” improved with AXS-05 versus 31% with placebo.
- A Phase 3 study, STRIDE-1 failed to achieve the primary endpoint in treatment-resistant disorder, but another Phase 3, GEMINI, and a Phase 2, ASCEND, in major depressive disorder were successful.
- In July, the company said it was on track to file AXS-05 marketing application in Q4.
Axsome +20% as depression drug shows improvement in patient outcomes
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