- Looking to make a comeback after a big Phase 3 flop, Sage Therapeutics Inc SAGE revealed data from another Phase 3 evaluating zuranolone in patients with Major Depressive Disorder (MDD).
- Though the trial achieved the primary endpoint of statistically significant improvements in depressive symptoms compared with placebo at Day 15, some results have made investors react, thus sending SAGE shares down early Tuesday.
- Zuranolone whiffed on a key secondary endpoint, the CGI-Severity scale (measures illness severity), only achieving a -0.2 difference compared to placebo.
- And though patients who responded positively to the HAMD-17 (Depression score) scale at day 15 maintained 86.1% of their improvement four weeks after stopping treatment, that figure did not come in as statistically significant.
- Another measurement using the MADRS scale (Depression Rating score) also showed how responders retained 87.6% of their improvement, failing to hit statistical significance as well.
- Regarding safety, patients in the treatment arm reported higher rates of treatment-related side effects vs. placebo including drowsiness (15.3% vs 3.0%), dizziness (13.8% vs 2.2%), headache (10.8% vs 7.8%) and sedation (7.5% vs 0.4%).
- In November 2020, Biogen Inc BIIB announced to pay $1.5 billion upfront to Sage under an agreement to develop zuranolone and SAGE-324 in the U.S.
- Price Action: SAGE shares are down 11.5% at $64.50, and BIIB is down 0.46% at $404.29 during the premarket session on the last check Tuesday.
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