Relmada Stock Tumbles To 52-Week Low On Failed Depression Trial

• Relmada Therapeutics Inc's (NASDAQ: RLMD) RELIANCE III study (REL-1017-303) of REL-1017 in the monotherapy setting for Major Depressive Disorder (MDD) did not achieve its primary endpoint.

• The product candidate failed to achieve a statistically significant improvement in depression symptoms compared to the placebo.

• The REL-1017 treatment arm showed a symptom score reduction of 14.8 points at Day 28 versus 13.9 points for the placebo arm, a higher-than-expected placebo response.

• In August, the FDA granted Fast Track designation to REL-1017 for major depressive disorder.

• Paradoxical results were observed in certain study sites, where placebo dramatically outperformed REL-1017. Relmada is investigating the nature of these results.

• REL-1017, administered for 28 days to 232 subjects in RELIANCE 3, demonstrated favorable tolerability and safety, confirming the results of Phase 1 and Phase 2 studies, with no opioid-like effects, withdrawal effects, and psychotomimetic effects.

• There were no adverse events related to QTcF prolongation.

• Relmada continues to enroll patients in RELIANCE I and RELIANCE II, two ongoing Phase 3 studies evaluating REL-1017 as a potential adjunctive treatment for MDD.

• Price Action: RLMD shares are down 78.1% at $6.94 during the premarket session on the last check Thursday.

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