Relmada shares plunge on Phase 3 trial failure

CORAL GABLES, Fla. - Relmada Therapeutics , Inc. (NASDAQ:RLMD ) experienced a significant drop in its stock value, falling 75% during pre-open trading on Wednesday. The decline came after the company disclosed that the independent Data Monitoring Committee (DMC) found the Phase 3 Reliance II study of REL-1017, intended as an adjunctive treatment for major depressive disorder (MDD), to be futile based on interim analysis. The DMC's assessment suggests that the trial is unlikely to achieve its primary efficacy endpoint with statistical significance.

Chief Executive Officer of Relmada, Sergio Traversa, expressed disappointment with the interim analysis outcome. Traversa stated, "Based on these results, Relmada will evaluate the full dataset to determine next steps for the REL-1017 program." He also acknowledged the contributions of the investigative sites and patients involved in the trial.

Despite the setback with REL-1017, Relmada confirmed its ongoing commitment to the development of REL-P11, a candidate for treating metabolic disease, which is currently in a Phase 1 first-in-human study. The company also reported a robust financial position, with approximately $54.1 million in cash and cash equivalents as of September 30, 2024.

It is important to note that while the DMC did not find any new safety concerns related to REL-1017, the futility of the Reliance II trial at this stage indicates a reassessment of the program's future is necessary. Relmada is expected to conduct a thorough review of the available data to inform its strategic decisions moving forward.

Commenting on the news, Mizuho (NYSE:MFG ) analyst Uy Ear said, "We're hoping for the DMC to recommend no or a modest sample size increase from the interim analysis given the protocol changes & rigorous trial oversight. The futility finding is truly disappointing & likely means end for REL-1017 in MDD. RLMD likely to trade down sharply."

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Source: Investing.com