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Shares of Relmada Therapeutics (NASDAQ:RLMD) plunged over 80% Thursday after the company announced that its drug to treat major depressive disorder did not achieve its primary endpoint.
Relmada shares closed Wednesday’s session at $31.69 per share, but they are now down at $6.54.
Following the news, Oppenheimer downgraded the shares of Relmada from Outperform to Perform with a price target of $7, down from $64 per share.
“We downgrade RLMD from Outperform to Perform based on the negative results of the Ph3 RELIANCE-III trial for REL-1017 in MDD monotherapy, which missed the primary endpoint due to a higher-than-expected placebo response. We consequently lower our expectations for the upcoming Ph3 RELIANCE-I/II trials of REL-1017 in the MDD adjunctive setting that we anticipate to read out by YE22 as we see direct negative read-across,” wrote the analysts.
Relmada stated in its press release that REL-1017 demonstrated “very favorable tolerability and safety,” but analysts were less than optimistic.
“Although RLMD notes that REL-1017 was safe/well-tolerated in RELIANCE-III and that ‘paradoxical results’ for placebo were observed only at certain study sites, we caution against optimism for RELIANCE-I and RELIANCE-II as we note site overlap, consistent protocol, and parallel timing,” the analysts added.
“RLMD is now investigating the details that led to failure for REL-1017. RLMD has already conducted a post-hoc analysis using the band-pass method, which excludes sites with implausibly high/low placebo responses (MADRS10 >14pts and 3pts), showing a meaningful placebo-adjusted response of >4.9pts on MADRS (p0.05). However, we note 58 sites according to CT.gov, and suspect this result was a function of clinical trial execution.”
