Relmada's Trial Failure Removes Competitor Risk For This Company's Newly Launched Depression Product

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  • On Thursday, Relmada Therapeutics Inc RLMD reported a failed Phase 3 Major Depressive Disorder monotherapy trial for its REL-1017.
  • BofA analyst noted this was a potential competitor to Axsome Thearpeutic Inc's AXSM recently approved Auvelity.
  • The analyst said he would "not be surprised" to see Axsome shares trade with some strength as investors might heavily discount the competitive threat based on the mono trial miss despite Relmada still having data pending for two studies investigating 1017 as an adjunctive treatment. 
  • He added that Axsome consensus forecasts for U.S. Auvelity sales in MDD "do not appear to reflect a disruptive and direct" in-class competitive threat.
  • BofA analyst maintains an Underperform rating on Axsome, mainly due to what he sees as Auvelity commercial risk ahead of the Q4 launch.
  • Post-Relmada's 1017 Phase 3 monotherapy miss, the company has two pending Phase 3 adjunct trial MDD readouts (est. readout 4Q22). 
  • The analyst thinks it is fair to say that hitting on two adjunctive trials will be challenging.
  • On safety, BofA noted that topline REL-1017 was reported positive, including no opioid-like effects or AEs related to QTcF prolongation. 
  • Price Action: AXSM shares are up 3.61% at $47.88, and RLMD shares are up 1.47% at $6.57 on the last check Friday.
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