According to a report from Psychedelic Alpha, Usona has finished submitting its application for psilocybin in major depressive disorder, making it the second psychedelic under review by the agency at present.

  • Compass is developing COMP360, a proprietary synthetic psilocybin, specifically for treatment-resistant depression.
  • The company has previously said that it expects to complete its full submission to the FDA for the drug in the fourth quarter of 2026. 
  • Compass is slated to report its third-quarter earnings on Tuesday, when management is expected to provide further updates on its regulatory timeline.

Shares of Compass Pathways (CMPS) fell 28% on Monday after rival and non-profit research organization Usona Institute reportedly completed its application to the U.S. Food and Drug Administration for a psilocybin treatment in major depressive disorder.

The stock is now on track for its worst day since June 2025, if the losses hold.

Rival Application Pressures CMPS, HELP

According to a report from Psychedelic Alpha, Usona has finished submitting its application for psilocybin in major depressive disorder, making it the second psychedelic under review by the agency at present. Usona, like Compass Pathways, has a Commissioner's National Priority Voucher which is designed to support an accelerated review potentially lasting one to two months after acceptance.

Compass, meanwhile, is developing COMP360, a proprietary synthetic psilocybin, specifically for treatment-resistant depression. The company has two positive late-stage trials, a rolling NDA already underway, and has guided that it expects to complete its full submission in the fourth quarter of 2026, with a potential commercial launch in the first half of 2027, subject to FDA approval and Drug Enforcement Administration (DEA) rescheduling for psychedelic drugs.

Compass is slated to report its third-quarter earnings on Tuesday, when management is expected to provide further updates on its regulatory timeline. According to data from Fiscal AI, Wall Street on average expects the company to report a loss per share of $0.41.

In addition, shares of Helus Pharma fell sharply by 18% on Usona’s application news, on track for its worst day since March 2026. Helus is developing its own psychedelic-based HLP003 as an adjunctive treatment for MDD; the company expects to file an application for the drug’s approval in 2028.

How Did CMPS Retail Traders React?

On Stocktwits, retail sentiment around CMPS stock jumped from 'neutral' to 'bullish' territory over the past 24 hours, while message volume stayed at 'high' levels.

A Stocktwits user dismissed the selloff, noting that the Usna competition has been known for years and expressed optimism for positive updates on the company’s earnings call.

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Another user opined that the stock is entering “make or break season.”

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CMPS stock has gained 19% year-to-date. 

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