Compass Pathways To Complete COMP360 FDA Filing Within Two Weeks — CEO Nath Eyes Launch In First Half Of 2027

• The drugmaker reported a diluted net loss of $0.31 per share in Q3, beating analysts’ expectations of a $0.41 per share loss, according to Fiscal.ai.
• Compass ended September with $444 million in cash, which it expects will fund operations and capital expenditure requirements into 2028.
• Beyond TRD, Compass is evaluating COMP360 in a late-stage trial for PTSD.

Compass Pathways (CMPS) was on investors’ radar on Tuesday, after the company said it expects to complete its New Drug Application for its depression treatment within two weeks, potentially paving the way for a commercial launch in the first half of 2027.

CMPS shares were up more than 10% in pre-market trading.

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Compass Gears Up COMP360 Launch

COMP360 is a synthetic psilocybin-based treatment being developed for treatment-resistant depression (TRD), a form of depression in which a patient’s condition does not improve after at least two antidepressant medications.

CEO Kabir Nath said the company is preparing for a potential launch in the first half of 2027. “With the imminent completion of our NDA submission and the potential for a quick approval, we are executing with urgency and discipline to launch this much-needed treatment in the first half of 2027.”

Compass said it has already picked its commercial team for the drug while the selection of a sales team is currently underway.

COMP360 Meets Primary Goal In 2 Phase 3 Trials

COMP360 achieved its primary goals in two Phase 3 trials involving more than 1,000 patients, showing significant improvements in depression symptoms after six weeks. In September, 52-week follow-up data showed additional benefits from repeat treatment, with improvements lasting up to one year.

Compass is also evaluating COMP360 in a late-stage trial for post-traumatic stress disorder (PTSD).

The company expects COMP360 to be a “blockbuster opportunity” catering to an estimated market of four million people in the U.S.

Compass’ Cash Runway Extends Into 2028

The drugmaker reported a diluted net loss of $0.31 per share in the third quarter (Q3), narrowing from $1.44 a year earlier and beating analysts’ expectations of a $0.41 per share loss, according to Fiscal.ai.

Compass ended September with $444 million in cash, which it expects will fund operations and capital expenditures through 2028. Compass is a pre-revenue firm and does not have any FDA-approved drug.

Retail Expects CMPS To Be Launch Ready By 2026-End

Retail sentiment for CMPS on Stocktwits flipped to ‘extremely bullish’ from ‘bearish’ over the past 24 hours, amid an 8,800% surge in message volumes.

One user expects the company to be launch-ready by the end of the year.

The stock is up 34.6% so far in 2026.

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