RegulatoryCompany release

Compass Pathways to complete rolling NDA for COMP360 psilocybin in treatment-resistant depression within two weeks

🇺🇸 COMPASS Pathways plc (CMPS) · Tue 03 Nov 2026

The company says it will finish its FDA submission shortly and plans a first-half 2027 launch if approved, backed by a priority voucher and $444.0 million in cash.

Compass Pathways plc said on 3 November 2026, alongside its third-quarter results, that it expects to complete its rolling New Drug Application (NDA) to the US Food and Drug Administration for COMP360 psilocybin in treatment-resistant depression (TRD) within the next two weeks.

The company points to a National Priority Voucher that it says could shorten the FDA's review to one to two months. It also cites a White House executive order directing the Drug Enforcement Administration (DEA) to review rescheduling promptly. Psilocybin is currently a controlled substance, so scheduling decisions are a key step between any approval and commercial availability.

On finances, Compass reported cash of $444.0 million, which it expects to fund operations into 2028. The company says it plans to launch in the first half of 2027, provided the FDA approves the product.

The source material available for this report was limited to the company's summary of its results. Details such as the NDA's data package, the voucher's terms and the timing of any DEA action were not provided.

What it means for your team

  • Regulatory teams should watch for confirmation that the rolling NDA is complete and for any FDA acceptance or action date, since the company links a faster review to its priority voucher.
  • Market-access and commercial planners face a launch timeline tied to both FDA approval and DEA scheduling; the company has not detailed the latter's timing.
  • Quality and supply-chain teams in the controlled-substance space may need to prepare for the handling requirements that follow any rescheduling decision.

Company's press release (SEC filing): COMPASS Pathways plc ↗

Article written by VigiEye from the official source (COMPASS Pathways plc). Claims are the company's own. AI-assisted; check the source before acting.

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