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Ensysce closes Cy Biopharma deal as UK regulator seeks more data on CY200 trial

🇺🇸 Ensysce Biosciences, Inc. (ENSC) · Thu 12 Nov 2026

Ensysce's Q3 report shows the psilocybin-based CY200 Phase 2a protocol is under UK review, with the MHRA and an ethics committee requesting further information.

Ensysce Biosciences reported third-quarter 2026 results on 12 November, highlighting the completion in August of its acquisition of Cy Biopharma. The deal brings CY200, a psilocybin-based candidate for complex regional pain syndrome, into the company's pipeline.

In September Ensysce submitted the Phase 2a protocol for CY200, designated CYBIO 001, to the UK Medicines and Healthcare products Regulatory Agency (MHRA). On 6 November, the MHRA and the ethics committee asked for additional information. The company said it is preparing its response.

Separately, Ensysce finished enrolment in Part 3 of PF614-MPAR-102, a study of its opioid candidate designed to protect against overdose.

Financially, the company reported $29.7 million in cash. It booked a non-cash in-process research and development (IPR&D) charge of $79.9 million linked to the acquisition, which drove a net loss of $82.3 million for the quarter.

What it means for your team

  • A request for further information from the MHRA and an ethics committee is a routine step in clinical trial review, but the timing of any approval of CYBIO 001 will depend on how the company answers.
  • Teams following psychedelic-derived therapeutics should note that CY200 is moving towards a UK Phase 2a study in a pain indication.
  • The completed enrolment in Part 3 of PF614-MPAR-102 marks progress for Ensysce's overdose-protection opioid programme.
  • The large net loss reflects a non-cash IPR&D charge from the acquisition rather than operating spend alone.

Company's press release (SEC filing): Ensysce Biosciences, Inc. ↗

Article written by VigiEye from the official source (Ensysce Biosciences, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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