Ensysce Biosciences, Inc.

Ensysce Biosciences Phase 2 Protocol for CY200 - A Neuroplastigen for the Treatment of CRPS - Submitted to the UK MHRA

Ensysce Biosciences submitted the Phase 2a protocol (CYBIO_001) for CY200, a neuroplastigen, to the UK MHRA for treatment of Complex Regional Pain Syndrome Type 1. The multicenter, randomized, double-blind, placebo-controlled proof-of-concept study will evaluate CY200's analgesic efficacy, safety, and tolerability in adults. CY200 comes from the recently acquired Cy Biopharma Inc.; MHRA review is a pivotal step toward trial initiation. No financial figures were disclosed, and forward-looking statements flag possible Nasdaq delisting and financing risks.

•1mo ago

Ensysce Biosciences' Professor Richard Langford Selected to Speak at FDA Public Hearing on the Potential Future Therapeutic Use of Psychedelic Drugs

Richard Langford, chief medical officer of Ensysce Biosciences' newly acquired unit Cy Biopharma, has been selected to present in person at the FDA's September 14, 2026 public hearing on the potential future therapeutic use of psychedelic drugs. Langford is among a limited group of stakeholders invited to comment in the afternoon session on access considerations and best practices for data collection; the hearing supports Executive Order 14401, which directs federal agencies to accelerate research and review of psychedelic therapies for serious mental health conditions. Ensysce announced its acquisition of Cy Biopharma on August 6, 2026 and is advancing neuroplastogenic therapies for Complex Regional Pain Syndrome Type 1, a condition the company says has no approved therapeutic options. The speaking slot gives the clinical-stage micro-cap a seat in shaping the regulatory pathway for psychedelic-based medicines, though the event carries no near-term clinical, regulatory, or financial catalyst.

•1mo ago

Ensysce Biosciences Completes Final Phase of PF614-MPAR-102 Clinical Study

Ensysce Biosciences completed enrollment in Part 3 of the PF614-MPAR-102 clinical study, which evaluates the company's abuse-resistant opioid technology. The MPAR technology is designed to provide therapeutic opioid exposure at prescribed doses while automatically limiting release to protect against oral overdose. CEO Dr. Lynn Kirkpatrick highlighted the program's Breakthrough Therapy designation and its potential to address the urgent challenge of prescription opioid overdose risk.

•2mo ago

Ensysce Biosciences Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Ensysce Biosciences completed the acquisition of Cy Biopharma and secured up to $38.6 million in financing, extending its cash runway into late 2027 and adding CY200 as its new lead pipeline asset. Q2 2026 financial results reported a net loss of $2.6 million with cash at $0.7 million at quarter-end, though the acquisition immediately bolstered the balance sheet with approximately $31 million in net cash post-close. The company plans to use the proceeds primarily to advance CY200 through a randomized Phase 2 trial for Complex Regional Pain Syndrome while continuing development of PF614-MPAR under remaining NIDA grant funds.

•2mo ago

Ensysce Biosciences Awarded $5.3 Million Installment in NIDA Funding Completing Multi-Year $15 Million Federal Grant

Ensysce Biosciences received a $5.3 million installment from the National Institute on Drug Abuse, completing a $15.1 million multi-year grant for its MPAR technology. The non-dilutive funds will support the PF614-MPAR-102 clinical study and long-term non-clinical studies required for a New Drug Application submission. PF614-MPAR, which holds FDA Breakthrough Therapy designation, utilizes a proprietary chemical control mechanism to actively limit opioid release in cases of excessive dosing.

•3mo ago

Ensysce Biosciences Enrolls First Patient in Final Phase of PF614-MPAR-102 Clinical Study

Ensysce Biosciences announced the enrollment of the first patient in Part 3, the final stage of the PF614-MPAR-102 clinical study evaluating its novel MPAR overdose-protection technology. The MPAR technology is engineered to provide active protection against oral overdose by restricting release when excessive doses are taken, addressing a key risk in opioid therapy. PF614-MPAR previously received Breakthrough Therapy designation from the FDA and the study is supported by the National Institute on Drug Abuse.

•4mo ago