Ensysce Biosciences, Inc. reports developments as a clinical-stage pharmaceutical company focused on pain and central nervous system therapeutics designed to reduce opioid abuse and overdose risk. Its recurring updates center on the TAAP™ (Trypsin-Activated Abuse Protection) prodrug platform, the MPAR® (Multi-Pill Abuse Resistance) overdose-protection platform, and product candidates including PF614 and PF614-MPAR.
Company news also covers clinical-study progress, FDA-related designations and regulatory engagement, peer-reviewed data, scientific conference presentations, intellectual-property updates, financing transactions, financial results, Nasdaq compliance matters, board and governance changes, and strategic-review disclosures.
Ensysce Biosciences (ENSC) submitted its Phase 2a CY200 study protocol to the UK medicines regulator on September 24, 2026.
The proposed study, CYBIO_001, would compare CY200 with placebo in adults with complex regional pain syndrome (CRPS) Type 1. It is designed as a multicenter, randomized, double-blind trial to assess pain relief, safety and tolerability. The study is planned for the UK, where the protocol was submitted to the Medicines and Healthcare products Regulatory Agency (MHRA). CY200 is a drug candidate from Ensysce's newly acquired Cy Biopharma. The announcement reports a protocol submission, not findings from the proposed study.
Ensysce Biosciences (ENSC) advanced its Complex Regional Pain Syndrome (CRPS) program in September 2026 by hosting a clinical symposium at PainWeek 2026 and participating in a U.S. FDA hearing on psychedelic drug regulation.
The PainWeek symposium, attended by more than 320 pain management professionals, featured Dr. Jeff Gudin presenting Ensysce’s program to develop safer opioids for severe pain and detailed background on CRPS Type 1. Dr. Richard Langford outlined a novel CRPS approach based on the neuroplastogenic platform Ensysce recently added through its acquisition of Cy Biopharma.
Following the conference, an Ensysce team joined an FDA hearing focused on regulatory frameworks, training, credentialing, patient safety and real‑world data for psychedelic therapies. Dr. Langford provided comments on access considerations and best practices for data collection and standardization, including the role of interventional pain physicians in delivering psychedelic drugs.
Ensysce Biosciences (ENSC)/b) announced that Richard Langford of its recently acquired subsidiary Cy Biopharma is presenting at the FDA’s public hearing on the “Potential Future Therapeutic Use of Psychedelic Drugs” on September 14, 2026.Dr. Langford, Chief Medical Officer of Cy Biopharma, is part of a limited group of stakeholders speaking in the afternoon session on “Considerations for access; Best practices for data collection and standardization” at the FDA’s White Oak Campus. Ensysce completed the acquisition of Cy Biopharma on August 6, 2026, and is advancing novel neuroplastogenic, psychedelic-based therapies initially targeting Complex Regional Pain Syndrome Type 1 (CRPS), which currently has no approved therapeutic options. The FDA hearing, held with federal partners, supports Executive Order 14401 directing agencies to accelerate research, review and approval of psychedelic drugs for serious mental health conditions.
Ensysce Biosciences (ENSC) will participate in multiple investor conferences and industry events in September 2026 to highlight its clinical-stage neuroplastogenic and pain-therapy programs.
The company will present at the 2026 Cantor Global Healthcare Conference at the Waldorf Astoria in New York, with a company presentation scheduled for 9:10 a.m. ET on Friday, September 10. Ensysce will also attend the H.C. Wainwright 28th Annual Global Investment Conference at the Lotte New York Palace Hotel in New York City from September 14–16, and the FDA public hearing on psychedelic drugs on September 14 at the FDA’s White Oak Campus in Silver Spring, Maryland. Additional appearances include the Life Sciences Product Launch Summit on September 22 in Boston, part of Biotech Week Boston, and the 20th Annual Pain Therapeutics Summit on September 28–29 in San Francisco. Investors may schedule one-on-one meetings with management by emailing ENSC@mzgroup.us.
Ensysce Biosciences (NASDAQ: ENSC) reported completion of enrollment in the final stage (Part 3) of its PF614-MPAR-102 clinical study, the second study of its MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology for opioids. The program holds Breakthrough Therapy designation and is supported by the National Institute on Drug Abuse (Award DA047682).
According to Ensysce, PF614-MPAR is chemically engineered to provide therapeutic opioid exposure when taken as prescribed while automatically limiting additional release at excessive doses, acting as a built-in “safety switch.” Published data to date indicate maintained therapeutic plasma levels at normal doses with significantly blunted exposure at supratherapeutic levels.
The company is also advancing its TAAP and MPAR® platforms into candidates for pain, ADHD, opioid use disorder, and a psychedelic-based program for Complex Regional Pain Syndrome.
Ensysce Biosciences (NASDAQ: ENSC) reported second quarter 2026 results and completed the stock‑for‑stock acquisition of Cy Biopharma on August 6, 2026, adding lead asset CY200, an FDA Orphan Drug‑designated candidate for Complex Regional Pain Syndrome (CRPS) Type 1.
The transaction, together with concurrent private placement financings, provides up to $77.2 million in funding: $17.1 million cash from Cy Biopharma’s pre‑acquisition notes and approximately $21.5 million in gross proceeds from Series C preferred stock, plus a second tranche of up to $38.6 million tied to clinical milestones. According to Ensysce, this extends cash runway into late 2027, with potential to reach 2028 if the second tranche is triggered.
Q2 2026 federal grant revenue was $1.16 million, R&D expenses $2.47 million, G&A $1.27 million, and net loss attributable to common stockholders $2.57 million (vs. $1.73 million in Q2 2025). Cash at June 30, 2026 was $0.68 million, increasing by about $31 million after quarter‑end from the Cy Biopharma deal and related financings. Ensysce also advanced PF614 and PF614‑MPAR programs, secured the third year of a $15.1 million NIDA grant, retained $5.3 million in remaining grant funds, and gained new MPAR patent protection in Taiwan through 2042.
Ensysce Biosciences (NASDAQ: ENSC) completed the stock-for-stock acquisition of Cy Biopharma, adding CY200, a clinical-stage neuroplastogenic therapy with U.S. FDA Orphan Drug Designation for treating Complex Regional Pain Syndrome (CRPS) Type 1. Cy Biopharma contributed approximately $17.1 million in cash from a pre-acquisition convertible note financing.
Concurrently, Ensysce agreed to a private placement of Series C non-voting convertible preferred stock, expected to raise about $43 million in gross proceeds over two tranches, led by Ally Bridge Group with several specialist investors. In total, Cy equityholders will receive 282,122 Series C shares (282.122 million common on an as-converted basis), while investors in the private placement will receive 120,260 Series C shares (120.26 million common as-converted).
Subject to stockholder approval for conversion, fully diluted ownership (excluding the milestone tranche) is expected to be approximately 74.94% Cy Biopharma holders, 17.49% new investors, and 7.57% existing Ensysce holders, implying a combined fully diluted equity value of about $122.9 million before transaction fees. The proceeds are expected to fund CY200 through Phase 2 proof-of-concept data and into registrational development.
Ensysce Biosciences (NASDAQ: ENSC) received a new $5.3 million installment from the National Institute on Drug Abuse (NIDA), marking the third consecutive year of support and completing a multi‑year $15.1 million federal grant for its MPAR® overdose‑protection technology and lead candidate PF614‑MPAR.
According to Ensysce, this funding will finance completion of the PF614‑MPAR‑102 clinical study and required long‑term non‑clinical work supporting a future New Drug Application. PF614‑MPAR, which has U.S. FDA Breakthrough Therapy designation, is designed to actively limit opioid release in oral overdose situations via a proprietary chemical control mechanism.
Ensysce Biosciences (NASDAQ:ENSC) enrolled the first patient in the final stage of its PF614-MPAR-102 clinical study, advancing its PF614-MPAR opioid candidate with MPAR® overdose-protection technology.
The trial, supported by the National Institute on Drug Abuse, follows Breakthrough Therapy designation from the FDA for PF614-MPAR.
Ensysce Biosciences (NASDAQ:ENSC) reported Q1 2026 results and clinical progress. Cash was $0.7 million at March 31, 2026 versus $4.3 million at year-end 2025, with a subsequent $2.0 million convertible preferred financing tranche closed in April.
Q1 federal grants were $1.0 million (down from $1.3 million). R&D expenses rose to $3.3 million from $1.9 million, G&A declined to $1.2 million from $1.4 million, and net loss widened to $3.6 million from $1.9 million. Operationally, Ensysce reached 50% interim enrollment in its pivotal PF614-301 Phase 3 trial, secured IRB approval for PF614-MPAR-102 Part 3, published peer-reviewed MPAR clinical data, gained a European patent allowance for ADHD candidate PF8026, advanced OUD candidate PF9001 with HEAL and NIDA support, and its Board launched a formal review of strategic alternatives.