Ensysce Biosciences

ENSC

Börsenwert 10,1 Mio. $

~ Submission to the UK MHRA for review marks critical step towards initiating a Phase 2 Study with CY200 ~ SAN DIEGO, CA / ACCESS Newswire / September 24, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on CRPS (Complex Regional Pain Syndrome), today announced the submission of the protocol for a Phase 2a clinical study of CY200, the Company's newest drug candidate from the newly acquired Cy Biopharma Inc. This landmark milestone involved the submission of protocol CYBIO_001 entitled "A Phase 2A, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group, Proof of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability of CY200 in Participants with Complex Regional Pain Syndrome Type 1" to the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK where the study will be conducted. CYBIO_001 is designed to evaluate the analgesic efficacy of CY200 compared to placebo in adult participants with CRPS Type 1.

SAN DIEGO, CA / ACCESS Newswire / September 15, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company") a clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on CRPS (Complex Regional Pain Syndrome), hosted a symposium at PainWeek 2026. The Symposium was attended by more than 320 pain management professionals.

SAN DIEGO, CA / ACCESS Newswire / September 14, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company") a clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on CRPS (Complex Regional Pain Syndrome), today announced that Richard Langford, Chief Medical Officer of Cy Biopharma, has been selected to present in person at the U.S. Food and Drug Administration's ("FDA") public hearing, "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs," being held today, Monday, September 14, 2026 at the FDA's White Oak Campus in Silver Spring, Maryland. Dr. Langford is among a limited group of stakeholders granted the opportunity to provide comments at the hearing in the afternoon session 'Considerations for access; Best practices for data collection and standardization".

SAN DIEGO, CA / ACCESS Newswire / September 2, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company") a clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on CRPS (Complex Regional Pain Syndrome), today announced its participation in the following upcoming investors conferences and industry events. 2026 Cantor Global Healthcare Conference being held Wednesday, September 9th to Saturday, September 12th at the Waldorf Astoria in New York City.

~ ~ The Second Study Fully Enrolled for Breakthrough Therapy-Designated, First-in-Class Opioid Designed to Protect Against Oral Overdose ~ ~ SAN DIEGO, CA / ACCESS Newswire / August 31, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on complex pain, and advancing next-generation pain and central nervous system therapeutics designed to reduce abuse and overdose risk, today announced completion of enrollment in the final stage of the PF614-MPAR-102 clinical study. The study evaluated its novel MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology.

~Major symposium to highlight breakthrough innovations in severe pain and Complex Regional Pain Syndrome (CRPS) ~ ~Discussions to feature a first-in-class approach to neural reset and novel chemical safety switch technology ~ SAN DIEGO, CA / ACCESS Newswire / August 20, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company") a clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on complex pain, today announced that it will host an educational symposium at PAINWeek 2026, entitled A New Era in Pain Therapeutics. The symposium will present a vision for the future of pain management-one that introduces an entirely new therapeutic approach for one of medicine's most debilitating chronic pain conditions and one that combines effective analgesia with improved safety.

Ensysce Biosciences, Inc. (ENSC) Discusses Acquisition of Cy Biopharma and Private Placement Financing Prepared Remarks Transcript

Acquisition of Cy Biopharma Completed, Adding CY200 for Complex Regional Pain Syndrome Up to $77 million in new funding with the acquisition of Cy Biopharma Company to host a Corporate Update Call on Tuesday, August 18, 2026, at 11:00 a.m. ET SAN DIEGO, CA / ACCESS Newswire / August 13, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on complex pain, today reported financial and operational results for the second quarter ended June 30, 2026.

Acquisition includes clinical-stage neuroplastogenic therapy with U.S. FDA Orphan Drug Designation for the treatment of Complex Regional Pain Syndrome (CRPS) Up to $77 million in private financing consisting of $21.5 million in private placement financing at initial close plus $17.1 million of Cy Biopharma's cash and cash equivalents from a pre-acquisition convertible note financing and up to $38.6 million upon achievement of clinical trial milestone Pro forma cash expected to fund CY200 through Phase 2 proof-of-concept data and into registrational development SAN DIEGO, CA / ACCESS Newswire / August 6, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company") today announced it has completed the acquisition of Cy Biopharma, Inc. ("Cy Biopharma"), a privately held clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on complex pain. Concurrent with the acquisition that brought in $17.1 million in cash from a pre-acquisition convertible note financing, Ensysce entered into a definitive agreement for the sale of Series C non-voting convertible preferred stock (with a conversion ratio of preferred to common at 1:1,000) (the "Series C Preferred Stock") in a private placement financing, which is expected to result in gross proceeds to the Company of approximately $21.5 million at the initial close before deducting placement agent fees and other offering and transaction expenses, and includes up to a $38.6 million follow-on tranche that is expected to fund development of CY200 into 2028.

Funds Advance FDA-Designated Breakthrough Therapy First-in-Class Opioid with Oral Overdose-Protection SAN DIEGO, CA / ACCESS Newswire / July 14, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics engineered to minimize abuse and overdose risk, today announced receipt of a Notice of Award for $5.3 million from the National Institutes on Drug Abuse (NIDA)1 to support the development of its novel MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology, and the lead agent, PF614-MPAR. This marks the third consecutive year of NIDA funding under this award, reflecting sustained institutional confidence in the MPAR® program as it progresses toward late-stage development.