Full Press Release Details
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". Ensysce announced the acquisition of Cy Biopharma on August 6, 2026.
The FDA is holding the hearing in collaboration with federal partners to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings. The hearing supports implementation of Executive Order 14401, "Accelerating Medical Treatments for Serious Mental Illness," which directs federal agencies to accelerate the research, review and approval of psychedelic drugs for the treatment of serious mental health conditions.
"The FDA's hearing marks an important step forward for the responsible development of psychedelic-based medicines, and we are pleased that Richard will be contributing to that dialogue directly with regulators," said Lynn Kirkpatrick, Ph.D., Chief Executive Officer of Ensysce Biosciences. "With the addition of the Cy Biopharma team, we have begun advancing novel neuroplastogenic therapies specifically to enhance the treatment of a complex pain condition, Complex Regional Pain Syndrome Type 1 (CRPS). CRPS currently has not approved therapeutic options, and having a seat at the podium for this discussion underscores our commitment to helping shape the path to patients."
Ensysce Biosciences is a clinical-stage biotechnology company developing novel neuroplastogenic therapies using psychedelics that go beyond mood disorders and address the root cause of chronic pain through central nervous system modulation. The company is also developing a new class of highly novel opioids for the treatment of severe pain while minimizing the risk of both drug abuse and overdose. For more information, please visit www.ensysce.com .
Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. All forward-looking statements are based upon management's estimates and forecasts and reflect the current views, assumptions, expectations and opinions of the Company as of the date hereof. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expected, including (i) possible Nasdaq delisting; (ii) failure to obtain stockholder approval for the conversion of the Series C non-voting convertible preferred stock into shares of common stock of the combined company; (iii) risks related to the combined company's ability to manage its operating expenses and its expenses associated with the acquisition; (iv) unexpected costs, charges or expenses resulting from the acquisition; (v) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; (vi) the uncertainties associated with the combined company's product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement and completion of clinical trials, studies and evaluations; (vii) risks related to the inability of the combined company to obtain sufficient additional capital, including the continuation of government funding, to continue to advance these or other product candidates; (viii) failure to achieve the clinical trial milestone for the Milestone Closing; (ix) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (x) risks related to the failure to realize any value from product candidates currently being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (xi) risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. These statements are also subject to risks and uncertainties described in Ensysce's most recent annual report on Form 10-K and quarterly report on Form 10-Q and in other filings that it makes with the U.S. Securities and Exchange Commission (the "SEC"), available at www.sec.gov . Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, except as required under applicable law.