BioXcel Therapeutics Inc. filed SEC Form 8-K: Other Events
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| Item 8.01 | Other Events. |
TRANQUILITY II Phase 3 Trial – FDA Inspection Update
On March 3, 2025, the Company announced that the U.S. Food and Drug Administration has concluded that the inspection of a single site in its TRANQUILITY II Phase 3 trial is closed under 21 C.F.R.20.64(d)(3) and released the Establishment Inspection Report. The FDA has designated “Voluntary Action Indicated” for the site, which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
SERENITY At-Home Pivotal Phase 3 Trial Update
In September 2024, the Company initiated patient enrollment in its SERENITY At-Home pivotal Phase 3 trial, evaluating the safety of BXCL501, the Company’s investigational, proprietary, orally dissolving film formulation of dexmedetomidine, in the at-home setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. As of February 28, 2025, 23 clinical trial sites have been opened and are enrolling patients.
Topline data results, which are expected in the second half of 2025, are intended to support a supplemental new drug application (sNDA) submission to potentially expand the label of IGALMI® (dexmedetomidine) sublingual film.
Nasdaq Update
On February 28, 2025, the Company received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC confirming that the Company has regained compliance with the minimum closing bid price requirement under Nasdaq Listing Rule 5550(a)(2).
Chief of Product Development and Medical Officer Resignation
On February 28, 2025, Vincent J. O’Neill, M.D. resigned as Executive Vice President, Chief of Product Development and Medical Officer of the Company.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: March 3, 2025 | BIOXCEL THERAPEUTICS, INC. |
| /s/ Javier Rodriguez | |
| Javier Rodriguez | |
| Chief Legal Officer |