Bioxcel Therapeutics Inc SEC Filings

BioXcel Therapeutics (BTAI) updated its regulatory timeline, stating it now expects to complete submission of a supplemental New Drug Application (sNDA) for an IGALMI® label expansion early in the first quarter of 2026.

The filing highlights two recently completed studies that will anchor the sNDA package: the SERENITY At-Home pivotal Phase 3 safety trial for agitation associated with bipolar disorders or schizophrenia, which delivered positive topline safety and exploratory efficacy data in August 2025, and an October 2025 correlation study that also reported positive results. IGALMI® is currently FDA‑approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings, and the planned sNDA seeks to expand use to at‑home settings.

BioXcel Therapeutics (BTAI) announced positive correlation results linking the patient/caregiver-rated mCGI-S scale with the clinician-rated PEC from the SERENITY At Home program, supporting its planned supplemental NDA in the first quarter of 2026.

The prospective, open-label, in-clinic study in 33 patients showed strong, statistically significant correlations between PEC and mCGI-S (ρ=0.89; p<0.0001 for patients and ρ=0.88; p<0.0001 for informants). No serious adverse events were reported, and the safety profile remains consistent with the IGALMI® label.

Multiple Millennium-related entities report passive stakes in BioXcel Therapeutics, Inc. Integrated Core Strategies (US) LLC reports beneficial ownership of 1,026,054 shares and Millennium Management LLC, Millennium Group Management LLC and Israel A. Englander each report beneficial ownership of 1,028,053 shares, representing 5.2% of the outstanding common stock for each reporting person. The filing is submitted on Schedule 13G, indicating the holders state their position is passive and not intended to influence control of the issuer. The filing includes a joint filing agreement among the reporting parties.

BioXcel Therapeutics insider activity: Vimal Mehta, CEO and President and a director, reported two small acquisitions of common stock and corresponding restricted stock units in mid-September 2025. On 09/14/2025 he received 163 RSUs (vesting contingent) and 163 shares were recorded as acquired; on 09/15/2025 he received 219 RSUs and 219 shares were recorded as acquired. Following these transactions Mr. Mehta directly beneficially owned 20,493 shares. He also discloses indirect ownership of 480,343 shares held of record by BioXcel LLC, of which he is a manager, and one shareholding is reported as held by spouse.

Richard I. Steinhart, Chief Financial Officer of BioXcel Therapeutics, Inc. (BTAI), reported the acquisition of shares from vesting restricted stock units. On 09/14/2025 he received 163 shares upon vesting of RSUs and on 09/15/2025 he received 317 shares, increasing his direct beneficial ownership by those amounts. The RSUs were originally granted on March 14, 2022 (521 RSUs) and March 15, 2023 (562 RSUs) with staged vesting schedules tied to continued employment. The transactions were reported on a Form 4 signed 09/16/2025.

Javier Rodriguez, identified as Chief Legal Officer, Senior Vice President and Corporate Secretary of BioXcel Therapeutics, Inc. (BTAI), filed a Form 4 reporting transactions on September 14, 2025 and September 15, 2025. The filing discloses restricted stock unit activity tied to two prior grants: 521 RSUs awarded on March 14, 2022, and 562 RSUs awarded on March 15, 2023, each granted with time-based vesting schedules.

The tables show derivative and non-derivative entries reflecting 33 and 35 underlying shares associated with the reported transactions and list the number of vested RSU shares as 163 and 317 respectively in the derivative-security section. The Form 4 was signed by an attorney-in-fact on behalf of the reporting person on September 16, 2025.

Frank Yocca, Chief Scientific Officer of BioXcel Therapeutics, Inc. (BTAI), reported Form 4 transactions showing restricted stock units converting to shares on September 14 and 15, 2025. Table II lists 163 underlying shares from RSUs reported 09/14/2025 and 317 underlying shares from RSUs reported 09/15/2025, each recorded at $0. The form explains that each RSU equals one share and notes prior grants of 521 RSUs on March 14, 2022 and 562 RSUs on March 15, 2023 with scheduled vesting (25% after one year, then 6.25% quarterly). The filing was signed by an attorney-in-fact on 09/16/2025.

BioXcel Therapeutics reported results from the SERENITY At-Home Phase 3 trial showing 246 patients randomized and data collected on 2,628 agitation episodes over 12 weeks in 215 patients. Of those, 2,437 episodes were treated in 208 patients and 168 patients (81%) completed the full 12-week trial. Treated patients averaged 11.7 agitation episodes each; episodes were classified as mild (664), moderate (1,369) or severe (395). All patients successfully self-administered the film. Enrolled patients were 45% bipolar and 55% schizophrenia. The company now estimates a total addressable market of 57–77 million annual agitation episodes versus a prior estimate of 23 million, citing higher episode frequency supported by trial and survey data. Patient and physician feedback indicated a significant unmet need for an effective fast-acting at-home treatment; patients said they would take BXCL501 for 80% of episodes and 90% would take it at onset.