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The FDA has granted Breakthrough Therapy designation to BioXcel Therapeutics' (BTAI) BXCL501, an orally dissolving thin film formulation of dexmedetomidine for the acute treatment of agitation associated with dementia.Breakthrough Therapy status provides for more intensive guidance from the F...
NEW HAVEN, Conn., March 15, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today...
BioXcel Therapeutics, Inc. (BTAI) Q4 2020 Earnings Conference Call March 11, 2021 08:30 ET Company Participants Vimal Mehta - Chief Executive Officer Richard Steinhart - Chief Financial Officer Will Kane - Chief Commercial Officer Frank Yocca - Chief Scientific Officer Vince O’Neill - ...
BioXcel Therapeutics ([[BTAI]] +3.0%) has completed the rolling submission of its New Drug Application (“NDA”) to the FDA for BXCL501 targeting agitation associated with schizophrenia and bipolar disorders I and II.An orally dissolving thin film formulation of dexmedet...
BioXcel Therapeutics (BTAI): Q4 GAAP EPS of -$0.87 beats by $0.07.Cash and cash equivalents of $213.1MPress Release For further details see: BioXcel Therapeutics EPS beats by $0.07
New Drug Application (“NDA”) submitted to the U.S. Food and Drug Administration (“FDA”) for BXCL501 for the acute treatment of schizophrenia and bipolar disorder related agitation TRANQUILITY achieved primary and secondary endpoints with both dos...
NEW HAVEN, Conn., March 11, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscienc...
We revisit BioXcel Therapeutics in-depth for the first time in five months. The company has seen several encouraging developments on the pipeline front and continues to receive favorable analyst commentary. We update the investment case on this intriguing biotech concern in the pa...
NEW HAVEN, Conn., March 04, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscienc...
BioXcel Therapeutics (BTAI) announces an update to its BXCL501 dementia program.Following the end of Phase 2 meeting with the FDA, the Company plans to finalize study design, dosing, and endpoints for its Phase 3 registrational program, expected to begin in H2. The Company is also providing a...
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NEW HAVEN, Conn., July 30, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its second quarter 2024 financ...
Focused market-access strategy generates estimated net revenue of approximately $1.1 million, highest quarterly net revenue since commercial launch Represents 90% increase from the prior quarter and 141% increase from the second quarter of 2023 NEW HAVEN, Conn., July 16, 2024 (GLO...
Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose) For each episode occurring over seven days, a reduction in agitation was observed and no serious adverse events were reported following treatmen...