PDUFA target action date of November 14, 2026 Potential first FDA-approved treatment option for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient)...
sNDA submitted seeking approval of IGALMI ® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia sNDA submission timeline supports...
NEW HAVEN, Conn., March 11, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence to develop transformative...
NEW HAVEN, Conn., March 10, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence to develop transformative...
BXCL501 demonstrated clinical benefits and favorable tolerability profile for treatment of opioid withdrawal symptoms Results from this NIDA-funded study support potential future development...
Discussion will focus on the high unmet need and the lack of FDA-approved treatment options associated with acute agitation episodes in Alzheimer’s dementia Large patient population affected by...
Third party commercial assessment shows larger than expected potential total addressable market for IGALMI ® in the at-home setting Strong prescriber interest, patient demand, and positive payer...
sNDA submission supports the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI ® Submission timeline supports potential...
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