BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting
BioXcel Therapeutics, Inc. (BTAI)
Last bioxcel therapeutics, inc. earnings: 11/14 07:00 am
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Source: GlobeNewswire
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) setting NEW HAVEN, Conn., April 01, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for approval of IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026. “The regulatory acceptance of our sNDA for IGALMI marks a key milestone in our company’s mission to improve the lives of millions of patients suffering from agitation associated with bipolar disorders or sch
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News
- BioXcel Therapeutics (BTAI) was downgraded by <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=BTAI&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> from "hMarketBeat
- BioXcel Therapeutics (BTAI) had its price target lowered by HC Wainwright from $6.00 to $5.00. They now have a "buy" rating on the stock.MarketBeat
- Mosaic Therapeutics appoints Dr Vince O'Neill, MD, as Head of R&D [Yahoo! Finance]Yahoo! Finance
- How The BioXcel Therapeutics (BTAI) Story Is Shifting With BXCL501 Hopes And Dilution Risks [Yahoo! Finance]Yahoo! Finance
- BioXcel Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results as Company Prepares for Potential IGALMI® Approval in Outpatient Setting [Yahoo! Finance]Yahoo! Finance
BTAI
Earnings
- 11/12/25 - Miss
BTAI
Sec Filings
- 4/1/26 - Form 8-K
- 3/30/26 - Form SCHEDULE
- 3/27/26 - Form S-8
- BTAI's page on the SEC website