BioXcel Therapeutics Aktie

The FDA has accepted the supplemental new drug application (sNDA) from BioXcel Therapeutics for IGALMI for the acute treatment of agitation in bipolar disorder and schizophrenia in home and outpatient settings. A PDUFA decision date was set for November 14, 2026. The company also reported a registered direct placement of about $8 million and positive phase‑2 results for another program; analysts raised earnings estimates and issued differing price targets. » Mere på de.investing.com

BioXcel Therapeutics submitted a supplemental new drug application (sNDA) to the FDA on January 14, 2026, seeking approval for IGALMI as a sublingual film for the acute treatment of agitation in bipolar disorder or schizophrenia for home use. IGALMI is currently only approved for use under medical supervision; approval for home use could come by the end of 2026. The micro‑cap company faces significant financial difficulties (market capitalization around 40.24 million USD, revenue decline of ~67% over the past 12 months) and analysts expect no profitable result for 2025 (EPS estimate -3.25 USD). » Mere på de.investing.com

BioXcel Therapeutics plans to submit a supplemental new drug application (sNDA) to the FDA later this month to allow IGALMI to be used at home for treatment of acute agitation in bipolar disorder and schizophrenia. Approval could come as early as 2026 through an accelerated review; IGALMI is currently approved only for use under medical supervision. The sublingual film contains dexmedetomidine and may cause side effects such as low blood pressure, heart rhythm disturbances and drowsiness. The company is described as a micro‑cap with a market valuation of $38 million and trades at $1.74 per share. » Mere på de.investing.com