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  • BioXcel (BTAI) Stock Climbs As FDA Clears Clinical Trial Site Inspection

    BioXcel (BTAI) Stock Climbs As FDA Clears Clinical Trial Site Inspection

    Following a significant regulatory update, BioXcel Therapeutics, Inc. (NASDAQ: BTAI) stock saw a sharp increase in value. As of the recent market check, BTAI stock price rose by 96.14%, reaching $4.20. This significant rise is a reaction to recent events involving the FDA’s (U.S. Food and Drug Administration) assessment of its clinical trial location.

    Reaching a Regulatory Milestone

    The FDA has finished inspecting one site in the TRANQUILITY II Phase 3 study, according to BioXcel. The inspection status was closed and an Establishment Inspection Report was issued by the agency in accordance with 21 C.F.R. 20.64(d)(3). Although minor concerns may have been found, the site was classified as “Voluntary Action Indicated,” which means that regulatory action is not necessary.

    The completion of this inspection, together with the positive results of an independent audit carried out in October 2023, further confirms the accuracy of the trial data, BTAI stressed.

    These results will be included in a prospective supplementary new drug application (sNDA) filing for regulatory evaluation, according to BioXcel. Furthermore, BTAI is proceeding with its primary neuroscience candidate, BXCL501, after receiving FDA comments on the plan for its TRANQUILITY In-Care Phase 3 study.

    Promoting Clinical Development

    BXCL501 is a patented sublingual film formulation of the selective alpha-2 adrenergic receptor agonist dexmedetomidine that has received FDA approval. It is sold under the brand name IGALMI. The experimental formulation is now being studied for the treatment of acute agitation associated with schizophrenia, bipolar disorder, and Alzheimer’s dementia in home-based settings, despite having previously been licensed for certain uses.

    The TRANQUILITY In-Care Trial

    The 12-week, double-blind, placebo-controlled TRANQUILITY In-Care study aims to assess the safety and efficacy of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s disease in a care facility setting. BioXcel Therapeutics expects more regulatory contacts as its clinical projects advance, which might affect how its drug development activities develop in the future.

  • Here is why BioXcel Therapeutics Inc. (BTAI) underperformed on Tuesday?

    Here is why BioXcel Therapeutics Inc. (BTAI) underperformed on Tuesday?

    BioXcel Therapeutics Inc. (BTAI) stock started the Tuesday, June 22, 2021, trading by losing 3.63% in the morning session and closed at $36.85 per share. The decline continued in the after-market session and BTAI shares further plunged 8.06% and closed the day at $33.88 per share. BTAI shares have fallen 35.32% over the last 12 months, and they have moved down 1.26% in the past week. Over the past three months, the stock has lost 13.48%, while over the past six months, it has declined 28.11%.

    Let’s have a brief look at its recent news and developments.

    Proposed Public Offering of Common Stock

    On June 22, 2021, BioXcel Therapeutics, Inc commenced an underwritten public offering of $100.0 million of shares of its common stock. BioXcel LLC expects to grant the underwriters a 30-day option to purchase up to $15.0 million of additional shares of common stock at the public offering price, less underwriting discounts, and commissions.

    The net proceeds from the offer will be used for funding of clinical trials, commercialization preparation, and general corporate purposes.

    Hosting of  Virtual Commercial Day

    BioXcel Therapeutics will be hosting a virtual Commercial Day on Friday, June 25, 2021, from 12:00 PM ET – 1:30 PM ET.

    The event is organized to provide an update on the Company’s launch readiness plans and market insights for BXCL501. The corporate leadership of the company will be joined by members of the Company’s commercial leadership team, as well as an industry expert, Dr Leslie S. Zun, Professor of Emergency Medicine at Chicago Medical School.

    Participation in recent three upcoming healthcare investor conferences

    BioXcel Therapeutics recently participated in the following healthcare investor conference. The company was presented by Dr Vimal Mehta, Founder and Chief Executive Officer of BioXcel.

    • The company took part in a fireside chat at BofA Securities Napa Biopharma Conference which held on Monday, June 14, 2021.
    • BTAI participated in Goldman Sachs 42nd Annual Global Healthcare Conference which held on Wednesday, June 9, 2021.
    • The company also presented itself in a fireside chat at Jefferies Virtual Healthcare Conference which held on Wednesday, June 2, 2021.

    FDA accepted NDA filing of BXCL501

    On May 19, 2021, BioXcel Therapeutics, Inc said that the U.S. Food and Drug Administration has accepted the filing of a New Drug Application for BXCL501.

    BXCL501 is the Company’s proprietary, investigational, orally dissolving thin film formulation of dexmedetomidine, for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.

    The FDA has a target action date of January 5, 2022. At this time, the FDA is not planning to hold an advisory committee meeting to discuss the application.

    Conclusion

    The commencing of a public offering of BTAI common stock could be the reason behind its poor performance on Tuesday. We are unsure how BTAI will perform in the remaining days of the week.