Incannex Granted FDA Fast Track Designation for IHL-42X in Obstructive Sleep Apnea (OSA) MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA). The Fast Track designation was supported by promising safety, efficacy, and pharmacokine...
Incannex Provides Shareholder Update Highlighting Clinical Progress, Capital Discipline, and EOY 2025 Strategic Focus Company outlines continued progress across clinical, regulatory, and capital initiatives positioning for sustained long-term growth MELBOURNE, Australia and NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL)(“Incannex” or the “Company”), a clinical-stage pharmaceutical company developing innovative combination therapies for high-impact medical conditions, provides a shareholder update highlighting recent progress across its clinical and c...
Incannex Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Requirement MELBOURNE, Australia and NEW YORK, Oct. 22, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company developing innovative combination therapies for high-impact medical conditions, today announced that it has received an additional 180-calendar-day extension from the Nasdaq Stock Market (“Nasdaq”) to regain compliance with the minimum bid price requirement, as outlined in Nasdaq Listing Rule 5550(a)(2). Incannex now has until April 20, 2026...
Incannex Reports Positive Results from Phase 2 Clinical Trial of PSX-001 (Psi-GAD) for Generalised Anxiety Disorder Psi-GAD delivers statistically significant and clinically meaningful improvements across validated measures of anxiety, mood, disability, and quality of life; results establish PSX-001 as a leading psilocybin-assisted therapy in development globally MELBOURNE, Australia and NEW YORK, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”) is pleased to report positive data from its Phase 2 clinical trial of PSX-001 (formerly ...
Incannex Healthcare Authorizes $20 Million Share Repurchase Program MELBOURNE, Australia and NEW YORK, Aug. 22, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company developing innovative combination therapies for high-impact conditions, today announced that its Board of Directors has authorized a share repurchase program (the “Repurchase Program”) for up to $20 million of the Company’s outstanding shares of common stock (“Common Stock”). Under the Repurchase Program, the Company may repurchase shares of...
Incannex Receives Positive Patient-Reported Outcomes and Compelling Phase 2 Efficacy Data for IHL-42X in Obstructive Sleep Apnoea Exit interviews and clinical results reinforce strong potential for meaningful improvements in sleep quality, cognitive function, and daily life MELBOURNE, Australia and NEW YORK, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company developing innovative combination therapies for prevalent medical conditions, today announced new patient-reported outcome findings from a subset of participants in its...
Incannex Confirms Strong Cash Position; No Plans or Requirement to Fully Utilise ATM in Near Term MELBOURNE, Australia, July 31, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”) announced, in response to recent questions it received from a number of its stockholders, that it does not presently intend to use the full capacity available under its at the market offering program (the “ATM”) in the near-term. As previously disclosed in the Company’s Form 8-K filed with the U.S. Securities and Exchange Commission on July 24, 2025, the Company is und...
Incannex Reports Positive Topline Results from RePOSA Phase 2 Trial of IHL-42X Statistically and clinically significant improvements across key clinical endpoints; IHL-42X reduced AHI by up to 83% from baseline. IHL-42X demonstrates compelling clinical benefit and an outstanding safety profile that exceeded expectations. NEW YORK and MELBOURNE, Australia, July 30, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”) is excited to share positive topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate ...
Incannex Healthcare Expands Clinical Advisory Board to Support Obstructive Sleep Apnea Program with Appointment of Dr. Charlene E. Gamaldo NEW YORK and MELBOURNE, Australia, July 25, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces the appointment of Charlene E. Gamaldo, M.D. to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board. Incannex Chief Medical Officer Dr. Lou Barbato commented:“We are fortunate to wel...
Incannex Healthcare Expands Clinical Advisory Board to Support Obstructive Sleep Apnea Program with Appointment of Dr. Douglas B. Kirsch NEW YORK and MELBOURNE, Australia, June 24, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces the appointment of Douglas B. Kirsch, M.D., FAAN, FAASM to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board. “We are honored to welcome Dr. Kirsch to the IHL-42X Clinical Advisory...
Incannex achieves key milestone with database lock for RePOSA Phase 2 trial of IHL-42X Top-line results expected July 2025 as development of first-in-class OSA drug advances NEW YORK and MELBOURNE, Australia, June 18, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, is pleased to announce that it has achieved database lock for the RePOSA Phase 2 clinical trial of IHL-42X, its lead drug candidate for obstructive sleep apnoea (OSA), on...
Incannex Healthcare Forms Joint Venture with Mind Medicine Australia to Expand Access to Psychedelic-Assisted Therapy Expanded platform improves access, scales operations, and advances Incannex’s position in next-generation mental health treatment NEW YORK and MELBOURNE, Australia, June 17, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces entering into a 50:50 joint venture with Mind Medicine Australia (“MMA”) to operate a ...
Incannex Healthcare Cancels All Outstanding Series A Warrants Following Strategic ATM Execution Capital structure streamlined and potential dilution from Series A Warrants eliminated ahead of key Phase 2 clinical milestones NEW YORK and MELBOURNE, Australia, June 12, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces it has successfully canceled all remaining Series A Warrants pursuant to its letter agreements with the holder...
Incannex Healthcare Inc. Expands IHL-42X Clinical Advisory Board with Appointments of Four Industry and Academic Leaders to Advance Obstructive Sleep Apnea (OSA) Program NEW YORK and MELBOURNE, Australia, June 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today announced the recent appointment of four distinguished experts to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board: Scott A. Sands, Ph.D., Associate Professor...
Incannex Healthcare Inc. Advances IHL-42X RePOSA Trial to Phase 3 Following FDA Protocol Clearance Streamlined U.S.-only study design builds on Phase 2 momentum for IHL-42X in obstructive sleep apnea NEW YORK and MELBOURNE, Australia, May 29, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company developing novel combination therapies, today announced that the Phase 3 component of the RePOSA clinical trial will proceed. The U.S. Food and Drug Administration (FDA) previously reviewed and authorized the protocol to proceed under the Compa...
Incannex Healthcare Inc. Enters Agreement to Cancel Remaining Series A Warrants, Eliminating Up to 347.2 Million Shares from Potential Dilution Ahead of IHL-42X Phase 2 Topline Results MELBOURNE, Australia and NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, today announced that it has entered into a binding agreement to cancel the remaining 172 million Series A Warrants issued under a previous financing arrangement contingent upon Incannex paying...
Incannex Healthcare Inc. Executes Strategic Cancellation of 50.4% of Series A Warrants, Significantly Reducing Potential Dilution Raises $12.5M via ATM to Strengthen Shareholder Position Ahead of IHL-42X Phase 2 Data NEW YORK and MELBOURNE, Australia, May 20, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company pioneering the development of combination drug therapies, today announced the successful completion of a $16.7 million gross proceeds capital raise through its at-the-market (ATM) facility. $12....
Incannex Announces Potential Reduction of Up to 50.4% of its Series A Warrants NEW YORK and MELBOURNE, Australia, May 16, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (“Incannex”), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, announced its entry on May 15, 2025 into agreements with the outstanding holders of its Series A Warrants (the “Letter Agreements”) permitting Incannex to potentially reduce up to 50.4% of the shares of common stock underlying its previously issued Series A Warrants. The Letter Agreements p...
Incannex Healthcare Inc. Reports Fiscal Third Quarter 2025 Financial Results and Business Updates NEW YORK and MELBOURNE, Australia, May 15, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today reported fiscal second quarter financial results and provided business highlights for the quarter ended March 31, 2025. “The third quarter of 2025 represents a pivotal period of progress for Incannex as we continue to execute on our IHL-42X development program,” said ...
Incannex Healthcare Inc. Provides Clinical Program Update on IHL-42X, an Oral Once-Daily Treatment for Obstructive Sleep Apnea (OSA) Patient dosing completed in Phase 2 portion of Phase 2/3 RePOSA study evaluating IHL-42X oral treatment for OSA.End-of-study follow-up assessments on track for completion by May 17, 2025.Topline results expected in July 2025. NEW YORK and MELBOURNE, Australia, May 14, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today provi...
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