Incannex Healthcare Limited (IXHL)

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 pharmacokinetic results from the three clinical trials completed to date within the IHL-42X development program.

Incannex Healthcare Inc. (IXHL) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Incannex Healthcare Inc. (NASDAQ: IXHL - Get Free Report) shares were up 1.1% during trading on Friday. The company traded as high as $0.3749 and last traded at $0.3610. Approximately 6,205,588 shares changed hands during trading, a decline of 44% from the average daily volume of 11,166,855 shares. The stock had previously closed at $0.3571.

Dallas, Texas--(Newsfile Corp. - November 20, 2025) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners updates their coverage on Incannex Healthcare Inc. (NASDAQ: IXHL). In 4Q25, Incannex continued to build the clinical and patient-reported evidence base for IHL-42X in obstructive sleep apnoea (OSA), following full Phase 2 RePOSA data and exit-interview analyses.

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 corporate initiatives and outlining key priorities for the remainder of 2025. Recent Highlights IHL-42X (OSA) Phase 2 – Statistically significant efficacy, outstanding patient-reported outcomes, and strong safety profile – Incannex reported Phase 2 data for IHL-42X demonstrating statistically significant and clinically meaningful reductions in Apnea-Hypopnea Index (AHI) of up to 83% from baseline, confirming the potential of IHL-42X to meaningfully improve disease severity in obstructive sleep apnea (OSA).

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).

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 Psi-GAD), a psilocybin-assisted psychotherapy treatment for Generalised Anxiety Disorder (GAD). The results confirm statistically significant and clinically meaningful improvements across every key endpoint assessed in the study, reinforcing PSX-001's potential as a best-in-class therapy for patients with moderate to severe GAD.

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”).

Dallas, Texas--(Newsfile Corp. - August 19, 2025) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners updates their coverage on Incannex Healthcare Inc. (NASDAQ: IXHL). Recently, IXHL has made significant progress on its IHL-42X asset after very positive topline results from the Phase 2 study have returned, with more granular data trickling in.

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 RePOSA Phase 2 trial of IHL-42X for the treatment of obstructive sleep apnoea (OSA). These new insights, collected through structured exit interviews, add to an already compelling data package highlighting the significant potential of IHL-42X to improve both clinical and patient-centric outcomes in individuals living with OSA.

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 under no obligation to issue any shares of its common stock pursuant to the ATM and any utilisation of the ATM will be at the discretion of the Company, taking into account prevailing market conditions and strategic priorities.

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 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.

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.

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 schedule as of 16 June 2025. This marks a major milestone in the development of IHL-42X, confirming the completion of clinical data collection and enabling final statistical analysis to begin.

Expanded platform improves access, scales operations, and advances Incannex's position in next-generation mental health treatment Expanded platform improves access, scales operations, and advances Incannex's position in next-generation mental health treatment