Incannex Healthcare Inc

Incannex Healthcare Ltd. is a clinical stage pharmaceutical development company, which engages in the research and development associated with medicinal cannabinoid and psychedelic pharmaceutical products and therapies. It operates through the following segments: Psychedelic Products, Cannabinoid Products, and Corporate. The Psychedelic Products segment is involved in the use of psychedelic medicine and therapies for the treatment of mental health disorders. The Cannabinoid Products segment focuses on the use of medicinal cannabinoid products. The Corporate segment consists of management of the organization, capital management, and management of resources. The company was founded on April 27, 2001 and is headquartered in Melbourne, Australia.

Earnings data Q3 2024

Earnings data Q4 2024

Earnings data Q3 2025

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Incannex Healthcare, Inc. is a biotech company, which engages in developing cannabinoid and psychedelic compound medicines. It focuses on the research and development for medicinal cannabis pharmaceutical products and psychedelic medicine therapies for treatment of a range of indications. The company was founded on July 5, 2023 and is headquartered in Norwest, Australia.

NEW YORK and MELBOURNE, Australia, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today announced the appointment of Lou Barbato, M.D., as Chief Medical Officer (CMO) effective immediately. Dr. Barbato's drug development experience includes senior clinical development and operational roles at Jazz Pharmaceuticals, AbbVie, Biogen, Novartis, and Solvay. He joins Incannex as the company continues to advance its lead clinical-stage programs in obstructive sleep apnea, generalized anxiety disorder, and rheumatoid arthritis.

Incannex Announces Appointment of Dr. Lou Barbato as Chief Medical Officer

Dallas, Texas--(Newsfile Corp. - October 2, 2024) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners initiates their coverage on Incannex Healthcare Inc. (NASDAQ: IXHL) To view the full announcement, including downloadable images, bios, and more, click here. Key Takeaways: Advancing proprietary, synthetic first and best-in-class cannabinoid and psychedelic-assisted therapeutics Conducting FDA phase 2/3 trial, IHL-42X, for the treatment of Obstructive Sleep Apnea (OSA) IHL-42X pivotal phase 2 top-line data expected first half 2025 Click image above to view full announcement.

Stonegate Initiates Coverage on Incannex Healthcare Inc. (IXHL)

NEW YORK and MELBOURNE, Australia, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious chronic diseases and significant unmet medical needs, today reported fiscal full year financial results and provided business updates.

Incannex Healthcare Inc. Reports Fiscal Full Year 2024 Financial Results and Business Updates

A new survey conducted by Quantum Research Group, LLC finds that more than half of patients diagnosed with sleep apnea are not satisfied with their current treatment. Nearly 70 percent of patients express a willingness to switch to a prescribed pill-form treatment.

Sleep Apnea Pill: Quantum Research Survey Shows Sleep Apnea Patients Seeking CPAP Alternatives

NEW YORK and MELBOURNE, Australia, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies is pleased to announce that it has received approval from the US Food and Drug Administration (‘FDA') to conduct the Company's Investigational New Drug (‘IND') opening Phase 2 clinical trial. The trial will investigate Incannex's psilocybin pharmaceutical formulation, known as PSX-001, in conjunction with psychotherapy in patients with generalised anxiety disorder in the United States and the United Kingdom.

FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed

NEW YORK and MELBOURNE, Australia, July 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic-assisted psychotherapies, is pleased to announce that it has completed participant dosing in the IHL-42X Bioavailability/Bioequivalence (BA/BE) clinical trial.

Dosing completed in 115 participant bioavailability/bioequivalence clinical trial for proprietary sleep apnea drug candidate IHL-42X

NEW YORK and MELBOURNE, Australia, May 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that patient dosing has commenced in the Company's Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients with obstructive sleep apnea (‘OSA').

Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

MELBOURNE, Australia and NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for treatment of Opioid Use Disorder (OUD).

Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder

Dallas, Texas--(Newsfile Corp. - May 1, 2024) - Stonegate Healthcare Partners is pleased to announce the publication of its latest report, titled "Potentially Transformative therapies for Generalized Anxiety Disorder (GAD)." This report explores the pervasive issue of GAD, a condition affecting millions worldwide, and potentially transformative therapies which will change the landscape of future treatments.

Stonegate Healthcare Partners Releases Report on Potentially Transformative Therapies for Generalized Anxiety Disorder (GAD)

MELBOURNE, Australia and NEW YORK, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-N for tobacco smoking cessation and control of relapse.

Incannex Completes Successful Pre-IND Meeting with the FDA for CannQuit-N; a Novel Solution for Tobacco Smoking Cessation

Highlights: Clarion's Head of Psychiatry, Professor Suresh Sundram, has been approved by the TGA to prescribe MDMA for Post-traumatic Stress Disorder and psilocybin for Treatment-resistant Depression, alongside extensive psychotherapy. Clarion Clinics' built-for-purpose clinic in Melbourne is now open for treatment, and will begin screening patients immediately.

Clarion Clinics Open for Psychedelic-Assisted Treatments

MELBOURNE, Australia and NEW YORK, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a pharmaceutical company developing novel medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to announce that patient dosing has commenced in the Phase 2 clinical trial assessing IHL-675A in patients with rheumatoid arthritis (RA).

Incannex Commences Dosing in Phase 2 Clinical Trial Assessing IHL-675A in Patients with Rheumatoid Arthritis

Highlights: 72 patients treated at purpose-built facilities within Monash University, Melbourne, Australia. Topline results from the trial anticipated within current Q1 2024.

Incannex Completes Dosing and Therapy in Phase 2 “PsiGAD” Clinical Trial Assessing Psilocybin-assisted Psychotherapy for Generalized Anxiety Disorder; Data Analysis Commences

MELBOURNE, Australia and NEW YORK, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that an independent Institutional Review Board (IRB) has approved the protocol for the Company's Phase 2/3 clinical trial to be conducted in the United States to assess safety and efficacy of proprietary combination drug candidate IHL-42X in patients with obstructive sleep apnea (OSA). IRB approval of the protocol is a key step in activation of clinical trial sites for the RePOSA study.

Incannex Receives IRB Approval for the RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

Highlights: Incannex subsidiary, Clarion Clinics, has received Human Research Ethics Committee (HREC) endorsement for administration of psychedelic-assisted therapies for TRD and PTSD. HREC approval is required for the administration of psychedelic drugs in Australia.

Clarion Clinics Receives Ethics Board Endorsement for the First Dedicated Psychedelic-Assisted Therapy Clinic in Australia

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MELBOURNE, Australia and NEW YORK, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to provide the following update on its proprietary IHL-42X drug candidate.

Incannex Update on IHL-42X Drug Candidate in Phase 2/3 Clinical Trial in Obstructive Sleep Apnea

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MELBOURNE, Australia and NEW YORK, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ: IXHL) is pleased to announce that its previously announced transaction to redomicile Incannex Healthcare from Australia to the United States has been implemented as of yesterday, November 28, 2023 New York time (November 29, 2023 Melbourne time).

Incannex Healthcare Announces Completion of its Redomiciliation to the United States

MELBOURNE, Australia, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL) (the “Company” or “Incannex”) is pleased to announce that the Federal Court of Australia (“Court”) has today made orders approving the scheme of arrangement in relation to the Company's proposed re-domiciliation from Australia to the United States (“Scheme”), under which Incannex Healthcare Inc. (“Holdco”) will become the ultimate parent company of Incannex Healthcare Limited following the implementation of the Scheme.

Federal Court of Australia Approves Incannex's Re-Domiciliation and Lodgement of Court Orders With ASIC

MELBOURNE, Australia, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a pharmaceutical company developing cannabinoid pharmaceutical medicines and psychedelic therapies for unmet medical needs, is pleased to announce that it will be featured as a presenting company at the H.C. Wainwright 25th Annual Global Investment Conference - September 11-13, 2023. Incannex will be presenting and taking one on one meetings virtually. Mr Joel Latham, CEO and Managing Director of Incannex, will provide an overview of the Company's business during the presentation.

Incannex Announces Participation at the H.C. Wainwright 25th Annual Global Investment Conference - September 11-13, 2023

MELBOURNE, Australia, Aug. 24, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that its subsidiary Psychennex Pty Ltd has commenced preparations of an investigational new drug (‘IND') application to the U.S. Food and Drug Administration (‘FDA') for the Company's psilocybin assisted psychotherapy development program (‘Psi-GAD').

Incannex to Prepare FDA IND Application for Psilocybin-assisted Psychedelic Psychotherapy Program, Known as Psi-GAD

MELBOURNE, Australia, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs, is pleased to announce that it has received approval from the US Food and Drug Administration (‘FDA') to conduct the Company's Investigational New Drug (‘IND') opening pivotal IHL-42X Phase 2/3 clinical trial in the United States as planned.

Review of IND Application for IHL-42X by US FDA has been completed; Clinical Trial for Patients with Obstructive Sleep Apnoea May Proceed

Highlights: Incannex subsidiary, Clarion Clinics Group Pty Ltd (Clarion) begins accepting registrations of interest in its psychedelic-assisted therapy (PAT) treatments ahead of planned Q3 opening. First clinic in Abbotsford, Melbourne, nearing fit-out completion.

Clarion Clinics Begins Accepting Registrations for Psychedelic Treatment Interest as Part of Pre-Screening in Readiness for Opening

MELBOURNE, Australia, July 28, 2023 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL), (‘Incannex' or the ‘Company'), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 June 2023. Incannex is undertaking a multitude of U.S. Food and Drug Administration (‘FDA') research and development (‘R&D') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals.

News for Incannex Healthcare Inc Stock (IXHL)