| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | November 22, 2024 4:01 P.M. |
| Form: | S-3 | ||||||
| |||||||
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- SEC Filing
Incannex Healthcare Inc. (NASDAQ:IXHL), a cannabinoid and psychedelic medicine biotechnology company, announced the successful completion of a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for the treatment of opioid use disorder (OUD). A number of FDA representatives shared insights on the CannQuit-O development program during the pre-IND teleconference in addition to providing recommendations on the proposed clinical development strategy. CannQuit-O combines CBD and an off-patent prescription opioid antagonist, and/or partial agonist-antagonist within the formulation. It's a chewable tablet with unique ch
NEW YORK and MELBOURNE, Australia, Nov. 14, 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 reported fiscal first quarter financial results and provided business highlights for the quarter ended September 30, 2024. "The first quarter reflects ongoing progress for Incannex, building on the momentum of a transformative year. Our commitment to pioneering novel oral synthetic cannabinoid combination therapeutics and our oral synthetic psilocybin treatment remains strong, and we look forward to sharing further update
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
Announced strategic financing with Arena Investors, providing access to up to $59.0 million USD in gross proceeds to Incannex Announced positive top-line results from our Phase 2 proof-of-concept clinical trial of PSX-001, known as the PsiGAD1 study, in which synthetic psilocybin in combination with psychotherapy was observed to significantly reduce anxiety scores and to be well tolerated in patients with generalised anxiety disorder (GAD) Commenced dosing in the RePOSA Phase 2/3 clinical trial of IHL-42X, an oral investigational treatment for patients with obstructive sleep apneaReceived Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) t
4 - Incannex Healthcare Inc. (0001873875) (Issuer)
3 - Incannex Healthcare Inc. (0001873875) (Issuer)
5 - Incannex Healthcare Inc. (0001873875) (Issuer)
EFFECT - Incannex Healthcare Inc. (0001873875) (Filer)
10-Q - Incannex Healthcare Inc. (0001873875) (Filer)
DEF 14A - Incannex Healthcare Inc. (0001873875) (Filer)
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
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. Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X During the quarter, Inc
MELBOURNE, Australia, June 16, 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 it has recruited two highly experienced lead principal investigators (PIs) for the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of obstructive sleep apnoea (‘OSA'). Dr John D Hudson of FutureSearch Trials of Neurology, Austin, Texas and Dr Russell Rosenberg of Neurotrials Research Inc, Atlanta, Georgia. Recruiting the lead PIs is a cri
MELBOURNE, Australia, July 27, 2022 /PRNewswire/ -- 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 2022. Incannex is undertaking a multitude of U.S. Food and Drug Administration ('FDA') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals. Cannabinoid IHL-42X: positive phase 2a clinical trial results in patients with obstructive sleep apnoea In June 2022, Incannex announced positive results from full analysis of its phase 2 clinical trial o
Highlights: Positive phase 2a clinical trial results for IHL-42X with 60% of trial participants experiencing at least a 55% reduction in the Apnoea Hypopnea Index ('AHI') 20% of IHL-42X clinical trial participants experienced a reduction in AHI of greater than 80% completes comprehensive in vivo study on the neuroprotective capability of IHL-216A with results being analysed to be released within 2-3 weeks treatment commences in the phase 2a clinical trial to assess psilocybin and specialised psychotherapy for the treatment of generalised anxiety disorder initiates a second clinical psychedelic therapy program in a leading-edge academic field of virtual reality (VR) exposure response therapy