| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | December 6, 2024 4:01 P.M. |
| Form: | S-1 | ||||||
| |||||||
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Positive IHL-42X PK findings for the treatment of Obstructive Sleep Apnea (OSA) support future 505(b)(2) New Drug Application (NDA) submissionNew OSA Clinical Advisory Board Announced; Appoints Dr. Alison Wimms, Representing ResMed NEW YORK and MELBOURNE, Australia, Feb. 14, 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 December 31, 2024. "Patients with obstructive sleep apnea need new and convenient therapeutic options to manage this serious, chroni
NEW YORK and MELBOURNE, Australia, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing combination medicines today announced the appointment of Alison Wimms, Ph.D. as an advisor to its newly formed IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board where she will represent ResMed. Dr. Wimms brings two decades of sleep medicine industry and research expertise to her advisory role at Incannex. Dr. Wimms holds a Doctor of Philosophy (Ph.D.) in Medicine, and Master of Medicine (Sleep Medicine) and Bachelor of Science degrees from the University of Sydney. "Incannex's
Demonstrated bioavailability of IHL-42X, Incannex's proprietary combination formulation, confirming delivery of both dronabinol and acetazolamideAchieved similar PK and equivalent total drug exposure levels of IHL-42X and the reference listed drugs (RLD) for dronabinol and acetazolamide, building a scientific bridge to established safety and toxicology data with the potential to support a future FDA 505(b)(2) new drug application (NDA)Pharmacokinetic results for IHL-42X will inform analysis of anticipated Phase 2/3 data assessing IHL-42X in patients with obstructive sleep apneaContinued excellent safety and tolerability findings, with no serious adverse events reported NEW YORK and MELBOURN
4 - Incannex Healthcare Inc. (0001873875) (Issuer)
3 - Incannex Healthcare Inc. (0001873875) (Issuer)
5 - Incannex Healthcare Inc. (0001873875) (Issuer)
8-K - Incannex Healthcare Inc. (0001873875) (Filer)
10-Q - Incannex Healthcare Inc. (0001873875) (Filer)
8-K - Incannex Healthcare Inc. (0001873875) (Filer)
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
Positive IHL-42X PK findings for the treatment of Obstructive Sleep Apnea (OSA) support future 505(b)(2) New Drug Application (NDA) submissionNew OSA Clinical Advisory Board Announced; Appoints Dr. Alison Wimms, Representing ResMed NEW YORK and MELBOURNE, Australia, Feb. 14, 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 December 31, 2024. "Patients with obstructive sleep apnea need new and convenient therapeutic options to manage this serious, chroni
NEW YORK and MELBOURNE, Australia, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing combination medicines today announced the appointment of Alison Wimms, Ph.D. as an advisor to its newly formed IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board where she will represent ResMed. Dr. Wimms brings two decades of sleep medicine industry and research expertise to her advisory role at Incannex. Dr. Wimms holds a Doctor of Philosophy (Ph.D.) in Medicine, and Master of Medicine (Sleep Medicine) and Bachelor of Science degrees from the University of Sydney. "Incannex's
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