reports
Incannex Healthcare Inc. Expands IHL-42X Clinical Advisory Board with ...
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 Foll...
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...
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 S...
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 ...
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 R...
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, ...
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...
Incannex Healthcare Completes Phase 2 Enrollment in RePOSA Phase 2/3 T...
Incannex Healthcare Completes Phase 2 Enrollment in RePOSA Phase 2/3 Trial of IHL-42X, an Oral Once-Daily Treatment for Obstructive Sleep Apnea (OSA) Topline Phase 2 clinical data expected in the first half 2025 NEW YORK and MELBOURNE, Australia, April 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing new oral combination medicines, today announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructiv...
Incannex Healthcare Inc. Announces Pricing of $12.5 Million Private Pl...
Incannex Healthcare Inc. Announces Pricing of $12.5 Million Private Placement Priced at the Market Under Nasdaq Rules Funds to support the advancement of Incannex’s IHL-42X Phase 2/3 Obstructive Sleep Apnea (OSA) clinical program through U.S. Phase 2 completion, topline readout, and its expansion into a global Phase 3 study. NEW YORK and MELBOURNE, Australia, March 07, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today announced that it has entered into s...
Incannex Healthcare Inc. Reports Fiscal Second Quarter 2025 Financial ...
Incannex Healthcare Inc. Reports Fiscal Second Quarter 2025 Financial Results and Business Updates 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 fin...
Incannex Healthcare Appoints Alison Wimms, Ph.D. to Newly Formed IHL-4...
Incannex Healthcare Appoints Alison Wimms, Ph.D. to Newly Formed IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board Dr. Wimms brings extensive industry and clinical development experience in sleep medicine innovation 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 Boa...
Incannex Healthcare Announces Positive Topline Results from Pharmacoki...
Incannex Healthcare Announces Positive Topline Results from Pharmacokinetics (PK) Study of IHL-42X, an Oral Combination Medicine for the Treatment of Obstructive Sleep Apnea 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 a...
Incannex Healthcare Inc. Reports Fiscal First Quarter 2025 Financial R...
Incannex Healthcare Inc. Reports Fiscal First Quarter 2025 Financial Results and Business Updates 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 transformat...
Incannex Announces Appointment of Dr. Lou Barbato as Chief Medical Off...
Incannex Announces Appointment of Dr. Lou Barbato as Chief Medical Officer 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, Nov...
Incannex Healthcare Inc. Reports Fiscal Full Year 2024 Financial Resul...
Incannex Healthcare Inc. Reports Fiscal Full Year 2024 Financial Results and Business Updates 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...
Incannex Healthcare Announces Strategic Financing for up to $60 Millio...
Incannex Healthcare Announces Strategic Financing for up to $60 Million with Arena Investors Incannex to Receive Funding of Up to $10 Million in Convertible Notes and $50 Million Equity Line of Credit NEW YORK and MELBOURNE, Australia, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (the “Company” or “Incannex”), a clinical-stage biopharmaceutical company developing life-changing medicines for people with chronic diseases and significant unmet medical needs, today announced it has entered into an agreement to issue up to $10 million in secured convertible not...
FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assi...
FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed Approval from FDA to proceed with 94 patient Phase 2 clinical trial received following review of IND dossier containing information on the clinical trial, as well as safety and quality of the investigational drug product.PsiGAD2, short for Psilocybin for Generalised Anxiety Disorder trial two, follows the PsiGAD1 proof of concept trial, which demonstrated a 12.8 point reduction in the Hamilton Anxiety Rating Sacle (HAM-A) score from baseline in th...
Dosing completed in 115 participant bioavailability/bioequivalence cli...
Dosing completed in 115 participant bioavailability/bioequivalence clinical trial for proprietary sleep apnea drug candidate IHL-42X IHL-42X is a fixed dose combination drug targeting obstructive sleep apnea (OSA), a medical condition with no available registered pharmaceutical treatment for millions of sufferers in the USA alone.bioavailability/bioequivalence (‘BA/BE’) clinical trial assessed the pharmacokinetics and tolerability of IHL-42X consistent with FDA development plan.Analysis of data underway, however, no serious adverse events were reported.Phase 2/3 FDA IND-enabling RePOSA clin...
Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol t...
Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea 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’). IHL-42X is th...
Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit...
Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder 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). The pre-IND teleconference included representati...
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