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

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 notes to Arena Investors, LP (Arena) and its affiliates. Under the terms of the agreements, Incannex will also secure a $50 million equity line of credit (ELOC) with Arena affiliate, Arena Business Solutions ("ABS"), which the Company does not anticipate drawing upon at closing. "We are pleased to be partner

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 the psilocybin treatment group. 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 c

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 clinical trial continues after dosing commenced in May 2024. NEW YORK and MELBOURNE, Australia, July 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (‘Incannex' or the ‘Company'), a clinical-stage pharmaceutical comp

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 the Company's proprietary fixed dose combination drug for treatment of obstructive sleep apnea. Commencement of patient dosing in the United States represents a significant milestone in its development. Initiating dosing in the trial follo

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 representatives from various divisions of the FDA providing input on the CannQuit-O development program. The Agency had reviewed the CannQuit-O meeting package and provided recommendations on the proposed clinical development

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ:IXHL), (‘Incannex' or the ‘Company'), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024. Incannex is undertaking various U.S. Food and Drug Administration (‘FDA') research and development (‘R&D') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies. The nearest-to-market projects in the Company's therapeutic pipeline are: IHL-42X drug candidate for Obstructive Sleep Apnea (‘OSA') - Phase 2/3 studies underway.IHL-675A drug candidate for Rheumatoid Arthritis (‘RA') - Phase 2b studi

Highlights: PsiGAD1 trial achieves primary endpoint; PsiGAD psilocybin-assisted therapy demonstrated a statistically significant HAM-A reduction of 12.8 points from baseline, representing a 9.2-point improvement over psychotherapy with placebo (p <0.0001), exceeding the company's expectations. 44% of patients in the psilocybin group demonstrated at least 50% reduction in anxiety score and 27% of patients showed disease remission– a remission rate more than 5 times higher than that of therapy with placebo. Newly developed and formulated PSX-001 psilocybin drug product has been finalised - cGMP manufacture for clinical trial supply underway. Incannex to submit an Investigational New Drug (IND

- 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

DEA Revisits Proposed Ban On Two Psychedelic Compounds: Researchers Disagree, Insist On Hearings The Drug Enforcement Administration (DEA) is revisiting its stance on the classification of two psychedelic compounds, 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC).   The agency has proposed both be listed as Schedule I substances under the Controlled Substances Act (CSA). If added to the Schedule I list, these compounds would be officially considered as having high abuse potential with no recognized medical use. The evaluation is being disputed by experts. Three formal requests for a hearing were submitted, prompting a reconsideration by the agency.

Intranasal 5-MeO-DMT Clinical Trial Offers Hope For Treatment-Resistant Depression Partners Beckley Psytech and atai Life Sciences (NASDAQ:ATAI) have jointly announced positive initial results from a Phase 2a study of Beckley’s novel formulation of 5-MeO-DMT in Treatment Resistant Depression (TRD.)  BPL-003 is a synthetic and patent-protected benzoate salt formulation of 5-MeO-DMT (aka mebufotenin) designed for intranasal administration. The open-label study assessed safety, tolerability and efficacy of the compound at a single 10mg dose, alongside psychological support, in patients with moderate-to-severe TRD (who withdrew from concomitant antidepressants.) Learn more. Utah Hospita

Recent advancements within the field of mental health with the use of psilocybin-assisted therapy, as well as Colorado’s forward-thinking legislation about this therapy, have proven exciting. Psilocybin-assisted therapy showcased promising results in treating Generalized Anxiety Disorder (GAD). This condition often leaves individuals grappling with excessive worry and anxiety for extended periods. A Phase 2 clinical trial conducted by Incannex Healthcare (OTC:IXHL) illuminated the potential of psilocybin therapy to offer relief where traditional treatments may falter due to side effects or high costs associated with conventional methods. Amidst these clinical breakthroughs, in Colorad

FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placement Clinical-stage psychedelics biopharma company Cybin Inc. (NYSE:CYBN) announced that the Food and Drug Administration has granted Breakthrough Therapy designation to CYB003, its proprietary deuterated psilocybin analog targeting the adjunctive treatment of Major Depressive Disorder (MDD.)  It makes the group of psychedelic-based treatments for mental health conditions that have in recent years received such status granted by the U.S. federal agency five therapies total: Cybin's, MindMed's (NASDAQ:MNMD) LSD-derived treatment for

https://www.marijuanamoment.net/indiana-lawmakers-send-psilocybin-research-funding-bill-to-governor/The Indiana legislature has sent a bill to the governor's desk that includes provisions to fund clinical research trials into psilocybin.The House and Senate both passed the underlying legislation on health care issues, which was amended to add the psychedelics language, last week.The reform provisions that lawmakers attached to the broader legislation were taken from a standalone measure from Sen. Ed Charbonneau (R) that cleared the Senate last month and then advanced through a House committee.Charbonneau said in a press release on Friday that the intent of the proposal is to provide funding

Madhukar Bhalla, Chief Financial Officer and Secretary of Incannex Healthcare Inc. (the “Company”), recently notified the Company of his decision to resign from his positions effective as of February 28, 2024. Mr. Bhalla’s decision does not reflect any disagreement with, or the existence of any irregularities in, the Company’s operations, policies, accounting principles, practices, financial statements or disclosures.   The Company’s Board of Directors has appointed Joseph Swan, the current Treasurer and Controller of the Company, as its Chief Financial Officer and Secretary effective as of February 29, 2024. Mr. Swan will maintain his position as Treasurer of the Company.