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Incannex Healthcare Inc. Reports Fiscal Full Year 2024 Financial Results and Business Updates
GlobeNewswire News Room· 2024-09-30 20:01
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, ...
FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed
GlobeNewswire News Room· 2024-08-05 11:30
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, Austra ...
FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed
Newsfilter· 2024-08-05 11:30
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, Austra ...
Dosing completed in 115 participant bioavailability/bioequivalence clinical trial for proprietary sleep apnea drug candidate IHL-42X
Newsfilter· 2024-07-30 11:30
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 i ...
Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea
GlobeNewswire News Room· 2024-05-30 11:30
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 ...
Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea
Newsfilter· 2024-05-30 11:30
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 ...
Incannex(IXHL) - 2024 Q3 - Quarterly Report
2024-05-15 17:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM___________ TO__________ Commission File Number 001-41106 Incannex Healthcare Inc. (Exact name of Registrant as specified in its Charter) | Delaware | 93-2403210 | | -- ...
Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder
Newsfilter· 2024-05-07 11:30
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 ...
Incannex(IXHL) - 2024 Q2 - Quarterly Report
2024-02-14 11:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM___________ TO__________ Commission File Number 001-41106 Incannex Healthcare Inc. (Exact name of Registrant as specified in its Charter) | Delaware | 93-24 ...
Incannex(IXHL) - 2023 Q4 - Annual Report
2023-10-31 10:37
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...