Incannex(IXHL)

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ZCMD, ABCL, VOR, IXHL, OVID, BFRG Rally After Hours On Clinical Momentum And Recent Updates
RTTNews· 2025-10-02 05:09
Core Insights - Several biotech and healthcare stocks experienced significant after-hours gains on October 1, driven by technical momentum and recent clinical updates rather than new disclosures [1] Company Summaries - Zhongchao Inc. (ZCMD) saw a 14.04% increase in after-hours trading, rising to $1.30 from $1.14, despite no new filings or press releases [2] - AbCellera Biologics Inc. (ABCL) rose 11.41% in after-hours trading, closing at $6.64, following an 18.49% gain during the regular session, attributed to recent clinical trial progress [3][4] - Vor Biopharma Inc. (VOR) surged 9.53% in after-hours trading, recovering from a 19.42% drop during the regular session, with no new updates since a recent announcement regarding clinical data presentation [5] - Incannex Healthcare Inc. (IXHL) gained 6.48% in after-hours trading, partially recovering from a 6.94% drop, with the latest update showing positive Phase 2 trial results for PSX-001 [6] - Ovid Therapeutics Inc. (OVID) shares rose 8.03% in after-hours trading, building on a 5.38% gain during the regular session, with recent earnings report indicating a narrower net loss and higher revenue [7] - Bullfrog AI Holdings Inc. (BFRG) advanced 3.44% in after-hours trading, following a 3.57% rise during the regular session, after announcing an expansion of its sales and marketing team [8]
Incannex(IXHL) - 2025 Q4 - Annual Report
2025-09-29 17:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2025 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 (State or other ...
Incannex Reports Positive Results from Phase 2 Clinical Trial of PSX-001 (Psi-GAD) for Generalised Anxiety Disorder
Globenewswire· 2025-08-26 12:00
Core Insights - Incannex Healthcare Inc. reported positive results from its Phase 2 clinical trial of PSX-001, a psilocybin-assisted therapy for Generalised Anxiety Disorder (GAD), indicating its potential as a leading treatment globally [1][12] Trial Design Overview - The Phase 2 study was randomized, double-blind, and placebo-controlled, enrolling 73 adults with moderate to severe GAD, who received either a 25 mg dose of synthetic psilocybin or placebo [2] - Participants underwent two dosing sessions with equal psychological support, ensuring treatment effects were attributable to psilocybin [2] Efficacy Results - The trial demonstrated statistically significant improvements across all primary and secondary endpoints, with a notable 12.8-point reduction in HAM-A scores for the Psi-GAD group compared to a 3.6-point reduction in the placebo group (p<0.0001) [4] - A clinically meaningful response was observed in 44.1% of patients treated with Psi-GAD, achieving a ≥50% reduction in HAM-A scores, significantly higher than the placebo group [5] - The Psi-GAD group also showed a 7.4-point reduction in GAD-7 scores versus 3.5 points for placebo (p<0.0004) [7] - Improvements in functional impairment were noted with a 6.0-point reduction in SDS scores for Psi-GAD compared to 1.3 points for placebo (p<0.007) [8] - Statistically significant antidepressant effects were observed with a 3.9-point reduction in PHQ-9 scores for Psi-GAD versus 0.3 points for placebo (p<0.005) [9] - Quality of life, measured by the PWI, improved by 10.6 points in the Psi-GAD group compared to 2.7 points for placebo (p<0.002) [10] Safety and Tolerability - Treatment with Psi-GAD was well tolerated, with no serious adverse events reported and only one withdrawal from the trial [11] - Most treatment-emergent adverse events were mild to moderate and transient, with no increased risks of suicidality or psychosis noted [11] Company Statements - Dr. Lou Barbato, Chief Medical Officer, emphasized the statistically significant and durable treatment effects observed across multiple measures, positioning Psi-GAD as a leader in anxiety treatment innovation [12] - Joel Latham, President and CEO, highlighted the results as a major milestone for Incannex, reinforcing confidence in their clinical pipeline and strategy [13] Next Steps - Incannex is preparing to initiate a multi-jurisdiction Phase 2 clinical trial and is refining formulation strategies to strengthen its intellectual property position [14][16]
Incannex Healthcare Authorizes $20 Million Share Repurchase Program
Globenewswire· 2025-08-22 12:00
Core Viewpoint - Incannex Healthcare Inc. has announced a share repurchase program for up to $20 million of its outstanding common stock, reflecting confidence in its clinical pipeline and market valuation [1][3]. Summary by Sections Share Repurchase Program - The program allows the company to repurchase shares through various methods, including open market purchases and privately negotiated transactions, in compliance with applicable securities laws [2]. - The timing and amount of repurchases will depend on market conditions and available capital resources [2]. Company Leadership Commentary - CEO Joel Latham stated that the repurchase program demonstrates confidence in the company's pipeline and strategy, and aims to enhance long-term shareholder value [3]. - The initiative is part of a broader commitment to sustainable shareholder value and disciplined capital allocation [3]. Company Overview - Incannex is focused on developing combination medicines for chronic conditions such as obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [4]. - The lead clinical program, IHL-42X, targets obstructive sleep apnea and is an oral fixed-dose combination of dronabinol and acetazolamide [4]. - Other clinical-stage candidates include IHL-675A for inflammatory conditions and PSX-001 for generalized anxiety disorder, both of which are in Phase 2 development [4].
Stonegate Updates Coverage on Incannex Healthcare Inc. (IXHL) 3Q 2025 - Update
Newsfile· 2025-08-19 20:29
Core Insights - Incannex Healthcare Inc. (NASDAQ: IXHL) has made significant progress with its IHL-42X asset, achieving positive topline results from the Phase 2 study, with maximum reductions in Apnoea-Hypopnoea Index (AHI) of up to 83% for the high-dose group and 79% for the low-dose group [1][7] - The treatment was well tolerated, with no serious adverse events reported, and 57.6% of participants noted a perceived improvement in their obstructive sleep apnea (OSA) [1][7] - IXHL has eliminated approximately $347 million in potentially dilutive Series A Warrants through around $24.7 million in at-the-market (ATM) proceeds, enhancing financial flexibility for advancing IHL-42X towards commercialization [7] Clinical and Regulatory Developments - The Phase 2 trial of IHL-42X demonstrated statistically significant reductions in AHI and broad improvements in patient-reported outcomes, indicating both efficacy and safety [7] - Beyond IHL-42X, IXHL is advancing other assets, including PSX-001 for generalized anxiety disorder (GAD) with IND clearance in the U.S. and U.K., and IHL-675A, which is in Phase 2 for rheumatoid arthritis, with data expected in the second half of 2025 [7]
Incannex Receives Positive Patient-Reported Outcomes and Compelling Phase 2 Efficacy Data for IHL-42X in Obstructive Sleep Apnoea
Globenewswire· 2025-08-08 12:00
Core Insights - Incannex Healthcare Inc. announced new patient-reported outcomes from its RePOSA Phase 2 trial of IHL-42X for obstructive sleep apnoea (OSA), indicating strong potential for improving sleep quality and cognitive function [1][4] - The exit interviews conducted aligned with FDA guidance and assessed patient experiences, revealing significant motivation among participants for improved health and alternatives to traditional therapies [2][3] Clinical Efficacy - The RePOSA Phase 2 trial showed statistically significant improvements in key endpoints for patients receiving IHL-42X compared to placebo, indicating its potential to reduce OSA severity and enhance quality of life [5] - The Apnoea-Hypopnoea Index (AHI) showed maximum reductions of up to 83% in the high-dose group and 79% in the low-dose group, with both groups achieving statistically significant reductions compared to placebo [6] - 57.6% of participants reported perceived improvements in their OSA, with 89.5% of those describing the changes as meaningful [7] - Reduction rates of ≥30% in AHI were observed in 33.3% of the low-dose group and 41.2% of the high-dose group, while reductions exceeding 50% were seen in 13.9% (low-dose) and 14.7% (high-dose) [8] - Statistically significant improvements in sleep-related impairment and fatigue were noted in the low-dose group, along with better oxygenation during sleep in both dose groups [9] Patient-Reported Outcomes - Clinically significant improvements were observed in various sleep quality metrics, including the Functional Outcomes of Sleep Questionnaire-10 and the Epworth Sleepiness Scale, demonstrating enhanced sleep quality and reduced fatigue [10] - Objective sleep parameters also improved, with a 29.8% reduction in Wake After Sleep Onset (WASO) and a 30.3% decrease in AHI during supine sleep in the high-dose group [11] - IHL-42X did not reduce the proportion of time spent in REM sleep, which is crucial for memory consolidation and emotional regulation [12] Safety Profile - IHL-42X was well tolerated across both low- and high-dose cohorts, with no serious adverse events reported and most treatment-emergent adverse effects being mild or moderate [14] Company Overview - Incannex Healthcare is focused on developing combination medicines targeting chronic conditions, including OSA, rheumatoid arthritis, and generalized anxiety disorder, with IHL-42X being its lead clinical program [15]
Incannex Confirms Strong Cash Position; No Plans or Requirement to Fully Utilise ATM in Near Term
Globenewswire· 2025-07-31 12:00
MELBOURNE, Australia, July 31, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) ("Incannex" or the "Company") announced, in response to recent questions it received from a number of its stockholders, that it does not presently intend to use the full capacity available under its at the market offering program (the "ATM") in the near-term. As previously disclosed in the Company's Form 8-K filed with the U.S. Securities and Exchange Commission on July 24, 2025, the Company is under no obligatio ...
Incannex Reports Positive Topline Results from RePOSA Phase 2 Trial of IHL-42X
GlobeNewswire News Room· 2025-07-30 12:00
Core Insights - Incannex Healthcare Inc. announced positive topline results from its RePOSA Phase 2 clinical trial for IHL-42X, a novel oral drug candidate for obstructive sleep apnoea (OSA), highlighting its potential as a transformative therapy for the over 900 million people affected globally [2][5][11] - The trial demonstrated statistically significant and clinically meaningful improvements across key endpoints, reinforcing IHL-42X's potential as a best-in-class therapy for OSA patients [2][3][5] Clinical Efficacy - IHL-42X showed a reduction in the Apnoea-Hypopnoea Index (AHI) by up to 83% in the high-dose group and 79% in the low-dose group, with 33.3% of low-dose and 41.2% of high-dose patients achieving over 30% reduction in AHI [6][10] - Statistically significant improvements were observed in patient-reported outcomes, including sleep-related impairment and fatigue, indicating enhanced quality of life for patients [6][10] Safety Profile - IHL-42X was well tolerated, with no serious adverse events reported and most treatment-emergent adverse effects being mild or moderate, supporting its potential for broad patient use [4][7] Next Steps - Incannex is preparing for an End-of-Phase 2 meeting with the FDA to discuss the path to registration and optimize Phase 3 trial design [8][9] - The company will continue to evaluate clinical data and complete the full Clinical Study Report, marking a new phase toward late-stage development and potential commercialization [9][10] Company Overview - Incannex is focused on developing combination medicines targeting chronic conditions, including OSA, and is advancing multiple clinical-stage product candidates [11]
Incannex Healthcare Expands Clinical Advisory Board to Support Obstructive Sleep Apnea Program with Appointment of Dr. Charlene E. Gamaldo
Globenewswire· 2025-07-25 11:30
Core Insights - Incannex Healthcare Inc. has appointed Dr. Charlene E. Gamaldo to its IHL-42X Obstructive Sleep Apnea Clinical Advisory Board, enhancing the company's expertise in sleep medicine [1][2] - The Phase 2 data readout for IHL-42X is expected next week, indicating the company's confidence in the asset and commitment to its development [2] - IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, currently in the RePOSA Phase 2/3 clinical trial, targeting obstructive sleep apnea by addressing its underlying pathophysiology [6][9] Company Overview - Incannex is focused on developing combination medicines for chronic conditions, including obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [9][10] - The company is advancing three clinical-stage product candidates, with IHL-42X being the lead program designed to target the mechanisms of obstructive sleep apnea [9][10] - IHL-42X aims to benefit a broader range of patients, including the 67% of individuals with obstructive sleep apnea who are not classified as obese, addressing a significant gap in care [8] Clinical Development - The RePOSA Phase 2/3 clinical trial for IHL-42X is expected to enroll over 560 patients globally, with the Phase 2 portion conducted in the United States [6][7] - A topline readout from the U.S. Phase 2 portion is anticipated in July 2025, which will provide critical data on the efficacy of IHL-42X [7][8] - IHL-42X targets two key physiological pathways associated with obstructive sleep apnea, differentiating it from traditional weight loss therapies [8]
Incannex Healthcare Expands Clinical Advisory Board to Support Obstructive Sleep Apnea Program with Appointment of Dr. Douglas B. Kirsch
Globenewswire· 2025-06-24 11:30
Core Insights - Incannex Healthcare Inc. has appointed Dr. Douglas B. Kirsch to its IHL-42X Obstructive Sleep Apnea Clinical Advisory Board, enhancing the board's expertise at a crucial time for the program [1][2][4] Company Overview - Incannex is a clinical-stage biopharmaceutical company focused on developing combination drug therapies for significant health conditions, including obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [8] - The company's lead product, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide, designed to target the underlying mechanisms of obstructive sleep apnea [8] Product Development - IHL-42X is currently in the RePOSA Phase 2/3 clinical trial, which aims to enroll over 560 patients globally, with topline Phase 2 data expected in July 2025 [5][6] - The therapy targets two physiological pathways associated with obstructive sleep apnea: intermittent hypoxia and hypercapnia, offering a differentiated approach that may benefit a broader range of patients [7] Clinical Expertise - Dr. Kirsch brings extensive experience in sleep medicine, having served as President of the American Academy of Sleep Medicine and currently overseeing clinical sleep medicine services at Atrium Health [2][3] - His addition to the advisory board is expected to be instrumental in advancing IHL-42X through late-stage development [2][4] Market Potential - Obstructive sleep apnea affects approximately 1 billion people globally and around 30 million in the United States, with a significant portion of cases remaining underdiagnosed and undertreated [7] - IHL-42X has the potential to address this critical gap in care, improving outcomes for millions suffering from this chronic condition [7]