Incannex Healthcare Ltd Stock Price, News & Analysis

Incannex Healthcare (Nasdaq: IXHL) announced on January 22, 2026 the formation of a Clinical Advisory Board to support the PSX-001 program in generalized anxiety disorder. The CAB will provide independent clinical, scientific, and regulatory guidance as PSX-001 advances to its next phase, advising on trial design, endpoint selection, and regulatory engagement. The inaugural members include C. Neill Epperson, Charles B. Nemeroff, and Alan F. Schatzberg, all senior psychiatry researchers with extensive publication and NIH-funded research histories.

Incannex Healthcare (Nasdaq: IXHL) was awarded the Research and Development Award in the Respiratory Disorders category at the 2025 Clinical Trials Arena Excellence Awards for its work on IHL-42X, an oral fixed-dose combination for moderate-to-severe obstructive sleep apnea (OSA).

The program is described as late-stage and supported by a Phase 2 clinical program with objective polysomnography outcomes, validated patient-reported measures, and structured exit interviews; the release states a favorable safety and tolerability profile observed to date and continued development toward potential chronic use if approved.

Incannex Healthcare (Nasdaq: IXHL) reported 2025 progress and a 2026 outlook highlighting clinical, regulatory and financial momentum. Key 2025 achievements include two positive Phase 2 readouts (IHL-42X for OSA and PSX-001 for GAD), FDA Fast Track designation for IHL-42X, and reported reductions in AHI of up to 83%. The company said it has > $70 million in cash, completed a $12.5 million private placement, eliminated Series A warrants, and authorized a $20 million share repurchase program, providing runway well into 2027. 2026 priorities include advancing IHL-42X toward later-stage development and progressing PSX-001 clinical and regulatory planning.

Incannex Healthcare (Nasdaq: IXHL) announced on Dec 3, 2025 that the U.S. FDA has granted Fast Track designation to IHL-42X, its oral fixed-dose combination candidate for obstructive sleep apnea (OSA). The designation was supported by three clinical trials, including the Phase 2 RePOSA study showing statistically significant reductions in Apnea‑Hypopnea Index (AHI) with individual reductions up to 83%, strong patient‑reported outcomes, and an excellent safety profile. Under Fast Track, IHL-42X gains more frequent FDA interactions, eligibility for rolling review, and potential access to Accelerated Approval and Priority Review if criteria are met. Incannex expects written FDA feedback on the Phase 2 data package and will announce agreed next steps toward late‑stage development.

Incannex Healthcare (NASDAQ: IXHL) updated coverage following 1Q 2026 activity and Phase 2 results. IHL-42X showed statistically significant Apnoea‑Hypopnoea Index (AHI) reductions versus placebo, with maximum AHI reductions up to 83% (high dose) and 79% (low dose). Exit interviews reported 57.6% of participants perceived meaningful OSA improvement. Safety was favorable with no serious adverse events and mainly mild, transient treatment‑emergent events. Management is preparing FDA interactions for Phase 3 planning. The company reported quarter‑end cash of $73.3M, net loss of $6.4M, and operating expenses of $6.8M, which the company says supports at least twelve months of runway. PSX‑001 showed meaningful anxiety reduction and a multi‑jurisdiction PsiGAD2 study is being prepared under an open IND.

Incannex (Nasdaq: IXHL) provided a shareholder update on Oct 30, 2025 highlighting Phase 2 successes, capital discipline, and late‑stage planning for 2026. Key clinical results include IHL‑42X showing up to an 83% AHI reduction from baseline with strong patient‑reported outcomes and a favorable safety profile, and PSX‑001 demonstrating statistically significant improvements on HAM‑A and multiple secondary measures with sustained benefit over 11 weeks and no serious adverse events. The company reports no use of its ATM since Aug 28, 2025 and total shares outstanding remain 347,705,507. Incannex plans FDA engagement to define pivotal pathways, maintain operational readiness, and explore partnerships and disciplined capital deployment.

Incannex (Nasdaq: IXHL) announced Nasdaq has granted a 180-calendar-day extension to regain compliance with the minimum bid price rule, giving the company until April 20, 2026 to maintain a closing bid of at least US$1.00 for the required consecutive trading days.

Nasdaq said Incannex meets all other continued listing criteria. The company said it may cure the deficiency within the extension period, including by a reverse stock split if needed, and reaffirmed its recent operational progress, noting delivery of two Phase 2 clinical data packages and an "extremely strong cash position."

Incannex Healthcare (NASDAQ: IXHL) has announced positive results from its Phase 2 clinical trial of PSX-001 (Psi-GAD), a psilocybin-assisted psychotherapy treatment for Generalised Anxiety Disorder (GAD). The randomized, double-blind, placebo-controlled study involving 73 adult participants showed statistically significant improvements across all endpoints.

Key findings include a 12.8-point reduction in HAM-A scores compared to 3.6-point reduction in placebo (p<0.0001), with 44.1% of patients achieving clinical response and 27% reaching full disease remission. The treatment demonstrated strong safety profile with no serious adverse events reported.

The company plans to advance to multi-jurisdiction Phase 2 clinical trials and is exploring strategic partnerships to accelerate PSX-001's development.

Incannex Healthcare (Nasdaq: IXHL), a clinical-stage biopharmaceutical company, has announced a $20 million share repurchase program. The program allows the company to repurchase its common stock through various methods, including open market purchases and privately negotiated transactions.

CEO Joel Latham emphasized that this initiative reflects confidence in their pipeline strength and strategy, suggesting the current market valuation doesn't reflect their clinical program progress. The repurchase program demonstrates Incannex's commitment to enhancing shareholder value while maintaining disciplined capital allocation for their late-stage clinical pipeline advancement.