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Incannex Healthcare Receives Fast Track Approval for IHL-42X
$68.9M in Cash, Positive Phase 2 Results for PSX-001
Published on Feb. 23, 2026
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Incannex Healthcare Inc. (NASDAQ: IXHL) has received fast track approval for its IHL-42X drug, which showed promising results in a Phase 2 trial for treating obstructive sleep apnea (OSA). The company also reported $68.9 million in cash and cash equivalents, as well as positive Phase 2 data for its PSX-001 drug.
Why it matters
The fast track approval for IHL-42X could accelerate its development and bring a new treatment option to the market for the millions of people suffering from OSA. The strong cash position and positive clinical data across Incannex's pipeline suggest the company is well-positioned to continue advancing its drug candidates.
The details
In the Phase 2 RePOSA trial, both low and high-dose IHL-42X achieved statistically significant reductions in Apnea-Hypopnoea Index (AHI) versus placebo, with maximum AHI reductions of up to 83% in the high-dose arm. Exit interviews showed 57.6% of participants reported perceived improvement in their OSA, and most of those described the change as meaningful to daily life. IHL-42X was also well tolerated across both dose cohorts.
- Incannex reported $68.9 million in cash and cash equivalents as of the end of the second quarter of 2026.
- The positive Phase 2 results for PSX-001 were also announced in this update.
The players
Incannex Healthcare Inc.
A biopharmaceutical company developing innovative cannabinoid pharmaceutical products.
IHL-42X
Incannex's drug candidate for the treatment of obstructive sleep apnea, which has received fast track approval.
PSX-001
Another drug candidate in Incannex's pipeline that has shown positive Phase 2 results.
What’s next
The company plans to continue advancing the development of IHL-42X and PSX-001 towards potential regulatory approvals.
The takeaway
Incannex's fast track approval for IHL-42X and positive clinical data across its pipeline demonstrate the company's progress in developing innovative treatments for unmet medical needs. The strong cash position provides the resources to further these development efforts.
