Incannex Healthcare shares surge 20.47% intraday after FDA grants Fast Track designation for IHL-42X in obstructive sleep apnea.

Incannex Healthcare surged 20.47% intraday after announcing the U.S. FDA granted Fast Track designation for its IHL-42X, an oral fixed-dose combination candidate for obstructive sleep apnea. The designation, supported by Phase 2 RePOSA trial results showing up to 83% reductions in Apnea-Hypopnea Index and favorable safety outcomes, enables more frequent FDA interactions, rolling review of future New Drug Applications, and potential access to Accelerated Approval or Priority Review. Strong Phase 2 efficacy and safety data, coupled with the unmet need for OSA treatments, drove positive sentiment. Retail traders on Stocktwits emphasized the market opportunity, with one noting the drug could address a condition affecting nearly a billion people. The move aligns with the company’s strategic focus on advancing IHL-42X and addressing regulatory milestones.