Incannex Healthcare shares rise 17.17% after-hours after FDA grants Fast Track to IHL-42X for OSA.

Incannex Healthcare Inc. surged 17.17% in after-hours trading following the U.S. Food and Drug Administration’s (FDA) Fast Track designation for its IHL-42X oral treatment for obstructive sleep apnea (OSA). The designation, announced on December 3, 2025, was supported by strong Phase 2 RePOSA trial results, including statistically significant 83% reductions in Apnea-Hypopnea Index (AHI) and favorable safety profiles. Fast Track status enables more frequent FDA interactions, rolling review of future New Drug Applications, and potential access to Accelerated Approval and Priority Review pathways. The company emphasized the unmet medical need for OSA pharmacotherapy and highlighted plans to seek detailed FDA feedback on its development strategy. Joel Latham, CEO, called the milestone a pivotal regulatory achievement, underscoring IHL-42X’s potential to address a $10 billion market gap. The stock’s sharp rise reflects optimism over expedited regulatory timelines and the drug’s clinical promise in a high-growth therapeutic area.