FDA grants Fast Track designation to Incannex's IHL-42X for obstructive sleep apnea

Incannex Healthcare Inc.

FDA Fast Track designation for Incannex's IHL-42X for obstructive sleep apnea (OSA).
Phase 2 RePOSA study showed up to 83% reduction in AHI; safety and patient-reported outcomes positive.
Fast Track enables rolling NDA submission, more FDA interaction, and potential Accelerated Approval.
Incannex expects to receive FDA feedback on Phase 2 data and map path to late-stage development.

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