Incannex Granted FDA Fast Track Designation for IHL-42X in Obstructive Sleep Apnea (OSA)
Incannex Healthcare Inc. (IXHL)
Company Research
Source: GlobeNewswire
MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA). The Fast Track designation was supported by promising safety, efficacy, and pharmacokinetic results from the three clinical trials completed to date within the IHL-42X development program. These include the Company’s successful Phase 2 “RePOSA” study demonstrating statistically significant reductions in Apnea-Hypopnea Index (AHI), with individual reductions of up to 83%, outstanding patient-reported outcomes, and an excellent safety profile. Fast Track designation is granted by the FDA to drug candidates that treat serious conditions and address unmet medical needs with t
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News
- Stonegate Updates Coverage on Incannex Healthcare Inc. (IXHL) 1Q 2026 [Yahoo! Finance]Yahoo! Finance
- Incannex Provides Shareholder Update Highlighting Clinical Progress, Capital Discipline, and EOY 2025 Strategic FocusGlobeNewswire
- Incannex Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price RequirementGlobeNewswire
- Incannex Healthcare (NASDAQ:IXHL) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
IXHL
Sec Filings
- 12/3/25 - Form 8-K
- 11/14/25 - Form 10-Q
- 11/14/25 - Form 4
- IXHL's page on the SEC website