Incannex (IXHL) Healthcare announces that the U.S. Food and Drug Administration has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea. 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, with individual reductions of up to 83%, outstanding patient-reported outcomes, and an excellent safety profile.
Claim 50% Off TipRanks Premium and Invest with Confidence
- Unlock hedge-fund level data and powerful investing tools designed to help you make smarter, sharper decisions
- Stay ahead of the market with the latest news and analysis so your portfolio is always positioned for maximum potential
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on IXHL:
- Incannex Healthcare Reports Increased Cash Reserves Amid Losses
- Psychedelic: Compass Pathways, NeuroKaire enter R&D collaboration
- Incannex Healthcare Highlights Clinical Progress in Shareholder Update
- Incannex provides shareholder update including 2025 priorities
- Incannex Healthcare Granted Nasdaq Compliance Extension