Incannex Healthcare Appoints Three Clinical Advisors
Incannex Healthcare announced the appointment of three additional members to its recently established Clinical Advisory Board: Murray Stein, MD, MPH; Andrew Cutler, MD; and Amir Kalali, MD. The CAB was formed to provide independent clinical and scientific guidance as the Company progresses PSX-001 into its next phase of clinical and regulatory development. Among its roles, the CAB will advise Incannex on clinical trial design, endpoint selection, regulatory engagement, and broader development strategy as PSX-001 advances.
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Incannex Secures FDA Fast Track Designation for IHL-42X in OSA Treatment
- Fast Track Designation: Incannex Healthcare's IHL-42X oral fixed-dose combination drug has received FDA Fast Track designation, supporting its potential in treating obstructive sleep apnea (OSA) and marking a significant advancement for the company in clinical stages.
- Clinical Trial Results: In three clinical trials, IHL-42X demonstrated promising safety and efficacy, with individual reductions in the Apnea-Hypopnea Index (AHI) of up to 83%, which not only enhances patient quality of life but also establishes a strong foundation for the company's future market competitiveness.
- Enhanced Regulatory Interaction: With the Fast Track designation, Incannex will benefit from more frequent structured interactions with the FDA to discuss clinical strategies and data requirements, which will expedite the new drug application process and increase the likelihood of market access.
- Significant Market Potential: OSA affects millions globally, and with no approved oral pharmacotherapy currently available, the successful development of IHL-42X will fill this market gap, potentially providing substantial commercial opportunities and long-term growth for the company.
What’s Driving Incannex's Pre-market Surge?
FDA Fast Track Designation: Incannex Healthcare's IHL-42X, an oral fixed-dose combination for obstructive sleep apnea, has received Fast Track designation from the FDA based on positive clinical trial results.
Future Feedback from FDA: The company anticipates receiving detailed feedback from the FDA regarding its Phase 2 data and clinical development strategy, with plans to update stakeholders after reviewing this information.
Market Reaction: Following the announcement, Incannex's shares rose by 21% in pre-market trading.
Disclaimer: The views expressed in the article are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
