Investing.com -- Incannex Healthcare Inc. (NASDAQ:IXHL) stock surged 19.2% in premarket trading Wednesday after the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its obstructive sleep apnea (OSA) treatment candidate, IHL-42X.
The designation was supported by promising results from three clinical trials, including the company’s Phase 2 "RePOSA" study which demonstrated statistically significant reductions in Apnea-Hypopnea Index (AHI), with individual reductions of up to 83%.
Fast Track status will provide Incannex with more frequent FDA interactions, eligibility for rolling review of its future New Drug Application, and potential access to Accelerated Approval and Priority Review pathways.
"We believe Fast Track designation for IHL-42X is one of the most significant regulatory milestones in Incannex’s history," said Joel Latham, President and CEO of Incannex. "OSA affects millions of people globally, yet there remains no approved oral pharmacotherapy, a gap we are determined to close."
The clinical-stage biopharmaceutical company expects to receive detailed written feedback from the FDA regarding its Phase 2 data and clinical development strategy, with plans to provide further updates on the regulatory path forward once this feedback is reviewed.
Mark Bleackley, Chief Scientific Officer at Incannex, noted that the designation "supports the potential for IHL-42X to address the unmet need for an oral pharmacotherapy for OSA patients."
Incannex is developing IHL-42X as an oral fixed-dose combination product candidate for OSA, a serious condition that impacts both short and long-term aspects of patient health and quality of life.
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