Incannex Healthcare Inc. (NASDAQ:IXHL) surged 19.2% in premarket trading on Wednesday after revealing that the U.S. Food and Drug Administration has granted Fast Track status to IHL-42X, its investigational treatment for obstructive sleep apnea (OSA).

The designation follows encouraging outcomes from three separate clinical studies, including the company’s Phase 2 “RePOSA” trial, where patients experienced statistically meaningful reductions in Apnea-Hypopnea Index (AHI), with some individuals seeing decreases of up to 83%.

Fast Track status opens the door to closer and more frequent engagement with the FDA, allows the company to submit portions of its future New Drug Application on a rolling basis, and provides potential access to Accelerated Approval as well as Priority Review options.

“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.”

Incannex expects detailed written guidance from the agency on its Phase 2 data package and overall clinical strategy. The company said it plans to update the market once it has reviewed the FDA’s feedback.

Mark Bleackley, Chief Scientific Officer at Incannex, emphasized that the Fast Track decision “supports the potential for IHL-42X to address the unmet need for an oral pharmacotherapy for OSA patients.”

IHL-42X is being advanced as a fixed-dose oral combination therapy aimed at treating OSA — a widespread and serious disorder that undermines both short-term functioning and long-term health outcomes.

Incannex Healthcare stock price

This content is for informational purposes only and does not constitute financial, investment, or other professional advice. It should not be considered a recommendation to buy or sell any securities or financial instruments. All investments involve risk, including the potential loss of principal. Past performance is not indicative of future results. You should conduct your own research and consult with a qualified financial advisor before making any investment decisions.
Some portions of this content may have been generated or assisted by artificial intelligence (AI) tools and been reviewed for accuracy and quality by our editorial team.