(RTTNews) - Incannex Healthcare (IXHL) announced that the 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. The Fast Track designation was supported by safety, efficacy, and pharmacokinetic results from the three clinical trials completed to date within the IHL-42X development program.
Incannex expects to receive detailed written feedback from the FDA in response to its Phase 2 data package and clinical development strategy. The company expects to provide further updates once it has received and reviewed this feedback.
Shares of Incannex are up 21% in pre-market trade on Wednesday.
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