- FDA Fast Track status followed strong Phase 2 efficacy and safety results for IHL-42X.
- The designation provides benefits including a rolling review and closer FDA engagement.
- Stocktwits users highlighted the scale of OSA unmet need and long-term optimism.
Incannex Healthcare shares rose nearly 15% on Wednesday after the company said the U.S. Food and Drug Administration (FDA) granted Fast Track designation to IHL-42X, its oral fixed-dose combination candidate for obstructive sleep apnea.
FDA Fast Track Status
Incannex said the designation was supported by results from three completed clinical trials, including its Phase 2 RePOSA study, which showed statistically significant reductions in Apnea-Hypopnea Index with individual reductions of up to 83%, along with favorable patient-reported outcomes and an “excellent safety profile.”
The company said the Fast Track status allows more frequent interactions with the FDA, eligibility for rolling review of a future New Drug Application, and potential access to Accelerated Approval and Priority Review if criteria are met.
Incannex said it expects detailed written feedback from the FDA on its Phase 2 data package and development strategy and will provide updates once it has reviewed the agency’s guidance.
Generalized Anxiety Disorder Data Adds Momentum
In August, the company reported positive mid-stage trial results for PSX-001 in generalized anxiety disorder. The study showed statistically significant improvements across all key endpoints, including a strong reduction on the Hamilton Anxiety Rating Scale among 73 participants.
Stocktwits Traders Cheer Fast Track Status
On Stocktwits, retail sentiment for Incannex was ‘extremely bullish’ amid ‘high’ message volume.
One user said, “this is incredible news. Fast tracked serves unmet medical needs, meaning this is the only pill in existence for a disease that affect nearly a billion people.”
Another bullish user called the stock a “long hold” and expects further positive developments.
Incannex Healthcare’s stock has declined 79% so far in 2025.
For updates and corrections, email newsroom[at]stocktwits[dot]com.