Incannex Healthcare - IHL-42X gearing up for FDA studies
Incannex Healthcare announced the initiation of a bioavailability/bioequivalence (BA/BE) study assessing the company’s lead clinical asset IHL-42X. Results from the BA/BE study are a prerequisite to pursue the FDA’s 505(b)(2) new drug application regulatory pathway, which forms a critical part of management’s expedited clinical development strategy for its assets, so we see the commencement as positive preparatory activity. Additionally, management intends to open an investigational new drug (IND) application with the FDA in Q1 CY23 to initiate Phase II/III studies of IHL-42X. Incannex’s clinical strategy is to progress development through later-stage FDA studies, so we view this confirmation from management as encouraging for IHL-42X’s overall development. We continue to value Incannex at US$714.7m or US$11.74 per ADR.
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