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Neuren eagerly awaits the FDA’s approval

The next major milestone for Neuren is to achieve FDA approval of Trofinetide for Rett Syndrome with the target action date set for 12 March 2023. Historical studies have shown that drugs for neurological disorders are approved about 83% of the time. If approved, Neuren will be one of only a handful of ASX listed companies with an FDA approved pharmaceutical product.

Approval would trigger the transition from a clinical development company to a company generating substantial revenues and cash flows. At this point, Neuren’s compound Trofinetide is well ahead of any of the competing solutions that are under development.