Neuren Pharmaceuticals becomes another Australian Biotech Success Story after US FDA Approves Treatment for Rett Syndrome

March 16th, 2023

Victorian based Neuren Pharmaceuticals’ North American partner, Acadia Pharmaceuticals, has received news this week that its treatment for Rett syndrome was approved by the US Food and Drug Administration.

Neuren Pharmaceuticals and Acadia Pharmaceuticals had previously entered an exclusive licence in 2018 to develop and commercialise trofinetide for the treatment of Rett syndrome and other indications.

Trofinetide, to be sold under the brand name DAYBUE, is now the first drug to be approved for the treatment of the neurodevelopmental disorder in adult and paediatric patients older than two.

Under the agreement, Neuren Pharmaceuticals will receive substantial milestone payments and this success has seen Neuren Pharmaceuticals’ share price rise from around $4 in March 2022, to over $12 in March 2023.

Neuren Pharmaceuticals reported receipt of cash refundable R&D Tax Offsets of $1.4M and 2.5M for the 2022 and 2021 years respectively within the company’s ASX filings.

Once the company achieves turnover greater than $20M it can no longer receive substantial refunds under the R&D Tax Incentive, however, this is an example of how the R&D Tax incentive can be used as a springboard to launch an Australian success story.

Neuren Pharmaceuticals should be commended on this outcome and the company joins the likes of other recent Australian medical technology successes including Telix, PolyNovo, Pro-Medicus, CSL, Resmed and Cochlear.

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