This ASX 200 stock is charging higher on FDA approval news

Neuren Pharmaceuticals Ltd (ASX: NEU) shares are starting the week strongly.

In morning trade, the ASX 200 stock is up 3.5% to $19.59.

Why is this ASX 200 stock rising today?

Investors have been bidding the pharmaceuticals company's shares higher today after it received approval from regulators in the United States for a new product.

According to the release, its partner in the United States, Acadia Pharmaceuticals (NASDAQ: ACAD), has received US Food and Drug Administration (FDA) approval of Daybue STIX. It is a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and paediatric patients two years of age and older. It is a rare genetic disorder that affects the way the brain develops, impacting the ability to use muscles for eye and body movements and language.

It notes that the new powder formulation offers children and adults living with Rett syndrome new flexibility and choice regarding the dose volume and taste of their Daybue treatment.

The ASX 200 stock advised that the approval of this new formulation was supported by the results of a bioequivalence study. This study demonstrated that both original Daybue oral solution and the new Daybue STIX powder formulation provide comparable exposure.

This confirmed bioequivalence means patients can expect the same efficacy and safety established by the oral solution formulation when using Daybue STIX.

Acadia has advised that it expects Daybue STIX to be available on a limited basis starting in the first quarter of 2026.

After which, it will be more broadly available early in the second quarter of 2026. The current oral solution formulation will remain available.

Acadia has an exclusive worldwide licence for the development and commercialisation of trofinetide (Daybue). This agreement sees Neuren receive royalties on all net sales of trofinetide and is eligible to receive additional payments on achievement of commercial and development milestones.

Neuren's CEO, Jon Pilcher, was pleased with the news. Commenting on the approval, he said:

The Neuren team is excited about the approval of this new treatment option for Rett syndrome families and the continued investment and innovation for trofinetide by our global partner, Acadia. Caregivers can mix Daybue STIX with a variety of water-based liquids providing flexibility to modify the taste and volume of their loved-one's dose. We look forward to seeing the impact as Daybue STIX becomes more broadly available during 2026.

The post This ASX 200 stock is charging higher on FDA approval news appeared first on The Motley Fool Australia.

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