11:27 AM EDT, 06/03/2024 (MT Newswires) -- Denali Therapeutics ( DNLI ) said Monday that the US Food and Drug Administration has picked DNL126 to take part in the support for clinical trials advancing rare disease therapeutics, or START, pilot program.

The company said that DNL126 is an investigational enzyme replacement therapy designed to cross the blood-brain barrier to potentially treat MPS IIIA, or Sanfilippo syndrome type A, a progressive disease that causes neurodegeneration.

Under START, Denali Therapeutics ( DNLI ) will have chances to get advice and engage in ad hoc communication with FDA review staff to go over product-specific development issues, the company said.

The company added that it is conducting a phase 1/2 trial of DNL126 for children with MPS IIIA and expects increased engagement with the regulator to ultimately support a marketing application for the therapy.

Shares of Denali Therapeutics ( DNLI ) rose 9% in recent trading.

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