Denali's (DNLI) Candidate Selected for FDA's START Pilot Program

Since DNL126 has been selected as a START participant, it can interact with the FDA frequently. The company expects the increased level of engagement from the FDA, to facilitate alignment on the most efficient development path to ultimately support a marketing application for DNL126 in MPS IIIA. Please note that Denali has another candidate in its pipeline, tividenofusp alfa (DNL310), which is engineered to cross the BBB via receptor-mediated transcytosis into the brain. The candidate is being developed as ...