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Denali Outperforms Industry in 3 Months: Here’s Why

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Denali Therapeutics Inc. (NASDAQ: DNLI) is having a good run in 2024. Shares of this biopharmaceutical company have risen 11.9% in the past three months against the industry’s decline of 6%.

Denali is developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative and lysosomal storage diseases.  The recent upward price trajectory can be attributed to positive updates.

Earlier in the month, the company announced that the FDA has selected its experimental candidate, DNL126, in support of clinical trials advancing the rare disease therapeutics (START) Pilot Program. The candidate is an investigational enzyme replacement therapy designed to cross the BBB for the potential treatment of MPS IIIA (Sanfilippo syndrome type A).

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The newly launched START Pilot program was initiated to accelerate the pace of the development of novel drugs that are intended to address the significant need in the treatment of rare diseases.

Denali is conducting a multicenter, open-label, phase I/II study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory clinical efficacy of DNL126 in participants with MPS IIIA. 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.

The pipeline progress …

Full story available on Benzinga.com

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