Denali Therapeutics Inc. Price & Performance (DNLI)

Denali Therapeutics has begun a rolling submission for FDA approval of tividenofusp alfa, targeting Hunter syndrome. The company expects to complete its application by May and is preparing for a potential U.S. launch in late 2025 or early 2026. The therapy aims to address both cognitive and physical symptoms, a first for this rare disease.12

Despite recent progress in drug development, Denali Therapeutics’ stock remains under pressure, trading near its yearly low and showing a nearly 40% decline year-to-date. Analysts note the company’s strong cash position but warn of rapid cash burn, keeping investors wary amid ongoing clinical trial expenses and uncertain near-term returns.13

Ongoing engagement between Denali Therapeutics and the FDA’s Center for Drug Evaluation and Research has paved the way for accelerated approval pathways for both tividenofusp alfa and DNL126. These programs, targeting Hunter and Sanfilippo syndromes respectively, reflect a productive regulatory relationship and may speed up access to novel treatments for rare genetic conditions.24