A Biotech Bet on Breaking the Blood-Brain Barrier: Denali’s High-Stakes Gamble

Despite posting consistent losses and witnessing significant insider selling, Denali Therapeutics is capturing intense market interest. The biotech firm’s shares, down more than 30% since the start of the year and trading nearly 53% below their all-time peak, are being watched for one primary reason: a pioneering therapy for neurodegenerative diseases is nearing a regulatory verdict that could redefine the company’s future.

The most significant near-term catalyst for Denali is scheduled for January 5, 2026. On this date, the U.S. Food and Drug Administration (FDA) is set to rule on the approval of DNL310, a treatment for Hunter syndrome. The application is undergoing an accelerated Priority Review. The therapy’s groundbreaking nature stems from its design to cross the blood-brain... Read more...