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Investing.com - Oppenheimer maintained its Outperform rating and $35.00 price target on Denali Therapeutics Inc. (NASDAQ:DNLI) Monday, highlighting an upcoming regulatory catalyst for the company’s Hunter syndrome treatment.
The research firm identified the potential FDA acceptance of tividenofusp alfa (DNL310) Biologics License Application (BLA) as an "underappreciated value driver" for the company’s stock, which has faced pressure throughout 2024 amid broader regulatory uncertainty.
Denali initiated a rolling BLA submission seeking accelerated approval for DNL310 in early April, with the company confirming the submission was complete during its first-quarter update.
Oppenheimer expects the FDA to announce acceptance of the BLA filing soon and believes a priority review designation is "highly likely" for the Hunter syndrome treatment candidate.
The firm’s maintained Outperform rating comes as Denali’s shares have underperformed this year, with Oppenheimer suggesting the upcoming regulatory milestone could serve as a key catalyst for the stock.
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