B.Riley Reiterates Buy Rating on Denali Therapeutics Inc. (DNLI)
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Denali Therapeutics Announces Successful Meeting with the FDA and Plans to File for Accelerated Approval of Tividenofusp Alfa (DNL310) for the Treatment of MPS II (Hunter Syndrome)
September 3, 2024 8:00 AM EDTRecent successful meeting with the FDA provides path to file for accelerated approval and subsequent conversion to full approval
Plan to submit biologics license application (BLA) early in 2025 under the accelerated approval pathway
New Phase 1/2 data will be presented this week at SSIEM 2024 demonstrating robust and durable biomarker responses and positive effects on clinical outcomes
SOUTH SAN FRANCISCO, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the outcome of a recent successful meeting with the Center for Drug Evaluation and Research... More
