24/7 Market News Snapshot 02 April, 2025 – Denali Therapeutics Inc. Common Stock (NASDAQ:DNLI)

April 2, 2025

DENVER, Colo., 02 April, 2025 (247marketnews.com) – (NASDAQ:DNLI) are discussed in this article.
Denali Therapeutics Inc. (DNLI) has recently experienced a significant rise in share prices, opening at $12.07 and climbing to $14.51, reflecting an 18.04% increase from the previous day’s close at $12.29. This upward momentum, accompanied by a robust trading volume of 1.82 million shares, underscores strong investor interest, although caution is advised as the stock approaches overbought territory, indicated by its relative strength index (RSI). Support levels are recognized at $12.07, with resistance near $15.00, highlighting a promising short-term outlook tempered by potential volatility.

In conjunction with its stock performance, Denali is making strides in advancing its Biologics License Application (BLA) for tividenofusp alfa, intended for the treatment of Hunter syndrome (MPS II). This move has received approval for a rolling submission by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), reinforcing Denali’s commitment to innovating therapies for rare diseases. The company has engaged in constructive discussions with CDER, aiming to utilize cerebrospinal fluid heparan sulfate as a surrogate endpoint in the BLA data package. The complete submission is projected for the first half of May 2025, with expectations for a possible U.S. launch occurring late 2025 or early 2026.

Dr. Carole Ho, Denali’s Chief Medical Officer, emphasized the importance of this regulatory milestone in their mission to provide new treatment alternatives for the Hunter syndrome community. Additionally, Denali is progressing with its DNL126 program targeting Sanfilippo syndrome Type A (MPS IIIA), further enhancing its commitment to addressing the needs of patients suffering from these complex conditions. As Denali advances its drug development initiatives, it continues to focus on pioneering transformative solutions in neurodegenerative and lysosomal storage disorders.

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