Tonix Pharmaceuticals stock halted ahead of FDA approval news
On Tuesday, Deutsche Bank (ETR:DBKGn) initiated coverage on Denali Therapeutics Inc. (NASDAQ: NASDAQ:DNLI) with a Buy rating and set a price target of $31.00. The new assessment comes as Denali’s shares are seen as attractively priced, providing a favorable risk/reward balance due to its extensive pipeline, robust scientific foundation, and an expected increase in significant developments throughout 2025. InvestingPro analysis supports this view, showing the stock is currently undervalued, with analyst targets ranging from $24 to $87.
Denali Therapeutics has experienced a significant reduction in market capitalization, with a 66% decrease from its all-time highs over the past four years, currently valued at $3 billion. According to InvestingPro data, the stock has dropped over 9% in the past week alone, though it maintains strong financial health with more cash than debt and a current ratio of 9.98. Despite this downturn, Deutsche Bank’s analysts anticipate that Denali will make a notable stride forward with the anticipated 2025 filing for approval of its leading drug candidate, tividenofusp alfa (DNL310), for the treatment of MPS II. This move could mark the company’s transition to a commercial-stage entity in 2026.
The upcoming 12 to 18 months are expected to be a critical period for Denali, with several key events on the horizon. Updates from Phase 1/2 trials of DNL126 for MPS IIIA, Phase 2b LUMA study results of DNL151 in Parkinson’s disease (in partnership with Biogen (NASDAQ:BIIB)), and Phase 2 trial outcomes of DNL758 for ulcerative colitis (UC) in collaboration with Sanofi (NASDAQ:SNY) are among the anticipated catalysts.
Success in clinical and regulatory milestones for Denali’s drug candidates could result in a positive impact on the company’s stock value. Furthermore, such achievements are likely to offer broader implications for the potential of Denali’s Transport Vehicle (TV) platform technology. With these considerations in mind, Deutsche Bank has launched its coverage with a confident outlook on the biotechnology firm’s stock prospects.
In other recent news, Denali Therapeutics has been the subject of multiple analyst reports. Stifel analysts have maintained their Buy rating on the company with a steady price target of $37.00, emphasizing the potential for Denali’s DNL310 to receive regulatory approval for the treatment of Hunter syndrome. The company is working on submitting a Biologics License Application (BLA) for this treatment, which could lead to accelerated approval.
Denali Therapeutics has also received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for DNL310. This designation is expected to expedite the review process due to the drug’s potential to significantly improve treatment over existing options.
Meanwhile, Jefferies analysts have also maintained a Buy rating on Denali Therapeutics, with a price target of $45.00. They highlighted the potential approval of DNL310 for Hunter Syndrome by the end of 2025.
On the other hand, H.C. Wainwright analyst Andrew Fein adjusted the price target on Denali Therapeutics to $87.00 from the previous $90.00, while maintaining a Buy rating. This adjustment followed the announcement of topline data from Denali’s Phase 2/3 HEALEY trial, which did not meet its primary endpoint.
These are the recent developments regarding Denali Therapeutics.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.