Denali Therapeutics Inc. (DNLI) announced that its meeting with the Center for Drug Evaluation and Research ("CDER") division of the FDA for the advancement of pipeline candidate tividenofusp alfa (DNL310) was successful. Tividenofusp alfa (DNL310) is being evaluated for the treatment of MPS II (Hunter syndrome). The meeting with CDER outlined a path for Denali to file a biologics license application (BLA) seeking accelerated approval of tividenofusp alfa (DNL310) for the treatment of MPS II and its subsequ ...

Denali Therapeutics Inc. (DNLI) closed the last trading session at $21.64, gaining 2.1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $38.87 indicates a 79.6% upside potential. The mean estimate comprises 15 short-term price targets with a standard deviation of $16.35. While the lowest estimate of $22 indicates a 1.7% increase from the current price level, the most optimistic ana ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38311 Denali Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 46-3872213 (Sta ...

Exhibit 99.1 Denali Therapeutics Reports Second Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif., – August 1, 2024 – Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the second quarter ended June 30, 2024, and provided business highlights. ...

SOUTH SAN FRANCISCO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the second quarter ended June 30, 2024, and provided business highlights. "In the second quarter, our Enzyme Transport Vehicle franchise gained additional momentu ...

SOUTH SAN FRANCISCO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the second quarter ended June 30, 2024, and provided business highlights. "In the second quarter, our Enzyme Transport Vehicle franchise gained additional momentu ...

Denali Therapeutics Inc. (DNLI) shares ended the last trading session 9.7% higher at $23.53. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 5.2% loss over the past four weeks. The FDA recently selected its experimental candidate, DNL126, in support of clinical trials advancing the rare disease therapeutics Pilot Program. The pipeline progress has been encouraging as well. Earnings and revenue growth expectations c ...

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Core Viewpoint - Denali Therapeutics Inc. is experiencing positive momentum in 2024, driven by its robust pipeline and strategic collaborations, despite potential risks associated with pipeline setbacks [2][5]. Financial Position - As of March 31, 2024, Denali's cash, cash equivalents, and marketable securities totaled approximately $1.43 billion [1]. - In February, Denali completed a private investment in public equity (PIPE) financing, generating gross proceeds of $500 million [1]. Pipeline Development - Denali is developing SAR443122/DNL758 (eclitasertib), a peripheral RIPK1 inhibitor for ulcerative colitis treatment [1]. - The company is advancing DNL126, an investigational enzyme replacement therapy for MPS IIIA, under the FDA's START Pilot Program, which aims to expedite rare disease therapeutics [6][8]. - Denali is conducting a multicenter, open-label, phase I/II study for DNL126, with expectations for increased FDA engagement to support its marketing application [8]. Collaborations - Denali has partnerships with major companies like Biogen and Sanofi for various candidates, including BIIB122/DNL151 for Parkinson's disease [9]. - A funding agreement with a third party for a global phase IIa study of BIIB122/DNL151 includes a committed funding of $75 million, with $12.5 million received in January 2024 [11]. - Denali and Sanofi are co-developing SAR443820/DNL788, although the ALS study has been discontinued due to unmet primary endpoints [15]. Market Performance - Denali's shares have risen 11.9% over the past three months, contrasting with a 6% decline in the industry [5].

This company is expected to post quarterly loss of $0.69 per share in its upcoming report, which represents a year-over-year change of -153.1%. Revenues are expected to be $24.23 million, down 91.8% from the year-ago quarter. The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> Denali owns an impressive pipeline of targeted therapeutic candidates for neurodegenerative diseases and its recent pipeline progress has been encour ...