Denali Therapeutics

Denali Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of a portfolio of product candidates for neurodegenerative diseases. Its product pipeline includes LRRK2, RIPK1, TREM2, and Tau. The company was founded by Ryan J. Watts, Marc Tessier-Lavigne, and Alexander Schuth on October 14, 2013 and is headquartered in San Francisco, CA.

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DNLI reports a wider-than-expected loss in the third quarter of 2024. Nonetheless, the pipeline progress has been encouraging.

Denali Q3 Earnings Miss Estimates, Pipeline Progress Encouraging

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2024, and provided business highlights.

Denali Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights

Denali Therapeutics (DNLI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Denali Therapeutics Inc. (DNLI) May Report Negative Earnings: Know the Trend Ahead of Q3 Release

Denali Therapeutics (DNLI) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.

Strength Seen in Denali Therapeutics (DNLI): Can Its 10.1% Jump Turn into More Strength?

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS II and its subsequent conversion to full approval.

Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug

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 (CDER) division of the U.S. Food and Drug Administration (FDA) providing a path to filing a biologics license application (BLA) for accelerated approval and subsequent conversion to full approval for tividenofusp alfa (DNL310) for the treatment of MPS II (Hunter syndrome). Agreement was reached that cerebrospinal fluid heparan sulfate (CSF HS) is reasonably likely to predict clinical benefit and can be used as a surrogate endpoint to support accelerated approval for tividenofusp alfa in MPS II. Based on discussions with CDER, Denali will include preclinical and clinical data on biomarkers (CSF HS and neurofilament light (NfL)) and safety in the BLA for tividenofusp alfa as a treatment of MPS II and intends to submit the BLA under the accelerated approval pathway in early 2025.

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)

Denali Therapeutics' proprietary Transport Vehicle technology enables drug delivery across the blood-brain barrier, targeting neurodegenerative diseases. DNL310, targeting MPS II, and DNL343 for ALS are key drug candidates with potential, though competition is significant. The company's $500 million capital raise supports its aggressive R&D investment, providing a runway for developing its pipeline.

Denali Therapeutics: A Promising Biotech With Revolutionary BBB-Crossing Technology

SOUTH SAN FRANCISCO, Calif., Aug. 14, 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 and lysosomal storage diseases, today announced publication of nonclinical data in the August 14, 2024 issue of Science Translational Medicine (link) demonstrating the ability of the Oligonucleotide Transport Vehicle (OTV) platform to achieve broad biodistribution of antisense oligonucleotides (ASOs) in the central nervous system (CNS) and skeletal and cardiac muscle following intravenous (IV) administration.

Denali Therapeutics Announces Publication in Science Translational Medicine Demonstrating the Potential of the Oligonucleotide Transport Vehicle Platform to Achieve Broad Biodistribution of Antisense Oligonucleotides in the CNS and Muscle Following Intravenous Administration

The consensus price target hints at a 79.6% upside potential for Denali Therapeutics (DNLI). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts Believe Denali Therapeutics (DNLI) Could Rally 79.62%: Here's is How to Trade

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.

Denali Therapeutics Reports Second Quarter 2024 Financial Results and Business Highlights

Denali Therapeutics (DNLI) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions could translate into further price increase in the near term.

Denali Therapeutics (DNLI) Stock Jumps 9.7%: Will It Continue to Soar?

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Denali (DNLI) gains 11.9% in three months on positive updates on its candidates.

Denali (DNLI) Outperforms Industry in 3 Months: Here's Why

Denali Therapeutics (DNLI) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Denali Therapeutics (DNLI) Moves 5.8% Higher: Will This Strength Last?

Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock?

Why Is Denali Therapeutics (DNLI) Up 15.6% Since Last Earnings Report?

Denali's (DNLI) DNL126, an investigational enzyme replacement therapy, gets selected for the START Pilot Program, intended to accelerate the development of rare disease therapies.

Denali's (DNLI) Candidate Selected for FDA's START Pilot Program

SOUTH SAN FRANCISCO, Calif., June 03, 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 and lysosomal storage diseases, today announced that the U.S. Food and Drug Administration (FDA) has selected DNL126 for participation in the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program. DNL126 is an investigational enzyme replacement therapy designed to cross the BBB for the potential treatment of MPS IIIA (Sanfilippo syndrome type A).

Denali Therapeutics Announces FDA Has Selected DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo Syndrome Type A) for START Pilot Program Intended to Accelerate Development of Rare Disease Therapies

Denali Therapeutics Inc.'s DNL-310 is currently being explored in an ongoing phase 2/3 COMPASS study for treatment of patients with MPS II; Enrollment completion expected in 2024. Denali is in talks with CDER division of FDA to seek for Accelerated Approval pathway for DNL-310 for the treatment of patients with MPS II. Biomarker and safety data from a phase 1/2 study, using DNL-126 for the treatment of patients with MPS IIIA, expected end of 2024.

Denali Therapeutics: MPS Treatment Program Continues With End Of 2024 Data

Denali (DNLI) Q1 loss narrows year over year due to lower expenses despite nil revenues.

Denali (DNLI) Q1 Earnings Miss, Pipeline Progress in Focus

SOUTH SAN FRANCISCO, Calif., May 07, 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 first quarter ended March 31, 2024, and provided business highlights.

Denali Therapeutics Reports First Quarter 2024 Financial Results and Business Highlights

SOUTH SAN FRANCISCO, Calif., May 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 and lysosomal storage diseases, today announced that the Sean M. Healey & AMG Center in collaboration with the Northeast ALS Consortium (NEALS) completed enrollment for Regimen G of the Phase 2/3 HEALEY ALS Platform Trial , which evaluates Denali's eIF2B agonist DNL343.

Denali Therapeutics Announces Completion of Enrollment for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial

Denali Therapeutics (DNLI) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

Why Denali Therapeutics (DNLI) Stock Might be a Great Pick

Why Is Denali Therapeutics (DNLI) Up 2.8% Since Last Earnings Report?

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Denali's stock performance has been flat despite the biotech sector's 20% rise; recently raised $500 million in a PIPE. ALS trial failure with partner Sanofi pressured stock; Denali's focus is on transport vehicle (TV) technology and BBB crossing. Denali boasts a strong financial position with $1.53 billion in cash, extending operational runway significantly.

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