Denali Therapeutics Inc., a biopharmaceutical company, discovers and develops therapeutic candidates for neurodegenerative diseases in the United States. The company offers leucine-rich repeat kinase 2 (LRRK2) inhibitor product candidates, including DNL201 that has completed Phase 1b clinical trials and DNL151, which are in Phase 1 and Phase 1b clinical trials for Parkinson's disease. It is also developing receptor interacting serine/threonine protein kinase 1 (RIPK1) product candidates, such as DNL747, a selective and brain-penetrant small molecule RIPK1 inhibitor product candidate that is in Phase 1b clinical trial for Alzheimer's disease and amyotrophic lateral sclerosis (ALS). In addition, the company develops enzyme transport vehicle: iduronate 2-sulfatase, an enzyme replacement therapy program for MPS II, a lysosomal storage disorder; antibody transport vehicle (ATV): alpha-synuclein (aSyn) program, a protein that spreads throughout the brain in Parkinson's disease; ATV: triggering receptor expressed in myeloid cells 2, a therapeutic candidate designed to rescue microglial function in Alzheimer's disease; and ATV: Tau, a therapeutic targeting the spreading of Tau. Denali Therapeutics Inc. has collaboration agreement with Takeda Pharmaceutical Company and Genentech, Inc., Sanofi, F-star Gamma Limited, F-star Biotechnologische Forschungs-Und Entwicklungsges M.B.H, F-star Biotechnology Limited, SIRION Biotech GmbH, Genzyme Corporation, Harvard University, the Michael J. Fox Foundation, Centogene, and MedGenome Labs Private Ltd; and a research and option agreement with Secarna Pharmaceuticals GmbH & Co. KG. to develop antisense therapies in the field of neurodegenerative diseases. The company was formerly known as SPR Pharma Inc. and changed its name to Denali Therapeutics Inc. in March 2015. Denali Therapeutics Inc. was incorporated in 2013 and is headquartered in South San Francisco, California.
IPO Year: 2017
Exchange: NASDAQ
Website: denalitherapeutics.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 10/10/2024 | Mkt Perform | Raymond James | |
| 10/7/2024 | Overweight → Neutral | Cantor Fitzgerald | |
| 12/13/2023 | $32.00 | Buy | Citigroup |
| 11/20/2023 | $28.00 | Overweight | JP Morgan |
| 10/24/2023 | $85.00 → $35.00 | Overweight | Cantor Fitzgerald |
| 9/6/2023 | $38.00 | Buy | B. Riley Securities |
| 1/30/2023 | $50.00 | Outperform | SVB Securities |
| 12/5/2022 | Outperform | Cowen | |
| 11/2/2022 | $38.00 | Neutral → Buy | BTIG Research |
| 11/2/2022 | $40.00 | Buy | BofA Securities |
8-K - Denali Therapeutics Inc. (0001714899) (Filer)
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10-Q - Denali Therapeutics Inc. (0001714899) (Filer)
8-K - Denali Therapeutics Inc. (0001714899) (Filer)
8-K - Denali Therapeutics Inc. (0001714899) (Filer)
144 - Denali Therapeutics Inc. (0001714899) (Subject)
144 - Denali Therapeutics Inc. (0001714899) (Subject)
144 - Denali Therapeutics Inc. (0001714899) (Subject)
10-Q - Denali Therapeutics Inc. (0001714899) (Filer)
8-K - Denali Therapeutics Inc. (0001714899) (Filer)
Raymond James resumed coverage of Denali Therapeutics with a rating of Mkt Perform
Cantor Fitzgerald downgraded Denali Therapeutics from Overweight to Neutral
Citigroup initiated coverage of Denali Therapeutics with a rating of Buy and set a new price target of $32.00
JP Morgan resumed coverage of Denali Therapeutics with a rating of Overweight and set a new price target of $28.00
Cantor Fitzgerald resumed coverage of Denali Therapeutics with a rating of Overweight and set a new price target of $35.00 from $85.00 previously
B. Riley Securities initiated coverage of Denali Therapeutics with a rating of Buy and set a new price target of $38.00
SVB Securities initiated coverage of Denali Therapeutics with a rating of Outperform and set a new price target of $50.00
Cowen initiated coverage of Denali Therapeutics with a rating of Outperform
BTIG Research upgraded Denali Therapeutics from Neutral to Buy and set a new price target of $38.00
BofA Securities initiated coverage of Denali Therapeutics with a rating of Buy and set a new price target of $40.00
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4 - Denali Therapeutics Inc. (0001714899) (Issuer)
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Recent successful meeting with the FDA provides path to file for accelerated approval and subsequent conversion to full approvalPlan to submit biologics license application (BLA) early in 2025 under the accelerated approval pathwayNew 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 (CDER) division of the U.S. Food and Drug Administration (FDA) providing a path to filing a biologi
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. Oligonucleoti
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 momentum with continued engagement with the FDA on an accelerated approval pathway for tividenofusp alfa (DNL310, ETV:IDS) in MPS II and the FDA's selection of DNL126 (ETV:SGSH) in MPS IIIA for
First exploration agreement initiated under strategic partnership between Flagship and Pfizer to accelerate the development of innovative medicines Collaboration leverages ProFound's proprietary ProFoundry™ Platform to identify potential novel protein therapeutics from the expanded human proteome ProFound and Pioneering Medicines, Flagship's in-house drug development unit will jointly conduct exploration activities CAMBRIDGE, Mass., June 12, 2024 /PRNewswire/ -- Flagship Pioneering and ProFound™ Therapeutics, a Flagship-founded company pioneering the expanded human proteome to develop novel medicines for a multitude of diseases, today announced a collaboration to conduct foundational researc
START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological products for rare diseasesDNL126 was selected as one of three CDER-regulated products based on eligibility criteria including the potential for clinical benefit for a rare neurodegenerative disease and the drug sponsor's ability to advance development towards a marketing application Participation in START is expected to facilitate and accelerate development of DNL126 through more rapid and ad hoc communication with FDA review staff SOUTH SAN FRANCISCO, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biop
Third research collaboration signed under strategic partnership between Novo Nordisk and Flagship Pioneering to develop novel treatment approaches for cardiometabolic and rare diseases Collaboration leverages Metaphore's MIMICTM platform in the discovery and development of up to two multitarget therapeutics leveraging GLP-1R and related biology for obesity management Metaphore will jointly conduct R&D programs with Pioneering Medicines, Flagship's in-house drug development unit, and Novo Nordisk to advance foundational and preclinical development activities Novo Nordisk may pay up to $600 million in upfront, development, and commercial milestone payments, as well as tiered royalties on annu
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. "It has been an impactful first quarter, and we are excited about multiple opportunities to accelerate and expand our portfolio. We presented new positive two-year clinical data on tividenofusp alfa in MPS II at WORLDSymposiumTM, and we are encouraged by recent interactions
The company's DELVE™ Platform combines computation and high-throughput biology to systematically discover the therapeutic potential of proteins tuned through millennia of viral evolution The company emerges after three years of platform development with an initial commitment of $50 million from Flagship Pioneering Flagship Pioneering, the bioplatform innovation company, today unveiled Prologue Medicines, a company unlocking the therapeutic potential of the viral proteome for the creation of powerful new medicines. Flagship has initially committed $50 million to advance the company's Decoding Evolutionary Logic of Variant Ensembles (DELVE)™ Platform and harness its power to develop a pip
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. "We are excited to move to the next phase of Regimen G and evaluate the effects of DNL343," said Merit Cudkowicz, MD, MSc, principal investigator and sponsor
O'Shea is a Seasoned Global Executive with more than 20 Years' Experience across the Agriculture, Food and Pharmaceutical Industries CAMBRIDGE, Mass., April 8, 2024 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Invaio Sciences, a bioplatform company accelerating the leap to nature-positive agriculture, today announced that Amy O'Shea has joined Flagship Pioneering as CEO-Partner and Invaio as Chief Executive Officer and Board Director. O'Shea is a seasoned global executive with more than 20 years' experience across the agriculture, food, and phar
JP Morgan analyst Jessica Fye maintains Denali Therapeutics (NASDAQ:DNLI) with a Overweight and raises the price target from $28 to $29.
https://endpts.com/biogen-is-pursuing-more-dealmaking-this-year-with-plans-to-spend-up-to-8B/
U.S. stocks were mixed, with the Dow Jones index falling around 100 points on Monday. Shares of Stericycle, Inc. (NASDAQ:SRCL) rose sharply during Monday's session after the company inked a deal to be acquired by Waste Management Inc. (NYSE:WM) for approximately $7.2 billion, including debt. Stericycle shares climbed 15% to $59.28 on Monday. Here are some other big stocks recording gains in today’s session. GameStop Corp. (NYSE:GME) shares jumped 34.5% to $31.13 after Roaring Kitty on a Reddit post, shared his position on the stock. MarineMax, Inc. (NYSE:HZO) jumped 27% to $36.16. OneWater Marine Inc. is reportedly said to be in advanced discussions to acquire MarineMax. L
DNL126 is an investigational enzyme replacement therapy designed to cross the BBB for the potential treatment of MPS IIIA (Sanfilippo syndrome type A).
U.S. stocks were mixed, with the Dow Jones gaining around 70 points on Wednesday. Shares of Louisiana-Pacific Corporation (NYSE:LPX) rose sharply during Wednesday's session following better-than-expected first-quarter financial results. LPX reported net sales growth of 24% year-over-year to $724 million, beating the consensus of $688.85 million. Louisiana-Pacific shares climbed 15% to $83.93 on Wednesday. Here are some other big stocks recording gains in today's session. Cricut, Inc. (NASDAQ:CRCT) shares surged 31% to $7.25 after the company reported better-than-expected first-quarter GAAP EPS results. MaxCyte, Inc. (NASDAQ:MXCT) jumped 27.6% to $5.01 following upbeat qua
Wedbush analyst Laura Chico maintains Denali Therapeutics (NASDAQ:DNLI) with a Outperform and lowers the price target from $31 to $30.
Stifel analyst Paul Mattels maintains Denali Therapeutics (NASDAQ:DNLI) with a Hold and lowers the price target from $26 to $22.
HC Wainwright & Co. analyst Andrew Fein reiterates Denali Therapeutics (NASDAQ:DNLI) with a Buy and maintains $95 price target.
O'Shea is a Seasoned Global Executive with more than 20 Years' Experience across the Agriculture, Food and Pharmaceutical Industries CAMBRIDGE, Mass., April 8, 2024 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Invaio Sciences, a bioplatform company accelerating the leap to nature-positive agriculture, today announced that Amy O'Shea has joined Flagship Pioneering as CEO-Partner and Invaio as Chief Executive Officer and Board Director. O'Shea is a seasoned global executive with more than 20 years' experience across the agriculture, food, and phar
Banks was Most Recently the President and CEO of Tyson Foods and has been a Board Member of Indigo since July 2022 Company Closes Financing Round at Nearly $270 Million Indigo Also Appoints Nader Bekhouche and Noubar Afeyan to Board of Directors CAMBRIDGE, Mass., Jan. 9, 2024 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Indigo Ag, an innovative leader and trusted partner in sustainable agriculture, today announced that Dean Banks will join Flagship Pioneering as CEO-Partner and CEO of Indigo Ag, effective February 1, 2024. Banks will also continue as an Indigo board member, a role he has held since July 2022. Indigo also announced the appointments of Nader Be
Memorandum of Understanding with UK Government Outlines Areas of Cooperation CAMBRIDGE, Mass. and LONDON, Nov. 27, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, today marked the official launch of its UK presence with an event co-hosted in partnership with the UK Government's Office for Life Sciences, bringing together top leaders from industry, government, and academia with a focus on breakthrough innovation. The event marked Flagship's public announcement of its strategic commitment to the UK life sciences ecosystem a week after launching Quotient Therapeutics, its first company located in both the UK and US.
CAMBRIDGE, Mass., Oct. 2, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and ProFound™ Therapeutics, a company pioneering the discovery of a vastly expanded human proteome and using its newfound insights to unlock a universe of potential new medicines, today announced that John Lepore, M.D., will join Flagship Pioneering as CEO-Partner, and ProFound as Chief Executive Officer, effective October 16, 2023. Dr. Lepore joins ProFound after 17 years at GSK where he had extensive experience leading large international R&D organizations across diverse t
ProFound™ Therapeutics, a company pioneering the discovery of a vastly expanded human proteome and using its newfound insights to unlock a universe of potential new medicines, today announced the appointment of Klaus Urbahns, Ph.D., as Chief Scientific Officer. Urbahns will lead the Company's platform and drug discovery and development efforts to advance first-in-class therapeutics leveraging the company's ProFoundry™ Platform. Urbahns brings three decades of robust drug discovery and development experience to ProFound, with a successful track record in discovering and advancing first-in-human medicines from the lab to the clinic. He joins ProFound after 13 years at Merck KGaA, where he m
CAMBRIDGE, Mass., Sept. 11, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, announced today the appointment of Amanda Kay as Senior Partner and Chief Business Development Officer. In this role, she will be responsible for driving and supporting business development across the Flagship ecosystem, leading the effort to forge strong partnerships between Flagship companies and the biopharma industry. She will also work closely with the Pioneering Medicines unit of Flagship as we continue to invest in and grow our corporate alliance strategy. "Partner
CAMBRIDGE, Mass., Aug. 29, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, announced today that pharma and healthcare leader David Khougazian is joining as Growth Partner. In this role, he will help scale and grow several Flagship-founded companies, working together with leaders at Flagship and its ecosystem of companies on organizational development, long-term strategy, financing, and business development. Khougazian joins Flagship from Sanofi where he spent over two decades most recently leading Sanofi's engagement in global emerging markets inc
CAMBRIDGE, Mass., Aug. 14, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Ampersand Biomedicines, a company programming smarter medicines that act specifically at the site of disease and nowhere else, today announced that Jason Gardner, Ph.D., has joined Flagship Pioneering as CEO-Partner, and Ampersand as Chief Executive Officer and member of its Board of Directors. Gardner brings more than two decades of leadership experience across pharmaceutical and biotechnology companies, with deep expertise in drug discovery and development, and a succ
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