SEC Form SC 13G/A filed by Denali Therapeutics Inc. (Amendment)
$DNLI
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Stay ahead of the competition with Standout.work - your AI-powered talent-to-startup matching platform.
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 4/10/2025 | Neutral → Overweight | Cantor Fitzgerald | |
| 3/7/2025 | $41.00 → $33.00 | Overweight | Morgan Stanley |
| 2/11/2025 | $31.00 | Buy | Deutsche Bank |
| 1/7/2025 | $31.00 | Outperform | Robert W. Baird |
| 1/3/2025 | Outperform | William Blair | |
| 12/16/2024 | $37.00 | Hold → Buy | Stifel |
| 10/10/2024 | Mkt Perform | Raymond James | |
| 10/7/2024 | Overweight → Neutral | Cantor Fitzgerald |
4 - Denali Therapeutics Inc. (0001714899) (Issuer)
4 - Denali Therapeutics Inc. (0001714899) (Issuer)
4 - Denali Therapeutics Inc. (0001714899) (Issuer)
144 - Denali Therapeutics Inc. (0001714899) (Subject)
SCHEDULE 13G/A - Denali Therapeutics Inc. (0001714899) (Subject)
10-Q - Denali Therapeutics Inc. (0001714899) (Filer)
Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launchDNL126 accelerated approval path for Sanfilippo syndrome Type A aligned with FDA; Phase 1/2 study nearing completion of enrollment; planning underway for a global Phase 3 confirmatory studyOn track to submit regulatory applications in 2025 to begin clinical testing of one to two additional TransportVehicleTM (TV)-enabled programsPreclinical research on ATV:Abeta program for Alzheimer's disease published in the journal Science SOUTH SAN FRANCISCO, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNL
FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approvalTividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brainTividenofusp alfa leads company's broader TransportVehicle™-enabled pipeline SOUTH SAN FRANCISCO, Calif., July 07, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) seeking accelerated approval for tividenofusp alfa for the treatment of Hunter syndrome (mucopolysaccharidoses type II, or MPS II), a rare and progressive genetic disorder. The FD
SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. "The completion of our BLA submission for tividenofusp alfa represents a pivotal milestone—not only in our commitment to delivering a potentially transformative therapy to individuals living with Hunter syndrome, but also in Denali's evolution as a fully integrated, late-stage development and commercial organization," said Ryan Watts, Ph.D., CEO of Denali Therapeutics. "We are now preparing for commercial launch in late 2025 or early 2026. If approved, tividenofusp alfa would be t
Cantor Fitzgerald upgraded Denali Therapeutics from Neutral to Overweight
Morgan Stanley resumed coverage of Denali Therapeutics with a rating of Overweight and set a new price target of $33.00 from $41.00 previously
Deutsche Bank initiated coverage of Denali Therapeutics with a rating of Buy and set a new price target of $31.00
SC 13G - Denali Therapeutics Inc. (0001714899) (Subject)
SC 13G/A - Denali Therapeutics Inc. (0001714899) (Subject)
SC 13G/A - Denali Therapeutics Inc. (0001714899) (Subject)
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.