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Jefferies Reiterates Buy Rating on Denali Therapeutics Inc. (DNLI)

Mon, 02 Mar 2026 17:08:53 -0500

Jefferies analyst Andrew Tsai reiterated a Buy rating and $40 price target on Denali Therapeutics Inc. (NASDAQ: DNLI)

The analyst commented, "In a published CRL letter, FDA comments on RGX‑121 (AAV9 gene therapy) in Hunter disease seem directionally (+) for Tivi/DNL310 (ETV:IDS), which has produced compelling/robust Phase I/II data. In our view, the FDA issues center mostly around '121's Phase I/II design, a program-specific issue (idiosyncratic). As such, we continue to assign a high 70-80%+ PoS to Tivi's Apr 5, 2026 PDUFA. A caveat is DNLI is working with CDER (vs CBER for RGX-121). We remain 70-80% confident in Tivi's (ETV:IDS)

Denali Therapeutics Inc. (DNLI) PT Lowered to $34 at Stifel

Fri, 27 Feb 2026 07:26:49 -0500

Stifel analyst Paul Mattels lowered the price target on Denali Therapeutics Inc. (NASDAQ: DNLI) to $34.00 (from $37.00) while maintaining a Buy rating.

Denali Therapeutics Inc. (DNLI) Tops Q4 EPS by 2c

Thu, 26 Feb 2026 17:21:30 -0500

Denali Therapeutics Inc. (NASDAQ: DNLI) reported Q4 EPS of ($0.73), $0.02 better than the analyst estimate of ($0.75).

For earnings history and earnings-related data on Denali Therapeutics Inc. (DNLI) click here.

Form 10-K Denali Therapeutics Inc. For: Dec 31

Thu, 26 Feb 2026 16:16:00 -0500

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Form 10-K Denali Therapeutics Inc. For: Dec 31

Thu, 26 Feb 2026 16:16:00 -0500

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Form S-8 Denali Therapeutics Inc.

Thu, 26 Feb 2026 16:13:00 -0500

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Form S-8 Denali Therapeutics Inc.

Thu, 26 Feb 2026 16:13:00 -0500

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Form 8-K Denali Therapeutics Inc. For: Feb 26

Thu, 26 Feb 2026 16:10:00 -0500

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Form 8-K Denali Therapeutics Inc. For: Feb 26

Thu, 26 Feb 2026 16:10:00 -0500

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Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

Thu, 26 Feb 2026 16:01:00 -0500

Tividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndrome
DNL126 (ETV:SGSH) Phase 1/2 preliminary data presented at 2026 WORLDSymposium™, supporting plans to pursue an accelerated approval path in Sanfilippo syndrome type A
Start-up activities underway for DNL628 (OTV:MAPT) Phase 1b study for Alzheimer's disease and DNL952 (ETV:GAA) Phase 1 study for late-onset Pompe disease
TransportVehicle™ platform and clinical pipeline progressing across lysosomal storage disorders and neurodegenerative diseases

SOUTH SAN FRANCISCO, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today

Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

Thu, 26 Feb 2026 16:01:00 -0500

Tividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndrome
DNL126 (ETV:SGSH) Phase 1/2 preliminary data presented at 2026 WORLDSymposium™, supporting plans to pursue an accelerated approval path in Sanfilippo syndrome type A
Start-up activities underway for DNL628 (OTV:MAPT) Phase 1b study for Alzheimer's disease and DNL952 (ETV:GAA) Phase 1 study for late-onset Pompe disease
TransportVehicle™ platform and clinical pipeline progressing across lysosomal storage disorders and neurodegenerative diseases

SOUTH SAN FRANCISCO, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today

Wolfe Research Starts Denali Therapeutics Inc. (DNLI) at Peerperform

Tue, 24 Feb 2026 09:05:47 -0500

(Updated - February 24, 2026 9:05 AM EST)

Wolfe Research analyst Rudy Li initiates coverage on Denali Therapeutics Inc. (NASDAQ: DNLI) with a Peerperform rating.

The analyst comments "1. We like Denali's TransportVehicle (TV) platform with a portfolio of products leveraging different modalities (enzymes, oligonucleotides, and antibodies) ➢ 10-30x greater brain exposure than conventional delivery ➢ Strong collaboration with multiple biopharma companies 2. That said, the near-term commercial opportunity for mucopolysaccharidoses (MPS) is limited in relatively small but competitive markets (multiple gene therapies in development) ➢ Lead asset Tividenofusp alfa/DNL310 should be approved in MPS II by the PDUFA date of April

Wolfe Research Starts Denali Therapeutics Inc. (DNLI) at Peerperform

Tue, 24 Feb 2026 09:05:47 -0500

(Updated - February 24, 2026 9:05 AM EST)

Wolfe Research analyst Rudy Li initiates coverage on Denali Therapeutics Inc. (NASDAQ: DNLI) with a Peerperform rating.

Drug-Delivery Breakthroughs, Cross-Indication Research Accelerate New Momentum in CNS and Oncology Development