Denali Therapeutics Inc. (DNLI)
DNLI Q1 Loss Narrower Than Expected, Avlayah Approval Boosts Prospects
Denali narrows its Q1 loss and gains FDA approval for Avlayah, the first new Hunter syndrome treatment option in nearly 20 years.
Denali: The First Commercial Validation Of The Blood-Brain Barrier Platform
Denali Therapeutics has transitioned from a speculative platform to a commercial-stage rare disease company with FDA approval of AVLAYAH for Hunter syndrome. DNLI's TransportVehicle technology enables delivery of biologics across the blood-brain barrier, providing significant differentiation and commercial potential in neurodegenerative and lysosomal storage diseases. With $1.17 billion in pro-forma liquidity and a focused initial launch, DNLI is positioned for 2.8 years of runway, reducing near-term capital risk.
DNLI Gains 25.4% Year to Date: Should You Buy, Sell or Hold the Stock?
DNLI secures FDA nod for Avlayah, a first-in-decades Hunter syndrome therapy, but pipeline risks and Takedas exit complicate the outlook.
Denali Stock Falls as Partner Takeda Ends Collaboration Deal
DNLI's shares decline after Takeda exits DNL593 partnership, leaving Denali to fully control and fund the therapy as it advances studies and plans 2026 data release.
Denali Wins FDA Nod for Hunter Syndrome Drug, Stock Up
DNLI surges after FDA approves Avlayah, its first commercial drug and a breakthrough Hunter syndrome therapy targeting the brain.
Denali Therapeutics Inc. (DNLI) Discusses FDA Approval and Commercial Launch Plans for AVLAYAH for Hunter Syndrome Transcript
Denali Therapeutics Inc. (DNLI) Discusses FDA Approval and Commercial Launch Plans for AVLAYAH for Hunter Syndrome Transcript
Denali Therapeutics Inc. (DNLI) Presents at Stifel 2026 Virtual CNS Forum Transcript
Denali Therapeutics Inc. (DNLI) Presents at Stifel 2026 Virtual CNS Forum Transcript
Cantor Fitzgerald L. P. Makes New $653,000 Investment in Denali Therapeutics Inc. $DNLI
Cantor Fitzgerald L. P. acquired a new position in shares of Denali Therapeutics Inc. (NASDAQ: DNLI) during the undefined quarter, according to its most recent disclosure with the SEC. The institutional investor acquired 45,000 shares of the company's stock, valued at approximately $653,000. A number of other hedge funds and other institutional investors
Denali Gains 11.8% in a Month: Buy, Sell or Hold the Stock?
DNLI stock jumps as investors eye an April 5, 2026, FDA decision on tividenofusp alfa for Hunter syndrome, a key catalyst for growth.
Denali Therapeutics Inc. (DNLI) Presents at TD Cowen 46th Annual Health Care Conference Transcript
Denali Therapeutics Inc. (DNLI) Presents at TD Cowen 46th Annual Health Care Conference Transcript
FDA reversals leave investors worrying about the fates of other experimental drugs
The FDA in the past year has denied or discouraged applications of at least eight new drugs, according to RTW Investments. The agency initially refused to review Moderna's flu shot before reversing course.
DNLI Q4 Loss Narrower Than Expected, Hunter Syndrome Drug in Focus
Denali posts narrower-than-expected Q4 loss as FDA extends review of tividenofusp alfa, with $966M cash backing pipeline advances and no Q4 revenues.
