Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Source: GlobeNewswire
First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage diseaseFirst FDA-approved medicine in emerging new class of biotherapeutics that leverage transferrin receptor to cross blood-brain barrierDenali’s first medicine enabled by its TransportVehicle™ platform designed to deliver biotherapeutics to whole body, including brainRare Pediatric Disease Priority Review Voucher (PRV) awarded in connection with FDA approvalDenali to host conference call and webcast today at 12:30 p.m. Eastern time SOUTH SAN FRANCISCO, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for AVLAYAH™ (tividenofusp alfa-eknm), the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. AVLAYAH is an enzyme replacement therapy indicated for the treatment of ne
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News
- Denali Therapeutics (DNLI) had its price target raised by Morgan Stanley from $40.00 to $42.00. They now have an "overweight" rating on the stock.MarketBeat
- Denali Therapeutics (DNLI) had its price target raised by The Goldman Sachs Group, Inc. from $35.00 to $40.00. They now have a "buy" rating on the stock.MarketBeat
- Denali Therapeutics (DNLI) had its price target raised by Stifel Nicolaus from $34.00 to $41.00. They now have a "buy" rating on the stock.MarketBeat
- Denali Therapeutics (DNLI) had its price target raised by BTIG Research from $36.00 to $38.00. They now have a "buy" rating on the stock.MarketBeat
- Denali Therapeutics (DNLI) had its price target raised by Robert W. Baird from $29.00 to $32.00. They now have an "outperform" rating on the stock.MarketBeat
DNLI
Earnings
- 2/26/26 - Beat
DNLI
Sec Filings
- 3/26/26 - Form SCHEDULE
- 3/25/26 - Form 8-K
- 2/26/26 - Form 10-K
- DNLI's page on the SEC website