Denali Therapeutics Wins FDA Accelerated Approval for AVLAYAH in Hunter Syndrome, Eyes Launch Boost [Yahoo! Finance]
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Source: Yahoo! Finance
first enzyme replacement therapy engineered to cross the blood–brain barrier using Denali's Transport Vehicle, with approval based on the surrogate biomarker CSF heparan sulfate (HS) , potentially creating a regulatory precedent for other lysosomal storage disorders. Denali is conducting the randomized COMPASS phase II/III confirmatory trial versus standard ERT to validate clinical benefit on neurologic and somatic outcomes, and the approval could bolster read-throughs for programs like DNL126 (Sanfilippo) if CSF HS is accepted as an approvable surrogate. AVLAYAH is expected to launch in the U.S. imminently, priced at $5,200 per 150 mg vial with estimated annual maintenance costs of about $270,000–$811,000 depending on weight; Denali targets roughly 75% of the ~500 U.S. prevalent MPS II patients and intends to transfer or sell a Rare Pediatric Disease Priority Review Voucher to support operations. Interested in Denali Therapeutics Inc.? Here are five stocks we like better. Ana
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DNLI
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