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8 stories mentioning DNLIUpdated 2d ago

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Wire

Denali Therapeutics Completes Sale of Rare Pediatric Disease Priority Review Voucher

Denali Therapeutics (DNLI) said Tuesday in a regulatory filing it has completed the sale of its rare pediatric disease priority review voucher to an unnamed pharmaceutical company for gross proceeds of $195 million.Denali said it received the priority review voucher when Avlayah was approved by the US Food and Drug Administration to treat Hunter syndrome in March.Price: $23.62, Change: $+0.04, Percent Change: +0.19%

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Sectors

Sector Update: Healthcare Stocks Advance Premarket Thursday

Healthcare stocks were advancing premarket Thursday, with the State Street Health Care Select Sector SPDR ETF (XLV) up 0.2% and the iShares Biotechnology ETF (IBB) 0.5% higher.Denali Therapeutics (DNLI) stock was up more than 1% after the company said it has signed an agreement to sell its rare pediatric disease priority review voucher for gross proceeds of $195 million.Pfizer (PFE) shares were down more than 1% after the company said Chief Financial Officer Dave Denton will step down from his position on Aug. 15 after accepting a position outside the pharmaceutical industry in the consumer goods sector.NovoCure (NVCR) stock was down more than 15% after the company said a phase 3 trial evaluating its tumor treating fields therapy in patients with newly diagnosed glioblastoma failed to meet its primary endpoint.

$DNLI$IBB$NVCR$PFE$XLV
Sectors

Sector Update: Health Care

Healthcare stocks were advancing premarket Thursday, with the State Street Health Care Select Sector SPDR ETF (XLV) up 0.2% and the iShares Biotechnology ETF (IBB) 0.5% higher.Denali Therapeutics (DNLI) stock was up 1.8% after the company said it has signed an agreement to sell its rare pediatric disease priority review voucher for gross proceeds of $195 million.

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Wire

Denali Therapeutics' Focus Shifts to Other Pipeline Assets After Phase 2b Study Failure, Morgan Stanley Says

Denali Therapeutics' (DNLI) investors will now look at its other pipeline assets and broader platform validation after its phase 2b trial for BIIB122 treating idiopathic Parkinson's disease failed to meet the primary and secondary endpoints, Morgan Stanley said in a Friday note.Despite clear target engagement, the lack of clinical benefit has led to the halt of BIIB122 development in idiopathic Parkinson's disease, according to the note. Denali will independently continue development of the phase 2a study for the drug, now called DNL151, in carriers of a pathogenic LRRK2 variant, according to the note.The company's TransportVehicle platform is designed to enable large-molecule biologics to cross into the brain, in contrast with the small-molecule approach of the original trial, Morgan Stanley analysts noted.In the new phase 2a study, clinical efficacy remains unproven, and biomarker success may not result in positive outcomes, according to the note. The new study is not likely to offset the failure of the original trial in the near term, the analysts said.Morgan Stanley revised its 2026 GAAP EPS estimates to $2.80 from $2.93, 2027 estimates to $2.07 from $2.63, and 2028 estimates to $1.72 from $2.36.Morgan Stanley maintained the company's stock rating at overweight and lowered the price target to $35 from $40.Price: $19.27, Change: $+0.63, Percent Change: +3.38%

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Wire

Morgan Stanley Cuts Price Target on Denali Therapeutics to $35 From $40, Keeps Overweight Rating

Denali Therapeutics (DNLI) has an average rating of buy and mean price target of $34.67, according to analysts polled by FactSet.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://finwires.com/en/contact)Price: $18.88, Change: $-0.42, Percent Change: -2.18%

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Sectors

Sector Update: Healthcare Stocks Mixed Premarket Friday

Health care stocks were mixed premarket Friday, with the State Street Health Care Select Sector SPDR ETF (XLV) 0.6% higher and the iShares Biotechnology ETF (IBB) down 0.1%.Biogen (BIIB) and Denali Therapeutics (DNLI) are discontinuing further development of BIIB122 in idiopathic Parkinson's disease after a phase 2b study failed to meet its primary or secondary endpoints, the companies said. Biogen shares were down 1% and Denali Therapeutics stock lost more than 3% pre-bell.Medline (MDLN) shares were up more than 1% after the company priced its upsized secondary offering of about 72.6 million of its class A shares on behalf of certain selling stockholders at $37 apiece.Gilead Sciences (GILD) said the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion supporting approval of Trodelvy as a first-line treatment for certain patients with metastatic triple-negative breast cancer. Gilead Sciences shares were 0.4% higher pre-bell.

$BIIB$DNLI$GILD$IBB$MDLN$XLV
Sectors

Sector Update: Healthcare

Health care stocks were mixed premarket Friday, with the State Street Health Care Select Sector SPDR ETF (XLV) 0.5% higher and the iShares Biotechnology ETF (IBB) down 0.1%.Biogen (BIIB) and Denali Therapeutics (DNLI) are discontinuing further development of BIIB122 in idiopathic Parkinson's disease after a phase 2b study failed to meet its primary or secondary endpoints, the companies said. Biogen shares were down 1% and Denali Therapeutics stock lost more than 3% pre-bell.

$BIIB$DNLI
Wire

Denali Therapeutics Seeing Encouraging Signals From Avlayah Launch, Oppenheimer Says

Denali Therapeutics (DNLI) is seeing encouraging early launch enthusiasm for Avlayah following its recent US Food and Drug Administration approval for Hunter syndrome, Oppenheimer said in a Sunday note.The firm said first patients were treated in a commercial setting in April, with strong interest across patient segments, geographies, and disease type.Oppenheimer said Avlayah's approval validates Denali's streamlined development approach and could support future commercialization across the company's disease pipeline.Startup activities remain underway for a global phase 3 study of DNL126 expected to begin in H2, while patient dosing for the phase 1 DNL952 study is expected to start soon, the firm said.Oppenheimer maintained its outperform rating and $40 price target on Denali Therapeutics.Price: $19.92, Change: $+0.30, Percent Change: +1.53%

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