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Wedbush Research
  • Wedbush Research
Dylan Shindler ... (+2)
  • Dylan Shindler
  • Laura Chico
 PRESS RELEASE

Denali Therapeutics Reports First Quarter 2025 Financial Results and B...

Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. “The completion of our BLA submission for tividenofusp alfa represents a pivotal milestone—not only in our commitment to delivering a potentially transformative therapy to individuals living with Hunter ...

Wedbush Research
  • Wedbush Research
UBI UBISOFT ENTERTAINMENT SA
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David Nierengarten ... (+8)
  • David Nierengarten
  • Dennis Pak
  • Dylan Shindler
  • Laura Chico
  • Martin Fan
  • Ritika Das
  • Robert Driscoll
  • Yun Zhong
 PRESS RELEASE

Denali Therapeutics Announces Initiation of BLA Filing for Accelerated...

Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FDA on DNL126 Through START Program Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026Alignment through recent interactions with CDER on path to accelerated approval and conversion to full approval for tividenofusp alfaProductive collaboration continues under START for an accelerated development and approval path for...

Wedbush Research
  • Wedbush Research
David Nierengarten ... (+8)
  • David Nierengarten
  • Dennis Pak
  • Dylan Shindler
  • Laura Chico
  • Martin Fan
  • Ritika Das
  • Robert Driscoll
  • Yun Zhong
Wedbush Research
  • Wedbush Research
UBI UBISOFT ENTERTAINMENT SA
XNCR XENCOR INC.
XENE XENON PHARMACEUTICALS INC
VYGR VOYAGER THERAPEUTICS INC.
TTWO TAKE-TWO INTERACTIVE SOFTWARE INC.
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RARE ULTRAGENYX PHARMACEUTICAL INC.
O REALTY INCOME CORPORATION
NVCR NOVOCURE LTD.
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MU MICRON TECHNOLOGY INC.
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HD HOME DEPOT INC.
GME GAMESTOP CORP. CLASS A
GERN GERON CORP.
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ARDX ARDELYX INC
AAP ADVANCE AUTO PARTS INC.
FRX_CN FENNEC PHARMACEUTICALS
7974 NINTENDO CO. LTD.
EA ELECTRONIC ARTS INC.
ANAB ANAPTYSBIO INC.
ARGX ARGENX ADS
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ISR ISORAY
AMD ADVANCED MICRO DEVICES INC.
AAPL APPLE INC.
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David Nierengarten ... (+7)
  • David Nierengarten
  • Dennis Pak
  • Dylan Shindler
  • Laura Chico
  • Martin Fan
  • Robert Driscoll
  • Yun Zhong
Wedbush Research
  • Wedbush Research
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 PRESS RELEASE

Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financia...

Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth quarter and year ended December 31, 2024, and provided business highlights. “In 2024, we made significant strides across our portfolio, particularly with our Enzyme Transport Vehicle (ETV) programs, achieving a path to a potential accelerated approval for our lead program in MPS II,” said Ryan Watts, Ph.D., CEO of Denali. “In 2025, we wi...

 PRESS RELEASE

Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up...

Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa Long-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in hearing, cognition and adaptive behaviorLong-term safety data with median follow-up of two years, and out to more than four years, demonstrate that tividenofusp alfa was generally well tolerated Regulatory submission for accelerated approval is planned for early 2025; U.S. launch preparation is ongo...

Wedbush Research
  • Wedbush Research
SGI SOMNIGROUP INTERNATIONAL INC
W WAYFAIR INC.
KMX CARMAX INC.
XNCR XENCOR INC.
XENE XENON PHARMACEUTICALS INC
WSM WILLIAMS-SONOMA INC.
VYGR VOYAGER THERAPEUTICS INC.
TTWO TAKE-TWO INTERACTIVE SOFTWARE INC.
RARE ULTRAGENYX PHARMACEUTICAL INC.
NVCR NOVOCURE LTD.
NBIX NEUROCRINE BIOSCIENCES INC.
MNRO MONRO INC
LOW LOWE'S COMPANIES INC.
KURA KURA ONCOLOGY INC.
INTC INTEL CORPORATION
HURN HURON CONSULTING GROUP INC.
HD HOME DEPOT INC.
GPC GENUINE PARTS COMPANY
GME GAMESTOP CORP. CLASS A
GERN GERON CORP.
FATE FATE THERAPEUTICS INC
DKS DICK'S SPORTING GOODS INC.
CTMX CYTOMX THERAPEUTICS INC.
BPMC BLUEPRINT MEDICINES CORP.
BMRN BIOMARIN PHARMACEUTICAL INC.
BIIB BIOGEN INC.
BBY BEST BUY CO. INC.
AZO AUTOZONE INC.
ASND ASCENDIS PHARMA A/S SPONSORED ADR
ARDX ARDELYX INC
AAP ADVANCE AUTO PARTS INC.
CDR CD PROJEKT S.A.
FRX_CN FENNEC PHARMACEUTICALS
7974 NINTENDO CO. LTD.
EA ELECTRONIC ARTS INC.
ORLY O'REILLY AUTOMOTIVE INC.
CVCO CAVCO INDUSTRIES INC.
FND FLOOR & DECOR HOLDINGS INC. CLASS A
CVNA CARVANA CO. CLASS A
ANAB ANAPTYSBIO INC.
ARGX ARGENX ADS
MRSN MERSANA THERAPEUTICS
ISR ISORAY
IBM INTERNATIONAL BUSINESS MACHINES CORPORATION
APLS APELLIS PHARMACEUTICALS
DNLI DENALI THERAPEUTICS INC
RCUS ARCUS BIOSCIENCES
PRPL PURPLE INNOVATION
TSEM TOWER SEMICONDUCTOR LTD
SRRK SCHOLAR ROCK HOLDING CORPORATION
KNSA KINIKSA PHARMACEUTICALS
REPL REPLIMUNE GROUP
ARVN ARVINAS HOLDING
YMAB Y-MABS THERAPEUTICS
STRO SUTRO BIOPHARMA
STOK STOKE THERAPEUTICS
IGMS IGM BIOSCIENCES
SWTX SPRINGWORKS THERAPEUTICS
PFSI PENNYMAC FINANCIAL SERVICES INC.
ASO ACADEMY SPORTS AND OUTDOORS
KROS KEROS THERAPEUTICS
ITOS ITEOS THERAPEUTICS
LRMR LARIMAR THERAPEUTICS INC
PRAX PRAXIS PRECISION MEDICINES
U UNITY SOFTWARE
TVTX TRAVERE THERAPEUTICS INC
VRDN VIRIDIAN THERAPEUTICS INC
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DAWN DAY ONE BIOPHARMACEUTICALS INC
ELEV ELEVATION ONCOLOGY
OMGA OMEGA THERAPEUTICS
APP APPLOVIN CORP
ATXS ASTRIA THERAPEUTICS INC
PAY PAYMENTUS HLDGS INC
AVTE AEROVATE THERAPEUTICS INC
GFS GLOBALFOUNDRIES INC
GMTX GEMINI THERAPEUTICS INC
CINT CI&T INC
VIGL VIGIL NEUROSCIENCE INC
TYRA TYRA BIOSCIENCES INC
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DDI DOUBLEDOWN INTERACTIVE CO LTD
APGE APOGEE THERAPEUTICS INC
EMBRAC B EMBRACER GROUP AB
PLTK-US PLAYTIKA
SKLZ-US SKILLZ INC
RH-US RESTORATION HARDWARE INC.
PASG-US PASSAGE BIO
David Nierengarten ... (+7)
  • David Nierengarten
  • Dennis Pak
  • Dylan Shindler
  • Laura Chico
  • Martin Fan
  • Robert Driscoll
  • Yun Zhong
 PRESS RELEASE

Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrom...

Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™ SOUTH SAN FRANCISCO, Calif., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced upcoming oral (platform) and poster presentations at the 21st Annual WORLDSymposium™, which will be held February 3-7, 2025, in San Diego, California. The oral presentation includes clinical results related to its Hunter syndrome (MPS II) investigational therapeutic, tividenofusp alfa (DNL...

 PRESS RELEASE

Denali Therapeutics Announces Key Anticipated 2025 Milestones and Prio...

Denali Therapeutics Announces Key Anticipated 2025 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases FDA Breakthrough Therapy Designation received for tividenofusp alfa for Hunter syndrome (MPS II); on track to submit biologics license application (BLA) in early 2025Preparing for commercial launch of tividenofusp alfa for Hunter syndrome in late 2025 or early 2026Enable accelerated approval pathway for DNL126 for Sanfilippo syndrome Type A (MPS IIIA)Expand and advance portfolio of multiple TransportVehicleTM (TV) ena...

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