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Denali Therapeutics Inc. (DNLI) Presents at TD Cowen 46th Annual Health Care Conference Transcript

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⚡ Quantum Brief
Denali Therapeutics co-founder Alex Schuth highlighted 2026 as a pivotal year, with its first potential FDA approval for Tividenofusp alfa targeting Hunter syndrome, set for an April 5 PDUFA decision. The company’s core mission—developing blood-brain barrier-penetrating therapies—remains central, leveraging proprietary tech to enable large-molecule delivery for previously untreatable neurological diseases. Schuth emphasized strong FDA dialogue and confidence in Tividenofusp alfa’s approval prospects, marking a potential milestone for Denali’s pipeline and rare disease treatment advancements. Founded in 2015, Denali aims to revolutionize brain-targeted therapies, with 2026 expected to validate its platform through regulatory and clinical progress. The presentation underscored Denali’s transition from R&D to commercial-stage biotech, with upcoming catalysts including data readouts and expanded pipeline development.
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SA Transcripts158.86K FollowersFollow5ShareSaveCommentsPlay Earnings CallPlay Earnings Call Denali Therapeutics Inc. (DNLI) TD Cowen 46th Annual Health Care Conference March 4, 2026 9:50 AM EST Company Participants Alexander Schuth - Co-Founder, CFO, COO & Secretary Conference Call Participants Joseph Thome - TD Cowen, Research Division Presentation Joseph ThomeTD Cowen, Research Division Hi, everyone. Thank you for joining us in the room and online for the third day of TD Cowen's 46th Annual Healthcare Conference. I'm Joe Thome, one of the Senior Biotech Analysts here on the team at TD Cowen. And it's my pleasure to have with me today Denali Therapeutics. And up here with me, we have Co-Founder, CFO and COO, Alex Schuth. So thank you very much for being here. Maybe before we dive into the individual programs, if you want to just give a brief kind of high-level overview of kind of where the company is at and what we should expect for the rest of 2026. Question-and-Answer Session Alexander SchuthCo-Founder, CFO, COO & Secretary Absolutely. I mean, first of all, Joe, thanks so much for the invitation to the conference and for the great coverage, always. I do want to highlight the title of your last note, which I really enjoyed, must-see TV ready for prime time. So thanks for that. So 2026, we're very excited. It's a big year for us. It's actually -- we founded the company back in 2015 with the premise with the idea that the blood-brain barrier is breaking open, that we can pioneer a technology that can deliver large molecules through the blood-brain barrier and open up the brain for treatments that were not possible before. So 2026, first and foremost, eagerly awaiting our PDUFA date for our first drug for Tividenofusp alfa for Hunter syndrome. That is April 5. We feel very good about the ongoing dialogue with the FDA, and I'm sure we can talk

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