Denali Therapeutics Inc. (DNLI) Analyst/Investor Day Transcript
Denali Therapeutics Inc. (DNLI) Analyst/Investor Day Transcript
Denali: Regulatory Delay Is A Strategic Opportunity
Denali Therapeutics (DNLI) is transitioning from a clinical-stage to a commercial-stage biotech, leveraging its innovative blood-brain barrier Transport Vehicle platform. DNLI's financials reflect increased investment in manufacturing and commercialization, with sufficient cash runway (~1.5 years) to support upcoming product launches. Tividenofusp Alfa (DNL310) for MPS II is the lead candidate, with FDA review delayed to April 2026 but no major clinical concerns cited by regulators.
Denali Therapeutics Inc. (DNLI) Presents at Jefferies London Healthcare Conference 2025 Transcript
Denali Therapeutics Inc. ( DNLI ) Jefferies London Healthcare Conference 2025 November 18, 2025 7:30 AM EST Company Participants Ryan Watts - Co-Founder, President, CEO & Director Alexander Schuth - Co-Founder, CFO, COO & Secretary Conference Call Participants Lin Tsai - Jefferies LLC, Research Division Presentation Lin Tsai Jefferies LLC, Research Division Okay. We're going to get started with our next session.
DNLI Posts Narrower-Than-Expected Q3 Loss, Advances MPS IIIA Drug
Denali's Q3 loss widens year over year as expenses rise, while the FDA delays its review of the firm???s key Hunter syndrome therapy to 2026.
FDA Extends Review of DNLI's Hunter Syndrome Drug by Three Months
Denali Therapeutics faces an FDA review delay for its Hunter syndrome drug, pushing potential approval of tividenofusp alfa to April 2026.
Denali Therapeutics Inc. (DNLI) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Denali Therapeutics Inc. (NASDAQ:DNLI ) Morgan Stanley 23rd Annual Global Healthcare Conference September 8, 2025 1:05 PM EDT Company Participants Ryan Watts - Co-Founder, President, CEO & Director Conference Call Participants Sean Laaman - Morgan Stanley, Research Division Presentation Sean Laaman Head of Healthcare Research & Equity Analyst Good afternoon, everyone, and welcome to Morgan Stanley Global Healthcare Conference. I'm Sean Laaman, Head of U.S. mid-cap biotech equity research at the firm.
DNLI Tops on Q2 Earnings, Expects Decree on Hunter Syndrome Drug in '26
Denali Therapeutics posts narrower-than-expected Q2 loss. The company advances multiple rare disease therapies toward potential approvals.
DNLI's BLA for Hunter Syndrome Drug Gets FDA's Priority Review
Denali's lead drug for Hunter syndrome wins FDA Priority Review, marking a key step toward commercial-stage status.
Why Is Denali Therapeutics (DNLI) Up 0.7% Since Last Earnings Report?
Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock?
Denali Q1 Loss Wider Than Expected, Hunter Syndrome Drug in Focus
DNLI reports a wider-than-expected loss for the first quarter of 2025. Denali submits a BLA for tividenofusp alfa under the FDA?
DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up
Denali stock up as it begins rolling BLA submission with the FDA for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome.
Why You Shouldn't Bet Against Denali (DNLI) Stock
Denali (DNLI) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.
