Overview

• Denali Q3 net loss widens to $126.9 mln from $107.2 mln last year

• Operating expenses increased due to R&D and commercial launch preparations

• FDA extends tividenofusp alfa review timeline to April 2026 from January

Outlook

• Denali expects to launch tividenofusp alfa for Hunter syndrome after FDA review by April 2026

• Company plans global Phase 3 study for DNL126 in Sanfilippo syndrome type A

• Denali submitted applications to start clinical studies for Alzheimer's and Pompe diseases

Result Drivers

• R&D EXPENSES - Increase in R&D expenses driven by operations at new manufacturing facility and personnel-related costs

• COMMERCIAL LAUNCH PREPARATIONS - Increase in general and administrative expenses due to preparations for tividenofusp alfa commercial launch

Key Details

Analyst Coverage

• The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 19 "strong buy" or "buy", no "hold" and no "sell" or "strong sell"

• The average consensus recommendation for the biotechnology & medical research peer group is "buy"

• Wall Street's median 12-month price target for Denali Therapeutics Inc is $30.00, about 50.4% above its November 5 closing price of $14.89

Press Release: ID:nGNX9zKDmR

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(This story was created using Reuters automation and AI based on LSEG and company data. It was checked and edited by a Reuters journalist prior to publication.)