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

Metric Beat/Mis Actual Consensu

s s

Estimate

Q3 Net -$126.90

Income mln

Q3 Basic -$0.74

EPS

Q3 $137.43

Operatin mln

g

Expenses

Q3 -$137.43

Operatin mln

g Income

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 ( DNLI ) is $30.00, about 50.4% above its November 5 closing price of $14.89

Press Release:

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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.)