All News #Library
Rare Diseases
Denali CEO Celebrates Launch Of Rare Disease Drug
22 Apr 2026 //
BIOSPACE
Denali Delivers ‘Welcome Positive’ for Rare Disease Space
26 Mar 2026 //
BIOSPACE
US FDA approves Denali`s genetic disorder therapy for children
25 Mar 2026 //
PRESS RELEASE
Denali’s Hunter Syndrome Drug Gains Focus After REGENXBIO Setback
16 Mar 2026 //
BIOSPACE
Denali Unveils LSD Advances at 2026 WORLD Symposium
05 Feb 2026 //
GLOBENEWSWIRE
NEJM Publishes Denali`s DNL310 Phase 1/2 Hunter Study
30 Dec 2025 //
GLOBENEWSWIRE
Denali Ph. 1 Pompe Plans Hit With Clinical Hold
04 Dec 2025 //
FIERCE BIOTECH
Denali`s Hunter Syndrome Drug Latest To Be Hit By FDA Delay
14 Oct 2025 //
FIERCE BIOTECH
Denali Extends FDA Review Of Tividenofusp Alfa For MPS II
13 Oct 2025 //
GLOBENEWSWIRE
FDA accepts Denali`s BLA for Tividenofusp Alfa in Hunter Syndrome
07 Jul 2025 //
GLOBENEWSWIRE
Denali Therapeutics Initiates BLA Filing for Hunter Syndrome (MPS II)
02 Apr 2025 //
GLOBENEWSWIRE
First rare disease therapies chosen for FDA START programme
05 Jun 2024 //
PHARMAPHORUM
FDA picks Denali, Neurogene and more for rare disease program
04 Jun 2024 //
FIERCE BIOTECH

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