Novartis asset delpacibart zotadirsen remains under FDA priority review

Novartis’ delpacibart zotadirsen is under FDA priority review for Duchenne muscular dystrophy, according to Fierce Biotech. The asset came to Novartis through its takeover of Avidity Biosciences.

Priority review remains in focus

Fierce Biotech reported that Novartis CEO Vas Narasimhan cited delpacibart zotadirsen’s priority review status while discussing the company’s plans for its neuromuscular disease portfolio. The review places the Duchenne muscular dystrophy program alongside other Avidity-derived assets still moving through development.

For pharmaceutical and biotech sales professionals, the development is a regulatory milestone to monitor in the Duchenne muscular dystrophy space. Fierce Biotech identified delpacibart zotadirsen as being under FDA priority review, while another Avidity asset, delpacibart braxlosiran, is in a phase 3 trial for facioscapulohumeral muscular dystrophy.

Portfolio context after del-desiran setback

The priority review disclosure came as Novartis addressed a phase 3 failure for del-desiran in myotonic dystrophy type 1. Fierce Biotech reported that Novartis linked the setback to a partial impairment charge in the third quarter.

Narasimhan told Fierce Biotech that the Avidity acquisition remains on track and that Novartis continues to see potential in antibody-oligonucleotide approaches for neuromuscular disease. He also said del-desiran remains in the company pipeline, citing clinical activity in secondary and exploratory endpoints.

Novartis’ comments frame delpacibart zotadirsen’s FDA priority review as a key active regulatory process within a broader neuromuscular portfolio that includes programs at different stages of development.

What to watch

• FDA action on delpacibart zotadirsen for Duchenne muscular dystrophy.
• Continued phase 3 development of delpacibart braxlosiran.
• Further Novartis updates on del-desiran and its neuromuscular disease strategy.