Nanoform does not submit its marketing authorization application as planned

Pharmaceutical technology company Nanoform delays nanoenzalutamide marketing authorization application in Europe due to regulatory feedback.

The company said on Monday that the application originally planned for May 2026 cannot be submitted on schedule.

According to the release, the European Medicines Agency considered the product’s scientific basis to be strong, but current regulatory requirements prevent progress with the planned generic type of application, as not all bioequivalence criteria are met.

Nanoform and its partners are now evaluating alternative approval routes. The new schedule will be announced later, at the latest in connection with the interim report to be published in May, the release says.

Plans outside of Europe will not change.