NasdaqGS:NUVLBiotechs
What Nuvalent (NUVL)'s FDA NDA Filing for Neladalkib in ALK-Positive NSCLC Means For Shareholders
Nuvalent, Inc. recently submitted a New Drug Application to the U.S. FDA for neladalkib, an investigational ALK-selective inhibitor for TKI pre-treated advanced ALK-positive non-small cell lung cancer, supported by Phase 1/2 ALKOVE-1 trial data showing encouraging activity and a generally well-tolerated safety profile.
The filing is bolstered by neladalkib’s breakthrough therapy and orphan drug designations, underscoring its potential role in addressing difficult-to-treat ALK-positive NSCLC...