Keenova Announces Positive Phase 3 XIAFLEX Results for Plantar Fibromatosis

Keenova reported positive Phase 3 results for XIAFLEX showing statistically significant pain improvement in plantar fibromatosis.

Key Highlights:

• Phase 3 pivotal trial met primary endpoint: significant, clinically meaningful pain reduction vs placebo on NRS.
• Key ranked secondary endpoints tied to difficulty and activity limitation (FFI) were met, supporting functional benefit.
• Additional secondary measures improved significantly: FFI pain subscale, global assessments, treatment satisfaction, nodule characteristics.
• Safety profile consistent with approved uses of XIAFLEX; most adverse events mild/moderate and no treatment-related serious AEs.
• Keenova intends to submit an FDA application for the plantar fibromatosis indication in Q4 2026; plans launch targeting 2028 patient population.

Original SEC Filing:

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