Keenova Therapeutics reports positive Phase 3 results

• Keenova Therapeutics achieved statistically significant primary and secondary endpoints in its Phase 3 trial of XIAFLEX.
• The pivotal study demonstrated meaningful foot pain reduction and functional improvements in adults with plantar fibromatosis.
• The biopharmaceutical firm plans a formal United States FDA regulatory submission during the fourth quarter of 2026.

Keenova Therapeutics (NYSE:MNK) reported positive top-line Phase 3 clinical trial results for its injectable enzyme therapy XIAFLEX in adult patients suffering from progressive plantar fibromatosis.

The pivotal late-stage study successfully achieved its primary endpoint, demonstrating statistically significant and clinically meaningful reductions in localized foot pain compared directly against a placebo.

"The data from this study reinforce the potential of this non-surgical injection to significantly reduce pain and improve physical function for individuals living with this debilitating condition," the company stated in its clinical directory.

Efficacy benchmarks met key ranked secondary endpoints on the Foot Function Index, yielding significant improvements across the standardized pain subscale, global disease severity, and overall nodule characteristics.

Following the announcement, Keenova Therapeutics' share price was up at $18.45.

The biologic candidate maintained a favorable safety and tolerability profile that matched historical datasets, presenting mostly mild or moderate localized adverse events with zero treatment-related serious incidents.

The developer intends to file a supplemental biologics license application with the Food and Drug Administration in the fourth quarter of 2026 to support a projected commercial product launch in 2028.