Keenova Therapeutics plc 8K

Keenova Therapeutics announced that its Phase 3 trial of XIAFLEX for plantar fibromatosis met primary and key secondary endpoints, and it plans to seek FDA approval in late 2026.

On July 8, 2026, Keenova Therapeutics plc reported positive top-line results from its pivotal Phase 3 clinical trial (EN3835-309) evaluating XIAFLEX (collagenase clostridium histolyticum) for the treatment of plantar fibromatosis, announcing that the study met its primary endpoint of statistically significant and clinically meaningful pain reduction versus placebo on the Numeric Rating Scale and achieved key ranked secondary endpoints related to function and activity limitation on the Foot Function Index, with additional supportive secondary measures and a safety profile consistent with prior XIAFLEX indications; based on these results, Keenova plans to submit an FDA application for this new indication in the fourth quarter of 2026 and anticipates a potential U.S. launch around 2028 for an estimated treated population of about 300,000 patients, subject to regulatory approval.

Filing Facts

CIK

1567892

Ticker

-

Form

8K

Source Type

sec

Accession

0001104659-26-081562

Alert Tier

6