Update from Larimar Therapeutics
In a press release today, March 24, 2025, Larimar Therapeutics shared several clinical and regulatory updates on their nomlabofusp program in FA.
Larimar reported that the Open Label Extension Study in adults continues to enroll, and that the adolescent cohort of the Pediatric PK run-in study is anticipated to complete dosing at the end of this month.
Larimar also obtained feedback from both the FDA and EMA on the global Phase 3 study protocol and reported that they are on track to initiate this study by mid-2025, with potential sites in the U.S., Europe, U.K., Canada, and Australia.
As part of the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, Larimar shared that they have had more frequent interactions with the FDA, which have been informative as the company plans its Biologics License Application (BLA) submission.
