The FDA indicated that it is retaining its clinical hold for now and that more data is required to lift the hold. Larimar is delving deeper into previously completed studies to see if more research is necessary. The company also plans to work with the FDA to figure out the best way to deliver this data. As part of its efforts to satisfy the agency’s request, Larimar is reevaluating recommendations on scheduling the scheduled Jive open-label expansion and pediatric multiple-ascending dosage clinical trials.
Thursday, March 3, 2022
Larimar Therapeutics Inc. (NASDAQ: LRMR) Announces That The FDA Has Retained the Clinical Hold on CTI-1601
BioPharma Journal, March 2, 2022. Larimar Therapeutics Inc. has announced that it has received feedback from the US FDA about the clinical hold in its CTI-1601 program.
