Fulcrum Therapeutics halted development of pociredir after FDA deemed any PRC2 inhibitor carries high malignancy risk following tazemetostat’s global withdrawal, leaving it without clinical-stage assets. Shares plunged 49% after hours and the company launched a strategic review to explore a sale or other value-maximizing transactions while cutting expenses.
On May 28, the FDA communicated heightened malignancy concerns for PRC2 inhibitors after the global withdrawal of tazemetostat. These risks, combined with preclinical tumor observations for pociredir, left no viable regulatory path forward and led to full program discontinuation.
Pociredir’s termination removes Fulcrum’s only clinical-stage program, following the prior discontinuation of losmapimod in a failed 2024 trial. Shares plunged 49% in after-hours trading as investors reacted to the loss of any near-term pipeline.
The company initiated a comprehensive strategic review to explore mergers, acquisitions, business combinations or asset sales aimed at maximizing shareholder value. It also plans significant operating expense cuts and capital preservation measures, with no set timeline for review completion.
