Fulcrum Therapeutics has begun a strategic review that may result in it getting sold, a move made after the company’s main medicine hit a possibly insurmountable obstacle.
On Tuesday, Fulcrum disclosed that, late last month, it received the official record from a recent meeting with the Food and Drug Administration. The meeting revolved around next steps for pociredir, an experimental treatment for sickle cell disease that Fulcrum had ushered through early-stage human testing.
According to the company, FDA staff were worried about pociredir’s safety, given emerging data that showed higher-than-expected rates of “secondary” blood cancers in patients who had received an Ipsen drug, Tazverik, which was pulled from the market in March. Fulcrum’s drug works in a similar-but-different way, and the company tried to make the case that these differences are important to assessing overall benefits and risks. The FDA, though, still concluded the potential hazards were too great and “left no viable regulatory path forward.”
Fulcrum has therefore made the “very difficult decision to discontinue development of pociredir,” said CEO Alex Sapir. The company is now exploring strategic alternatives, including potentially merging or selling either assets or the entire business. It’s also started efforts to “significantly reduce” operating expenses and preserve capital, though specific details weren’t provided. Fulcrum had a third of a billion dollars in cash, cash equivalents, and marketable securities as of March 31.
