Unum gets a reprieve from the FDA — partial hold lifted after 9 days
The FDA has lifted the partial hold on Unum Therapeutics’ ACTR707 in combination with rituximab in patients with CD20+ B cell non-Hodgkin lymphoma.
In a filing with the SEC early Monday, the company noted that the agency acted to lift the hold just 9 days after they dropped it on the biotech. It was Unum’s third hold at the FDA, with the first linked to the death of 2 patients ahead of their IPO. This time around the agency acted after Unum filed a safety report on a patient who developed a possible new malignancy, possibly linked to their drug.
Their latest setback came as Unum executed its latest R&D shift. ACTR707 is being sidelined now, just as ACTR087 was before it. Unum plans to file an IND application for BOXR1030 in late 2020 as it works to get back into the clinic. It has a long way to go, though, in restoring faith among investors.
Their stock $UMRX jumped 11% this morning in what looks to be another crushing day for most stocks. Shares are trading at 32 cents with the market cap hovering around $10 million. At one point in the fall of 2018 the stock hit a high of $16-plus.