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.

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