UroGen Pharma down after FDA posts UGN-102 briefing documents

Shares of Urogen Pharma (URGN) are down $2.62, or 27%, or $7.23 after the FDA confirmed an ODAC meeting for UGN-102 will occur on May 21 and posted the associated briefing documents. The FDA acknowledged that complete response rates reflect true drug activity as lesions “would not be expected to resolve spontaneously in the absence of treatment,” but the agency “does not agree” with the statement that the CR rate for UGN-102 was higher or more durable than that for TURBT as ATLAS and “the FDA does not consider ATLAS appropriately designed to compare efficacy in the recurrent-only population given the loss of randomization when considering this exploratory subgroup as well as the issues regarding the non-inferiority design and primary endpoint definition,” the document stated. The discussion question prior to voting is, “Given uncertainty regarding interpretation of duration of response in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), discuss whether randomized trials should be required in the future to assess the effectiveness of therapies in this disease setting.”