FDA starts the priority review clock for Symbiomix; Cornerstone gets a green light on pivotal studies
→ The FDA accepted Symbiomix’s NDA for Solosec (secnidazole oral granules), an antibiotic designed to treat bacterial vaginosis, and stamped it with a priority review status that will cut the decision process down to six months. The PDUFA date is September 17.
→ Cranbury, NJ-based Cornerstone Pharmaceuticals got a regulatory green light to launch pivotal studies of their lead drug, CPI-613, in patients with acute myeloid leukemia (AML) and pancreatic cancer. Said Cornerstone COO Sanjeev Luther: “The FDA has provided valuable feedback to inform a design that will enhance the robustness of our trials. This would allow the Agency to assess them as registrational trials.”
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