Concert Pharmaceuticals Inc. (CNCE) announced Tuesday that it successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration or FDA for CTP-499, its investigational therapy targeting diabetic nephropathy.
During the meeting, the FDA indicated general agreement with Concert's proposed Phase 3 development plan providing flexibility to conduct either two clinical trials with CTP-499 or a single trial evaluating two doses of CTP-499 compared to placebo. A reduction in the rate of progression of renal disease, measured by a time-to-event analysis of the composite of increases in serum creatinine (greater than or equal to 50%) or end stage renal disease, versus placebo-treated patients, was agreed to be an acceptable Phase 3 endpoint to support the filing of a potential New Drug Application (NDA).
The company currently plans to submit a request for a Special Protocol Assessment or SPA to the FDA later this year.
For comments and feedback contact: editorial@rttnews.com
Business News
April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.