NetworkNewsBreaks – Concert Pharmaceuticals’ (NASDAQ: CNCE) CTP-656 Obtains Orphan Drug Designation from FDA
Concert Pharmaceuticals (NASDAQ: CNCE) this morning reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for CTP-656, a next generation CFTR potentiator for the treatment of cystic fibrosis. The designation provides incentives such as tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design, and potential market exclusivity for seven years following approval. In December 2016, Concert initiated a phase 2 trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline data from the ongoing phase 2 trial is expected by…
