Ascelia Pharma (STO: ACE) has announced that the U.S. Food and Drug Administration (FDA) has scheduled a Type A meeting for September 9, 2026 to discuss the Complete Response Letter (CRL) issued on July 2, 2026 regarding the New Drug Application (NDA) for Orviglance.
According to Ascelia, the meeting follows the FDA’s acceptance of the company’s Type A meeting request and provides an opportunity for Ascelia Pharma and the FDA to review the company’s response to the issues outlined in the CRL, including statistical/clinical, product quality, and regulatory considerations supporting the Orviglance NDA.
In a statement, Magnus Corfitzen, CEO of Ascelia, commented, “The scheduling of this Type A meeting represents an important step in our ongoing dialogue with FDA regarding the Orviglance NDA. We have worked diligently to address the points raised in the CRL and have submitted a comprehensive briefing package that clearly presents the scientific, clinical, and regulatory foundation supporting the application. We remain confident in the strength of the Orviglance data package and look forward to a productive discussion with FDA on the path forward for bringing Orviglance to patients with severe kidney impairment who currently have limited liver imaging options.”
