Ascelia Pharma’s shares rose 8.2% to $0.595 on Tuesday after the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the company’s New Drug Application (NDA) for Orviglance, its lead MRI contrast agent for cancer imaging.
The Stockholm-listed biotech said the CRL, received in early July, cited questions related to image read methodology and product quality observations, though the FDA inspections during the review were completed without critical findings. A Type A meeting with the agency is scheduled for September 9 to discuss the path forward, with meeting minutes expected within 30 days of the session.
Magnus Corfitzen, CEO, acknowledged the setback while emphasizing a clear plan to address the FDA’s concerns. "We are not where we hoped to be at this point, but we have a clear plan, clear inflection points, and there continues to be an attractive opportunity for Orviglance," he said. The company, which focuses on rare cancer treatments, is based in Malmö, Sweden, and listed on Nasdaq Stockholm.
Andreas Norlin, Chief Scientific Officer, noted that the FDA’s product quality observations had been addressed in line with agency recommendations. He added that the questions in the CRL centered on aspects of the image read methodology, including the justification for rereads and interpretation of results.
Ascelia reported an operating loss of SEK 12 million in Q2 2027, an improvement from the same period in 2025 due to lower costs following the NDA submission process. The company held SEK 38 million in cash and equivalents at the end of June, after raising SEK 20 million in a directed share issue in April 2027. Cash runway has been extended into Q2 2027 following cost-reduction measures.
Orviglance holds orphan drug designation and targets a global addressable market of approximately $800 million, with nearly half in the U.S. Data on the agent was presented at the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) conference in June 2027, and the company filed a patent application for packaging and manufacturing improvements the same month.
