FDA Requires More Evidence for Ascelia’s Orviglance

The FDA requires additional clinical evidence for Ascelia Pharma's Orviglance. In official Type A meeting minutes, the agency indicated a prospective analysis of existing Phase 3 SPARKLE images using a different primary endpoint could support approval. Ascelia does not intend to conduct a new clinical study. The FDA confirmed Orviglance addresses a significant medical need, identified no serious safety concerns, and agreed a path to resolve previously identified quality issues. Ascelia's share price collapsed last summer after the FDA rejected its NDA. The FDA continues to require additional clinical evidence. CEO Magnus Corfitzen said, "Although we are disappointed that the FDA continues to request additional clinical evidence, the Type A meeting has provided greater clarity on the possible paths forward. We remain convinced of the strength of our data and will evaluate the most effective regulatory path forward in the United States, focusing on options based on the existing data from the SPARKLE study, while continuing our partnering activities to make Orviglance available to patients." Ascelia will continue work toward European approval and partnerships. DNB Carnegie maintains a 50 percent probability of approval and a fair-value range of SEK 0.30-2 per share, expecting a delayed launch and no near-term partnership revenue.