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An announcement from Ascelia Pharma AB ( (SE:ACE) ) is now available.
Ascelia Pharma reports that FDA review of its New Drug Application for Orviglance is progressing on schedule ahead of the July 3 PDUFA decision date, supported by nine clinical studies, including the pivotal Phase 3 SPARKLE trial showing significantly improved visualization of focal liver lesions without serious safety signals. The company also highlighted added scientific recognition through an upcoming oral presentation at ESGAR 2026, ongoing partnering discussions, and a SEK 20 million directed share issue completed after the quarter to enhance its balance sheet and strengthen its position in commercialization negotiations.
The interim figures for Q1 2026 show a reduced operating loss compared with the prior year and liquidity of SEK 33.9 million, indicating continued but controlled cash burn as Orviglance approaches potential approval. Management changes, with a new CFO appointed and the deputy CEO departing, alongside extended cash runway into 2027 from the new equity raise, position Ascelia to navigate the critical transition from late-stage development to potential market launch and partnership execution.
More about Ascelia Pharma AB
Ascelia Pharma AB is a clinical-stage pharmaceutical company focused on orphan oncology and diagnostic imaging. Its lead product candidate, Orviglance, is a gadolinium-free liver MRI contrast agent targeting patients with severe kidney impairment, a high-risk group for complications from standard gadolinium-based agents, and it has received Orphan Drug Designation from the U.S. FDA.
Average Trading Volume: 673,505
Technical Sentiment Signal: Sell
Current Market Cap: SEK362.2M
For detailed information about ACE stock, go to TipRanks’ Stock Analysis page.