Ascelia Pharma has announced positive outcomes from its recent meeting with the U.S. Food and Drug Administration (FDA) regarding the planned New Drug Application (NDA) for Orviglance, its lead product candidate. The Swedish biotech company confirmed it remains on track to submit the application by mid-2025, most likely during the first half of August.
The FDA provided "clear and concrete guidance" for the Orviglance NDA, according to the company's statement. This regulatory milestone represents a significant step forward in Ascelia's efforts to bring the novel contrast agent to market for patients with impaired kidney function who need liver MRI imaging.
"We are very pleased with the outcome of our meeting with the FDA and look forward to advancing the NDA submission for Orviglance in order to submit in the middle of the year, as planned," said Magnus Corfitzen, CEO of Ascelia Pharma. "This meeting with the FDA is another significant step forward in bringing Orviglance to market."
Strong Clinical Evidence Supports Application
Orviglance has completed its clinical development program with consistently positive efficacy and safety results across nine clinical studies involving a total of 286 patients and healthy volunteers. The Phase 3 SPARKLE study, which served as the pivotal trial for the product, met its primary endpoint with statistical significance.
The study demonstrated that Orviglance significantly improved visualization of focal liver lesions in patients with impaired kidney function, achieving statistical significance (p<0.001) for all three independent readers who evaluated the imaging results. This robust data package forms the core of the upcoming NDA submission.
The medical community has shown strong interest in Orviglance, with study data accepted for presentation at multiple scientific conferences. To date, Orviglance data has been featured in four oral presentations and four abstracts at key scientific meetings. Additionally, in April 2025, a new scientific publication in Investigative Radiology featured Orviglance in a comparison study to unenhanced MRI and to gadolinium-based contrast agents.
Financial Position Strengthened
Ascelia Pharma recently bolstered its financial position through the successful exercise of TO 1 warrants, which provided SEK 43 million (approximately USD 4.1 million) in additional financing before costs, with a subscription rate of 96 percent. According to the company, this extends its cash runway to at least the end of 2025, well beyond the planned NDA submission and other financial obligations.
"We now have a cash runway to at least end 2025, well beyond the NDA submission and repayment of the SEK 20 million loan to Fenja with reserved cash for a potential repayment of the SEK 7.5 million convertibles end of 2025," Corfitzen noted in the company's Q1 2025 report. "This runway excludes financing from partnering."
Addressing an Unmet Medical Need
Orviglance addresses a significant unmet need in diagnostic imaging. Patients with impaired kidney function cannot use gadolinium-based contrast agents, which are standard for liver MRI, due to the risk of nephrogenic systemic fibrosis, a potentially fatal condition. Orviglance provides an alternative for these vulnerable patients, potentially improving cancer detection and treatment planning.
The company is also advancing partnership discussions for the commercialization of Orviglance, aiming to maximize the product's market potential once approved.
Pipeline Development Continues
Beyond Orviglance, Ascelia Pharma is developing Oncoral, a novel irinotecan chemotherapy tablet initially targeted for the treatment of gastric cancer. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development. The oral formulation aims to offer improved patient outcomes and safety compared to traditional intravenous high-dose infusions administered in hospital settings.
As Ascelia Pharma progresses toward the Orviglance NDA submission milestone, the company remains focused on its mission of developing novel treatments for rare cancer conditions and addressing unmet medical needs in oncology.
