Ascelia Pharma AB Progresses with Orviglance NDA Submission

Ascelia Pharma AB, a biotechnology company operating in the health care sector, is making significant strides in the development of Orviglance, a medication aimed at treating liver metastases and gastric cancer. The company, listed on the Swedish Stock Exchange, is nearing the completion of its New Drug Application (NDA) for Orviglance to the U.S. Food and Drug Administration (FDA).

As of August 18, 2025, Ascelia Pharma has confirmed that the NDA file is essentially complete. The final electronic configuration of the file, a necessary step to meet FDA submission standards, is currently underway. This process is expected to be finalized within two to three weeks, after which the submission will be made. This timeline represents a slight delay from the company’s earlier target, with the submission now anticipated to occur by the end of August or early September.

The company’s progress was highlighted in multiple reports from financial news sources, including Redeye.se, Avanza.se, and Di.se, all noting the nearing completion of the NDA submission. Additionally, Ascelia Pharma provided an update on August 15, 2025, through Access Newswire and Nasdaq Nordic, reiterating the ongoing finalization of the electronic configuration of the NDA file.

Ascelia Pharma AB, with a market capitalization of 562,720,000 SEK, has experienced fluctuations in its stock price, with a close price of 4.74 SEK on August 14, 2025. The company’s 52-week high was 5.23 SEK on August 4, 2025, and its 52-week low was 2 SEK on September 12, 2024. The price-to-earnings ratio stands at -3.32, reflecting the company’s current financial metrics.

Ascelia Pharma continues to focus on improving the lives of patients with rare cancer conditions, with Orviglance representing a significant step forward in their drug development efforts. The company’s progress towards FDA submission is closely watched by investors and stakeholders in the biotechnology sector.