Ascelia Pharma’s Orviglance NDA Accepted by FDA as Cash Runway Extends Beyond 2026 Decision

Ascelia Pharma AB ( (SE:ACE) ) has provided an announcement.

Ascelia Pharma reported that the US Food and Drug Administration has formally accepted its New Drug Application for Orviglance, setting a PDUFA decision date of 3 July 2026 and confirming the completeness of a development package that includes nine clinical studies and a pivotal Phase 3 trial demonstrating significant improvements in liver lesion visualization and a favorable safety profile in patients with severe kidney impairment. Despite continued operating losses and declining cash balances, the company strengthened its finances with a directed share issue in September 2025, maintains a cash runway into the fourth quarter of 2026, and is advancing partnering discussions that have gained momentum now that the regulatory review timeline is clear, potentially improving its commercialization prospects and strategic position ahead of a possible US launch.

The most recent analyst rating on (SE:ACE) stock is a Hold with a SEK2.50 price target. To see the full list of analyst forecasts on Ascelia Pharma AB stock, see the SE:ACE Stock Forecast page.

More about Ascelia Pharma AB

Ascelia Pharma AB is a specialty pharmaceutical company focused on orphan oncology and imaging drugs, with its lead product candidate Orviglance being developed as a liver MRI contrast agent for patients with severe kidney impairment who are at high risk from currently used gadolinium-based agents. Orviglance has received Orphan Drug Designation from the FDA, positioning the company in a niche but clinically critical segment of the diagnostic imaging market.

Average Trading Volume: 1,119,216

Technical Sentiment Signal: Strong Sell

Current Market Cap: SEK329.9M

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