Photocure ASA

Photocure ASA announced that the U.S. Food and Drug Administration has published a proposed order to reclassify cystoscopic systems used for detecting bladder cancer from Class III to Class II. The FDA initiated the reclassification on its own initiative after reviewing scientific, clinical, and post-market evidence, concluding that special controls can ensure safety and effectiveness. The proposal applies to systems used with an approved optical imaging agent for photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. Photocure's President and CEO Dan Schneider called the move a very important regulatory milestone that will serve as a tremendous catalyst for the U.S. business. If finalized, the reclassification would move applicable systems from the premarket approval pathway to the 510(k) pathway with special controls, and Photocure believes it will facilitate innovation and expand access to blue light cystoscopy with Cysview.

Asieris Pharmaceuticals and its wholly-owned subsidiary Asieris Meditech Hong Kong Co., Ltd. have been taken to arbitration by Photocure before the American Arbitration Association over a dispute concerning milestone payments under the APL-1702 license agreement, with Photocure seeking 4.4 million dollars plus interest. Photocure granted Asieris an exclusive worldwide license for APL-1702, and the company had previously paid all triggered milestone amounts. Following the approval and launch of APL-1702, marketed as CEVIRA, in China in March 2026, Asieris paid 6.6 million dollars in April 2026, but contends that this approval did not trigger the full 11 million dollar payment obligation for that milestone, whereas Photocure asserts that the payment conditions have been met. In the first quarter of 2026, Asieris reported revenue of 71.09 million yuan and a net loss attributable to the parent company of 112 million yuan.