Xbrane Resubmits Ranibizumab Biosimilar Application to U.S. FDA

Xbrane Biopharma AB ( (SE:XBRANE) ) has issued an update.

Xbrane Biopharma has resubmitted its Biologics License Application to the U.S. Food and Drug Administration for a ranibizumab biosimilar to Lucentis, targeting eye diseases such as age-related macular degeneration, retinal vein occlusion and myopic choroidal neovascularization. The revised filing follows the resolution and verification of previously cited issues at a contract manufacturing site, with a new FDA review expected to take about six months, potentially paving the way for a cost-effective ophthalmic treatment option and expanding Xbrane’s presence in the U.S. biosimilar market.

More about Xbrane Biopharma AB

Xbrane Biopharma AB is a Swedish biopharmaceutical company that develops biological drugs using a patented platform designed to lower production costs compared with competing systems. The company focuses on biosimilar candidates addressing reference products with an estimated EUR 23 billion in peak annual sales, and its lead ophthalmology biosimilar Ximluci has already secured European approval and was launched in 2023.

Average Trading Volume: 60,828

Technical Sentiment Signal: Sell

Current Market Cap: SEK206.1M

See more insights into XBRANE stock on TipRanks’ Stock Analysis page.