Xbrane Sets April–May Target to Resubmit Ranibizumab Biosimilar BLA to U.S. FDA

An announcement from Xbrane Biopharma AB ( (SE:XBRANE) ) is now available.

Xbrane Biopharma plans to resubmit its Biologics License Application for its ranibizumab biosimilar to the U.S. Food and Drug Administration in April or May 2026, following additional feedback related to a previous Complete Response Letter focused on manufacturing observations. The delay stems from required corrective actions at the contract manufacturer’s facility, tied to a second product inspected alongside Ximluci, but Xbrane expects these actions to be completed and verified by the end of April, paving the way for a resubmission and a roughly six‑month FDA review period, while the drug continues to be marketed in Europe and the U.K.

The most recent analyst rating on (SE:XBRANE) stock is a Sell with a SEK6.00 price target. To see the full list of analyst forecasts on Xbrane Biopharma AB stock, see the SE:XBRANE Stock Forecast page.

More about Xbrane Biopharma AB

Xbrane Biopharma AB is a Swedish biotechnology company that develops biological drugs using a patented platform designed to lower production costs versus competing systems. The company focuses on biosimilar candidates targeting reference products with an estimated EUR 23 billion in annual peak sales, led by its ranibizumab biosimilar Ximluci, which is approved and launched in Europe and the U.K.

Average Trading Volume: 54,504

Technical Sentiment Signal: Strong Sell

Current Market Cap: SEK124M

See more data about XBRANE stock on TipRanks’ Stock Analysis page.