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The latest announcement is out from Xbrane Biopharma AB ( (SE:XBRANE) ).
Xbrane Biopharma AB announced plans to re-submit its Biologics License Application (BLA) for a ranibizumab biosimilar to the FDA in March 2026, following a Complete Response Letter due to issues at a contract manufacturer’s site. The company is addressing FDA’s corrective action requests and anticipates a six-month review process, aiming for approval by September 2026. This move is part of Xbrane’s commitment to offering a cost-effective treatment for conditions like Age-related Macular Degeneration, potentially strengthening its position in the biosimilar market.
The most recent analyst rating on (SE:XBRANE) stock is a Hold with a SEK10.00 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 biopharmaceutical company specializing in the development of biological drugs using a patented platform technology that reduces production costs. The company focuses on biosimilar candidates with a significant market potential, targeting an estimated EUR 23 billion in annual peak sales. Xbrane’s lead product, Ximluci®, has received market authorization in Europe and was launched in 2023. The company is headquartered in Solna, Sweden, and is listed on Nasdaq Stockholm.
Average Trading Volume: 171,356
Technical Sentiment Signal: Strong Sell
Current Market Cap: SEK207.3M
Find detailed analytics on XBRANE stock on TipRanks’ Stock Analysis page.