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Xbrane Biopharma Faces FDA Setback on Ranibizumab Biosimilar

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Xbrane Biopharma Faces FDA Setback on Ranibizumab Biosimilar

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

Xbrane Biopharma AB has received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application for a ranibizumab biosimilar candidate, intended for treating retinal disorders. The CRL follows unresolved observations from a re-inspection of a contract manufacturer’s site, despite previous corrective actions. Xbrane plans to address these issues promptly to allow for re-submission. The company’s Lucentis biosimilar has been successfully approved and distributed in Europe, highlighting its commitment to providing cost-effective treatment alternatives.

The most recent analyst rating on (SE:XBRANE) stock is a Hold with a SEK23.50 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 company specializing in the development of biosimilar drugs using a patented platform technology that reduces production costs. The company targets a market with an estimated annual peak sales of EUR 23 billion for its biosimilar candidates. Xbrane’s lead candidate, Ximluci®, has received market authorization in Europe and was launched in 2023. The company is listed on Nasdaq Stockholm.

YTD Price Performance: 15.93%

Average Trading Volume: 119,085

Technical Sentiment Signal: Strong Sell

Current Market Cap: SEK480.1M

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

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