Aktieanalys

Xbrane Biopharma: BLA submitted to the FDA - Redeye

Redeye Publicerad: 24 Apr 2023 10:56

Redeye endorses today’s news that Xbrane has submitted its BLA to the FDA for its biosimilar candidate to Lucentis, which is already launched under the name Ximluci in Europe. The FDA now has 60 days to validate the submission for a full review, which should take another ~10 months and set up for a potential Q2 2024 approval in the US. We acknowledge that the submission took place slightly later than we hoped for (Q1) but reiterate our SEK173 base case proposition as we believe the current share price fails to reflect the prospects of the ongoing launch of Ximluci in combination with additional pipeline catalysts anticipated in 2023.

Länk till analysen i sin helhet: https://www.redeye.se/research/896538/xbrane-biopharma-bla-submitted-to-the-fda?utm_source=finwire&utm_medium=RSS

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