Alvotech (Buy, TP: USD15.00) - CRL for AVT02 in the US
Alvotech said on Friday it had received a CRL for the approval application for AVT02 (adalimumab biosimilar) after the FDA’s facility inspection in Reykjavik. This is clearly negative news and introduces high uncertainty in the stock until the manufacturing issues have been resolved. The CRL included no issues relating to the clinical data for AVT02, which was good. Given the CRL and risk of a delayed launch of AVT02 in the US, we have cut our target price to USD15 (19) but reiterate our BUY.
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