Shares of biotech company Alvotech (NASDAQ:ALVO) are tanking today after it received a complete response letter (CRL) for its second BLA (Biologics License Application) for AVT02 from the U.S. Food and Drug Administration (FDA).
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AVT02 is a biosimilar candidate for AbbVie’s (NYSE:ABBV) Humira and the second BLA provided supporting data for the drug’s approval as a high-concentration biosimilar. The FDA highlighted that certain deficiencies at Alvotech’s Reykjavik facility need to be resolved for approval.
Now, the company plans to resubmit a BLA for the drug which means a review period of six months as well as a new Biosimilar User Fee Act (BsUFA) date.
Additionally, in the aftermath of the CRL, Alvotech is also planning to look at options to raise additional funds to keep advancing its product pipeline which includes 10 candidates in addition to AVT02. Potential funding avenues include equity financing, convertible bonds, or other types of debt.
Importantly, ATP Holdings which is the largest stakeholder in Alvotech has shown interest in offering potential financing of up to $100 million for the company.
Alvotech shares have tanked nearly 43.7% over the past three months already.
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