Alvotech Shares Climb After FDA Concludes Facility Inspection
January 19 2024 - 11:31AM
Dow Jones News
By Dean Seal
Shares of Alvotech jumped after the company said its drug
candidates AVT02 and AVT04 could be approved in the coming months
now that U.S. regulators have concluded their inspection of its
Iceland facility.
The stock was up 11% at $13.60 in early trading. Shares are now
up more than 16% since the start of the year.
The biotech company said Friday that the U.S. Food and Drug
Administration has completed its facility reinspection and
submitted just one observation to Alvotech, which the company
expects to respond to in the days to come.
"We believe that the observation is readily addressable, and we
intend to respond as quickly as possible," Chief Executive Robert
Wessman said.
Based on the conclusion of the reinspection, Alvotech believes
it is positioned to receive approval in the U.S. for AVT02, a
biosimilar candidate to Abbvie's Humira, by Feb. 24 and for AVT04,
a biosimilar to Janssen Pharmaceuticals' Stelara, by April 16.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
January 19, 2024 12:16 ET (17:16 GMT)
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