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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Alvontech | NASDAQ:ALVO | NASDAQ | Common Stock |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 13.50 | 10.00 | 13.94 | 0 | 09:00:00 |
From May 2023 to May 2024
By Mary de Wet
Alvotech said Wednesday that approval for AVT02, a biosimilar candidate for Abbvie's Humira, in the U.S. is likely to be delayed after the Icelandic company received a complete response letter from the Food and Drug Administration.
As a result, Alvotech said it would explore options to raise additional capital to continue advancing pipeline development in the near term.
ATP Holdings, a unit of Alvotech's largest shareholder, Aztiq, is interested in providing as much as $100 million from potential financing, Alvotech said.
The FDA letter was in response to the company's second biologics license application. In April, the FDA sent Alvotech a complete response letter for its initial application, which noted certain deficiencies at the company's Reykjavik facility.
Alvotech said it intends to resubmit the biologics license application for AVT02.
Write to Mary de Wet at mary.dewet@dowjones.com
(END) Dow Jones Newswires
June 28, 2023 19:48 ET (23:48 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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