Alvotech Faces Class Action After FDA Denies AVT05 Application
Written by Emily J. Thompson, Senior Investment Analyst
Source: Globenewswire
Updated: 1 hour ago0mins
- Legal Investigation Launched: Rosen Law Firm announces an investigation into Alvotech for potentially issuing misleading business information, indicating that shareholders who purchased Alvotech securities may be entitled to compensation.
- Stock Price Plunge: Following the FDA's complete response letter (CRL) on November 3, 2025, Alvotech's stock price fell by 34%, reflecting significant market concerns about the company's future prospects.
- FDA Feedback Issues: The CRL highlighted deficiencies found during the FDA's inspection of Alvotech's Reykjavik manufacturing facility, which must be resolved for the approval of AVT05, indicating substantial compliance challenges for the company.
- Class Action Preparation: Rosen Law Firm is preparing a class action to recover investor losses, reflecting potential implications for Alvotech's future financial health.
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Analyst Views on ALVO
Wall Street analysts forecast ALVO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ALVO is 10.67 USD with a low forecast of 8.00 USD and a high forecast of 14.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
2 Buy
1 Hold
0 Sell
Moderate Buy
Current: 5.070
Low
8.00
Averages
10.67
High
14.00
Current: 5.070
Low
8.00
Averages
10.67
High
14.00
Morgan Stanley
Overweight
downgrade
$14 -> $10
2025-12-03
New
Reason
Morgan Stanley
Price Target
$14 -> $10
2025-12-03
New
downgrade
Overweight
Reason
Morgan Stanley lowered the firm's price target on Alvotech to $10 from $14 and keeps an Overweight rating on the shares. The firm sees the EU Pharmaceuticals sector set up as neutral into 2026, with fundamentals intact at a low valuation premium compared to history, offset by better EPS growth elsewhere in Europe, the analyst tells investors in a year-ahead outlook note.
UBS
Buy
to
Buy
downgrade
$13 -> $10
2025-11-18
Reason
UBS
Price Target
$13 -> $10
2025-11-18
downgrade
Buy
to
Buy
Reason
UBS lowered the firm's price target on Alvotech to $10 from $13 and keeps a Buy rating on the shares.
Northland
Outperform
to
NULL
downgrade
$28 -> $10
2025-11-04
Reason
Northland
Price Target
$28 -> $10
2025-11-04
downgrade
Outperform
to
NULL
Reason
Northland lowered the firm's price target on Alvotech to $10 from $28 and keeps an Outperform rating on the shares after the company received a Complete Response Letter for AVT05 following FDA inspection findings at its Reykjavik site. The company lowered FY25 revenue and adjusted EBITDA guidance as a result, notes the firm, which expects outstanding BLAs for AVT03 and AVT06 to be delayed as well.
Deutsche Bank
Buy
to
Hold
downgrade
$14 -> $8
2025-11-04
Reason
Deutsche Bank
Price Target
$14 -> $8
2025-11-04
downgrade
Buy
to
Hold
Reason
Deutsche Bank downgraded Alvotech to Hold from Buy with a price target of $8, down from $14, after the company received a complete response letter from the FDA for AVT05. The CRL noted deficiencies from an FDA inspection of Alvotech's Reykjavik manufacturing facility, the analyst tells investors in a research note. After speaking to management, Deutsche says the issues identified by the FDA could also lead to CRLs for both the AVT03 and AVT06 launches.
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About ALVO
Alvotech SA is a biotechnology company. The Company is focused on the development and manufacture of biosimilar medicines for patients globally. It is engaged in developing a pipeline of monoclonal antibodies that target a variety of therapeutic areas including inflammatory diseases, oncology, and ophthalmology. The Company’s pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Its products pipeline includes AVT02, AVT04, AVT23, AVT03, AVT05, AVT06, AVT16, and AVT33. Its AVT02 is a monoclonal antibody and a biosimilar to Humira (adalimumab). AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara (ustekinumab). It has formed a network of strategic commercial partnerships to provide global reach and leverage expertise in markets that include the United States (U.S.), Europe, Japan, China, and other Asian countries and large parts of South America, Africa, and the Middle East.
About the author
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Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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