Alvotech (ALVO) Faces Investigation After 34% Stock Drop Following FDA Complete Response Letter
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Source: PRnewswire
- Stock Price Plunge: Alvotech's stock plummeted 34% in a single trading session after receiving a Complete Response Letter (CRL) from the FDA, dropping from $7.65 to $5.03, which directly undermined investor confidence and market valuation.
- Regulatory Investigation: Hagens Berman is investigating whether Alvotech misled investors about the readiness of its Reykjavik manufacturing facility to meet FDA standards, potentially impacting the company's reputation and accountability.
- Significant Financial Downgrade: Following the CRL, Alvotech was forced to drastically cut its 2025 revenue guidance from $700 million and reduce its adjusted EBITDA outlook by 58%, indicating severe financial strain on the company.
- Investor Outreach: Hagens Berman is urging affected investors to reach out for legal support, highlighting that potential issues with transparency and compliance could lead to broader legal ramifications for the company.
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: 4.830
Low
8.00
Averages
10.67
High
14.00
Current: 4.830
Low
8.00
Averages
10.67
High
14.00
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
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.
