Alvotech Under Investigation Following 34% Stock Drop After FDA CRL
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Should l Buy ALVO?
Source: Globenewswire
- 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, indicating severe market concerns regarding its manufacturing capabilities and regulatory compliance.
- Regulatory Investigation Launched: Hagens Berman is investigating whether Alvotech misled investors about significant manufacturing failures at its Reykjavik, Iceland facility prior to public disclosure, potentially undermining investor confidence in the company’s future.
- Major Financial Downgrade: The deficiencies cited in the FDA's CRL forced Alvotech to drastically cut its 2025 revenue guidance from $700 million and reduce its adjusted EBITDA outlook by 58%, posing a significant threat to the company's financial health.
- Investor Loss Alert: Hagens Berman is urging all investors who suffered substantial losses in Alvotech to contact them to participate in the investigation and seek potential compensation, reflecting concerns over the company's transparency and governance structure.
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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 8.60 USD with a low forecast of 5.00 USD and a high forecast of 10.00 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.
5 Analyst Rating
3 Buy
1 Hold
1 Sell
Moderate Buy
Current: 5.120
Low
5.00
Averages
8.60
High
10.00
Current: 5.120
Low
5.00
Averages
8.60
High
10.00
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.
Alvotech Under Investigation Following 34% Stock Drop After FDA CRL
- 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, indicating severe market concerns regarding its manufacturing capabilities and regulatory compliance.
- Regulatory Investigation Launched: Hagens Berman is investigating whether Alvotech misled investors about significant manufacturing failures at its Reykjavik, Iceland facility prior to public disclosure, potentially undermining investor confidence in the company’s future.
- Major Financial Downgrade: The deficiencies cited in the FDA's CRL forced Alvotech to drastically cut its 2025 revenue guidance from $700 million and reduce its adjusted EBITDA outlook by 58%, posing a significant threat to the company's financial health.
- Investor Loss Alert: Hagens Berman is urging all investors who suffered substantial losses in Alvotech to contact them to participate in the investigation and seek potential compensation, reflecting concerns over the company's transparency and governance structure.
See More
Alvotech Faces Securities Claims Investigation
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Alvotech (NASDAQ:ALVO) due to allegations of issuing materially misleading business information, indicating that investors may be entitled to compensation without any upfront costs.
- Significant Stock Drop: Following a press release on November 2, 2025, where Alvotech disclosed that the FDA issued a complete response letter for its Biologics License Application, the stock plummeted 34% on November 3 and nearly 4% on November 4, reflecting market concerns over compliance issues.
- Class Action Preparation: The firm is preparing a class action to recover investor losses, emphasizing the importance of selecting qualified legal counsel with a proven track record in securities litigation to ensure effective representation.
- Law Firm's Strength: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, showcasing its strong capabilities and reputation in the securities litigation space.
See More
Alvotech Faces Securities Claims Investigation by Rosen Law Firm
- Securities Claims Investigation: Rosen Law Firm is investigating Alvotech (NASDAQ: ALVO) for potential securities claims due to allegations of issuing materially misleading business information, which has negatively impacted investor confidence and the company's reputation.
- Stock Price Plunge: Following the November 2, 2025 press release regarding its Biologics License Application, Alvotech's stock price plummeted 34% on November 3 and nearly 4% on November 4, indicating significant market concerns about its future prospects.
- Class Action Preparation: Rosen Law Firm is preparing a class action to recover losses for investors, with no out-of-pocket fees required, which may encourage more affected shareholders to participate in the legal proceedings.
- Law Firm's Strength: Known for its successful track record in securities class actions, Rosen Law Firm recovered over $438 million for investors in 2019 alone, demonstrating its expertise and resource advantages in handling similar cases.
See More
Alvotech's AVT80 Biosimilar Study Achieves Success
- Clinical Trial Success: Alvotech's AVT80 biosimilar achieved primary endpoints in the AVT80-GL-P01 trial, demonstrating pharmacokinetic similarity to Takeda's Entyvio, which is expected to enhance its competitiveness in the bowel disease treatment market.
- Significant Market Potential: With Entyvio generating $6.4 billion in global net revenue last year, Alvotech's success could capture substantial market share, especially as biosimilars gain increasing attention in the pharmaceutical landscape.
- Positive Regulatory Feedback: Regulatory feedback indicates that the AVT80-GL-P01 trial results meet expectations, confirming pharmacokinetic similarity for AVT80 and AVT16 in subcutaneous and intravenous administration, laying a solid foundation for future market applications.
- Positive Stock Reaction: Following the announcement, Alvotech shares spiked approximately 3% in premarket trading, reflecting investor optimism regarding the biosimilar's prospects, which may further drive the company's financing and expansion plans.
See More
Alvotech Reports Positive Results for AVT80 Study
- Positive Study Results: Alvotech announced that its biosimilar AVT80 met all primary endpoints in clinical trials, demonstrating good safety and tolerability, paving the way for regulatory submissions.
- Strong Market Reaction: Following the announcement of positive pharmacokinetic study results, Alvotech's shares surged nearly 10% in pre-market trading on Thursday, reflecting investor optimism about the biosimilar's prospects.
- Significant Market Potential: With Entyvio's projected global net revenue of $6.4 billion in 2025, Alvotech's AVT80, if successfully launched, stands to capture a substantial share of this lucrative market.
- Extensive Industry Partnerships: Alvotech has established collaborations with multiple global pharmaceutical companies, including Teva and Cipla, showcasing its strong network and influence in the biosimilar market.
See More
Alvotech Reports Positive Results for AVT80 Clinical Study
- Clinical Trial Success: Alvotech's AVT80 pharmacokinetic study met all primary endpoints compared to Entyvio, indicating PK similarity in healthy adults and paving the way for regulatory submissions.
- Robust Study Design: The randomized, double-blind, single-dose, parallel-group study utilized a 108 mg/0.68 mL subcutaneous injection, ensuring reliable safety, tolerability, and immunogenicity data, thereby enhancing market competitiveness.
- Significant Market Potential: With Entyvio generating approximately $6.4 billion in global net revenues in 2025, AVT80, as its biosimilar candidate, is expected to capture market share and drive revenue growth for Alvotech.
- Strategic Development Focus: The successful clinical trial not only demonstrates Alvotech's capabilities in biosimilar development but also provides crucial support for the clinical similarity of AVT16 and AVT80, further solidifying its position in the global biopharmaceutical market.
See More
Alvotech Under Investigation Following 34% Stock Drop After FDA CRL
- 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, indicating severe market concerns regarding its manufacturing capabilities and regulatory compliance.
- Regulatory Investigation Launched: Hagens Berman is investigating whether Alvotech misled investors about significant manufacturing failures at its Reykjavik, Iceland facility prior to public disclosure, potentially undermining investor confidence in the company’s future.
- Major Financial Downgrade: The deficiencies cited in the FDA's CRL forced Alvotech to drastically cut its 2025 revenue guidance from $700 million and reduce its adjusted EBITDA outlook by 58%, posing a significant threat to the company's financial health.
- Investor Loss Alert: Hagens Berman is urging all investors who suffered substantial losses in Alvotech to contact them to participate in the investigation and seek potential compensation, reflecting concerns over the company's transparency and governance structure.
See More
Alvotech Faces Securities Claims Investigation
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Alvotech (NASDAQ:ALVO) due to allegations of issuing materially misleading business information, indicating that investors may be entitled to compensation without any upfront costs.
- Significant Stock Drop: Following a press release on November 2, 2025, where Alvotech disclosed that the FDA issued a complete response letter for its Biologics License Application, the stock plummeted 34% on November 3 and nearly 4% on November 4, reflecting market concerns over compliance issues.
- Class Action Preparation: The firm is preparing a class action to recover investor losses, emphasizing the importance of selecting qualified legal counsel with a proven track record in securities litigation to ensure effective representation.
- Law Firm's Strength: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, showcasing its strong capabilities and reputation in the securities litigation space.
See More
Alvotech Faces Securities Claims Investigation by Rosen Law Firm
- Securities Claims Investigation: Rosen Law Firm is investigating Alvotech (NASDAQ: ALVO) for potential securities claims due to allegations of issuing materially misleading business information, which has negatively impacted investor confidence and the company's reputation.
- Stock Price Plunge: Following the November 2, 2025 press release regarding its Biologics License Application, Alvotech's stock price plummeted 34% on November 3 and nearly 4% on November 4, indicating significant market concerns about its future prospects.
- Class Action Preparation: Rosen Law Firm is preparing a class action to recover losses for investors, with no out-of-pocket fees required, which may encourage more affected shareholders to participate in the legal proceedings.
- Law Firm's Strength: Known for its successful track record in securities class actions, Rosen Law Firm recovered over $438 million for investors in 2019 alone, demonstrating its expertise and resource advantages in handling similar cases.
See More
Alvotech's AVT80 Biosimilar Study Achieves Success
- Clinical Trial Success: Alvotech's AVT80 biosimilar achieved primary endpoints in the AVT80-GL-P01 trial, demonstrating pharmacokinetic similarity to Takeda's Entyvio, which is expected to enhance its competitiveness in the bowel disease treatment market.
- Significant Market Potential: With Entyvio generating $6.4 billion in global net revenue last year, Alvotech's success could capture substantial market share, especially as biosimilars gain increasing attention in the pharmaceutical landscape.
- Positive Regulatory Feedback: Regulatory feedback indicates that the AVT80-GL-P01 trial results meet expectations, confirming pharmacokinetic similarity for AVT80 and AVT16 in subcutaneous and intravenous administration, laying a solid foundation for future market applications.
- Positive Stock Reaction: Following the announcement, Alvotech shares spiked approximately 3% in premarket trading, reflecting investor optimism regarding the biosimilar's prospects, which may further drive the company's financing and expansion plans.
See More
Alvotech Reports Positive Results for AVT80 Study
- Positive Study Results: Alvotech announced that its biosimilar AVT80 met all primary endpoints in clinical trials, demonstrating good safety and tolerability, paving the way for regulatory submissions.
- Strong Market Reaction: Following the announcement of positive pharmacokinetic study results, Alvotech's shares surged nearly 10% in pre-market trading on Thursday, reflecting investor optimism about the biosimilar's prospects.
- Significant Market Potential: With Entyvio's projected global net revenue of $6.4 billion in 2025, Alvotech's AVT80, if successfully launched, stands to capture a substantial share of this lucrative market.
- Extensive Industry Partnerships: Alvotech has established collaborations with multiple global pharmaceutical companies, including Teva and Cipla, showcasing its strong network and influence in the biosimilar market.
See More
Alvotech Reports Positive Results for AVT80 Clinical Study
- Clinical Trial Success: Alvotech's AVT80 pharmacokinetic study met all primary endpoints compared to Entyvio, indicating PK similarity in healthy adults and paving the way for regulatory submissions.
- Robust Study Design: The randomized, double-blind, single-dose, parallel-group study utilized a 108 mg/0.68 mL subcutaneous injection, ensuring reliable safety, tolerability, and immunogenicity data, thereby enhancing market competitiveness.
- Significant Market Potential: With Entyvio generating approximately $6.4 billion in global net revenues in 2025, AVT80, as its biosimilar candidate, is expected to capture market share and drive revenue growth for Alvotech.
- Strategic Development Focus: The successful clinical trial not only demonstrates Alvotech's capabilities in biosimilar development but also provides crucial support for the clinical similarity of AVT16 and AVT80, further solidifying its position in the global biopharmaceutical market.
See More
