Alvotech Reports Positive Results for AVT80 Clinical Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Should l Buy ALVO?
Source: Newsfilter
- 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.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy ALVO?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
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: 5.210
Low
5.00
Averages
8.60
High
10.00
Current: 5.210
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 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 Faces Securities Claims Investigation
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Alvotech (NASDAQ: ALVO) for allegedly issuing materially misleading business information, indicating that affected shareholders may be entitled to compensation without any out-of-pocket costs.
- Significant Stock Decline: Following a press release on November 2, 2025, regarding a complete response letter from the FDA on its Biologics License Application, Alvotech's stock plummeted 34% on November 3 and nearly 4% on November 4, reflecting investor concerns about the company's future prospects.
- Class Action Preparation: The firm is preparing a class action to recover investor losses, encouraging affected investors to join through their website or by phone, highlighting their commitment to protecting investor rights in the face of potential misconduct.
- Firm's Track Record: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, showcasing their expertise and success in the field, which is crucial for investors when selecting legal counsel for such matters.
See More
Alvotech Enters Supply Agreements with Sandoz for Biosimilars
- Agreement Signing: Alvotech has entered into supply and commercialization agreements with Sandoz covering multiple biosimilar candidates in Canada, Australia, and New Zealand, marking a significant step in Alvotech's global market expansion.
- Clear Responsibility Allocation: Under the agreement, Sandoz will handle regulatory submissions, commercialization, and distribution in their respective regions, while Alvotech retains responsibility for development, global clinical activities, and manufacturing, ensuring product quality and supply chain stability.
- Product Segmentation: In Canada, the agreement includes one ophthalmology biosimilar candidate supplied as a prefilled syringe for intravitreal injection; in Australia and New Zealand, it encompasses three biosimilar candidates in immunology and gastroenterology, showcasing Alvotech's strategic positioning across multiple therapeutic areas.
- Market Dynamics: Sandoz is currently trading at 60.72 Swiss francs, down 0.75%, reflecting market attention on the biosimilars sector and investor expectations regarding the new collaboration.
See More
Alvotech Enters Supply Agreements with Sandoz for Biosimilars
- Strategic Partnership: Alvotech has signed supply and commercialization agreements with Sandoz covering multiple biosimilar candidates, aimed at paving the way for commercialization in global markets and further advancing Alvotech's strategic objectives.
- Market Coverage: The agreement includes one ophthalmology biosimilar candidate in Canada and three biosimilar candidates in immunology and gastroenterology in Australia and New Zealand, showcasing Alvotech's extensive market reach.
- Clear Responsibility Allocation: Under the agreements, Sandoz will handle regulatory submissions and commercial activities in their respective regions, while Alvotech focuses on development and manufacturing, ensuring product quality and supply stability.
- Enhanced Patient Access: This collaboration aims to support broad patient access following regulatory approvals, with Sandoz's strong market presence facilitating sustainable and affordable access to biologic medicines, thereby improving patient quality of life.
See More
Alvotech Faces Securities Claims Investigation by Rosen Law Firm
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Alvotech (NASDAQ: ALVO) for allegedly issuing materially misleading business information, highlighting serious concerns regarding the company's transparency.
- Significant Stock Drop: Following the FDA's complete response letter regarding its Biologics License Application on November 3, 2025, Alvotech's stock plummeted by 34%, reflecting a pessimistic outlook from the market on the company's future prospects.
- Class Action Preparation: The firm is preparing a class action lawsuit, allowing investors to seek compensation without any out-of-pocket costs, which enhances the appeal of legal action for affected investors.
- Firm's Reputation: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, demonstrating its expertise and influence in handling similar cases.
See More
Alvotech Settles Patent Disputes with Regeneron and Bayer
- Global Patent Settlement: Alvotech has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes related to its Eylea biosimilar, thereby ensuring its legitimacy and competitiveness in global markets.
- Market Entry Timeline: Under the agreement, Alvotech will launch the biosimilar in the UK and Canada starting January 1, 2026, and in the EEA and other countries (excluding the U.S.) and Japan (excluding DME) from May 1, 2026, significantly expanding its market reach.
- U.S. Market Outlook: Alvotech has secured a Q4 2026 license entry date for the U.S. market, pending regulatory approval, which lays a foundation for future revenue growth and reflects its strategic positioning in the biopharmaceutical sector.
- Confidential Terms Impact: While the remaining terms of the agreement remain confidential, the settlement provides a stable market environment for Alvotech and its commercial partners, enhancing their competitive advantage 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 Faces Securities Claims Investigation
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Alvotech (NASDAQ: ALVO) for allegedly issuing materially misleading business information, indicating that affected shareholders may be entitled to compensation without any out-of-pocket costs.
- Significant Stock Decline: Following a press release on November 2, 2025, regarding a complete response letter from the FDA on its Biologics License Application, Alvotech's stock plummeted 34% on November 3 and nearly 4% on November 4, reflecting investor concerns about the company's future prospects.
- Class Action Preparation: The firm is preparing a class action to recover investor losses, encouraging affected investors to join through their website or by phone, highlighting their commitment to protecting investor rights in the face of potential misconduct.
- Firm's Track Record: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, showcasing their expertise and success in the field, which is crucial for investors when selecting legal counsel for such matters.
See More
Alvotech Enters Supply Agreements with Sandoz for Biosimilars
- Agreement Signing: Alvotech has entered into supply and commercialization agreements with Sandoz covering multiple biosimilar candidates in Canada, Australia, and New Zealand, marking a significant step in Alvotech's global market expansion.
- Clear Responsibility Allocation: Under the agreement, Sandoz will handle regulatory submissions, commercialization, and distribution in their respective regions, while Alvotech retains responsibility for development, global clinical activities, and manufacturing, ensuring product quality and supply chain stability.
- Product Segmentation: In Canada, the agreement includes one ophthalmology biosimilar candidate supplied as a prefilled syringe for intravitreal injection; in Australia and New Zealand, it encompasses three biosimilar candidates in immunology and gastroenterology, showcasing Alvotech's strategic positioning across multiple therapeutic areas.
- Market Dynamics: Sandoz is currently trading at 60.72 Swiss francs, down 0.75%, reflecting market attention on the biosimilars sector and investor expectations regarding the new collaboration.
See More
Alvotech Enters Supply Agreements with Sandoz for Biosimilars
- Strategic Partnership: Alvotech has signed supply and commercialization agreements with Sandoz covering multiple biosimilar candidates, aimed at paving the way for commercialization in global markets and further advancing Alvotech's strategic objectives.
- Market Coverage: The agreement includes one ophthalmology biosimilar candidate in Canada and three biosimilar candidates in immunology and gastroenterology in Australia and New Zealand, showcasing Alvotech's extensive market reach.
- Clear Responsibility Allocation: Under the agreements, Sandoz will handle regulatory submissions and commercial activities in their respective regions, while Alvotech focuses on development and manufacturing, ensuring product quality and supply stability.
- Enhanced Patient Access: This collaboration aims to support broad patient access following regulatory approvals, with Sandoz's strong market presence facilitating sustainable and affordable access to biologic medicines, thereby improving patient quality of life.
See More
Alvotech Faces Securities Claims Investigation by Rosen Law Firm
- Securities Claims Investigation: Rosen Law Firm is investigating potential securities claims against Alvotech (NASDAQ: ALVO) for allegedly issuing materially misleading business information, highlighting serious concerns regarding the company's transparency.
- Significant Stock Drop: Following the FDA's complete response letter regarding its Biologics License Application on November 3, 2025, Alvotech's stock plummeted by 34%, reflecting a pessimistic outlook from the market on the company's future prospects.
- Class Action Preparation: The firm is preparing a class action lawsuit, allowing investors to seek compensation without any out-of-pocket costs, which enhances the appeal of legal action for affected investors.
- Firm's Reputation: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, demonstrating its expertise and influence in handling similar cases.
See More
Alvotech Settles Patent Disputes with Regeneron and Bayer
- Global Patent Settlement: Alvotech has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes related to its Eylea biosimilar, thereby ensuring its legitimacy and competitiveness in global markets.
- Market Entry Timeline: Under the agreement, Alvotech will launch the biosimilar in the UK and Canada starting January 1, 2026, and in the EEA and other countries (excluding the U.S.) and Japan (excluding DME) from May 1, 2026, significantly expanding its market reach.
- U.S. Market Outlook: Alvotech has secured a Q4 2026 license entry date for the U.S. market, pending regulatory approval, which lays a foundation for future revenue growth and reflects its strategic positioning in the biopharmaceutical sector.
- Confidential Terms Impact: While the remaining terms of the agreement remain confidential, the settlement provides a stable market environment for Alvotech and its commercial partners, enhancing their competitive advantage in the biosimilar market.
See More
