Alvotech Announces Positive Top-Line Results from Pivotal Pharmacokinetic Study for Proposed Biosimilar to Entyvio®

Rhea-AI Summary

Alvotech (NASDAQ: ALVO) reported positive top-line results from the pivotal PK study AVT80-GL-P01 comparing AVT80 to Entyvio (vedolizumab). The randomized, double-blind, single-dose, 3-arm study met all primary endpoints for PK similarity and assessed safety, tolerability and immunogenicity in healthy adults.

The company said the study is considered pivotal to support regulatory submissions for both subcutaneous AVT80 and intravenous AVT16. Entyvio global net sales were about US$6.4 billion in 2025.

Positive

• AVT80-GL-P01 met all primary PK endpoints demonstrating PK similarity to Entyvio
• Study designated pivotal to support regulatory submissions for AVT80 (SC) and AVT16 (IV)
• Entyvio market scale: combined 2025 net revenues ~US$6.4 billion

Negative

• Study conducted in healthy adult participants, not patients with UC or Crohn’s disease
• Single-dose, short-term design may not address long-term safety or immunogenicity risks

News Market Reaction

-1.96%

1 alert

-1.96% News Effect

-$32M Valuation Impact

$1.59B Market Cap

1K Volume

On the day this news was published, ALVO declined 1.96%, reflecting a mild negative market reaction. This price movement removed approximately $32M from the company's valuation, bringing the market cap to $1.59B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Dose strength: 108 mg/0.68 mL Study design arms: 3-arm study Entyvio net revenue: US$6.4 billion

3 metrics

Dose strength 108 mg/0.68 mL Single subcutaneous injection in AVT80-GL-P01 PK study

Study design arms 3-arm study Randomized, double-blind, parallel-group PK study AVT80-GL-P01

Entyvio net revenue US$6.4 billion 2025 combined worldwide net revenues from Entyvio sales

Market Reality Check

Price: $5.10 Vol: Volume 420,286 is 1.37x t...

normal vol

$5.10 Last Close

Volume Volume 420,286 is 1.37x the 20-day average of 307,393, indicating elevated trading interest ahead of this news. normal

Technical Shares at $5.09 are trading below the 200-day MA of $7.68 and sit 61.09% under the 52-week high.

Peers on Argus

ALVO declined 2.3% while key peers showed mixed moves: SUPN +1.36%, ANIP +1.98%,...

ALVO declined 2.3% while key peers showed mixed moves: SUPN +1.36%, ANIP +1.98%, HCM +1.65%, BHC -1.47%, INDV -3.51%. With peers not moving uniformly and no momentum flags, the reaction appears stock-specific rather than sector-driven.

Historical Context

5 past events · Latest: Feb 02 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 02	Commercialization deals	Positive	-0.9%	Sandoz supply and commercialization agreements for multiple biosimilar candidates.
Jan 29	Legal settlement	Positive	+2.5%	Global licensing and settlement for Eylea biosimilar enabling staged market entry.
Jan 07	Insider filing correction	Neutral	+1.5%	Correction of prior disclosure on ATP Holdings share sale vs acquisition.
Jan 06	Insider transactions	Positive	-6.5%	Large share acquisitions by ATP Holdings and closely associated entities.
Jan 06	CEO succession	Neutral	-6.5%	Planned CEO transition with founder moving to Executive Chairman role.

Pattern Detected

Recent news often skews positive or neutral, but price reactions have been mixed with several divergences, including sell-offs on partnership and insider-transaction headlines.

Recent Company History

Over the past few months, Alvotech has reported multiple strategic and corporate milestones. On Feb 02, 2026, it entered supply and commercialization agreements with Sandoz for multiple biosimilar candidates in Canada and Australia/New Zealand, yet the stock fell modestly. A Jan 29, 2026 global settlement for its Eylea biosimilar saw a positive reaction. January also featured corrected and initial disclosures of large shareholder transactions and a planned CEO succession, with notably negative moves around the succession and insider dealing headlines.

Market Pulse Summary

This announcement highlights successful top-line results from the pivotal AVT80-GL-P01 pharmacokinet...

Analysis

This announcement highlights successful top-line results from the pivotal AVT80-GL-P01 pharmacokinetic study, which met all primary endpoints comparing AVT80 with Entyvio and supports clinical similarity for both AVT16 and AVT80. The data advance Alvotech’s biosimilar strategy in an Entyvio market that generated US$6.4 billion in 2025 net revenue. Historically, the stock’s reactions to positive developments have been mixed, so investors may monitor upcoming regulatory submissions and further clinical or partnership updates as key milestones.

Key Terms

pharmacokinetics, immunogenicity, biosimilar, randomized, +4 more

8 terms

pharmacokinetics medical

"The study, which assessed the pharmacokinetics, safety, tolerability and immunogenicity"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

immunogenicity medical

"assessed the pharmacokinetics, safety, tolerability and immunogenicity of AVT80"

Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.

biosimilar medical

"a global biotechnology company specializing in the development and manufacture of biosimilar medicines"

A biosimilar is a medicine created to be highly similar to an existing complex drug made from living cells, matching its safety and effectiveness while allowing for small, natural variations. For investors, biosimilars matter because they introduce lower-cost competition when patents end, which can cut prices, shift market share, and change revenue forecasts for companies selling the original drugs, much like a generic version does for simpler chemical medicines.

randomized medical

"This was a randomized, double-blind, single dose, parallel-group design"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"This was a randomized, double-blind, single dose, parallel-group design"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

subcutaneous medical

"a single 108 mg/0.68 mL subcutaneous (SC) injection"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

ulcerative colitis medical

"moderate to severe Ulcerative Colitis, a disease that causes inflammation"

A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.

crohn’s disease medical

"moderate to severely active Crohn’s disease, a disease that causes inflammation"

A long-lasting inflammatory condition that can inflame any part of the digestive tract, causing pain, diarrhea, weight loss and fatigue; symptoms often flare up unpredictably and may require lifelong medication or surgery. Investors monitor Crohn’s disease because its chronic, costly nature creates steady demand for treatments, diagnostics and medical services, so new drugs, trial results or approval decisions can materially change sales prospects and company valuations — think of it like a recurring plumbing problem that drives ongoing repair business.

AI-generated analysis. Not financial advice.

• The study, which assessed the pharmacokinetics, safety, tolerability and immunogenicity of AVT80 compared to Entyvio^® in healthy adult participants, met all its primary endpoints
  
  

REYKJAVIK, Iceland, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT80, a biosimilar candidate to Entyvio^® (vedolizumab).

The PK study (AVT80-GL-P01), which compared AVT80 to Entyvio in healthy adult participants, met all its primary endpoints. This was a randomized, double-blind, single dose, parallel-group design, 3-arm study, designed to demonstrate the PK similarity, and to investigate safety, tolerability, and immunogenicity profiles of AVT80 and Entyvio in healthy adult participants after administration of a single 108 mg/0.68 mL subcutaneous (SC) injection.

“We are very pleased with this result, which is an important milestone in the development of our proposed biosimilar to Entyvio, allowing us to proceed towards regulatory submissions. This milestone further underlines the strength of our platform approach to biosimilars development and manufacture, combining a well-designed and executed clinical study with the design of a high-quality manufacturing process and strong analytical capabilities,” said Joseph McClellan, Chief Operating Officer.

Alvotech is currently developing AVT16, a proposed biosimilar to Entyvio for intravenous administration and AVT80, a proposed biosimilar to Entyvio for subcutaneous administration. The AVT80-GL-P01 study satisfies the demonstration of PK similarity for both the subcutaneous and intravenous routes of administration to Entyvio. Based on regulatory advice, the AVT80-GL-P01 clinical study is considered pivotal to support the demonstration of clinical similarity for AVT16 and AVT80.

Entyvio (vedolizumab) is indicated for the treatment of adult patients with moderate to severe Ulcerative Colitis, a disease that causes inflammation and ulcers in the lining of the bowel, and moderate to severely active Crohn’s disease, a disease that causes inflammation of the digestive tract. In 2025 combined net revenues world-wide from the sales of Entyvio were about US$6.4 billion [1].

About AVT16/AVT80
AVT16 and AVT80 contain a human monoclonal antibody (vedolizumab) and are biosimilar candidates to Entyvio^®. Vedolizumab targets and binds specifically to the alpha-4-beta-7 protein, which is preferentially expressed on T helper lymphocytes (white blood cells) which migrate into the gastrointestinal tract and cause inflammation, characteristic of Ulcerative Colitis and Crohn’s disease [2]. AVT16 and AVT80 are investigational products and have not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed.

For further information, contact:

Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com

Investors
Dr Balaji V Prasad (US)
Patrik Ling (SE)
Benedikt Stefansson (IS)
alvotech.ir@alvotech.com

Sources
[1] Takeda Quarterly Results
[2] Entyvio product information, EMA

Use of trademarks
Entyvio is a trademark of Millennium Pharmaceuticals.

About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, Humira^® (adalimumab) and Stelara^® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

FAQ

What did Alvotech (ALVO) announce about the AVT80-GL-P01 PK study on February 5, 2026?

Alvotech announced that the AVT80-GL-P01 study met all primary PK endpoints demonstrating similarity to Entyvio. According to the company, the randomized, double-blind, single-dose study also assessed safety, tolerability and immunogenicity in healthy adult participants.

How does the AVT80-GL-P01 result affect Alvotech's regulatory plans for AVT80 and AVT16 (ALVO)?

The result enables Alvotech to advance toward regulatory submissions for AVT80 and AVT16. According to the company, the study is considered pivotal to support demonstration of clinical similarity for both subcutaneous and intravenous proposed biosimilars.

What does meeting primary PK endpoints mean for AVT80 as a biosimilar to Entyvio (ALVO)?

Meeting primary PK endpoints indicates AVT80 showed comparable pharmacokinetics to Entyvio in the trial population. According to the company, this supports biosimilarity evidence needed for regulatory review alongside safety and immunogenicity data.

Will the AVT80-GL-P01 study results immediately change Alvotech (ALVO) commercial prospects?

The results are a development milestone but not a commercial approval. According to the company, the pivotal PK data support regulatory submissions; further review and approvals will determine market access and commercialization timing.

How large is the market opportunity indicated by Entyvio sales mentioned by Alvotech (ALVO)?

Entyvio reported combined net revenues of about US$6.4 billion in 2025, indicating a substantial market. According to the company, this underscores the commercial importance of developing a biosimilar to vedolizumab for IBD treatment.