Alvotech Reports Positive Clinical Trial Results for AVT80 Biosimilar to Entyvio
Alvotech announced successful clinical trial results for AVT80, a biosimilar to Takeda's Entyvio, meeting all primary endpoints. The company targets a $6.4 billion market opportunity with regulatory submissions planned.
On February 5, Alvotech announced strong initial results from a key clinical trial for AVT80, a potential biosimilar to the blockbuster drug Entyvio from Takeda. The randomized, double-blind study successfully met all primary goals, including proving AVT80 matches Entyvio's pharmacokinetics, and passed all safety, tolerability, and immune response criteria.
"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," noted the Chief Operating Officer.
The potential approval targets a significant market opportunity. The combined worldwide revenue for Entyvio in 2025 was roughly around $6.4 billion. Biosimilars like AVT80/AVT16 could slash costs for patients and payers once approved.
Alvotech is a biotechnology company specializing in the development, manufacturing, and commercialization of biosimilar medicines to provide affordable biologic alternatives globally. Based in Luxembourg, the company is strategically positioned within the drug manufacturers' specialty and generic industry, serving a global market with its innovative biosimilar solutions.
The company's market capitalization stands at $1.45 billion. Alvotech focuses on developing biosimilars for critical therapeutic areas, including autoimmune, eye, and bone disorders, as well as cancer. Its flagship product, AVT02, a biosimilar to Humira, targets a range of inflammatory conditions.
The current share price stands at $4.64, with a 52-week range from $4.58 to $12.58. The forward P/E ratio of 13.51 and the company's 10.60% revenue growth rate reflect its position in the biosimilar market. The company's earnings per share (EPS) is 0.23.
Of the analysts covering the stock, four have issued buy ratings, while one maintains a hold rating and another a sell. The average target price of $22.17 represents a potential upside, with the target price range spanning from $5.00 to $90.00. The stock's Relative Strength Index (RSI) of 26.73 indicates that it is currently oversold. The stock's 50-day and 200-day moving averages stand at $5.08 and $7.56, respectively.
The company's negative free cash flow of -$84.85 million may be reflective of the significant investments required in the biosimilar development space, where upfront costs are high but potential returns are substantial.