
Alvotech (ALVO) shares were up nearly 10% in Thursday’s pre-market trade after the company announced positive top-line results from its pharmacokinetic study.
The company stated that the study showed that AVT80, its biosimilar candidate to Entyvio, met all its primary endpoints.
“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,” said Alvotech COO Joseph McClellan.
Alvotech stated that it designed the study to evaluate the safety, tolerability, and immunogenicity profiles of AVT80 and Entyvio in healthy adult participants following a single 108 mg/0.68 mL subcutaneous (SC) injection.
Entyvio is indicated for the treatment of moderate to severe Ulcerative Colitis and moderate to severely active Crohn’s disease in adult patients. The biologic medication’s cumulative worldwide net revenue in 2025 was about $6.4 billion, the company said.
Alvotech also stated that it is currently developing AVT16, a proposed biosimilar to Entyvio for intravenous administration, while AVT80 is designed for subcutaneous administration.
The Pharmacokinetic study for AVT80 is crucial to demonstrating clinical similarity between AVT16 and AVT80, the company added.
Alvotech is a Reykjavik, Iceland-based biotechnology company that is focused exclusively on developing biosimilar medicines.
The company has two biosimilars, Humira and Stelara, already approved and marketed in multiple markets around the world. Alvotech has partnered with multiple companies globally, including Teva Pharmaceuticals, Cipla, Dr. Reddy’s, and Lotus Pharmaceuticals, among others.
Retail sentiment on Stocktwits around Alvotech was in the ‘bullish’ territory, with message volumes at ‘extremely high’ levels. The ALVO ticker was the fourth most trending ticker on the platform at the time of writing.
One bullish user called the top-line results “huge news” for Alvotech.
ALVO stock is down 1% year-to-date and 59% over the past 12 months.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<
Stay updated with all the latest Business News, including market trends, Share Market News, stock updates, taxation, IPOs, banking, finance, real estate, savings, and investments. Track daily Gold Price changes, updates on DA Hike, and the latest developments on the 8th Pay Commission. Get in-depth analysis, expert opinions, and real-time updates to make informed financial decisions. Download the Asianet News Official App from the Android Play Store and iPhone App Store to stay ahead in business.