Why Is ALVOTECH (ALVO) Stock Moving Today?

Alvotech shares rose 5.35% to $5.22 in early trading on Monday driven by the U.S. Food and Drug Administration’s acceptance for review of a Biologics License Application for AVT80. The approval expands the company’s proposed biosimilar program for Entyvio to include subcutaneous presentations. The stock opened with a $5.02 price, showing a 1.4% gap from the previous close, and reached a session high of $5.22 at 10:25 AM ET.

What Happened

Alvotech announced that the FDA has accepted its Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (Vedolizumab) for subcutaneous administration. This development marks a significant step in the company’s strategy to expand its biosimilar offerings. The prefilled syringe and autoinjector versions of AVT80 are intended for commercialization by Teva. The news was reported by Benzinga and Business Insider, highlighting the regulatory progress and its potential impact on Alvotech’s market position.

What The Data Shows

The stock opened at $5.02, showing a 1.4% gap from the prior close of $4.95. It reached a session high of $5.22 at 10:25 AM ET and closed the session at $5.21. Volume so far was 0.2 million shares, which is 0.3 times the 3-month daily average. The stock also printed one fresh 52-week low and six fresh 52-week highs on August 31. Alvotech’s fundamentals remain unprofitable, with a trailing twelve-month EPS of -0.61, a revenue decline of 12.1%, and a net margin of -36.3%. The stock has a market cap of $1.8 billion and a beta of 0.18.

What To Watch

Alvotech’s stock is currently without an upcoming earnings date. Investors should monitor the breadth of coverage and any follow-up developments regarding the FDA review of AVT80.