By the Top Tier Newswire AI Desk · August 31, 2026 at 10:33 AM ET · reviewed against 1 wire stories
ALVOTECH (ALVO) is up +5.35% in the latest session. Our newswire has captured 1 story on ALVO across 1 source in the last 36 hours, with AI sentiment reading bullish (avg 67/100).
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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.
AI-assisted analysis composed exclusively from headlines and data on the Top Tier newswire. Public view is delayed 4 hours from real time. Not financial advice.
ALVO · Aug 31 session (5-min) · +5.25% vs prior close · updated 8:57 PM ETAI sentiment, last 36h · averaged over 1 story · 67/100 bullish
The headlines behind the move
Story flow · 1 story on the wire, last 36h · hover or tap a dot for the headline
13d agoBusiness InsiderBULLISH 67Product/PR
Alvotech Announces FDA Acceptance for Review of Biologics License Application for AVT80, Expanding Proposed Biosimilar Program for Entyvio® to Subcutaneous Presentations
REYKJAVIK, Iceland, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced...
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