Alvotech SA

News & Events zu Alvotech SA (ALVO)

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ALVO-News

ALVO-Events

10/20 09:00

Apple Downgraded to Hold with Price Target Cut to $330

Stock futures are lower as renewed weakness in AI-related stocks looks set to erase some of Monday's rebound. Investors remain concerned about the debt and financing costs underpinning the AI infrastructure buildout. Meanwhile, oil prices are climbing, with Brent crude near $111 a barrel and West Texas Intermediate around $100.55, as escalating Middle East tensions and reports of attacks on vessels in the Gulf raise concerns about supply disruptions. Higher energy prices are adding to inflation worries following hotter-than-expected September CPI and PPI readings, while the 10-year Treasury yield is holding near 5.14%. The combination of elevated oil prices and borrowing costs continues to challenge equity valuations, particularly for growth stocks that rely on future earnings to justify current prices.In pre-market trading, S&P 500 futures fell 0.13%, Nasdaq futures fell 0.41% and Dow futures were about flat.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Alvotechup 8% after announcing that the FDA has approved a new manufacturing process for Simlandi, the company's biosimilar to HumiraUP AFTER EARNINGS -Equifaxup 6%Halliburtonup 4%RTXup 2%MSCIup 2%3Mup 1%Northrop Grummanup 1%KeyCorpup 1%DOWN AFTER EARNINGS -Genuine Partsdown 9%General Motorsdown 6%Mueller Industriesdown 4%GE Aerospacedown 3%Synchronydown 2%Hasbrodown 1%LOWER -Appledown 1% after Loop Capital downgraded the stock to Hold with a price target of $330, down from $370

10/20 05:30

Alvotech Receives FDA Approval for New Simlandi Manufacturing Process

Alvotech announced that the FDA has approved a new manufacturing process for Simlandi, Alvotech's biosimilar to Humira. The FDA approval allows Alvotech to introduce Process 2.0 for the manufacture of adalimumab drug substance in its DSM2 manufacturing suite in Reykjavik, Iceland. The new process more than doubles drug substance output per batch without changing the upstream manufacturing scale. The improvement was achieved through targeted process development, effective process transfer and successful process validation, with demonstrated comparability to the previously approved process, maintaining product quality, safety and efficacy.

10/6 17:00

Alvotech and Lotte Biologics Sign Long-Term Strategic Manufacturing Partnership

Alvotech and Lotte Biologics announced a long-term strategic manufacturing partnership. Under the agreement, Lotte Biologics will manufacture drug substance for multiple antibody biosimilar products at its Syracuse facility in New York for global supply, with the potential to further expand the collaboration over time. The Syracuse facility has 40,000 liters of bioreactor capacity for biologics manufacturing, supported by on-site process development and quality control capabilities. The site has an established track record in commercial biologics manufacturing and recently completed an unannounced FDA inspection with zero observations, further demonstrating its strong quality and regulatory capabilities. The agreement expands Alvotech's US-based manufacturing footprint while strengthening its global supply network. The additional capacity complements Alvotech's existing manufacturing partnerships and its in-house development and manufacturing capabilities, supporting its expanding portfolio and providing greater flexibility to meet demand across international markets.

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