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Alvotech Create: Alert

All | News | Filings
Date FiledTypeDescription
10/12/2023 6-K Quarterly results
10/03/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercialization of a Proposed Biosimilar to Xolair®"
08/01/2023 6-K Quarterly results
07/24/2023 6-K Quarterly results
07/12/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Master License and Supply Agreement by and between Alvotech and Mercury Pharma Group Limited (trading as Advanz Pharma Holdings)",
"Termination Agreement (Vedolizumab) by and between Alvotech and STADA Arzneimittel AG",
"Termination Agreement (Golimumab) by and between Alvotech and STADA Arzneimittel AG",
"Termination Agreement (Denosumab) by and between Alvotech and STADA Arzneimittel AG",
"Master License and Supply Agreement by and between Alvotech and Mercury Pharma Group Limited (trading as Advanz Pharma Holdings)"
06/29/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech Provides Regulatory Update on Second Biologics License Application for AVT02 REYKJAVIK, Iceland, June 28, 2023 - Alvotech , a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration has issued a complete response letter for Alvotech's second Biologics License Application for AVT02, a high-concentration biosimilar candidate for Humira ® . As the second of two BLAs submitted for AVT02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation. The CRL noted that certain deficiencies, which were conveyed following the FDA's reinspection of the company's Reykjavik facility t..."
06/13/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech and Teva Secure U.S. License Date for AVT04, a Proposed Biosimilar to Stelara ®"
06/06/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"2023 AGM Minutes",
"Announcement of the results of the 2023 AGM",
"Amended and restated articles of association of Alvotech",
"Announcement Granting of Stock Options"
05/24/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech and Advanz Pharma extend strategic partnership to commercialize five proposed biosimilars in Europe"
05/19/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech Reports Financial Results for First three Months of 2023 and Provides Business Update"
05/05/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Convening notice to the Annual and Extraordinary General Meeting of Shareholders",
"Convening notice to the Annual and Extraordinary General Meeting of Shareholders",
"Proxy Card",
"Proxy Card",
"Proxy Card"
05/04/2023 6-K Quarterly results
04/14/2023 6-K Quarterly results
03/28/2023 6-K Quarterly results
03/01/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech Reports Financial Results for Full Year 2022 and Provides Business Update",
"Corporate Governance Report",
"ESG Report"
02/10/2023 6-K Quarterly results
02/09/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara ® • Partners Alvotech and STADA have marketing authorization application for ustekinumab accepted for filing by the European Medicines Agency • EMA opinion on AVT04 could come as soon as the second half of 2023 • Reference product Stelara ® is prescribed to treat a variety of inflammatory conditions Reykjavik, Iceland & Bad Vilbel, Germany -February 9, 2023 - Alvotech , a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and global pharmaceutical company STADA Arzneimittel today announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT04, Alvotech's proposed biosimilar to Stelara ® . The compani..."
02/07/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech enters into commercialization agreement with Advanz Pharma for proposed biosimilar to Xolair ®"
02/07/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Bond Registration Document",
"Bond Registration Document"
01/24/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech and Bioventure Announce Approval of AVT02 as Simlandi in Saudi Arabia"
01/23/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Notice",
"Notice"
01/20/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Notice",
"Notice"
01/17/2023 6-K Quarterly results
01/11/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech Initiates Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi ® and Simponi Aria ® REYKJAVIK, ICELAND - Alvotech , a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi ® and Simponi Aria ® . The study will assess the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects. “We are delighted with the progress of the AVT05 development program,” said Joseph McClellan, Chief Scientific Officer. “As we enter our fifth biosimilar candidate into clinical studies, we reaffirm our commitment to improving patient lives by expanding access to affordable biologics.” In..."
01/06/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Notice",
"Notice"
12/22/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Notice",
"Notice"
12/16/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Notice",
"Notice"
12/08/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Announcement",
"Alvotech and STADA Broaden Access to Hukyndra ® adalimumab biosimilar in Europe • Hukyndra ® launches in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia, increasing availability of high-concentration, citrate-free adalimumab in Europe • Follows initial introduction of Hukyndra in nine countries: Austria, Estonia, Finland, France, Germany, Lithuania, Slovakia, Sweden, and Switzerland • Adalimumab is first product launched through an exclusive strategic partnership announced by Alvotech and STADA in November 2019 covering biosimilar candidates across immunology, oncology, and ophthalmology indications Reykjavik, Iceland; Bad Vilbel, Germany - 7 December 2022 - Alvotech and STADA are contributing to the availability of high-quality biologic treatments in Europe by ro...",
"Announcement"
12/01/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech submits its application for admission of the company's shares to trading on Nasdaq Iceland Main Market Alvotech S.A. has submitted its application to Nasdaq Iceland for admission of its shares for trading on the Nasdaq Iceland Main Market under the ticker symbol “ALVO”. The application awaits approval from Nasdaq Iceland. Alvotech's shares are currently listed on the Nasdaq Stock Market in the U.S. and on the Nasdaq First North Growth Market under the ticker symbol “ALVO”. Alvotech's shares were admitted to trading in the U.S. on June 16, 2022 and in Iceland on June 23, 2022 . On 12 August 2022, Alvotech announced that the Board of Directors had approved a plan to move its share listing to the Nasdaq Main Market in Iceland. For further information contact Alvotech Investor Relatio...",
"Alvotech Announces Changes to its Leadership Team",
"Announcement"
11/17/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Alvotech Secures Financing Facilities of Approximately $136 Million",
"Alvotech Announces Australian Marketing Authorization for AVT02, a Biosimilar to Humira ®",
"Summary of New Financing Arrangements",
"Amended and restated Convertible Bond Instrument (Tranche A)",
"Amended and restated Convertible Bond Instrument (Tranche B)",
"Subordinated Loan Agreement by and between Alvotech and Alvogen Lux Holdings S.à r.l.",
"Warrant Agreement by and between Alvotech and Alvogen Lux Holdings S.à r.l.",
"Share Purchase Agreement by and between Alvotech and ATP Holdings ehf.",
"Convertible Bond Instrument by and between Alvotech and the Bondholders named therein",
"Transition Services Agreement between Alvotech and Aztiq Consulting ehf."
11/16/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Announcement",
"Announcement"
10/27/2022 6-K Quarterly results
10/19/2022 6-K Quarterly results
10/17/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Alvotech's Partner Submits Application for Marketing Approval of First Biosimilar Candidate in Japan REYKJAVIK, ICELAND — Alvotech , a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner Fuji Pharma Co., Ltd. has submitted an application to the Japanese Ministry of Health, Labor and Welfare for marketing approval of the first biosimilar candidate developed under the companies' exclusive commercialization partnership. “I want to congratulate our partners at Fuji for reaching this important milestone,” said Robert Wessman, founder and Executive Chairman of Alvotech. “Our partnership is based on a joint commitment to increase patient access to vital biologic medicines, and we ..."
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