Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-2) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification:

Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-1) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification:

Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-3) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification:

Submission status for ALVOTECH USA INC's drug SIMLANDI (SUPPL-3) with active ingredient ADALIMUMAB-RYVK has changed to 'Approval' on 08/26/2024. Application Category: BLA, Application Number: 761299, Application Classification:

Submission status for ALVOTECH USA INC's drug SIMLANDI (SUPPL-6) with active ingredient ADALIMUMAB-RYVK has changed to 'Approval' on 08/26/2024. Application Category: BLA, Application Number: 761299, Application Classification:

Submission status for ALVOTECH USA INC's drug SELARSDI (ORIG-1) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 04/16/2024. Application Category: BLA, Application Number: 761343, Application Classification:

Submission status for ALVOTECH USA INC's drug SIMLANDI (ORIG-1) with active ingredient ADALIMUMAB-RYVK has changed to 'Approval' on 02/23/2024. Application Category: BLA, Application Number: 761299, Application Classification:

REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech's proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimu

REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech's proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimu

Addition is part of the annual reconstitution of the Nasdaq Biotech Index (NBI)Inclusion criteria include minimum market capitalization and daily trading volumes REYKJAVIK, Iceland, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its stock will be added to the Nasdaq Biotechnology Index (NASDAQ:NBI). The addition comes as a part of the annual reconstitution of the index. Alvotech's inclusion in the NBI will be effective when the U.S. market opens on Monday, December 23, 2024. The Nasdaq Biotechnology Index contains securities of Nasda

Total Revenues in the first nine months of 2024 increased by $300 million compared to same period in 2023, to $339 million, with Q3 revenues contributing $103 millionProduct revenues in the first nine months of 2024 increased over four-fold compared to the same period last year, to $128 million, with Q3 product revenues contributing $62 millionLicense and other revenues for the first nine months of 2024 increased by $203 from the same period last year, to $211 million, with Q3 license and other revenues contributing $41 millionAdjusted EBITDA was $87 million in the first nine months of 2024, compared to negative ($225) million for the same period last year, with Q3 adjusted EBITDA contributi

REYKJAVIK, Iceland, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in Citi's 2024 Global Healthcare Conference in Miami, Florida on December 4, 2024, and in Evercore's HealthCONx Conference in Coral Gables, Florida on December 5, 2024. Members of the management team will host one-on-one meetings at both conferences. Alvotech will also hold a fire-side chat at Evercore's HealthCONx Conference on Thursday, December 5, 2024 starting at 12:55 ET (17:55 GMT). A live audio webcast of Alvotech's fire-side chat at the Evercore He

REYKJAVIK, Iceland and LONDON, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech's proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. This is believed to be the first marketing authorization application filing announced globally f

REYKJAVIK, Iceland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first nine months of the year ended September 30, 2024, after U.S. markets close on Wednesday, November 13, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Thursday November 14, 2024, at 8:00 am ET (13:00 GMT).   Live audio of the conference call will also be webcast and available to members of the news media, investors, and the general public. Access information is posted on Alvotech's

REYKJAVIK, Iceland, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference, November 19-20, 2024. Members of the management team will host one-on-one meetings on both days. Alvotech will be presenting at the conference on Tuesday, November 19, 2024 at 9:00-9:25 am GMT. An audio webcast of the conference presentation will also be available to investors and the general public and can be accessed in the Investors Section of Alvotech's website under News and Events – Events and Presentations.

Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn's disease and ulcerative colitisThe FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024SELARSDI's U.S. launch for all indications is expected in Q1 2025 REYKJAVIK, Iceland & PARSIPPANY, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a

REYKJAVIK, Iceland, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab). "EMA acceptance marks an important step towards making AVT03 available to patients and caregivers in Europe," said Joseph McClellan, Chief Scientific Officer of Alvotech. "Successful progression in the development of multiple biosimilar candidates demonstrates how Alvotech is able to leverage its end-to-end

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Total Revenues in the first nine months of 2024 increased by $300 million compared to same period in 2023, to $339 million, with Q3 revenues contributing $103 millionProduct revenues in the first nine months of 2024 increased over four-fold compared to the same period last year, to $128 million, with Q3 product revenues contributing $62 millionLicense and other revenues for the first nine months of 2024 increased by $203 from the same period last year, to $211 million, with Q3 license and other revenues contributing $41 millionAdjusted EBITDA was $87 million in the first nine months of 2024, compared to negative ($225) million for the same period last year, with Q3 adjusted EBITDA contributi

REYKJAVIK, Iceland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first nine months of the year ended September 30, 2024, after U.S. markets close on Wednesday, November 13, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Thursday November 14, 2024, at 8:00 am ET (13:00 GMT).   Live audio of the conference call will also be webcast and available to members of the news media, investors, and the general public. Access information is posted on Alvotech's

Record Total Revenues of $236 million for the first six months of 2024, an over ten-fold increase compared to same period in 2023 Product revenues for the first six months were $66 million, a 190% increase from the same period last year, with Q2 product revenues contributing $53 million License and other revenues for the first six months increased to $170 million, with Q2 license and other revenues contributing $145 million Adjusted EBITDA in the first six months was $64 million, compared to negative ($147) million for the same period last year, with Q2 adjusted EBITDA contributing $102 million Achieved numerous development and perf

REYKJAVIK, Iceland, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first half of the year ended June 30, 2024, after U.S. markets close on Thursday, August 15, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Friday August 16, 2024, at 8:00 am EDT (12 noon GMT).   Live audio of the conference call will also be webcast and available to members of the news media, investors, and the general public.  Information on how to access the webcast or particip

Total revenues in Q1 2024 increased to $37 million compared to $16 million in the same period last year. Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year. Alvotech signed new commercialization agreements for its high concentration interchangeable biosimilar to Humira® in the U.S. and for its proposed biosimilar to Prolia® and Xgeva® in the U.S. and Europe. Alvotech raises topline revenue guidance to $400-$500 million and tightens guidance for bottom line range for 2024 to $100-$150 million. Management will conduct a business update conference call and live webcast on Wednesday May 22, 2024, at 8:00 am ET (12:00 pm GMT). REYKJAVIK, Ic

REYKJAVIK, Iceland, May 13, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2024, after U.S. markets close on Tuesday, May 21, 2024. Alvotech will also conduct a conference call with analysts to present the first quarter 2024 financial results and recent business highlights on Wednesday May 22, 2024, at 8:00 am EDT (12 noon GMT). Live audio of the conference call will be webcast and available to members of the news media, investors, and the general public. Information o

REYKJAVIK, Iceland, March 22, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO) (the "Company"), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, has increased the Company´s share capital by an amount of one hundred and thirty thousand (USD 130,000) by issuing thirteen million (13,000,000) ordinary shares. The Company's subsidiary, Alvotech Manco ehf. (the "subsidiary"), has subscribed to all of the newly issued shares for a price of USD 15.98 per share. The shares held by the subsidiary are treated as treasury shares without voting rights or dividend entitlement. Following the above-mentioned transactions, the subsidia

Total Revenues in 2023 were $93.4 million, up 10% from previous yearProduct Revenues in 2023 were $48.7 million, compared to $24.8 million in 2022, with Q4 2023 product revenues of $18.9 million, up by 37% from the same period last yearAlvotech's Simlandi™ biosimilar to Humira® (adalimumab) was approved in the U.S. as the first high-concentration biosimilar with interchangeable statusSales of Alvotech's Jamteki™ biosimilar to Stelara® (ustekinumab) started in Canada with launches expected in Japan in Q2 and Europe in Q3Positive top-line results were announced from a confirmatory efficacy study for Alvotech's proposed biosimilar to Eylea® (aflibercept) and PK studies for proposed biosimilars

REYKJAVIK, Iceland, March 05, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the full year 2023, after U.S. markets close on Wednesday, March 20, 2024. Following the release, Alvotech will conduct a conference call for analysts on Thursday, March 21, 2024, at 8:00 am ET (12 noon GMT). Live audio of the conference call will be webcast and available to members of the news media, investors and the general public. Information on how to access the webcast or participate by conference call is posted on Alvotech'

Product revenue for the nine months of 2023 increased to $29.8 million, compared to $11.1 million for the same period in 2022Marketing authorization was received for AVT04 in Canada and Japan, the first for a biosimilar to Stelara® (ustekinumab)The European Medicines Agency proposed market authorization for AVT04 in the 30 member states of the European Economic Area, pending a final decision by the European Commission Approvability of AVT02 and AVT04 in the U.S. now pending satisfactory US Food and Drug Administration (FDA) inspection of Alvotech's facility in Iceland, currently expected on January 10 – 19, 2024Management will conduct a business update conference call and live webcast on Wed

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