OMX

Bavarian Nordic Reports Positive Phase 3 Topline Results for Chikungunya Virus Vaccine in Adults and Adolescents

Retrieved on: 
Sunday, August 6, 2023
OMX, Biologics license application, CET, Vaccination, Infection, European Medicines Agency data breach, Immunity, Chikungunya, EDT, EMA, Nature, VLP, Adolescence, European Medicines Agency, Ageing, MAA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, CHIKV, Disease, Vaccine, Bavarian Nordic

COPENHAGEN, Denmark, August 6, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial ( NCT05072080 ) of its virus-like particle (VLP)-based chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317) in adults and adolescents aged 12 to 64 years of age.

Key Points: 
  • COPENHAGEN, Denmark, August 6, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial ( NCT05072080 ) of its virus-like particle (VLP)-based chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317) in adults and adolescents aged 12 to 64 years of age.
  • A total of 3,254 participants were enrolled and randomized to receive either a single intramuscular injection of CHIKV VLP, or placebo.
  • “We are highly encouraged by the positive topline results now demonstrated in both Phase 3 studies of our chikungunya vaccine candidate.
  • “With a fast and durable response, our vaccine has the potential to be the best in class to prevent chikungunya infections in adolescents to elderly adults.

Bavarian Nordic Receives USD 120 Million Contract for the Manufacturing of Smallpox and Mpox Vaccine from the U.S. Government

Retrieved on: 
Thursday, August 3, 2023
Vaccine, OMX, Travel, Office of Inspector General, U.S. Department of Health and Human Services, Emergent BioSolutions, Emergent, USD, Government, Administration, Development, EBITDA, RSV, Acquisition, Administration for Strategic Preparedness and Response, Mpox, Bavarian Nordic, BARDA, Pharmaceutical industry

In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen doses of the vaccine in 2023, valued at USD 3 million.

Key Points: 
  • In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen doses of the vaccine in 2023, valued at USD 3 million.
  • The agreement includes additional services totalling USD 21 million, of which the majority will be received in 2024 and 2025.
  • Together with our U.S. manufacturing partner, we have completed the manufacturing of all doses ordered by the U.S. government during the mpox outbreak.
  • Revenue is now expected to be approximately DKK 6,900 million (previously approximately DKK 6,000 million) and EBITDA is now expected to be approximately DKK 2,300 million (previously approximately DKK 2,200 million).

MOB-015 is recommended for approval in EU: Moberg Pharma

Retrieved on: 
Wednesday, June 28, 2023
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National approvals are expected to follow during upcoming months and timelines may vary between countries.

Key Points: 
  • National approvals are expected to follow during upcoming months and timelines may vary between countries.
  • "We are excited about the MOB-015 program, with its cutting-edge technology and the promising 76% mycological cure rate shown in the clinical trials.
  • We will initiate launch as quickly as possible following national approval, expecting to initiate launch preparations in Sweden before the end of the year.
  • Exact choice of countries will depend on time to national approval - which may vary.

Bavarian Nordic Reports Phase 3 Topline Results for its COVID-19 Booster Vaccine Candidate

Retrieved on: 
Tuesday, June 27, 2023
VLP, Vaccine, OMX, COVID-19, Pfizer–BioNTech COVID-19 vaccine, ABNCoV2, Bavarian Nordic, COVID, Vaccination, Safety, SARS-CoV-2

Booster study successfully met its primary objective, demonstrating non-inferiority to mRNA-vaccine

Key Points: 
  • Booster study successfully met its primary objective, demonstrating non-inferiority to mRNA-vaccine
    Regulatory pathway will depend upon the outcome of secondary endpoints, reporting in the third quarter of 2023
    COPENHAGEN, Denmark, June 27, 2023 – Bavarian Nordic A/S (OMX: BAVA) today reported topline results from a Phase 3 non-inferiority clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.
  • The two-part study enrolled a total of 4,205 adults who either previously completed primary vaccination or had already received one booster dose of a licensed COVID-19 vaccine.
  • Paul Chaplin, President and CEO of Bavarian Nordic said: “These Phase 3 results for our COVID-19 booster vaccine candidate have confirmed the VLP platform as a viable future pandemic vaccine platform.
  • Therefore, we have to generate additional data to assess the effectiveness of ABNCoV2 against the current circulating SARS-CoV-2 variants”.

Bavarian Nordic Reports Data from a Phase 3 Clinical Trial of its VLP-Based Chikungunya Virus Vaccine in Adults ≥65 Years of Age

Retrieved on: 
Tuesday, June 20, 2023
VLP, OMX, Bavarian Nordic, Vaccination, Chikungunya, Safety, CHIKV, Vaccine

COPENHAGEN, Denmark, June 20, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today the initial safety and immunogenicity results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of a virus-like particle (VLP)-based chikungunya virus (CHIKV) vaccine candidate CHIKV VLP (PXVX0317) in healthy adults ≥65 years of age.

Key Points: 
  • COPENHAGEN, Denmark, June 20, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today the initial safety and immunogenicity results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of a virus-like particle (VLP)-based chikungunya virus (CHIKV) vaccine candidate CHIKV VLP (PXVX0317) in healthy adults ≥65 years of age.
  • Results from a second Phase 3 study evaluating the safety and immunogenicity of CHIKV VLP in healthy adolescents and adults 12 to 64 years old will report data during the third quarter of 2023.
  • A total of 413 participants were enrolled and randomized 1:1 to receive either a single intramuscular injection of CHIKV VLP or placebo.
  • They also match what has previously been reported for younger adults in an earlier Phase 2 study, including a fast onset of protection.

AMG Lithium and Fortum Battery Recycling Oy Sign MoU for Supply of Recycled Lithium Hydroxide

Retrieved on: 
Wednesday, May 24, 2023
Lithium, OMX, Recycling, Metal, Fortum, AMG, Carbon, Battery, MOU, Memorandum of understanding, CO2

Amsterdam, 24 May 2023 --- AMG Critical Materials N.V. ("AMG", EURONEXT AMSTERDAM: "AMG") announces its wholly owned subsidiary, AMG Lithium GmbH (“AMG Lithium”), has signed a non-binding memorandum of understanding (“MOU”) with Fortum Battery Recycling Oy (OMX: FORTUM), a Nordic clean energy provider.

Key Points: 
  • Amsterdam, 24 May 2023 --- AMG Critical Materials N.V. ("AMG", EURONEXT AMSTERDAM: "AMG") announces its wholly owned subsidiary, AMG Lithium GmbH (“AMG Lithium”), has signed a non-binding memorandum of understanding (“MOU”) with Fortum Battery Recycling Oy (OMX: FORTUM), a Nordic clean energy provider.
  • According to the signed MoU, the lithium product recovered by Fortum Battery Recycling will be delivered to AMG Lithium for further processing.
  • Together, AMG Lithium and Fortum Battery Recycling aim to improve the entire battery recycling chain, contribute to reducing its CO2 footprint, and reduce the European battery value chain’s dependency on raw material imports.
  • “We are looking forward to working together with Fortum in order to de-carbonize and improve the battery recycling lithium supply chain in Europe.”

Emergent BioSolutions Finalizes Sale of Travel Health Business to Bavarian Nordic

Retrieved on: 
Monday, May 15, 2023
Vaccine, OMX, LLP, Travel, EBS, Sale, Patient, Wells Fargo, Barnes & Thornburg, NYSE, CHIKV, Emergent, Bavarian Nordic

GAITHERSBURG, Md., May 15, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced it has completed the sale of its travel health business to Bavarian Nordic (OMX: BAVA).

Key Points: 
  • GAITHERSBURG, Md., May 15, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced it has completed the sale of its travel health business to Bavarian Nordic (OMX: BAVA).
  • At closing Emergent received $270 million, subject to customary closing adjustments, and may receive up to an additional $110 million in potential future milestone payments.
  • Bavarian Nordic also acquired manufacturing facilities in Bern, Switzerland, and development facilities in San Diego, California.
  • The majority of Emergent employees supporting these products and facilities are joining Bavarian Nordic.

Nasdaq Stockholm Celebrates its 160th Anniversary

Retrieved on: 
Monday, March 20, 2023
OMX, Nasdaq Iceland, OMX AB, CSD, Stockholm Stock Exchange Building, Almedalen Week, OM, Baltic, Electronics, Exchange, Nasdaq Helsinki, SME, Stock exchange, HEX, Indian Trade Service, Carbon, Nasdaq Copenhagen, Nasdaq First North, London Stock Exchange, Acquisition, European Market Coupling Company, Growth, From Copenhagen Stock Exchange, SAX, Cryptocurrency, Renewable energy, Security (finance), Financial services, Nordic, Nasdaq Stockholm

STOCKHOLM, Sweden, March 20, 2023 (GLOBE NEWSWIRE) -- Nasdaq Stockholm celebrates its 160th Anniversary this year, marking the milestone with the launch of a series of internal and external events over the coming months in recognition of the deep history and heritage of the exchange, including a bell ceremony during the Almedalen Week.

Key Points: 
  • STOCKHOLM, Sweden, March 20, 2023 (GLOBE NEWSWIRE) -- Nasdaq Stockholm celebrates its 160th Anniversary this year, marking the milestone with the launch of a series of internal and external events over the coming months in recognition of the deep history and heritage of the exchange, including a bell ceremony during the Almedalen Week.
  • Founded in 1863, Nasdaq Stockholm has supported job creation and growth across the Swedish and European economy.
  • Today, Nasdaq Stockholm is Europe’s leading SME listing venue, welcoming more companies than any other venue in 2022.
  • “For 160 years, our market has facilitated efficient capital formation and advanced economic growth across our country,” said Fredrik Ekström, President of Nasdaq Stockholm.

Annual General Meeting in ALK on 23 March 2023

Retrieved on: 
Monday, February 27, 2023
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ALK (ALKB:DC / OMX: ALK B / AKBLF): The Annual General Meeting of ALK-Abelló A/S will take place on Thursday, 23 March 2023 at 4:00 PM (CET) at ALK-Abelló A/S, 1 Bøge Allé, 2970 Hørsholm, Denmark.

Key Points: 
  • ALK (ALKB:DC / OMX: ALK B / AKBLF): The Annual General Meeting of ALK-Abelló A/S will take place on Thursday, 23 March 2023 at 4:00 PM (CET) at ALK-Abelló A/S, 1 Bøge Allé, 2970 Hørsholm, Denmark.
  • The agenda of the meeting including the complete proposals from the Board of Directors to the AGM is attached.
  • For further information please contact:

Bavarian Nordic to Acquire Portfolio of Travel Vaccines from Emergent BioSolutions

Retrieved on: 
Wednesday, February 15, 2023
EBS, Vaccine, Human, Emergent BioSolutions, Q&A, Investment, Viral disease, NYSE, Acquisition, EBITDA, Cooley, DKK, Extrapyramidal system, Food, Research, Salmonella enterica subsp. enterica, CET, USD, Marketing, Danske Bank, Disease, Morgan Stanley, FDA, Infection, EU, Typhoid fever, Prevalence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, COVID-19, Cholera, OMX, Pharmaceutical industry, Fine chemical, Cryptocurrency, Bavarian Nordic, Chikungunya, Emergent, Nordea

A late-stage vaccine candidate targeting Chikungunya with expected Phase 3 read-out in the second half of 2023 and projected launch in 2025.

Key Points: 
  • A late-stage vaccine candidate targeting Chikungunya with expected Phase 3 read-out in the second half of 2023 and projected launch in 2025.
  • Travel vaccines are seeing a rebound after the COVID-19 pandemic and the expanded portfolio allows us to further explore synergies in our commercial presence across key markets.
  • There are currently no approved vaccines against Chikungunya, which analysts estimate could represent an annual market worth more than USD 500 million.
  • The management of Bavarian Nordic will host an investor/analyst call today, February 15, 2023, at 2 pm CET (8 am EST) to discuss the acquisition.