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Product-specific Q Code (Q0224) facilitates product reimbursement for PEMGARDA; corresponding M Code (M0224) defines reimbursement for product administration Reimbursement through Medicare/Medicaid represents approximately 50% of covered lives in target population WALTHAM, Mass., April ...
WALTHAM, Mass., April 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the company’s Board of Directors has appointed Jeremy Gowler as Interim Chief Exe...
PEMGARDA now commercially available in the U.S. for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise Based on anticipated net product revenue and continued optimization of operational expenses, company expects to end 2...
Received emergency use authorization for PEMGARDA™, a monoclonal antibody (mAb) authorized in the U.S. for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise PEMGARDA product availability in the U.S. anticipated i...
Analysis of secondary endpoint of symptomatic COVID-19 events in CANOPY is unrelated to regulatory filing or review, but may be hypothesis generating for future Invivyd discovery and development work Today’s update on Day 67 and Day 90 event rates is the first of two planned publ...
PEMGARDA (pemivibart) is authorized in the U.S. for PrEP of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise Emergency use authorization based on positive immunobridging data and on safety data from the CANOPY clinical trial along with ongoing in vitro ...
WALTHAM, Mass., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that David Hering, Chief Executive Officer of Invivyd, is scheduled to present in a fireside c...
EUA submission is based on positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and ongoing in vitro neutralization activity against relevant SARS-CoV-2 variants VYD222 demonstrates continued in vitro neutralization activity against major SARS-CoV-2 variants, in...
VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participants Data supportive of an immunobridging approach to the EVADE study of adintrevimab Overall favorable safety and tolerability profile of VYD222 including no study drug-related seriou...
Enrollment completed in CANOPY Phase 3 pivotal clinical trial investigating VYD222 for the prevention of symptomatic COVID-19 Company expects to have initial CANOPY primary endpoint data by late 2023 or early Q1 2024 Company aims to submit an application for Emergency Use Author...
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WALTHAM, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that Marc Elia, Chairman of the Invivyd Board of Directors, is scheduled to present in a fireside cha...
Launched PEMGARDA™ in the U.S. for COVID-19 pre-exposure prophylaxis (PrEP) in certain adults and adolescents with moderate-to-severe immune compromise Reported interim exploratory COVID-19 clinical event data from CANOPY Phase 3 clinical trial of VYD222 Received product-sp...
Pathway leverages immunobridging approach via serum virus neutralizing antibody (sVNA) titers enabled by prior successful COVID-19 treatment clinical trial “STAMP” conducted with prototype antibody adintrevimab Company anticipates submitting a COVID-19 treatment EUA applicat...