Invivyd
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Employees
- 95
- Market Cap
- $109.8M
- Website
- http://invivyd.com
- Introduction
Invivyd, Inc.(formerly Adagio Therapeutics, Inc.) engages in the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The firm develops antibodies that can neutralize SARS-CoV-2, SARS-CoV-1, and additional emergent coronaviruses. It offers, ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses. The company was founded by Tillman U. Gerngross, Ren Russo and Laura Walker on June 3, 2020 and is headquartered in Waltham, MA.
Invivyd reports clinical efficacy data from CANOPY phase 3 trial of pemivibart
Invivyd announced preprints on CANOPY phase 3 trial data of pemivibart for Covid-19 PrEP, showing long-term protection against JN.1 sublineages, and a novel method to predict mAb activity. CANOPY data supported the EUA of Pemgarda by the US FDA. Safety and efficacy results will be submitted to a scientific journal. Long-term follow-up data indicated strong protection over 12 months and during off-drug intervals. A preprint on assessing antibody activity against novel variants was also released.
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Long COVID lacks specific diagnostic tests; experts call for validated biomarkers and advanced tools. Orlynvah, an oral penem, received FDA approval for treating UTIs in adult women. Avian influenza H5N1 cases rise, emphasizing One Health approach. Hepatitis B guidelines promote universal screening and vaccination. Pemivibart shows promise in reducing COVID-19 risk, with a 76% RRR over 12 months.
Invivyd Announces Phase 3 Exploratory Clinical Efficacy Data Regarding Pemgarda
Invivyd announced positive CANOPY Phase 3 trial data for Pemivibart, showing 64% relative risk reduction in COVID-19 prevention over months 7-12, with 76% 12-month protection rate. No new safety signals were observed. The company revised its Pemgarda revenue forecast to $9.3 million for Q3, down from $150-200 million due to FDA warnings.
Invivyd Phase 3 Long-Term Exploratory Clinical Efficacy
CANOPY trial showed 64% risk reduction of symptomatic COVID-19 in months 7-12 with pemivibart, leading to 76% total 12-month risk reduction post-dosing, with no new safety issues observed.
Clinical Efficacy Endpoints from the Phase 3 CANOPY Study Evaluating Pemivibart
Invivyd presents Phase 3 CANOPY Study results on Pemivibart for COVID-19 prevention at IDWeek 2024, with efficacy endpoints and safety data discussed. Pemivibart, an investigational mAb, showed a 7.93% decrease in market value with a 5-day change of -5.23% and a 1st Jan change of -75.46%.
Invivyd Announces U.S. FDA Has Updated the PEMGARDA™ EUA Fact Sheet with Accurate ...
FDA updates PEMGARDA Fact Sheet, removing contested statement on KP.3.1.1's reduced susceptibility to pemivibart. New data shows neutralization potency in line with prior variants, including KP.3.1.1 and LB.1.
New Guidance Helps Clinicians Use Pemivibart to Protect Immunocompromised Patients
A patient under Dr. Scott Roberts' care tested positive for SARS-CoV-2 for over 500 days due to severe immunocompromise. The FDA authorized pemivibart for preexposure prophylaxis in immunocompromised individuals, and IDSA updated its guidelines to recommend its use. Despite concerns about efficacy against new variants, pemivibart offers a new preventive option for high-risk patients.
Invivyd Doses First Participants in Phase 1 Clinical Trial of VYD2311, a Next Generation
Invivyd, Inc. announced dosing of first participants in Phase 1 trial of VYD2311, a next-gen mAb candidate for COVID-19, showing high in vitro neutralization potency against post-Omicron variants. The trial, conducted in Australia, aims to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of VYD2311 through various routes of administration, including intramuscular. Preliminary data expected in Q4 2024, with further readouts anticipated throughout 2025.
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