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 15, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious... Read More

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 Executive Officer (CEO), effective immediately, while the Board institutes a search for a permanent CEO. Mr. Gowler succeeds Dave Hering.... Read More

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 2024 with at least $55 million in cash and cash equivalents Conference call today at 5 pm ET to discuss PEMGARDA launch progress WALTHAM,... Read More

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 imminently PEMGARDA is the first authorized mAb from Invivyd’s INVYMAB™ platform approach designed to address the challenge of rapid viral... Read More

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 public updates on symptomatic COVID-19 events in CANOPY; Invivyd plans to analyze all future events at Day 180 Further defining the relationship between... Read More

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 neutralizing activity against major... Read More

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 chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Thursday, February 8, 2024 at 1:00 p.m. ET in New... Read More

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, including JN.1, currently the fastest growing variant in the U.S. Company continues preparations for potential commercial launch if EUA is... Read More

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 serious adverse events (SAEs) to date VYD222 demonstrates continued in-vitro neutralization activity against major SARS-CoV-2 variants, including against... Read More

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 Authorization (EUA) in the U.S. as soon as practicable Company continues to advance INVYMAB TM , its proprietary platform approach designed for rapid,... Read More

WALTHAM, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that it will host a conference call on Thursday, November 9, 2023, at 4:30 p.m. ET to discuss its financial results for the quarter ended September 30, 2023, and recent business highlights. Listeners can... Read More

WALTHAM, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that it will present at the following investor conferences: Guggenheim 5 th Annual Inflammation, Neurology & Immunology (INI) Conference Fireside Chat Date: Tuesday, November 7, 2023 Fireside Chat Time: 3:50 PM... Read More

WALTHAM, Mass., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the first participant has been dosed in the CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody, for the prevention of symptomatic COVID-19.... Read More

WALTHAM, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that it will present at the following investor conferences: H.C. Wainwright 25th Annual Global Investment Conference Fireside Chat Date: Monday, September 11, 2023 Fireside Chat Time: 3:00 PM ET Location: New... Read More

WALTHAM, Mass., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced the appointment of William Duke as Chief Financial Officer. Mr. Duke will lead Invivyd’s financial strategy to support the company’s continued growth. Mr. Duke has more than 25 years of finance, accounting,... Read More

Reported positive initial Phase 1 VYD222 clinical trial data, including favorable safety data and robust serum neutralizing titers from all three dose levels tested Plans to pursue rapid initiation of a 750-participant pivotal clinical trial of VYD222 (CANOPY) that will utilize Day 28 serum neutralizing titers from a subset of the population as part of a potential EUA submission for the prevention of symptomatic COVID-19 The... Read More

WALTHAM, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that it will host a conference call on Thursday, August 10, 2023, at 4:30 p.m. ET to discuss its financial results for the quarter ended June 30, 2023, and recent business highlights. Listeners can register for... Read More

WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced the appointment of Sara Cotter to its board of directors. Ms. Cotter brings extensive leadership experience spanning healthcare investment management and drug development. “Ms. Cotter’s comprehensive knowledge... Read More

Continued favorable safety and tolerability profile for all dose levels tested Serum samples from all dose levels tested showed robust neutralization activity against Omicron XBB.1.5, one of the dominant SARS-CoV-2 variants circulating globally Ongoing analysis of serum neutralizing activity and pharmacokinetic data expected to support rapid anticipated transition to pivotal clinical trial WALTHAM, Mass., July 17, 2023... Read More

Unique, rapid development pathway for monoclonal antibodies (mAbs) using immunobridging via serum neutralizing titers could be enabled by previously generated clinical trial data from prototype antibody VYD222 and potential future Invivyd mAbs are planned to leverage this EUA pathway using consistent manufacturing platform and limited structural changes from proprietary prototype antibody ADG20 (adintrevimab) Company... Read More

VYD222 has been generally well-tolerated at all dose levels, with no serious adverse events reported to date As predicted by pre-clinical in vitro testing, early serum samples from the first, lowest dose cohort showed strong neutralization activity against Omicron XBB.1.5, one of the dominant SARS-CoV-2 variants circulating globally Initial Phase 1 data help support anticipated rapid transition to a pivotal clinical trial... Read More

WALTHAM, Mass., June 01, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage 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 at the Jefferies Healthcare Conference on Friday, June 9, 2023 at 11:30 a.m. ET in New York, NY. In addition to the presentation,... Read More

Completed dosing of the Phase 1 clinical trial of VYD222, a broadly neutralizing monoclonal antibody (mAb) candidate being developed to protect immunocompromised people from COVID-19 Initial data readouts from Phase 1 VYD222 clinical trial planned for Q2 with additional clinical readouts from the VYD222 program anticipated in 2023 Published landmark clinical research in Science Translational Medicine that provides strong... Read More

WALTHAM, Mass., May 04, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 11, 2023, at 4:30 p.m. ET to discuss its financial results for the quarter ended March 31, 2023, and recent business highlights. Listeners can register for the... Read More

WALTHAM, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) a clinical-stage 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 chat at H.C. Wainwright’s BioConnect Investor Conference on Tuesday, May 2, 2023 at 4:00 p.m. ET at the Nasdaq World... Read More

On track for initial readouts in Q2 2023 from ongoing Phase 1 VYD222 clinical trial being conducted in Australia, with cohort 1 dosing complete Discussions are underway with the FDA and global regulators regarding the company’s proposed VYD222 pivotal clinical trial design WALTHAM, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the... Read More

WALTHAM, Mass., April 12, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced the appointment of Robert Allen as chief scientific officer, and Stacy Price as chief technology and manufacturing officer. In his new role, Dr. Allen will oversee the scientific direction of the company and... Read More

WALTHAM, Mass., March 30, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced dosing of the first participants in a Phase 1 healthy volunteer trial of VYD222, a novel monoclonal antibody (mAb) candidate for COVID-19. The Phase 1 randomized, blinded, placebo-controlled, dose-ranging... Read More

Advancing VYD222 into clinical development based on in vitro data demonstrating neutralizing activity against multiple important variants of concern, including XBB.1.5 Anticipate near-term designation of an additional monoclonal antibody against SARS-CoV-2 with complementary binding properties to VYD222 for development Well capitalized with $372 million in cash, cash equivalents and marketable securities expected to support... Read More

Research published online today in peer-reviewed journal Science Translational Medicine Analysis of data from a Phase 2/3 COVID-19 prevention study (EVADE) of adintrevimab suggests clinically meaningful protection can be achieved at low neutralizing antibody titers Work builds on vaccine studies demonstrating neutralizing antibody titers as correlates of protection against disease and could inform evolution of regulatory... Read More

WALTHAM, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that it will host a conference call on Thursday, March 23, 2023, at 4:30 p.m. ET to discuss its financial results for the full year ended December 31, 2022, and recent business highlights. Listeners can... Read More

Company seeks to utilize emerging global COVID-19 regulatory frameworks to accelerate development of VYD222 and its pipeline of other candidates VYD222 mAb candidate has demonstrated in vitro neutralizing activity against dominant variants of concern, including XBB.1.5 Invivyd maintains guidance for initiating a clinical trial in the first quarter of 2023 WALTHAM, Mass., March 06, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc.... Read More

WALTHAM, Mass., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, today announced David Hering, chief executive officer of Invivyd, is scheduled to present at Cowen’s 43rd Annual Healthcare Conference on Monday, March 6, 2023 at 2:10 p.m. ET. A live webcast of the presentation will be available in... Read More

WALTHAM, Mass., Feb. 03, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical stage biopharmaceutical company on a mission to protect humanity from serious infectious diseases, today announced that Laura Walker, Ph.D., the company’s chief scientific officer and co-founder, decided to leave the company to pursue other opportunities. The management team has initiated a search process to identify her replacement.... Read More

WALTHAM, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, was invited to participate in an FDA-EMA workshop on SARS-CoV-2 monoclonal antibodies held on December 15, 2022. Invivyd's chief scientific officer, Laura Walker, Ph.D., alongside Eli Lilly and Company and Regeneron... Read More

Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, today announced the appointment of Christine Lindenboom, senior vice president investor relations & corporate communications at Alnylam Pharmaceuticals, Inc., to its board of directors. In addition, Redonda Miller, M.D., M.B.A., president of The Johns Hopkins Hospital, has stepped... Read More

Invivyd , (Nasdaq: IVVD) a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, today announced the appointment of Fred Driscoll as interim CFO as well as headcount changes to align resources to its key programs. The changes are designed to improve capital efficiency by reallocating resources to programs and functions to support our key activities on an... Read More

Invivyd, (Nasdaq: IVVD), formerly Adagio Therapeutics (Nasdaq: ADGI), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases announced today that it will have four poster presentations at ID Week 2022. The posters will share findings from several studies surrounding adintrevimab, including data from the Phase 1 and Phase 2/3 clinical trials. Poster details for the... Read More

Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap publicly traded companies recently issued a new audio interview with Invivyd. Toni had the pleasure of recently conducting the Interview with David Hering, Chief Executive Officer of Invivyd Inc. (NASDAQ:IVVD). Toni diligently focused on questions she thought would be on the minds of most current and potential... Read More