NEW HAVEN, Conn., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc . (Nasdaq: IVVD) today announced the appointment of Kristie Kuhl as Chief Communications Officer. Ms. Kuhl will lead the Company’s communications and patient advocacy efforts as Invivyd advances its mission of providing monoclonal antibodies for the prevention and treatment of viral disease. Ms. Kuhl brings deep expertise in healthcare and pharmaceutical... Read More

SPEAR proposal reflects current evidence on monoclonal antibodies in treatment for Long COVID and identifies VYD2311 as a promising next-generation candidate for the clinical study Recommendation is for a robust, comprehensive, translational study to evaluate the ability of VYD2311 to decrease circulating spike protein in eligible patients and to explore potential associated clinical benefits Study design contemplates... Read More

WALTHAM, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that it will present at the following investor conferences: Cantor Global Healthcare Conference 2025 Fireside Chat Date: Wednesday, September 3, 2025 Fireside Chat Time: 2:10 PM ET Location: New York, NY H.C. Wainwright 27th Annual Global Investment Conference Fireside Chat Date: Monday, September 8, 2025 Fireside Chat Time: 12:00... Read More

WALTHAM, Mass., Aug. 22, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced the closing of its previously announced underwritten public offering of 89,234,480 shares of its common stock, which includes the exercise in full by the underwriter of its option to purchase an additional 14,423,076 shares of common stock, at a public offering price of $0.52 per share and pre-funded warrants to purchase... Read More

WALTHAM, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced the pricing of an underwritten public offering of 74,811,404 shares of its common stock at an offering price of $0.52 per share and, to certain investors, in lieu of common stock, pre-funded warrants to purchase 21,342,442 shares of its common stock at a price of $0.5199 per pre-funded warrant. The gross proceeds from... Read More

WALTHAM, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Invivyd intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of Invivyd common stock sold in the public offering at the public offering price, less underwriting... Read More

New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA ® (pemivibart) against XFG Centers for Disease Control data and wastewater surveillance data indicate XFG variant appears to be driving a growing wave of COVID-19 in America VYD2311 in vitro neutralization data demonstrate similarly consistent and highly potent results against XFG Similar new, positive in vitro neutralization data... Read More

PEMGARDA ® (pemivibart) net product revenue of $11.8 million reported for Q2 2025, representing 413% growth year-over-year Invivyd’s target of near-term profitability (1H 2025) was not met but remains possible with the upcoming respiratory virus season Announced alignment with U.S. FDA on rapid pathway to full approval (BLA) of vaccine alternative monoclonal antibody candidate VYD2311 to protect American adults and... Read More

Alignment follows Type C meeting for VYD2311 as previously disclosed BLA pathway for VYD2311 to be supported by a single, Phase 2/3 randomized, double-blind, placebo-controlled trial with a primary endpoint of reduction in symptomatic COVID-19, resembling CANOPY Cohort B Company’s target product profile is low-dose, intramuscular, scalable, low-cost, long-lasting, protective option for target populations, including adults... Read More

WALTHAM, Mass., July 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced the addition of Akiko Iwasaki, Ph.D., Professor of Immunobiology at Yale School of Medicine, to the SPEAR (Spike Protein Elimination and Recovery) Study Group. The SPEAR Study Group was launched earlier this month to focus on the biology and clinical disease or injury associated with persistent presence of spike antigen from... Read More

NCCN Clinical Practice Guidelines in Oncology for the Prevention and Treatment of Cancer-Related Infections now recommend monoclonal antibodies for pre-exposure prophylaxis against COVID-19 in appropriate cancer populations Reflects growing alignment among NCCN, IDSA, and CDC on the role of monoclonal antibodies in protecting immunocompromised individuals from COVID-19 New data published online in JAMA Oncology from the... Read More

SPEAR Study Group initiated following multiple, independent reports of substantial clinical benefit associated with PEMGARDA ® (pemivibart) therapy among people with Long COVID SPEAR Study Group collaborators Drs. Michael Peluso, Amy Proal, and David Putrino are key thought leaders in the clinical and translational biology of Long COVID and Post-Vaccination Syndrome Initial SPEAR clinical efforts to be aimed at rigorous,... Read More

Attractive safety profile demonstrated across all dosing cohorts and routes of administration (IV, SC, and IM); all reported adverse events (AEs) deemed unrelated or classified as mild to moderate and largely related to injection site and infusion reactions with no serious or severe adverse events observed Following a single dose, serum concentrations of VYD2311 remained high at six months with an observed half-life of the... Read More

CANOPY assessed pemivibart safety and tolerability, antiviral immunobridging, and exploratory efficacy against COVID-19, and is the only clinical trial of an authorized or approved COVID-19 monoclonal antibody or vaccine with placebo-controlled clinical efficacy data in a contemporary, seropositive U.S. population and facing modern, immune-evasive SARS-CoV-2 viruses Pemivibart demonstrated strong protection from symptomatic... Read More

WALTHAM, Mass., May 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc . (Nasdaq: IVVD), today announced that PEMGARDA ® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Network ® (NCCN ® ) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. NCCN joins the Infectious Disease Society of America (IDSA) that updated its COVID-19 guidelines in August 2024 to recommend... Read More

FDA acknowledges that the benefit of repeat doses of COVID-19 vaccine boosters for Americans is uncertain; the updated regulatory framework for COVID-19 vaccines articulated by the Agency generally aligns with recent Invivyd Citizen Petition requests In contrast to vaccine boosters, monoclonal antibody (mAb) therapies, including pemivibart, underwent contemporary randomized, placebo-controlled trials to evaluate safety,... Read More

PEMGARDA™ (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contracted to an internalized sales force PEMGARDA revenue re-acceleration observed in Q2 2025 to date Invivyd continues to target near-term profitability (1H 2025) with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of operating expenses... Read More

WALTHAM, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from historical approaches to the development of vaccines and monoclonal antibodies (mAbs) for COVID-19 prevention, in order to rebuild American’s trust in scientific data, public health recommendations, and... Read More

WALTHAM, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that management will participate in a fireside chat at the H.C. Wainwright 3 rd Annual BioConnect Investor Conference on Tuesday, May 20, 2025, at 11:00 a.m. ET in New York, NY. In addition to the fireside chat, the management team will host investor meetings at the conference. Investors participating in the conference who are... Read More

Multiple HCPs have requested from Invivyd a monoclonal antibody (mAb) for treatment of active measles infection and post-exposure prophylaxis to reduce the consequence of outbreaks. Such a medicine could accelerate the pathway to functional eradication of measles Measles (rubeola) virus appears to offer an attractive target for best-in-class monoclonal antibody discovery and development utilizing Invivyd technology More than... Read More

WALTHAM, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 15, 2025, at 8:30 a.m. ET to discuss its financial results for the first quarter ended March 31, 2025, and provide recent business highlights. Listeners can register for the... Read More

WALTHAM, Mass., April 21, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it has signed a $30 million term loan facility with Silicon Valley Bank (SVB), a division of First Citizens Bank. The deal allows for drawdown of capital in the future if certain conditions and milestones are met. “We are... Read More

WALTHAM, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) is pleased to announce the appointment of Ajay Royan to its Board of Directors. Mr. Royan is a venture capitalist focused on transformational companies that have solved critical problems in healthcare, technology, and energy. Mr. Royan’s investment firm, Mithril, is a significant long-term holder of Invivyd stock, and Mr. Royan led the 2022... Read More

Achieved Q4 2024 PEMGARDA™ (pemivibart) net product revenue of $13.8 million, representing 48% growth over Q3 2024 net product revenue of $9.3 million; full-year 2024 net product revenue totaled $25.4 million 2024 year-end cash and cash equivalents of $69.3 million Continues to target near-term (by end of 1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and continued... Read More

New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA™ (pemivibart) against LP.8.1 Centers for Disease Control reports LP.8.1, XEC and KP.3.1.1 together constitute the majority of current national SARS-CoV-2 variants; current dominant variants are all susceptible to PEMGARDA Pemivibart antiviral activity remains within the range of expected assay variability since Omicron BA.2; affirms... Read More

FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs in a bridging analysis of sVNA 1 titer levels, otherwise the Agency is “unable to reasonably conclude that the known and... Read More

WALTHAM, Mass., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that Marc Elia, Chairman of the Invivyd Board of Directors, will be presenting at the Oppenheimer 35 th Annual Healthcare Life Sciences Conference. The presentation is set to take place at 1:20 PM ET on Wednesday, February 12th . The live webcast link will be available in the investor section of the company's website at... Read More

Teaming up to raise awareness of the continuing toll of COVID-19 in America, an ongoing mass disabling event causing an American death approximately every 9 minutes with over 59,000 deaths and 665,000 hospitalizations in 2024, as well as a lifetime of unknown impact, despite widespread vaccination In life as in football, Coach Harbaugh believes in options, including for those who are immunocompromised and may continue to... Read More

Recruitment completed and all doses administered for VYD2311 ongoing Phase 1/2 clinical trial (40 subjects) evaluating 3 routes of administration Phase 1/2 clinical data for VYD2311 to date are positive for both safety and pharmacokinetics, and are supported by antiviral activity data from Invivyd's standard virologic... Read More

Preliminary Q4 2024 PEMGARDA™ (pemivibart) net product revenue of $13.8 million, 48% growth over Q3 2024 net product revenue of $9.3 million Preliminary Q4 2024 total operating costs and expenses of approximately $32 million, 55% reduction compared to Q3 2024 operating costs and expenses of $71.6 million Preliminary ending 2024 cash and cash equivalents of $69.3 million and $10.9 million of accounts receivable Continues to... Read More

Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company’s previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy start... Read More

New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA™ (pemivibart) against XEC Centers for Disease Control reports XEC and KP.3.1.1 (previously disclosed as susceptible to PEMGARDA) together constitute the majority of national SARS-CoV-2 variants XEC data underscore continued pemivibart activity in the face of virus evolution including recently emerging types of structural changes to... Read More

The New England Journal of Medicine (NEJM) Letter to the Editor outlines the novel, rapid immunobridging authorization pathway for PEMGARDA and provides an updated correlate of protection curve for monoclonal antibody protection from symptomatic COVID-19 The updated correlate of protection analysis published in the Letter to the Editor indicates the potential for strong protection from symptomatic COVID-19 at titer levels... Read More

Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with $106.9 million in cash and cash equivalents Targets near-term (1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and various operational efficiency improvements PEMGARDA Fact Sheet updated to properly reflect neutralization activity of PEMGARDA against current circulating... Read More

CANOPY manuscript preprint includes six-month off-drug follow-up period that highlighted strong protection by pemivibart versus placebo in the immunocompetent Cohort B during KP.3 and KP.3.1.1 dominant wave CANOPY exploratory clinical efficacy data, to date, reconfirm a high level of risk reduction from developing symptomatic COVID-19 in immunocompetent participants Preprint describes Invivyd scientists’ novel method for... Read More

WALTHAM, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that management will participate in a fireside chat and 1x1 investor meetings at the Guggenheim Securities Healthcare Innovation Conference taking place November 11-13, 2024. Fireside Chat: Wednesday, November 13, 2024 at 2:30 PM... Read More

WALTHAM, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, November 14, 2024, at 8:30 a.m. ET to discuss its financial results for the third quarter ended September 30, 2024, and provide recent business highlights. Invivyd reported... Read More

Following strong protection (84% relative risk reduction versus placebo) demonstrated through month 6 with pemivibart, CANOPY clinical trial participants were followed for an additional six-month period (months 7-12), with no additional doses, to assess safety and efficacy as drug concentrations declined over time In the six-month off-drug follow-up period (months 7-12), substantially reduced concentrations of PEMGARDA... Read More

Preliminary Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with approximately $107 million in cash and cash equivalents Expects to finish 2024 with $65 million or more in cash and cash equivalents Withdraws formal revenue guidance due to recent growth headwind from U.S. FDA’s late-Q3 2024 warning on potential for substantially reduced activity of pemivibart through the PEMGARDA Fact... Read More

WALTHAM, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced the upcoming presentations of pemivibart data from its Phase 1 and Phase 3 clinical trials at IDWeek 2024. The conference is being held in Los Angeles, October 16-19, 2024. Invivyd will be presenting the following oral and poster... Read More

KP.3.1.1 and LB.1 in vitro neutralization potency values now reflected in the PEMGARDA Fact Sheet for Healthcare Providers are in-line with prior variants, including variants represented in the CANOPY Phase 3 clinical trial Invivyd continues active variant monitoring using validated, robust methods and is not aware of any circulating variants not susceptible to PEMGARDA at this time WALTHAM, Mass., Oct. 01, 2024 (GLOBE... Read More

Independent evaluation of KP.3.1.1 and LB.1 variants shows in vitro pseudovirus neutralization potency of PEMGARDA in-line with prior variants tested Proprietary, ongoing SARS-CoV-2 spike analyses demonstrate consistent structural stability of the pemivibart binding site to date, which has routinely predicted sustained... Read More

Centers for Disease Control and Prevention (CDC) reports death rate due to COVID-19 has continued to increase throughout 2024 Immunocompromised patients at greatest risk for serious infections or even death due to COVID-19 PEMGARDA™ available under Emergency Use Authorization (EUA) for certain immunocompromised adults and adolescents; recommended by Infectious Disease Society of Americas (IDSA) guidelines Covered by Medicare... Read More

WALTHAM, Mass., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will present at the following investor conferences: Morgan Stanley 22nd Annual Global Healthcare Conference Fireside Chat Date: Friday, September 6, 2024 Fireside Chat Time: 10:00 AM ET Location: New York, NY H.C.... Read More

WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced dosing of the first participants in the Phase 1 healthy volunteer clinical trial of VYD2311, a next generation monoclonal antibody (mAb) candidate for COVID-19. VYD2311 is a mAb with high in vitro neutralization potency shown... Read More

New pseudovirus in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) against KP.3.1.1, LB.1, and other SARS-CoV-2 variants tested Center for Disease Control reports KP.3.1.1 is the only major variant increasing in proportionality nationally Variants confirmed as susceptible to pemivibart in independent analyses contain key Q493E, s31del, and other mutations that are prominent in... Read More

In all-comer cohort of immunocompetent individuals at risk of contracting symptomatic COVID-19 in their everyday social interactions, participants receiving pemivibart experienced a 1.9% rate of confirmed symptomatic COVID-19 compared to an 11.9% rate for participants receiving placebo, an 84% relative risk reduction (nominal p= 0.000061) In immunocompromised participants, pemivibart demonstrated a rate of 3% of confirmed... Read More

PEMGARDA™ launched commercially in Q2 2024 with $2.3 million of net product revenue Notable acceleration of commercial results in early Q3 2024, with the anticipated peak fall/winter respiratory virus season approaching New commercial leadership with Chief Commercial Officer, Tim Lee, an experienced biopharmaceutical leader with demonstrated commercial success Achieved Medicare and Medicaid coverage, rapid growth in... Read More

WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Wednesday, August 14, 2024, at 8:30 a.m. ET to discuss its financial results for the second quarter ended June 30, 2024, and recent business highlights. Listeners can register for the webcast... Read More

WALTHAM, Mass., July 01, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that as part of the annual reconstitution of the Russell stock indexes, Invivyd will be included in the Russell 2000 ® Index and the broad-market Russell 3000 ® Index, effective at the open of U.S. equity markets today. Membership... Read More

Pseudovirus in vitro neutralization data show continued neutralizing activity of VYD222 (pemivibart) against the KP.1.1 FLiRT and KP.3 SARS-CoV-2 variants, virus selections representative of current dominant strains and the most recent FLiRT-containing viruses Invivyd’s new data is broadly concordant with preliminary pseudovirus data showing neutralizing activity of VYD222 against KP.2 FLiRT and KP.3 variants recently... Read More

WALTHAM, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that its management team is scheduled to participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 3:00 p.m. ET in New York, NY. In addition to the fireside chat, the management team... Read More

Newly outlined pathway provides a practical, expedient, repeatable immunobridging approach to potential emergency use authorization of serial, novel monoclonal antibodies (mAbs) to prevent and treat COVID-19 Pathway provides for the establishment of a master, registrational clinical trial protocol that is anticipated to streamline the evaluation of new mAbs in compact clinical programs Utilizing this framework, Invivyd plans... Read More

Mr. Lee joins Invivyd with a history of high-quality commercial execution at Alexion, Biohaven and Amylyx Appointment intended to accelerate the addition of commercial capabilities associated with orphan medicines to the ongoing PEMGARDA™ commercial launch William Duke, Jr., Chief Financial Officer, appointed as Principal Executive Officer WALTHAM, Mass., May 31, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a... Read More

WALTHAM, Mass., May 29, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will present preliminary, subset analyses from the CANOPY Phase 3 clinical trial of VYD222 (pemivibart) for pre-exposure prophylaxis of COVID-19 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and at... Read More

WALTHAM, Mass., May 22, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that two new independent directors, Dr. Srishti Gupta and Kevin F. McLaughlin, were elected to its Board of Directors at the annual meeting of stockholders on May 21, 2024. Dr. Gupta will serve as the Chairperson of the Compensation... Read More

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 chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference on Monday, May 20, 2024 at 3:00 p.m. ET in New York, NY. In... Read More

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-specific reimbursement codes covering PEMGARDA from the U.S. Centers for Medicare & Medicaid Services (CMS), covering approximately half of target... Read More

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 application for PEMGARDA™ (pemivibart) imminently COVID-19 treatment EUA pathway offers a novel, rapid pathway to potential second EUA for pemivibart Invivyd... Read More

WALTHAM, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 9, 2024, at 4:30 p.m. ET to discuss its financial results for the first quarter ended March 31, 2024, and recent business highlights. Listeners can register for the webcast via... Read More

Improvements realized through comprehensive resource realignment ensuring robust investment in the commercial launch of PEMGARDA TM and the discovery of novel monoclonal antibodies Company now expects to end 2024 with at least $75 million in cash and cash equivalents, an update to previously issued financial guidance WALTHAM, Mass., April 30, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company... Read More

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