Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Currently Dominant SARS-CoV-2 Variant LP.8.1WALTHAM, Mass., March 05, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA™ (pemivibart) against the currently dominant LP.8.1 variant of SARS-CoV-2. Notably, and consistent with all dominant variants for the past three years, LP.8.1 did not generate any meaningful change to the neutralization activity of pemivibart or VYD2311, the company’s next generation COVID-19 monoclonal antibody (mAb) candidate, as the epitope these mAbs target remains structurally intact. PEMGARDA (pemivibart) is authorized in the U.S. for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients.
FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA™ (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who Have No Alternative Therapeutic Options; No Change to the ExistingWALTHAM, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that Invivyd’s request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for PEMGARDA™ (pemivibart) to provide a treatment option for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate, was declined by the U.S. Food and Drug Administration (FDA). Existing PEMGARDA™ (pemivibart) EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients remains in effect.
Invivyd to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025WALTHAM, 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 35th Annual Healthcare Life Sciences Conference.
Invivyd Announces Partnership with Pro Football Coach Jim Harbaugh to Elevate Awareness and Ongoing Impact of COVID-19: Common, Not A ColdWALTHAM, Mass., Feb. 05, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced a strategic partnership with renowned professional football coach Jim Harbaugh to raise awareness about the ongoing short and potential long-term risks of COVID-19 to the broad population and especially people who are immunocompromised, and encourage people to learn more about their potential options. This collaboration will highlight Coach Harbaugh in live and social media initiatives.
Invivyd Announces Positive Phase 1/2 Clinical Data for VYD2311, a Monoclonal Antibody Designed to be a Superior Alternative to COVID-19 Vaccination for the Broad PopulationWALTHAM, Mass., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced positive data from its ongoing Phase 1/2 clinical trial of VYD2311, Invivyd's novel monoclonal antibody (mAb) candidate designed to be a superior alternative to COVID-19 vaccination for the broad population as frontline protection in a convenient form, as well as to provide a novel, potent, long-acting option for the treatment of COVID-19.
Invivyd Announces Preliminary Fourth Quarter 2024 Financial Results, Strong Revenue Growth, and Reiterates Goal of Near-Term ProfitabilityWALTHAM, Mass., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced preliminary fourth quarter (Q4) financial results.
Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA’s Gating Request for Completing Its Review of EUA Request for PEMGARDA™ (pemivibart) for the Treatment of Mild-to-Moderate COVID-19 in Certain ImmunocompromisedWALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced the submission to the U.S. Food and Drug Administration (FDA) of an updated immunobridging analysis of pemivibart as ongoing support of a potential amendment to the Emergency Use Authorization (EUA) for pemivibart, a half-life extended investigational monoclonal antibody (mAb), to include the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised patients for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. PEMGARDA™ (pemivibart) received an EUA from the FDA in March 2024 for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise.
Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Dominant SARS-CoV-2 Variant XECWALTHAM, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that new in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 variant XEC. As anticipated based on the structural biology of pemivibart and VYD2311, the data are largely consistent with those previously reported for KP.3.1.1. The Centers for Disease Control (CDC) estimates that XEC and KP.3.1.1 accounted for an aggregate 69% of U.S. circulating variants of SARS-CoV-2 for the two weeks ended December 21, 2024. Invivyd generated these new data as part of its ongoing industrial virology effort, which leverages a consistent, high-quality, independent, third-party pseudoviral system that routinely tests authentic Invivyd-produced pemivibart and is supported by extensive structure-based and proprietary analytics.
Invivyd Reports Third Quarter 2024 Financial Results and Recent Business HighlightsWALTHAM, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced financial results for the quarter ended September 30, 2024, and recent business highlights.
Invivyd Announces New England Journal of Medicine Publishes Letter to the Editor Highlighting Immunobridging Pathway Leading to PEMGARDA™ (pemivibart) Emergency Use Authorization; Comments on Adjacent Third-Party Letter to the EditorWALTHAM, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announces that The New England Journal of Medicine (NEJM) has published a peer-reviewed Letter to the Editor describing the PEMGARDA™ (pemivibart) immunobridging emergency use authorization (EUA) pathway, as well as an updated correlate of protection (CoP) curve for prevention of symptomatic COVID-19 via recombinant monoclonal antibodies (mAbs) such as pemivibart.
Invivyd Announces Preprints Conveying CANOPY Phase 3 Clinical Trial Data Including Long-Term Protection Versus Recent JN.1 Sublineages at Low Residual Titers, and Describing a Novel Approach for Predicting Monoclonal Antibody Activity Were Uploaded toWALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that a manuscript preprint conveying data from the CANOPY Phase 3 clinical trial of pemivibart, a half-life extended investigational monoclonal antibody (mAb) for the pre-exposure prophylaxis (PrEP) of COVID-19, including long-term protection shown versus recent JN.1 sublineages at low residual titers, was uploaded to MedRxiv, and a preprint describing a novel approach for predicting mAb activity was uploaded to BioRxiv.
Invivyd to Participate in the Guggenheim Securities Healthcare Innovation ConferenceWALTHAM, 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.
Invivyd to Host Third Quarter 2024 Financial Results and Corporate Update Conference Call on November 14, 2024WALTHAM, 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 preliminary third quarter 2024 results via press release on October 29, 2024.
Invivyd Reports Preliminary Third Quarter 2024 Results, Withdraws Prior Financial Guidance, and Targets Near-Term ProfitabilityWALTHAM, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today reported preliminary third quarter (Q3) 2024 financial results and an update to prior financial guidance.
Invivyd Phase 3 Long-Term Exploratory Clinical Efficacy Data Shows PEMGARDA™ (pemivibart) Provided Substantial Protection from Symptomatic COVID-19 Versus Placebo Over Six Months of Follow-Up, With No Additional Doses, In Immunocompetent ParticipantsWALTHAM, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced positive 12-month exploratory clinical efficacy data from the company’s ongoing CANOPY Phase 3 clinical trial of pemivibart, a half-life extended investigational monoclonal antibody (mAb), for the pre-exposure prophylaxis (PrEP) of COVID-19.
Invivyd to Present PEMGARDA™ (pemivibart) Data at Infectious Disease Week (IDWeek) 2024WALTHAM, 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 Announces U.S. FDA Has Updated the PEMGARDA™ EUA Fact Sheet with Accurate SARS-CoV-2 Variant Susceptibility and PEMGARDA Activity DataWALTHAM, Mass., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has re-issued an updated Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers (Fact Sheet) for PEMGARDA™ (pemivibart) to provide accurate in vitro neutralization activity of PEMGARDA against dominant circulating variants including KP.3.1.1 and LB.1.
Invivyd Provides Detailed Virology Data and Analysis of SARS-CoV-2 Structural Biology Predicting Anticipated Neutralization Activity for PEMGARDA™ (pemivibart)WALTHAM, Mass., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today provided detailed virology data supporting previously communicated neutralization activity results, along with a genetic and structural analysis of past and present SARS-CoV-2 variant spike proteins, including the established molecular target of pemivibart.
Invivyd at the Ready for Upcoming Respiratory Virus Season with PEMGARDA™ (pemivibart) to Help Protect Vulnerable Immunocompromised Persons from COVID-19WALTHAM, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced a business readiness update in response to a recent increase in COVID-19 cases nationwide.
Invivyd to Participate in Upcoming Investor ConferencesWALTHAM, 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:
Invivyd Doses First Participants in Phase 1 Clinical Trial of VYD2311, a Next Generation Monoclonal Antibody Candidate for COVID-19, Building on the Success of PEMGARDA™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 against post-Omicron COVID-19 variants tested to date.
Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Dominant SARS-CoV-2 Variants KP.3.1.1 and LB.1, and Other Variants of InterestWALTHAM, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that new pseudovirus in vitro neutralization data show continued neutralizing activity of PEMGARDATM (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, and others tested. The Center for Disease Control (CDC) estimates that KP.3.1.1 accounted for 42.2% of circulating variants of SARS-CoV-2 for the last two weeks of August and is the only major variant increasing in proportionality nationally.
Invivyd Announces PEMGARDA™ (pemivibart) Demonstrated 84% Relative Risk Reduction in Symptomatic COVID-19 Compared to Placebo in an Exploratory Analysis from Ongoing CANOPY Phase 3 Clinical TrialWALTHAM, Mass., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced positive 180-day exploratory clinical efficacy data from the company’s ongoing CANOPY Phase 3 clinical trial of pemivibart, a half-life extended investigational monoclonal antibody (mAb), for the pre-exposure prophylaxis (PrEP) of COVID-19.
Invivyd Reports Second Quarter 2024 Financial Results and Recent Business HighlightsWALTHAM, Mass., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced financial results for the quarter ended June 30, 2024, and recent business highlights.
Invivyd to Host Conference Call Discussing Second Quarter 2024 Financial Results and Business HighlightsWALTHAM, 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.
