Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Currently Dominant SARS-CoV-2 Variant LP.8.1
05. März 2025 07:05 ET
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Invivyd
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...
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 Existing PEMGARDA EUA for Pre-Exposure Prophylaxis of COVID-19 in Certain Immunocompromised Patients
24. Februar 2025 07:05 ET
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Invivyd
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...
Invivyd to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025
10. Februar 2025 07:00 ET
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Invivyd
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 35th...
Invivyd Announces Partnership with Pro Football Coach Jim Harbaugh to Elevate Awareness and Ongoing Impact of COVID-19: Common, Not A Cold
05. Februar 2025 09:30 ET
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Invivyd
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...
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 Population
03. Februar 2025 07:00 ET
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Invivyd
Recruitment completed and all doses administered for VYD2311 ongoing Phase 1/2 clinical trial (40 subjects) evaluating 3 routes of administrationPhase 1/2 clinical data for VYD2311 to date are...
Invivyd Announces Preliminary Fourth Quarter 2024 Financial Results, Strong Revenue Growth, and Reiterates Goal of Near-Term Profitability
03. Februar 2025 06:55 ET
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Invivyd
Preliminary Q4 2024 PEMGARDA™ (pemivibart) net product revenue of $13.8 million, 48% growth over Q3 2024 net product revenue of $9.3 millionPreliminary Q4 2024 total operating costs and expenses of...
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 Immunocompromised Patients
27. Januar 2025 07:01 ET
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Invivyd
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...
Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Dominant SARS-CoV-2 Variant XEC
10. Januar 2025 07:01 ET
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Invivyd
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...
Invivyd Reports Third Quarter 2024 Financial Results and Recent Business Highlights
14. November 2024 07:05 ET
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Invivyd
Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with $106.9 million in cash and cash equivalentsTargets near-term (1H 2025) profitability with existing cash...
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 Editor
14. November 2024 07:01 ET
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Invivyd
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...