Drugs / VYD222
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | 2024-01-03 | “today announced that it has requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for VYD222” invivyd.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05791318 | Mar 2023 → May 2024 | COVID-19 | Invivyd, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT06004128 Background | — | COVID-19 | Invivyd, Inc. | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-08-27 | Invivyd, Inc. | Results 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 Trial invivyd.com ↗
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. |
| 2024-08-14 | Invivyd, Inc. | Regulatory Invivyd Reports Second Quarter 2024 Financial Results and Recent Business Highlights invivyd.com ↗
Submitted EUA amendment request to FDA for PEMGARDA for the treatment of mild-to-moderate COVID-19 in certain immunocompromised patients. |
| 2024-06-14 | Invivyd, Inc. | Results Invivyd Announces Antiviral Activity of VYD222 (pemivibart) Against SARS-CoV-2 KP.1.1 FLiRT & KP.3 Variants invivyd.com ↗
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 |
| 2024-03-22 | Invivyd, Inc. | Results Invivyd Announces Interim Exploratory Data on VYD222 from Ongoing CANOPY Clinical Trial invivyd.com ↗
Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced interim exploratory COVID-19 clinical event data for VYD222, an investigational, monoclonal antibody (mAb) in development for the pre-exposure prophylaxis of COVID-19. |
| 2024-03-22 | Invivyd, Inc. | Regulatory Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19 invivyd.com ↗
PEMGARDA (pemivibart) is authorized in the U.S. for PrEP of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise |
| 2024-01-03 | Invivyd, Inc. | Regulatory Invivyd Submits Request for Emergency Use Authorization (EUA) to U.S. FDA for VYD222 for the Pre-exposure Prevention of COVID-19 in Immunocompromised Adults and Adolescents invivyd.com ↗ |
| 2023-12-18 | Invivyd, Inc. | Results Invivyd Announces Positive Initial Results from Ongoing CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of COVID-19 invivyd.com ↗ |
| 2023-07-17 | Invivyd, Inc. | Results Invivyd Announces Additional Positive Initial Data from Ongoing Phase 1 Clinical Trial of VYD222, a Monoclonal Antibody Candidate in Development for the Prevention of Symptomatic COVID-19 in Immunocompromised People invivyd.com ↗
The initial Phase 1 data showed that a single administration of VYD222 was generally well-tolerated at all three dose levels tested with no serious adverse events (SAEs) reported to date. |
| 2023-06-22 | Invivyd, Inc. | Results Invivyd Announces Positive Initial Data from Ongoing Phase 1 Clinical Trial of VYD222, a Monoclonal Antibody Candidate in Development for the Prevention of Symptomatic COVID-19 in Immunocompromised People invivyd.com ↗
Initial Phase 1 data show that a single administration of VYD222 was generally well-tolerated at all three dose levels tested with no serious adverse events (SAEs) reported to date. |
| 2023-04-25 | Invivyd, Inc. | Regulatory Invivyd Announces the FDA Has Cleared Its IND Application for VYD222, a Monoclonal Antibody Candidate for Prevention of COVID-19, and Provides Phase 1 VYD222 Clinical Trial Update invivyd.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VYD222 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06004128 ↗ |
| Modality | Monoclonal antibody | “VYD222, a monoclonal antibody targeting SARS-CoV-2” NCT05791318 ↗ |