Regulatory milestones approvals, filings & regulatory actions · 3 recorded
Milestone
Jurisdiction
Brand
Indication
Date
Sentence it was read from
Filedmild heart failure2 milestones
Filed
US (FDA)
PEMGARDA
mild heart failure
2024-11-14
“Submitted Emergency Use Authorization (EUA) amendment request to U.S. Food & Drug Administration (FDA) for PEMGARDA” invivyd.com ↗
Filed
US (FDA)
PEMGARDA
mild heart failure
2024-08-14
“Submitted EUA amendment request to FDA for PEMGARDA for the treatment of mild-to-moderate COVID-19 in certain immunocompromised patients.” invivyd.com ↗
RejectedIndication not stated1 milestone
Rejected (CRL)
US (FDA)
PEMGARDA
mild-to-moderate COVID-19 in immunocompromised patients
2025-02-24
“for whom alternative COVID-19 treatment options are not accessible or clinically appropriate, was declined by the U.S. Food and Drug Administration (FDA).” invivyd.com ↗
Invivyd, Inc. (Nasdaq: IVVD) today announced that results from its CANOPY Phase 3 clinical trial of pemivibart have been published online as an Advance Article in the peer-reviewed journal Clinical Infectious Diseases (CID) , available here .
Company announced in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA against LP.8.1, KP.3.1.1, and XEC, comprising the majority of SARS-CoV-2 variants currently circulating in the U.S, reinforcing the durability of PEMGARDA’s neutralizing activity shown amid viral evolution
Most recent updated analysis provided to FDA, incorporating current dominant SARS-CoV-2 variant XEC neutralization data, demonstrated substantially higher pemivibart titers in the critical early phase post-dosing (Days 0-5) as compared to adintrevimab
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.
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
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
Pemivibart potency against contemporary viruses KP.3.1.1 and LB.1 remains in-line with the totality of predominant variants dating back to 2022, including isolates identified during the conduct of the CANOPY Phase 3 clinical trial from late 2023 to early 2024.
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.
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, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) Q code (Q0224) covering product reimbursement for PEMGARDA.