Invivyd Completes Upsized DECLARATION Enrollment
PEMGARDA net product revenue was $14.3 million, up 21% from a year earlier, as the company completed enrollment in its upsized pivotal trial and said cash of $160.1 million should last through the VYD2311 readout.
Invivyd, Inc. (IVVD), a biopharmaceutical company developing monoclonal antibodies for viral disease prevention, completed enrollment in its upsized DECLARATION pivotal trial of VYD2311 in June 2026 and said the study is approaching its planned analysis, with top-line data later in the third quarter.
The company skipped a second-quarter earnings call and said it will hold an investor call after the study wraps. DECLARATION, a Phase 3, randomized, triple-blind, placebo-controlled trial of about 2,400 participants, is designed to support a potential Biologics License Application. Initial enrollment was reached in March. In April the company ran a conservative, algorithmic sample-size re-estimation to support adequate COVID-19 events and statistical power given variable attack rates; in June it completed the expanded enrollment.
LIBERTY, a Phase 3 study of about 210 participants comparing VYD2311 with an mRNA COVID vaccine and evaluating co-administration, was fully dosed in June, with top-line data also anticipated in late third-quarter 2026. A DRUMMER pediatric trial for children aged 0–11 will be actioned only if DECLARATION is successful.
PEMGARDA (pemivibart) net product revenue was $14.3 million for the quarter ended June 30, 2026, up 21% from $11.8 million a year earlier. The increase was driven by higher patient demand. Chief Financial Officer Bill Duke commented on continued PEMGARDA growth amid diminished COVID vaccine utilization. Year-over-year growth had been 22% in the first quarter, when revenue was $13.7 million.
In July 2026 Invivyd received twelve months’ advance notice of emergency use authorization termination for PEMGARDA and is in dialogue with the FDA about next steps. On June 30, 2026, the U.S. Department of Health and Human Services announced notice of termination of the pandemic declaration, effective June 29, 2027.
Research and development expenses were $29.4 million for the quarter ended June 30, 2026, versus $9.6 million a year earlier. The increase was primarily attributable to higher contract research costs for the DECLARATION and LIBERTY trials. Selling, general and administrative expenses were $29.5 million, versus $16.6 million a year earlier, primarily from higher personnel, communications and commercial-related costs.
Net loss was $44.4 million for the quarter, compared with $14.7 million a year earlier. Basic and diluted net loss per share was $0.14, versus $0.12. Loss from operations was $45.8 million.
Cash and cash equivalents were $160.1 million as of June 30, 2026, down from $184.2 million at March 31, 2026. The cash position is anticipated to provide runway through the DECLARATION pivotal data readout and support potential commercial launch readiness for VYD2311. Duke said the company has continued to manage expenses during a period of heavy clinical investment in the pivotal VYD2311 program, which it expects to complete shortly as it moves toward potential launch, if approved.
In May 2026 Invivyd reported positive, continued in vitro neutralization data for PEMGARDA and VYD2311 against SARS-CoV-2 variant BA.3.2.2 (“Cicada”). The company has begun IND-enablement and regulatory outreach for measles antibody candidate VMS063 toward IND readiness in the second half of 2026, and expects to advance RSV candidate VBY329 toward IND readiness in the same period. A Phase 2 trial of VYD2311 in Long COVID or COVID vaccine injury, planned with the SPEAR Study Group in January 2026, is expected to be initiated mid-2026.
Chairman Marc Elia said the company is looking forward to next steps for vulnerable Americans as the VYD2311 trials are planned to wrap up in the coming weeks.