Invivyd, INC 8-K filings

Invivyd announced second quarter 2026 financial results, highlighting a 21% increase in PEMGARDA net product revenue to $14.3 million and progress in key clinical trials for VYD2311.

Invivyd, Inc. received a deficiency letter from Nasdaq for failing to meet the minimum $1.00 bid price requirement for its common stock.

Invivyd, Inc. announced it has received a twelve-month advanced notice of termination for the Emergency Use Authorization (EUA) of its COVID-19 monoclonal antibody, PEMGARDA, from the U.S. FDA, effective June 29, 2027.

Invivyd, Inc. announced the results of its Annual Meeting of Stockholders held on May 19, 2026, including the election of directors and ratification of PricewaterhouseCoopers LLP as its independent auditor.

Invivyd announced first quarter 2026 financial results, highlighting a 22% year-over-year increase in PEMGARDA net product revenue to $13.7 million, while advancing its VYD2311 clinical programs.

Invivyd announced progress in its COVID-19 program with a slight delay in Phase 3 results and the advancement of a novel measles monoclonal antibody candidate, VMS063.

Invivyd, Inc. announced robust fourth-quarter and full-year 2025 financial results, highlighted by significant PEMGARDA revenue growth and rapid advancement of its pivotal VYD2311 clinical trial.

Invivyd, Inc. announced preliminary strong fourth quarter 2025 revenue for PEMGARDA and significant progress in its VYD2311 COVID and VBY329 RSV antibody programs.

Invivyd, Inc. announced that its investigational antibody VYD2311 received FDA Fast Track designation for COVID prevention, potentially accelerating its development and review.

Invivyd, Inc. announced the selection of VBY329, a potential best-in-class RSV antibody candidate, targeting IND readiness in the second half of 2026 for pediatric prophylaxis.

Invivyd, Inc. announced the pricing of a $125 million underwritten public offering of common stock and pre-funded warrants to fund pipeline development and commercial preparedness.

Invivyd, Inc. reported a 41% year-over-year increase in Q3 2025 PEMGARDA net product revenue to $13.1 million and received U.S. FDA IND clearance for its pivotal VYD2311 COVID prevention program.

Invivyd, Inc. presented its strategy for developing best-in-class antibody protection and treatment for viral threats, including COVID-19, highlighting its PEMGARDA and VYD2311 programs.

Invivyd, Inc. announced U.S. FDA Investigational New Drug (IND) clearance and alignment on the pivotal clinical program for VYD2311, a vaccine-alternative antibody to prevent COVID.

Invivyd, Inc. announced the appointment of Dr. Paul B. Bolno to its Board of Directors and regained compliance with Nasdaq's minimum bid price requirement.

Invivyd, Inc. successfully closed an underwritten public offering, raising approximately $53.5 million in net proceeds to advance its VYD2311 clinical program and other pipeline initiatives.

Invivyd reported strong Q2 2025 revenue growth for PEMGARDA and announced a rapid FDA pathway to full approval for its COVID-19 monoclonal antibody candidate VYD2311.

Invivyd, Inc. announced the formation of the SPEAR Study Group with leading researchers to rigorously assess the effects of monoclonal antibody therapy, including PEMGARDA, for Long COVID and COVID-19 Post-Vaccination Syndrome.

Invivyd, Inc. announced positive full Phase 1/2 clinical data for its next-generation COVID-19 monoclonal antibody candidate, VYD2311, demonstrating an attractive safety profile, long half-life, and robust modeled protective efficacy, with FDA discussions scheduled for early Q3 2025.

Invivyd, Inc. held its Annual Meeting of Stockholders on May 20, 2025, and elected directors and ratified the appointment of PricewaterhouseCoopers LLP as its independent accounting firm.

Invivyd announces Q1 2025 financial results, highlighting $11.3 million in PEMGARDA net product revenue and a strategic focus on achieving profitability in the first half of 2025.

Invivyd, Inc. announces a new pipeline discovery program focused on developing a monoclonal antibody treatment for measles, addressing a significant unmet need due to declining vaccination rates and the lack of approved therapies.

Invivyd, Inc. received a notification from Nasdaq that its common stock has fallen below the minimum bid price requirement for continued listing.

Invivyd, Inc. has entered into a $30 million term loan agreement with Silicon Valley Bank to bolster its financial flexibility ahead of key milestones.

Invivyd appoints Ajay Royan, founder of Mithril Capital and a significant Invivyd shareholder, to its Board of Directors, effective immediately.

Invivyd announces a 48% increase in Q4 PEMGARDA revenue and progress in its next-generation COVID-19 antibody program.

Invivyd announces that PEMGARDA (pemivibart) continues to demonstrate clinically meaningful in vitro neutralizing activity against the currently dominant SARS-CoV-2 variant LP.8.1.

Invivyd's request to expand the emergency use authorization of PEMGARDA for COVID-19 treatment in immunocompromised patients was declined by the FDA, while the existing authorization for pre-exposure prophylaxis remains in effect.

Invivyd reports a 48% increase in Q4 product revenue, a 55% reduction in operating costs, and positive Phase 1/2 clinical data for VYD2311, a potential alternative to COVID-19 vaccination.

Invivyd has provided the FDA with updated data showing pemivibart has substantially higher antiviral activity than adintrevimab, supporting its request to expand the Emergency Use Authorization (EUA) for PEMGARDA to include treatment of mild-to-moderate COVID-19 in certain immunocompromised patients.