Welcome to our dedicated page for Invivyd news (Ticker: IVVD), a resource for investors and traders seeking the latest updates and insights on Invivyd stock.
Invivyd, Inc. develops monoclonal antibody therapies for serious viral infectious diseases, with an initial focus on SARS-CoV-2. Company news commonly covers PEMGARDA (pemivibart), which received U.S. FDA emergency use authorization for pre-exposure prevention of COVID-19 in certain immunocompromised individuals, and pipeline work involving VYD2311 for COVID-19, VBY329 for RSV, and VMS063 for measles.
Updates also address clinical-study design and tolerability research, antibody platform presentations, financial results and corporate updates, public education efforts around antibodies and immune health, and Nasdaq inducement equity grants under the company’s 2026 Inducement Plan.
Invivyd (Nasdaq: IVVD) published a peer-reviewed correlate-of-protection model that links serum monoclonal antibody levels to clinical protection against symptomatic COVID-19 across multiple Omicron-era variants.
The model, using CANOPY Phase 3 data for pemivibart, aligns with observed outcomes and predicts meaningful protection even at low antibody concentrations, supporting variant-agnostic assessment of COVID mAbs.
Invivyd (Nasdaq: IVVD) said it is aligned with the U.S. FDA on LIBERTY, a Phase 3 trial to compare safety and immunology of its monoclonal antibody candidate VYD2311 versus mRNA COVID vaccines and to study co-administration.
The FDA requested specific monitoring of myocarditis/pericarditis adverse events of special interest for LIBERTY; DECLARATION Phase 3 topline data remain expected mid-2026 with ~1,770 total participants.
Invivyd (Nasdaq: IVVD) announced a national multimedia education partnership with champion skier Lindsey Vonn to raise public awareness about antibodies and infectious disease prevention. The campaign is planned to launch in early Spring 2026, with Vonn serving as the public spokesperson to connect antibody science to health and wellness. Vonn, a decorated Olympian and 84-time World Cup winner who returned to competition in 2024 and qualified in December for the Milan Cortina 2026 Olympic Winter Games, will help translate antibody concepts into accessible guidance for the American public.
Invivyd (Nasdaq: IVVD) and the SPEAR Study Group plan a Phase 2 trial of monoclonal antibody VYD2311 to evaluate safety, translational biology, and exploratory clinical efficacy in people with Long COVID or COVID vaccine injury, with initiation expected mid-2026. The randomized, double-blind, placebo-controlled design will test multiple long-term high doses of VYD2311 and enroll participants who demonstrate persistent infection or antigenemia where technologically detectable.
VYD2311 has shown in vitro antiviral activity across all clinically recorded SARS-CoV-2 variants tested since the Wuhan strain. Further trial details and clinicaltrials.gov registration are expected to be posted in coming months.
Invivyd (NASDAQ: IVVD) reported preliminary Q4 2025 PEMGARDA net product revenue of $17.2M, up 25% YoY and 31% QoQ. Ending cash and cash equivalents are expected to be $226.7M after >$200M raised in 2H 2025. The company initiated the DECLARATION Phase 3 randomized trial of VYD2311 (single IM dose and monthly arms; total expected enrollment 1,770) with topline data expected mid-2026, and VYD2311 received FDA Fast Track designation in Dec 2025. Invivyd nominated RSV candidate VBY329 for preclinical development (higher potency vs nirsevimab/clesrovimab) and targets a preclinical measles mAb select in 1H 2026. Further details to accompany the Form 10-K and regular filings.
Invivyd (Nasdaq: IVVD) announced the U.S. FDA granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody to prevent COVID in individuals with underlying risk factors for severe disease. Fast Track can enable priority review and rolling BLA submission if criteria are met.
Invivyd is conducting DECLARATION, a Phase 3, randomized, triple-blind, placebo-controlled, BLA‑enabling trial of VYD2311 with planned total enrollment of 1,770 participants. Participants receive a single or monthly intramuscular dose versus placebo. Top-line data are expected mid-2026.
Invivyd (Nasdaq: IVVD) initiated the DECLARATION Phase 3, randomized, triple-blind, placebo-controlled trial of VYD2311 on Dec. 23, 2025 to evaluate prevention of symptomatic COVID.
The study plans 1,770 participants across single-dose and monthly-dose IM arms vs placebo, with a primary endpoint of PCR-confirmed symptomatic COVID at three months and topline data expected mid-2026. DECLARATION is BLA-enabling and part of the company’s REVOLUTION program. Prior Phase 1/2 data at four times the planned DECLARATION dose reported only mild–moderate AEs and no serious AEs. Invivyd says it has produced commercial launch quantities of VYD2311 and secured capital to support the pivotal study and commercial preparedness.
Invivyd (Nasdaq: IVVD) announced that company management will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Tuesday, December 2, 2025 at 2:35 p.m. ET in Miami, FL.
A live webcast will be available in the investor section of the company website at investors.invivyd.com, and the presentation will be archived for approximately 90 days after the event.
Invivyd (Nasdaq: IVVD) nominated VBY329, a monoclonal antibody candidate for prevention of Respiratory Syncytial Virus (RSV) in newborns, infants, and children, and plans to advance it toward IND readiness in 2H 2026. In vitro data show average antiviral potency 1.5-fold vs nirsevimab and 1.2-fold vs clesrovimab, plus up to ~500-fold enhanced neutralization against nirsevimab-resistant RSV F protein variants in pseudovirus assays. VBY329 includes half-life extension and biophysical properties expected to provide equivalent or greater in vivo half-life versus comparators. Invivyd said it will present in vitro data at a future medical congress and continues discovery work on ultra-long half-life RSV antibodies for elderly and immunocompromised populations.
Invivyd (Nasdaq: IVVD) priced an underwritten public offering totaling approximately $125.0 million in gross proceeds on Nov 18, 2025. The offering comprises 44,000,000 shares of common stock at $2.50 per share and, to certain investors, 6,000,000 pre-funded warrants at $2.4999 each (exercise price $0.0001). The company granted underwriters a 30-day option to buy up to 7,500,000 additional shares. Closing is expected on or about Nov 19, 2025, subject to customary conditions.
Invivyd said net proceeds will fund commercial preparedness for potential launch of VYD2311, continued R&D (including RSV and measles programs), SPEAR Study Group work on monoclonal antibody effects in Long COVID and COVID-19 post-vaccination syndrome, and general corporate purposes. Cantor is sole book-running manager and H.C. Wainwright is lead manager. The offering is made from a shelf registration on Form S-3 (File No. 333-267643).