Invivyd Stock Price, News & Analysis

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).

Invivyd (Nasdaq: IVVD) on November 17, 2025 announced an underwritten public offering of shares of its common stock, with underwriters granted a 30-day option to purchase up to an additional 15% of the shares sold. All shares are being offered by Invivyd and the offering is subject to market conditions; timing, size and terms are not assured.

The company said it intends to use net proceeds, together with existing cash, for commercial preparedness for VYD2311, continued R&D for RSV and measles programs, SPEAR Study Group efforts on monoclonal antibody effects for Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and general corporate purposes.

Invivyd (NASDAQ: IVVD) reported Q3 2025 PEMGARDA net product revenue of $13.1M, up 41% YoY and 11% QoQ. The company ended Q3 with $85.0M cash and reported October 2025 ending cash of over $100M after raising proceeds from a $57.5M public offering and $29.8M ATM sales. Invivyd received FDA IND clearance and alignment for its REVOLUTION pivotal program for VYD2311, with two Phase 3 trials planned (DECLARATION, n=1,770; LIBERTY, n=210) and top-line data expected mid-2026. Q3 R&D expense fell to $8.0M from $57.9M a year earlier; SG&A was $15.0M. Net loss narrowed to $10.5M (Q3 2025).

Invivyd (Nasdaq: IVVD) will host a conference call on Thursday, November 6, 2025 at 8:30 a.m. ET to discuss third quarter 2025 financial results and provide a corporate update.

Interested parties may join the live webcast via the company's investor relations site and are advised to log in about 15 minutes before the start. A recording will be available on the investor relations website shortly after the event.

Invivyd (Nasdaq: IVVD) will host a live webcast on Thursday, October 30, 2025 at 8:30 a.m. ET to present an overview of the REVOLUTION clinical program for VYD2311, a vaccine-alternative monoclonal antibody candidate to prevent COVID.

Key presenters include Marc Elia (Chairman), Tim Lee (Chief Commercial Officer), Robert Allen, PhD (Chief Scientific Officer), and Mark Wingertzahn, PhD (SVP, Clinical Development). Listeners should join the webcast link 15 minutes before start; a replay will be posted to the company investor relations website about two hours after the call ends.