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 (IVVD) and the SPEAR Study Group initiated FLINTLOCK, a Phase 2 trial evaluating VYD2311 for Long COVID or Post-Vaccination Syndrome.
The randomized, double-blind, placebo-controlled study will assess safety, tolerability, clinical efficacy and pharmacokinetics—how the drug moves through the body—in adults aged 18–65. Treatment comprises an initial intravenous infusion followed by intramuscular injections on days 30 and 60. The total dose is targeted at 10 times the prophylactic dose assessed in DECLARATION and LIBERTY, but remains below doses previously assessed with a positive initial safety profile in first-in-human testing.
Functional performance tests, adverse-event monitoring and blood drug-level measurements will continue through Day 90. Invivyd expects initial data in mid-2027. FLINTLOCK is part of its broader REVOLUTION clinical program for VYD2311.
Invivyd (Nasdaq: IVVD) granted six newly hired non-executive employees stock options on October 1, 2026, as inducements to join the company.
The options cover 157,500 common shares at an exercise price of $0.8165 per share, matching the closing share price on the grant date. They vest over four years: 25% on the first anniversary of each employee’s start date, followed by equal monthly installments, subject to continuous service. The options have a 10-year term and were granted under the 2026 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
Invivyd (IVVD) reported Phase 3 LIBERTY results showing fewer adverse events with VYD2311 than with an mRNA COVID-19 vaccine. Among 210 adults, VYD2311 met both six-day co-primary safety endpoints and the 56-day secondary endpoint. Events occurring after dosing, injection-site reactions or hypersensitivity affected 56.5% of VYD2311 recipients versus 91.4% of vaccine recipients at six days; systemic adverse events affected 44.1% versus 68.1%. At 56 days, the first measure was 60.9% versus 91.4%.
Adding VYD2311 to the vaccine increased neutralizing titers by approximately 2.5x over 56 days without observed interference with vaccine-induced titers. Invivyd plans to seek accelerated approval using LIBERTY and DECLARATION data if the latter are supportive. DECLARATION safety and immune-response results are expected in October; clinical efficacy data would be unblinded after accelerated approval, if granted, subject to enough clinical events occurring.
Invivyd (IVVD) will participate in three investor conferences in New York in September 2026, featuring Chairman and CEO Marc W. Elia and other management members.
The company will attend Citi’s 2026 Biopharma Back to School Conference on September 9 (meetings only), the Cantor Global Healthcare Conference with a fireside chat on September 10 at 9:45 AM ET, and the H.C. Wainwright 28th Annual Global Investment Conference with a fireside chat on September 14 at 5:00 PM ET. Live webcasts of the fireside chats will be accessible and archived in the investor section of Invivyd’s website.
Invivyd (IVVD) granted stock options as inducement awards to six newly hired non-executive employees on September 1, 2026.
The employees received options to purchase an aggregate of 255,000 shares of Invivyd common stock under the 2026 Inducement Plan, in accordance with Nasdaq Listing Rule 5635(c)(4). The options have a per share exercise price of $0.8799, equal to the closing price on the grant date, and a 10-year term. Each option vests over four years, with 25% vesting on the first anniversary of the employee’s start date and the remainder vesting in equal monthly installments thereafter, subject to continuous service.
Invivyd (Nasdaq: IVVD) appointed Chairman Marc Elia as Chief Executive Officer, combining the roles of Chairman and CEO. Ajay Royan, founder of Mithril Capital and a long-term investor in Invivyd, was named Lead Independent Director. The company also added healthcare investor Ian Sheffield, founder and Managing Partner of North Country Holdings, to its Board as an independent director.
Invivyd reiterated that top-line data from its VYD2311 COVID-19 monoclonal antibody program are expected around the end of Q3 2026. Depending on these results, the company plans either a traditional or Accelerated Approval Biologics License Application pathway for VYD2311, subject to FDA review and approval.
Invivyd (Nasdaq: IVVD) reported Q2 2026 PEMGARDA® net product revenue of $14.3 million, up 21% from $11.8 million in Q2 2025, driven by higher patient demand. Ending cash and cash equivalents were $160.1 million, which the company anticipates will fund operations through the DECLARATION pivotal data readout and support potential commercial launch readiness for VYD2311.
The pivotal DECLARATION Phase 3 trial of VYD2311 completed enrollment and is approaching its planned analysis, with top-line data planned later in Q3 2026. The LIBERTY Phase 3 trial is fully dosed, with top-line data expected in late Q3 2026. Invivyd is also advancing additional monoclonal antibody candidates, including VMS063 for measles and VBY329 for RSV, toward IND readiness in 2H 2026.
Q2 2026 R&D expenses rose to $29.4 million from $9.6 million, SG&A to $29.5 million from $16.6 million, and net loss increased to $44.4 million from $14.7 million, with net loss per share of $0.14 versus $0.12 a year earlier.
Invivyd (Nasdaq: IVVD) reported that on August 1, 2026, it granted stock options to ten newly hired non-executive employees to purchase an aggregate of 277,500 common shares under the 2026 Inducement Plan, as material inducement awards in accordance with Nasdaq Listing Rule 5635(c)(4).
The options have a per-share exercise price of $0.535, equal to the July 31, 2026 closing price of Invivyd’s stock. Each option vests over four years, with 25% vesting on the first anniversary of the employee’s start date and the remainder vesting in equal monthly installments, subject to continued service. The options have a 10-year term and remain subject to the plan’s terms.
Invivyd (Nasdaq: IVVD) received FDA notice that the Emergency Use Authorization (EUA) for PEMGARDA will terminate on June 29, 2027, following HHS’ planned end of the COVID-19 EUA declaration.
The company remains in dialogue with FDA on next regulatory steps and believes existing clinical and post-authorization data can support a future Biologics License Application for PEMGARDA, a monoclonal antibody used for COVID-19 pre-exposure prophylaxis in certain immune-compromised patients.
Invivyd (Nasdaq: IVVD) granted stock options as employment inducements under Nasdaq Listing Rule 5635(c)(4). On July 1, 2026, 14 newly hired non-executive employees received options for an aggregate 493,000 common shares at an exercise price of $0.8544 per share.
Each option vests over four years, with 25% vesting on the first anniversary of the employee’s start date and the remainder vesting in equal monthly installments, subject to continuous service. The options have a 10-year term and were issued under the 2026 Inducement Plan.