Invivyd, Inc. logo IVVD - Invivyd, Inc.

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Invivyd Announces Receipt of Twelve Months' Advanced Notice of Emergency Use Authorization (EUA) Termination for PEMGARDA® and Provides an Update on Next Steps with the U.S. FDA

Invivyd Announces Receipt of Twelve Months' Advanced Notice of Emergency Use Authorization (EUA) Termination for PEMGARDA® and Provides an Update on Next Steps with the U.S. FDA

NEW HAVEN, Conn., July 06, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has sent Invivyd a Notice of Termination for the PEMGARDA® (pemivibart) Emergency Use Authorization (EUA), following the U.S. Department of Health and Human Services' (HHS) announcement of advanced Notice of Termination of the COVID-19 EUA declaration on June 30, 2026 (link), with an effective date of June 29, 2027.  Consequently, the EUA for PEMGARDA is set to terminate on June 29, 2027.  PEMGARDA (pemivibart) is Invivyd's investigational monoclonal antibody authorized by the FDA under an EUA since March 2024 for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

Jul 06, 2026 03:01 AM • globenewswire.com
Invivyd Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Invivyd Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEW HAVEN, Conn., July 02, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that on July 1, 2026, Invivyd granted 14 newly hired non-executive employees options to purchase an aggregate of 493,000 shares of its common stock, each as a material inducement for each employee's entry into employment with Invivyd. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and pursuant to the Invivyd, Inc. 2026 Inducement Plan.

Jul 02, 2026 03:01 AM • globenewswire.com
NovaBridge Biosciences Appoints Dr. Srishti Gupta as Chief Executive Officer

NovaBridge Biosciences Appoints Dr. Srishti Gupta as Chief Executive Officer

ROCKVILLE, Md., June 29, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a clinical-stage biopharmaceutical company advancing innovative medicines for areas of significant unmet need, today announced the appointment of Srishti Gupta, MD MPP as Chief Executive Officer and a member of the Company's Board of Directors, effective July 1, 2026.

Jun 29, 2026 03:00 AM • globenewswire.com
Invivyd Announces Completion of Enrollment in Phase 3 LIBERTY Trial Evaluating VYD2311 Antibody Versus mRNA COVID-19 Vaccine

Invivyd Announces Completion of Enrollment in Phase 3 LIBERTY Trial Evaluating VYD2311 Antibody Versus mRNA COVID-19 Vaccine

NEW HAVEN, Conn., June 16, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced enrollment of participants in its Phase 3 LIBERTY clinical trial is complete. The trial is comparing the safety and tolerability of the company's investigational COVID-19 monoclonal antibody VYD2311 with an mRNA COVID-19 vaccine. The trial is also evaluating the safety and immune response when both are given together. VYD2311 is being developed as an alternative to vaccines for preventing COVID-19. The LIBERTY study is a randomized, double-blind trial involving healthy adults. A primary endpoint of the trial is to assess the side effects and tolerability of COVID antibody versus vaccine through Day six, for a total of seven days. Invivyd expects to report initial results from the study in the third quarter of 2026. These results may be released alongside data from the company's pivotal DECLARATION clinical trial.

Jun 16, 2026 03:01 AM • globenewswire.com
Invivyd doses first participants in Phase 3 COVID-19 trial

Invivyd doses first participants in Phase 3 COVID-19 trial

Invivyd Inc (NASDAQ:IVVD) has dosed the first participants in its LIBERTY Phase 3 trial, a study testing the company's monoclonal antibody VYD2311 for the prevention of COVID-19 against and alongside an mRNA vaccine. The randomized, double-blind trial is evaluating the safety, tolerability and immune response of VYD2311 on its own, an mRNA COVID-19 vaccine on its own, and VYD2311 given together with a COVID-19 vaccine in healthy adults, the New Haven, Connecticut-based company said.

Jun 09, 2026 08:23 AM • proactiveinvestors.com
Invivyd Announces First Participants Dosed in LIBERTY, a Phase 3 Clinical Trial to Evaluate the Safety and Tolerability of VYD2311 Antibody Versus mRNA COVID Vaccine and to Characterize the Safety and Immunology of Antibody and mRNA Vaccine Co-Administration

Invivyd Announces First Participants Dosed in LIBERTY, a Phase 3 Clinical Trial to Evaluate the Safety and Tolerability of VYD2311 Antibody Versus mRNA COVID Vaccine and to Characterize the Safety and Immunology of Antibody and mRNA Vaccine Co-Administration

NEW HAVEN, Conn., June 09, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the first participants have been dosed in the LIBERTY Phase 3 clinical trial, a randomized, double-blind study that is evaluating the safety and tolerability and immunology of VYD2311 alone, an mRNA COVID-19 vaccine alone, and VYD2311 co-administered with a COVID-19 vaccine in healthy adults. VYD2311 is Invivyd's vaccine-alternative monoclonal antibody (mAb) investigational candidate for the prevention of COVID-19. Depending on study recruitment rate, Invivyd expects to report topline data from the LIBERTY trial in Q3 2026, to accompany anticipated data from the pivotal DECLARATION clinical trial.

Jun 09, 2026 03:01 AM • globenewswire.com
Invivyd Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Invivyd Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEW HAVEN, Conn., June 03, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that on June 1, 2026, Invivyd granted 17 newly hired non-executive employees options to purchase an aggregate of 513,500 shares of its common stock, each as a material inducement for each employee's entry into employment with Invivyd. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and pursuant to the Invivyd, Inc. 2026 Inducement Plan.

Jun 03, 2026 03:01 AM • globenewswire.com
Invivyd Announces Completion of Enrollment in Upsized DECLARATION Clinical Trial, a Phase 3 Pivotal Study of VYD2311, an Investigational Antibody to Prevent COVID

Invivyd Announces Completion of Enrollment in Upsized DECLARATION Clinical Trial, a Phase 3 Pivotal Study of VYD2311, an Investigational Antibody to Prevent COVID

NEW HAVEN, Conn., June 01, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced the completion of enrollment in the DECLARATION trial evaluating VYD2311, an investigational monoclonal antibody candidate for the prevention of symptomatic COVID-19.   DECLARATION is the company's Biologics License Application (BLA)-enabling, Phase 3 randomized, placebo-controlled clinical trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents. Top-line results continue to be expected in approximately late Q3 2026.

Jun 01, 2026 03:01 AM • globenewswire.com
Invivyd Reports First Quarter 2026 Financial Results and Recent Business Highlights

Invivyd Reports First Quarter 2026 Financial Results and Recent Business Highlights

Achieved Q1 2026 PEMGARDA® (pemivibart) net product revenue of $13.7 million, representing 22% growth versus Q1 2025 net product revenue of $11.3 million Invivyd in vitro data showed continued neutralizing activity of pemivibart and VYD2311 against SARS-CoV-2 variant BA.3.2.2 (“Cicada”), confirming anticipated activity DECLARATION trial Independent Data Monitoring Committee (IDMC) ad hoc review of unblinded VYD2311 safety data resulted in IDMC recommendation for reduction of post-dose monitoring time from two hours to thirty minutes Operating expense increase quarter-over-quarter primarily attributable to DECLARATION pivotal program costs for VYD2311 for which top-line data is anticipated in Q3 2026 Strong balance sheet with Q1 2026 ending cash and cash equivalents of $184.2 million; additional ~$20 million in gross proceeds from usage of at-the-market (ATM) offering facility in April 2026 Invivyd to host conference call today at 8:30AM ET NEW HAVEN, Conn., May 14, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the first quarter ended March 31, 2026, and recent business highlights.

May 14, 2026 03:01 AM • globenewswire.com
Invivyd and Collaborators Author New Manuscript Evaluating Early Tolerability of COVID Monoclonal Antibody and Comparing Results to COVID Vaccination

Invivyd and Collaborators Author New Manuscript Evaluating Early Tolerability of COVID Monoclonal Antibody and Comparing Results to COVID Vaccination

Invivyd authors evaluated early side effects of prior low-dose investigational monoclonal antibody adintrevimab from the EVADE study, demonstrating minimal tolerability issues Results allow for comparison to contemporary COVID-19 mRNA and protein vaccine tolerability, as well as epidemiologic extrapolation of systemic symptom days experienced via each approach Upcoming LIBERTY trial head-to-head study comparing safety and tolerability between VYD2311 and mRNA vaccine will build on these results in a rigorous, prospective fashion NEW HAVEN, Conn., May 11, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that a preprint of original research regarding COVID monoclonal antibody and vaccine systemic reactogenicity is now available on MedRxiv and is titled “Safety first: should the high tolerability of intramuscular anti-spike COVID-19 monoclonal antibody change our expectations of vaccine safety?

May 11, 2026 03:01 AM • globenewswire.com
Invivyd to Host First Quarter 2026 Financial Results and Corporate Update Call on May 14, 2026

Invivyd to Host First Quarter 2026 Financial Results and Corporate Update Call on May 14, 2026

NEW HAVEN, Conn., May 07, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 14, 2026 at 8:30 a.m. ET to discuss its first quarter 2026 financial results and provide a corporate update.

May 07, 2026 03:01 AM • globenewswire.com
Invivyd Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Invivyd Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEW HAVEN, Conn., May 05, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that on May 1, 2026, Invivyd granted 17 newly hired non-executive employees options to purchase an aggregate of 731,000 shares of its common stock, each as a material inducement for each employee's entry into employment with Invivyd. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and pursuant to the Invivyd, Inc. 2026 Inducement Plan.

May 05, 2026 03:01 AM • globenewswire.com
Invivyd Announces Chairman Marc Elia to Speak at POLITICO Health Care Summit

Invivyd Announces Chairman Marc Elia to Speak at POLITICO Health Care Summit

Elia to speak at the premier gathering of policy makers, industry leaders, and health experts between 11:30 AM ET – 12:00 PM ET on April 21 Event to be live streamed between 9:00 AM – 1:00 PM ET NEW HAVEN, Conn., April 20, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that Marc Elia, Chairman of the Invivyd Board of Directors, is a featured speaker at the POLITICO Health Care Summit on Tuesday, April 21.

Apr 20, 2026 03:01 AM • globenewswire.com

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