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

2026-07-06 07:01:00

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.

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

2026-07-02 07:01:00

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.

NovaBridge Biosciences Appoints Dr. Srishti Gupta as Chief Executive Officer

2026-06-29 07:00:00

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.

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

2026-06-16 07:01:00

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.

Invivyd doses first participants in Phase 3 COVID-19 trial

2026-06-09 12:23:48

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.

Invivyd doses first participants in Phase 3 COVID-19 trial

2026-06-09 08:22:00

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...

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

2026-06-09 07:01:00

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.

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

2026-06-03 07:01:00

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.