IVVD

8-K - Invivyd, Inc. (0001832038) (Filer)

8-K - Invivyd, Inc. (0001832038) (Filer)

U.S. Department of Health and Human Services (HHS) announced advanced Notice of Termination of the COVID-19 EUA declaration, effective June 29, 2027 Consequently, Invivyd received from the U.S. Food and Drug Administration (FDA) Notice of Termination of the PEMGARDA EUA, to be effective on June 29, 2027, after a twelve-month transition periodConsistent with EUA transition processes, Invivyd is in dialogue with FDA about appropriate next steps for PEMGARDAInvivyd intends to pursue every avenue to secure permanent, high quality medical protection from COVID infection for immune-compromised and other vulnerable Americans PEMGARDA has demonstrated strong protection from COVID in a contemporary r

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. The options have a per share exercise price of $0.8544, representing the closing price of Invivyd’s common stock on the grant date. Each option vests over four years, with 25% of the shares subject to such option vesting on the first a

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. Xi-Yong (Sean) Fu, PhD MBA will step down as Chief Executive Officer to pursue other opportunities. Dr. Fu will support the Company in an advisory capacity during the transition. Dr. Gupta is an experienced CEO who brings more than two decades of transformative leadership across biopharmaceuticals, global he

Invivyd expects to report topline data from LIBERTY in Q3 2026Data from LIBERTY can provide important insight into the VYD2311 clinical profile by direct comparison between COVID antibody prophylaxis and COVID vaccine LIBERTY is part of Invivyd's broader REVOLUTION clinical program, including DECLARATION, designed to generate medical practice-changing data to support VYD2311, a potential new option for prevention of COVID-19 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 m

LIBERTY clinical trial will evaluate the comparative safety and tolerability of VYD2311 versus mRNA COVID-19 vaccine, as well as explore the safety and immunology of co-administered VYD2311 and mRNA COVID-19 vaccineDepending on study recruitment rate, Invivyd expects to report topline data from LIBERTY in Q3 2026, to accompany anticipated data from the pivotal DECLARATION clinical trialPrior exploration of monoclonal antibody (mAb) interaction with vaccine published here suggests a minimal clinical consequence to a similar interaction today, but could provide data to aid in potential product labelling language, if approved. This earlier work demonstrated an expected, modest reduction in vacc

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. The options have a per share exercise price of $1.22, representing the closing price of Invivyd's common stock on the grant date. Each option vests over four years, with 25% of the shares subject to such option vesting on the first ann

DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of symptomatic COVID-19 versus placebo, at three months, from a single intramuscular (IM) dose, with protection beyond three months anticipated  A second arm is evaluating monthly IM doses of VYD2311 versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk people seek periodic extra protection from COVIDInvivyd previously conducted a pre-specified sample size re-estimation analysis designed to add statistical power robustness given future COVID event rate variability; upsizing was triggered an

NEW HAVEN, Conn., May 27, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) today announced that it will participate in upcoming investor events in June: 2026 Jefferies Global Healthcare Conference in New YorkFireside Chat Date & Time: Wednesday, June 3, 2026 4:55 p.m. ETLocation: New York, NYWebcast Link H.C. Wainwright "HCW @ Home" SeriesFireside Chat Date & Time: Monday, June 8, 2026 10:00 a.m. ETLocation: VirtualWebcast Link BTIG Infectious Disease Day 2026Date: Tuesday, June 16, 20261x1 Meetings Location: Virtual Live webcasts of the fireside chats will be available in the investor section of the company's website at investors.invivyd.com and will be archived following each eve

4 - Invivyd, Inc. (0001832038) (Issuer)

4 - Invivyd, Inc. (0001832038) (Issuer)

4 - Invivyd, Inc. (0001832038) (Issuer)

4 - Invivyd, Inc. (0001832038) (Issuer)

4 - Invivyd, Inc. (0001832038) (Issuer)

4 - Invivyd, Inc. (0001832038) (Issuer)

8-K - Invivyd, Inc. (0001832038) (Filer)

SCHEDULE 13G/A - Invivyd, Inc. (0001832038) (Subject)

S-8 - Invivyd, Inc. (0001832038) (Filer)

10-Q - Invivyd, Inc. (0001832038) (Filer)

8-K - Invivyd, Inc. (0001832038) (Filer)

Achieved Q1 2026 PEMGARDA® (pemivibart) net product revenue of $13.7 million, representing 22% growth versus Q1 2025 net product revenue of $11.3 millionInvivyd in vitro data showed continued neutralizing activity of pemivibart and VYD2311 against SARS-CoV-2 variant BA.3.2.2 ("Cicada"), confirming anticipated activityDECLARATION 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 minutesOperating expense increase quarter-over-quarter primarily attributable to DECLARATION pivotal program costs for VYD2311 for which top-line data is anticipated in Q3

Invivyd authors evaluated early side effects of prior low-dose investigational monoclonal antibody adintrevimab from the EVADE study, demonstrating minimal tolerability issuesResults allow for comparison to contemporary COVID-19 mRNA and protein vaccine tolerability, as well as epidemiologic extrapolation of systemic symptom days experienced via each approachUpcoming 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 antib

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.   Interested parties can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15

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. The options have a per share exercise price of $1.52, representing the closing price of Invivyd's common stock on the grant date. Each option vests over four years, with 25% of the shares subject to such option vesting on the first anniv