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)

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

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

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

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

BTIG Research initiated coverage of Invivyd with a rating of Buy and set a new price target of $10.00

D. Boral Capital downgraded Invivyd from Buy to Hold

Cantor Fitzgerald initiated coverage of Invivyd with a rating of Overweight and set a new price target of $10.00

Guggenheim upgraded Invivyd from Neutral to Buy and set a new price target of $9.00

Morgan Stanley upgraded Invivyd from Equal-Weight to Overweight and set a new price target of $10.00 from $4.00 previously

Morgan Stanley upgraded Invivyd from Underweight to Equal-Weight and set a new price target of $4.00 from $1.00 previously

H.C. Wainwright initiated coverage of Invivyd with a rating of Buy and set a new price target of $5.00

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

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

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

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

LIBERTY is part of the Company's broader REVOLUTION clinical program designed to elaborate the profile of monoclonal antibody-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable AmericansThe LIBERTY clinical trial will evaluate comparative safety and immunology of VYD2311 versus mRNA COVID vaccine, as well as explore the safety and immunology of co-administered VYD2311 and mRNA COVID vaccineFDA, providing feedback jointly from CDER and CBER, requested specific monitoring of adverse events of special interest (AESIs) relevant to mRNA COVID vaccines, citing the known risk of myocarditis/pericarditis in the young adult population following mRNA COVID vaccination;

The educational campaign will focus on teaching the American public about antibodies and preventing infectious diseaseThe collaboration will advance public understanding of antibodies as a centerpiece of modern wellness strategiesMedia campaign planned to launch in spring 2026 following Ms. Vonn's closely watched and inspiring comeback season NEW HAVEN, Conn., Jan. 22, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) today announced a partnership with renowned ski champion Lindsey Vonn to elevate public understanding of antibodies, one of the most important parts of the immune system, and their role in preventing disease. A national multimedia education campaign is planned to launch i

Phase 2 clinical trial will evaluate the safety, translational biology, and exploratory clinical efficacy of VYD2311 in people with Long COVID or COVID vaccine injuryParticipants to include people with Long COVID who demonstrate evidence of chronic infection or antigen persistence in a variety of tissues, and COVID vaccine-injured people including those who have demonstrated persistence of vaccine-delivered spike proteinDesign includes multiple highly active antibody doses administered over the long term to assess the safety and potential clinical benefit of VYD2311 treatment, versus placeboMillions of individuals continue to live with persistent and debilitating symptoms of Long COVID, unde

Preliminary Q4 2025 PEMGARDA® (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth quarter-over-quarterPreliminary ending 2025 cash and cash equivalents of $226.7 million after raising over $200 million from financing transactions in 2H 2025Announced initiation of DECLARATION Phase 3 pivotal clinical trial of vaccine-alternative antibody VYD2311 to prevent COVID, with top-line data expected mid-2026; Fast Track designation for VYD2311 granted by FDA in December 2025Potential best-in-class RSV antibody VBY329 nominated for preclinical developmentPreclinical measles mAb candidate selection targeted for 1H 2026 for treatment and prevention of

NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID. Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are met, programs with Fast Track designation can become eligible for priority review and rolling Biologics License Application (BLA) submission, which can reduce the timelines associated with regulatory

DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of COVID versus placebo, at three months, from a single intramuscular (IM) dose, with protection beyond three months anticipated  A second arm will evaluate monthly IM doses versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk persons seek periodic extra protection from COVIDPrimary endpoint is the reduction of PCR-confirmed symptomatic COVID incidence versus placebo; total expected enrollment of 1770 people across all three armsDECLARATION is part of the Company's REVOLUTION clinical prog

NEW HAVEN, Conn., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) today announced that 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 of the fireside chat will be available in the investor section of the company's website at investors.invivyd.com and will be archived for approximately 90 days following the presentation. About InvivydInvivyd, Inc. (NASDAQ:IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform uni

VBY329 is designed for the prevention of Respiratory Syncytial Virus (RSV) infections in newborns, infants, and children, and results from Invivyd's proprietary antibody discovery technology platformVBY329 meets Invivyd's target profile of higher potency and improved barrier to resistance compared to standard of care RSV medicines, as assessed in vitro: Antiviral potency 1.5-fold greater on average than nirsevimab and 1.2-fold greater on average than clesrovimab against established authentic RSV strains representing circulating variantsResistance profile compared to nirsevimab reflects up to approximately 500-fold greater enhanced neutralization activity against RSV F protein variants resis

NEW HAVEN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (NASDAQ:IVVD) today announced the pricing of an underwritten public offering of 44,000,000 shares of its common stock at an offering price of $2.50 per share and, to certain investors, in lieu of common stock, pre-funded warrants to purchase 6,000,000 shares of its common stock at a price of $2.4999 per pre-funded warrant. The gross proceeds from this offering are expected to be approximately $125.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Invivyd. The purchase price per share of each pre-funded warrant represents the per share offering price for the common s

NEW HAVEN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (NASDAQ:IVVD) today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Invivyd intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of Invivyd common stock sold in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Invivyd. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Can

SC 13D/A - Invivyd, Inc. (0001832038) (Subject)

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NEW HAVEN, Conn., Oct. 28, 2025 (GLOBE NEWSWIRE) -- WHAT: Invivyd, Inc. (NASDAQ:IVVD) is hosting the previously announced live webcast to present an overview of the company's REVOLUTION clinical program, Invivyd's development program for VYD2311, a vaccine-alternative monoclonal antibody candidate for the prevention of COVID. The session will feature key members of the Invivyd team. WHEN: Thursday, October 30, 2025, at 8:30 a.m. ET WHERE: Listeners are advised to join the webcast via the following link 15 minutes prior to the start time. A replay of the webcast will be available via the investor relations section of the company's website approximately two hours after the conclusion of

NEW HAVEN, Conn., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) today announced the appointment of Paul B. Bolno, M.D., to its Board of Directors and as a member of the Compensation Committee. Dr. Bolno is the President and CEO of Wave Life Sciences, a clinical-stage biotechnology company, and has served in those roles since 2013. "We are happy to have Dr. Bolno join our Board at this critical moment while we transition toward a future focused on helping large populations avoid becoming ill from major viral infectious diseases," said Marc Elia, Chairman of the Board of Invivyd. "Dr. Bolno's extensive experience in leading Wave Life Sciences through rapid pipeline developm

NEW HAVEN, Conn., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) today announced the appointment of Kristie Kuhl as Chief Communications Officer. Ms. Kuhl will lead the Company's communications and patient advocacy efforts as Invivyd advances its mission of providing monoclonal antibodies for the prevention and treatment of viral disease. Ms. Kuhl brings deep expertise in healthcare and pharmaceutical communications, and she has been recognized by industry media for her influence in health communications, including PRWeek's 2024 Health Influencer 30. She most recently served as Global Managing Director, Health & Wellness at Zeno Group, where she led the firm's healthcare p

WALTHAM, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) is pleased to announce the appointment of Ajay Royan to its Board of Directors. Mr. Royan is a venture capitalist focused on transformational companies that have solved critical problems in healthcare, technology, and energy. Mr. Royan's investment firm, Mithril, is a significant long-term holder of Invivyd stock, and Mr. Royan led the 2022 shareholder action that focused Invivyd on its mission to deliver protection from serious viral infectious diseases, starting with COVID-19. "We are delighted by Ajay's return to the Board of Invivyd as the company prepares to take the next step forward in scaling the medica

Mr. Lee joins Invivyd with a history of high-quality commercial execution at Alexion, Biohaven and AmylyxAppointment intended to accelerate the addition of commercial capabilities associated with orphan medicines to the ongoing PEMGARDA™ commercial launchWilliam Duke, Jr., Chief Financial Officer, appointed as Principal Executive Officer WALTHAM, Mass., May 31, 2024 (GLOBE NEWSWIRE) --  Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that Timothy Lee will be appointed Invivyd's Chief Commercial Officer and will join the company's executive leadership team. Mr. Lee's appointment follows th

WALTHAM, Mass., May 22, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that two new independent directors, Dr. Srishti Gupta and Kevin F. McLaughlin, were elected to its Board of Directors at the annual meeting of stockholders on May 21, 2024. Dr. Gupta will serve as the Chairperson of the Compensation Committee and Mr. McLaughlin will serve as the Chairperson of the Audit Committee. "We are delighted to welcome Dr. Gupta and Mr. McLaughlin to our Board during a transformational period of growth for the company," said Marc Elia, Chairman of the Invivyd Board of Direc

WALTHAM, Mass., April 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the company's Board of Directors has appointed Jeremy Gowler as Interim Chief Executive Officer (CEO), effective immediately, while the Board institutes a search for a permanent CEO. Mr. Gowler succeeds Dave Hering. "The Invivyd Board of Directors is positioning the company for its next phase of growth," said Marc Elia, Chairperson. "Invivyd is poised to lead a brand-new paradigm in delivering novel, impactful monoclonal antibody (mAb) therapies for the pre-exposure prophylaxis (PrEP)

WALTHAM, Mass., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced the appointment of William Duke as Chief Financial Officer. Mr. Duke will lead Invivyd's financial strategy to support the company's continued growth. Mr. Duke has more than 25 years of finance, accounting, and operations experience, including over a decade of senior leadership experience in the biotechnology industry. "Bill's wealth of financial leadership experience will be invaluable as the company continues to plan for the rapid initiation of a pivotal clinical study, a

WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced the appointment of Sara Cotter to its board of directors. Ms. Cotter brings extensive leadership experience spanning healthcare investment management and drug development. "Ms. Cotter's comprehensive knowledge of the biopharmaceutical industry, pairing both operating and capital markets expertise, make her an excellent addition to our board of directors," said Dave Hering, Chief Executive Officer of Invivyd. "Her keen industry insights and impressive accomplishments in drug d

WALTHAM, Mass., April 12, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced the appointment of Robert Allen as chief scientific officer, and Stacy Price as chief technology and manufacturing officer. In his new role, Dr. Allen will oversee the scientific direction of the company and has responsibility for supporting the discovery of therapies across Invivyd's pipeline. Dr. Allen brings more than 30 years of experience across the infectious disease space. Prior to joining Invivyd, he served as the chief scientific officer of SmartPharm Therapeutics,

NEW HAVEN, Conn., Nov. 03, 2025 (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, November 6, 2025, at 8:30 a.m. ET to discuss its third quarter 2025 financial results and provide a corporate update. Interested parties may join the live webcast by visiting this link and are advised to log in approximately 15 minutes prior to the start of the call. A recording of the webcast will be available on the company's investor relations website shortly after the event. About Invivyd Invivyd, Inc. (NASDAQ:IVVD) is a biopharmaceutical c

PEMGARDA™ (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contracted to an internalized sales forcePEMGARDA revenue re-acceleration observed in Q2 2025 to dateInvivyd continues to target near-term profitability (1H 2025) with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of operating expensesSince Emergency Use Authorization (EUA) of PEMGARDA in March 2024, no documented cases of anaphylaxis reported, across thousands of post-authorization dosesVYD2311 Phase 1 clinical trial data read-out anticipated later in Q2 2025 WALTHAM, Mass., May 15, 2025 (GLOBE NEWSWIR

WALTHAM, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 15, 2025, at 8:30 a.m. ET to discuss its financial results for the first quarter ended March 31, 2025, and provide recent business highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link and are advised to join 15 minutes prior to the start time. A replay of the webcast will be available via the company's investor relations website approximately two

Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with $106.9 million in cash and cash equivalentsTargets near-term (1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and various operational efficiency improvementsPEMGARDA Fact Sheet updated to properly reflect neutralization activity of PEMGARDA against current circulating variants tested; on track for continued growth now reflective of ongoing commercial optimizationNext generation molecule VYD2311 first-in-human clinical trial dosing began in August 2024 with anticipated preliminary data readout late Q4 2024Management to host conference call t

WALTHAM, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, November 14, 2024, at 8:30 a.m. ET to discuss its financial results for the third quarter ended September 30, 2024, and provide recent business highlights. Invivyd reported preliminary third quarter 2024 results via press release on October 29, 2024. Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link and are advised to join 15 minutes prior to the start time.

In all-comer cohort of immunocompetent individuals at risk of contracting symptomatic COVID-19 in their everyday social interactions, participants receiving pemivibart experienced a 1.9% rate of confirmed symptomatic COVID-19 compared to an 11.9% rate for participants receiving placebo, an 84% relative risk reduction (nominal p= 0.000061)In immunocompromised participants, pemivibart demonstrated a rate of 3% of confirmed symptomatic COVID-19, an encouraging potential signal of protection during the assessed time periodCANOPY data from planned exploratory clinical efficacy analyses during the 180-day period that included XBB* and JN.1* virus lineages Safety profile of pemivibart consistent wi

PEMGARDA™ launched commercially in Q2 2024 with $2.3 million of net product revenueNotable acceleration of commercial results in early Q3 2024, with the anticipated peak fall/winter respiratory virus season approachingNew commercial leadership with Chief Commercial Officer, Tim Lee, an experienced biopharmaceutical leader with demonstrated commercial successAchieved Medicare and Medicaid coverage, rapid growth in commercial coverage across national and regional plans, and strong growth in infusion center utilizationSubmitted Emergency Use Authorization (EUA) amendment request to U.S. FDA for PEMGARDA for the treatment of mild-to-moderate COVID-19 in certain immunocompromised patientsNext gen

WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Wednesday, August 14, 2024, at 8:30 a.m. ET to discuss its financial results for the second quarter ended June 30, 2024, and recent business highlights. Listeners 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

Launched PEMGARDA™ in the U.S. for COVID-19 pre-exposure prophylaxis (PrEP) in certain adults and adolescents with moderate-to-severe immune compromiseReported interim exploratory COVID-19 clinical event data from CANOPY Phase 3 clinical trial of VYD222 Received product-specific reimbursement codes covering PEMGARDA from the U.S. Centers for Medicare & Medicaid Services (CMS), covering approximately half of target populationAnnounced plans to pursue rapid immunobridging pathway to potential EUA for COVID-19 treatment in certain immunocompromised people, based on U.S. FDA feedbackContinued to advance VYD2311, the company's next monoclonal antibody candidate engineered with the company's state

WALTHAM, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 9, 2024, at 4:30 p.m. ET to discuss its financial results for the first quarter ended March 31, 2024, and recent business highlights. Listeners 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 advise