S-3 - Invivyd, Inc. (0001832038) (Filer)

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

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

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

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

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

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

424B5 - Invivyd, Inc. (0001832038) (Filer)

FWP - Invivyd, Inc. (0001832038) (Subject)

424B5 - Invivyd, Inc. (0001832038) (Filer)

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)

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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)

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

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

SPEAR proposal reflects current evidence on monoclonal antibodies in treatment for Long COVID and identifies VYD2311 as a promising next-generation candidate for the clinical study Recommendation is for a robust, comprehensive, translational study to evaluate the ability of VYD2311 to decrease circulating spike protein in eligible patients and to explore potential associated clinical benefits Study design contemplates maintaining high antiviral antibody titers over an extended period to maximally suppress underlying chronic infection that may drive Long COVID pathologyDrs. Amy Proal and David Putrino to present on behalf of SPEAR Study Group WALTHAM, Mass., Sept. 04, 2025 (GLOBE NEWSWIR

WALTHAM, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) today announced that it will present at the following investor conferences: Cantor Global Healthcare Conference 2025Fireside Chat Date: Wednesday, September 3, 2025Fireside Chat Time: 2:10 PM ETLocation: New York, NY H.C. Wainwright 27th Annual Global Investment ConferenceFireside Chat Date: Monday, September 8, 2025Fireside Chat Time: 12:00 PM ETLocation: New York, NY 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 for approximately 30 days following each event. In addition to the fireside chats, the

WALTHAM, Mass., Aug. 22, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (NASDAQ:IVVD) today announced the closing of its previously announced underwritten public offering of 89,234,480 shares of its common stock, which includes the exercise in full by the underwriter of its option to purchase an additional 14,423,076 shares of common stock, at a public offering price of $0.52 per share and pre-funded warrants to purchase 21,342,442 shares of its common stock at a public offering price of $0.5199 per pre-funded warrant, which represents the per share price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. All of the shares and pre-funded warr

WALTHAM, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (NASDAQ:IVVD) today announced the pricing of an underwritten public offering of 74,811,404 shares of its common stock at an offering price of $0.52 per share and, to certain investors, in lieu of common stock, pre-funded warrants to purchase 21,342,442 shares of its common stock at a price of $0.5199 per pre-funded warrant. The gross proceeds from this offering are expected to be approximately $50.0 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 sto

WALTHAM, Mass., Aug. 20, 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. Canto

New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA® (pemivibart) against XFG Centers for Disease Control data and wastewater surveillance data indicate XFG variant appears to be driving a growing wave of COVID-19 in AmericaVYD2311 in vitro neutralization data demonstrate similarly consistent and highly potent results against XFGSimilar new, positive in vitro neutralization data for pemivibart and VYD2311 against other SARS-CoV-2 viruses currently circulating in the U.S. (NB.1.8.1 ("Nimbus") and LF.7.9, as well as LP.8.1) affirm Invivyd's unique technology, reflect consistently stable target epitopes, and indicate ongoing, complete coverage of any te

PEMGARDA® (pemivibart) net product revenue of $11.8 million reported for Q2 2025, representing 413% growth year-over-yearInvivyd's target of near-term profitability (1H 2025) was not met but remains possible with the upcoming respiratory virus seasonAnnounced alignment with U.S. FDA on rapid pathway to full approval (BLA) of vaccine alternative monoclonal antibody candidate VYD2311 to protect American adults and adolescents from COVID-19Announced attractive safety profile and pharmacokinetics data for VYD2311 from our pre-pivotal first-in-human clinical trial, including 76-day observed half-life for IM route of administration, allowing for potential long-term protection WALTHAM, Mass., Aug.

Alignment follows Type C meeting for VYD2311 as previously disclosed BLA pathway for VYD2311 to be supported by a single, Phase 2/3 randomized, double-blind, placebo-controlled trial with a primary endpoint of reduction in symptomatic COVID-19, resembling CANOPY Cohort BCompany's target product profile is low-dose, intramuscular, scalable, low-cost, long-lasting, protective option for target populations, including adults and adolescents (12 years+; 40kg+) and, subject to FDA alignment, pediatrics (aged 0 to 12 years)Anticipate compact trial (12-week primary endpoint analysis) evaluating prevention of COVID-19 largely among ordinary Americans, enabling rapid enrollmentPlanned head-to-head saf

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

PEMGARDA now commercially available in the U.S. for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise Based on anticipated net product revenue and continued optimization of operational expenses, company expects to end 2024 with at least $55 million in cash and cash equivalentsConference call today at 5 pm ET to discuss PEMGARDA launch progress WALTHAM, Mass., April 04, 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 PEMGARDA™ is now available for purchase in the U.S. On March 22,

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,