IVVD - Earnings announcements

Confirmed, pooled, blinded COVID-19 events in the ongoing Phase 3 DECLARATION study of VYD2311 accumulated to date (~ 50% of study progress) can already provide sufficient statistical power to support the high end of anticipated VYD2311 efficacy Invivyd conducted a pre-specified sample size re-estimation analysis when 1,500 of 1,818 enrolled patients reached Day 45 of 90 total days (April 6th), designed to add robustness given future event rate variability; that upsizing was triggered and increases confidence in overall study statistical powerDECLARATION upsizing provides ~500 additional subjects and will likely shift study result timing modestly, by approximately two months, from original "

Achieved Q4 2025 PEMGARDA® (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth quarter-over-quarter2025 year-end 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 2025DECLARATION trial on track with full enrollment achievedDECLARATION trial Independent Data Monitoring Committee (IDMC) prespecified review of unblinded VYD2311 safety data resulted in IDMC re

NEW HAVEN, Conn., March 02, 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, March 5, 2026, at 8:30 a.m. ET to discuss its fourth quarter and full-year 2025 financial results and provide a corporate update. Interested parties may join the live webcast by visiting this link. Analysts wishing to participate in the question-and-answer session should use this link. Those who plan on participating are advised to join 15 minutes prior to the start time. A recording of the webcast will be available on the company's investor rel

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

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,

PEMGARDA (pemivibart) is authorized in the U.S. for PrEP of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise Emergency use authorization based on positive immunobridging data and on safety data from the CANOPY clinical trial along with ongoing in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1PEMGARDA is the first PrEP monoclonal antibody (mAb) to receive EUA from the U.S. FDA based on a novel, rapid, repeatable immunobridging trial design PEMGARDA is the first authorized mAb from Invivyd's novel technology platform approach designed to address the challenge of rapid viral evolutionProduct availability in the U.S. anticipated

Enrollment completed in CANOPY Phase 3 pivotal clinical trial investigating VYD222 for the prevention of symptomatic COVID-19Company expects to have initial CANOPY primary endpoint data by late 2023 or early Q1 2024Company aims to submit an application for Emergency Use Authorization (EUA) in the U.S. as soon as practicableCompany continues to advance INVYMABTM, its proprietary platform approach designed for rapid, serial generation of new antibodies to address viral threatsCash, cash equivalents and marketable securities of $264.9 million expected to support operating runway remains into the fourth quarter of 2024, excluding potential contribution of commercial product revenue Conference ca

WALTHAM, Mass., Nov. 02, 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 that it will host a conference call on Thursday, November 9, 2023, at 4:30 p.m. ET to discuss its financial results for the quarter ended September 30, 2023, 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 in the investor section of the company's website approximately two hours after the end of the call. Those

Reported positive initial Phase 1 VYD222 clinical trial data, including favorable safety data and robust serum neutralizing titers from all three dose levels testedPlans to pursue rapid initiation of a 750-participant pivotal clinical trial of VYD222 (CANOPY) that will utilize Day 28 serum neutralizing titers from a subset of the population as part of a potential EUA submission for the prevention of symptomatic COVID-19The company expects to have initial primary endpoint data from CANOPY by approximately the end of 2023Cash, cash equivalents and marketable securities of $298.4 million expected to support operating runway into the fourth quarter of 2024, excluding potential contribution of co

WALTHAM, Mass., Aug. 03, 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 that it will host a conference call on Thursday, August 10, 2023, at 4:30 p.m. ET to discuss its financial results for the quarter ended June 30, 2023, 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 in the investor section of the company's website approximately two hours after the end of the call. Those who p

Completed dosing of the Phase 1 clinical trial of VYD222, a broadly neutralizing monoclonal antibody (mAb) candidate being developed to protect immunocompromised people from COVID-19 Initial data readouts from Phase 1 VYD222 clinical trial planned for Q2 with additional clinical readouts from the VYD222 program anticipated in 2023 Published landmark clinical research in Science Translational Medicine that provides strong scientific rationale for using surrogate endpoints to expedite clinical development of mAbs for the prevention of symptomatic COVID-19 Well capitalized with $333.4 million in cash, cash equivalents and marketable securities expected to support operating runway into

WALTHAM, Mass., May 04, 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 that it will host a conference call on Thursday, May 11, 2023, at 4:30 p.m. ET to discuss its financial results for the quarter ended March 31, 2023, 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 in the investor section of the company's website approximately two hours after the end of the call. Those who plan

Advancing VYD222 into clinical development based on in vitro data demonstrating neutralizing activity against multiple important variants of concern, including XBB.1.5 Anticipate near-term designation of an additional monoclonal antibody against SARS-CoV-2 with complementary binding properties to VYD222 for development Well capitalized with $372 million in cash, cash equivalents and marketable securities expected to support operating runway into second half of 2024 Conference call scheduled for Thursday, March 23rd at 4:30 p.m. ET WALTHAM, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulne

WALTHAM, Mass., March 16, 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 that it will host a conference call on Thursday, March 23, 2023, at 4:30 p.m. ET to discuss its financial results for the full year ended December 31, 2022, 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