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

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

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

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

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

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

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

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

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

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

The New England Journal of Medicine (NEJM) Letter to the Editor outlines the novel, rapid immunobridging authorization pathway for PEMGARDA and provides an updated correlate of protection curve for monoclonal antibody protection from symptomatic COVID-19The updated correlate of protection analysis published in the Letter to the Editor indicates the potential for strong protection from symptomatic COVID-19 at titer levels well below doses explored clinically with pemivibart, consistent with recently disclosed CANOPY exploratory efficacy data, and useful for future drug developmentCompany expresses disappointment in NEJM's publication of a separate Letter to the Editor from a third-party, acad

CANOPY manuscript preprint includes six-month off-drug follow-up period that highlighted strong protection by pemivibart versus placebo in the immunocompetent Cohort B during KP.3 and KP.3.1.1 dominant waveCANOPY exploratory clinical efficacy data, to date, reconfirm a high level of risk reduction from developing symptomatic COVID-19 in immunocompetent participantsPreprint describes Invivyd scientists' novel method for predicting the activity of a monoclonal antibody in the face of variant evolution; method predicts continued neutralization activity for pemivibart against SARS-CoV-2 variant XEC, with formal assay assessment pending WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Inviv

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.

Preliminary Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with approximately $107 million in cash and cash equivalentsExpects to finish 2024 with $65 million or more in cash and cash equivalentsWithdraws formal revenue guidance due to recent growth headwind from U.S. FDA's late-Q3 2024 warning on potential for substantially reduced activity of pemivibart through the PEMGARDA Fact Sheet and other media based on contested, third-party, non-peer-reviewed, non-reproducible, virologic activity data from a non-pemivibart antibodyTargets near-term (1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, a

Following strong protection (84% relative risk reduction versus placebo) demonstrated through month 6 with pemivibart, CANOPY clinical trial participants were followed for an additional six-month period (months 7-12), with no additional doses, to assess safety and efficacy as drug concentrations declined over timeIn the six-month off-drug follow-up period (months 7-12), substantially reduced concentrations of PEMGARDA reduced the risk of symptomatic COVID-19 by 64% compared to placebo in an immunocompetent adult population, for total twelve-month risk reduction of 76% following two initial pemivibart doses (nominal p <0.0001)Months 7-12 follow-up period included the U.S. summer KP.3 and KP.3

WALTHAM, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced the upcoming presentations of pemivibart data from its Phase 1 and Phase 3 clinical trials at IDWeek 2024. The conference is being held in Los Angeles, October 16-19, 2024. Invivyd will be presenting the following oral and poster presentations: TitlePresenting AuthorPresentation TimingOral Presentation: Clinical Efficacy Endpoints from the Phase 3 CANOPY Study Evaluating Pemivibart ​Anna Holmes, Ph.D., Principal Clinical ScientistOctober 17 (11:18-11:30am PT/2:18 -2:30pm ET)​Poster: Results from

KP.3.1.1 and LB.1 in vitro neutralization potency values now reflected in the PEMGARDA Fact Sheet for Healthcare Providers are in-line with prior variants, including variants represented in the CANOPY Phase 3 clinical trialInvivyd continues active variant monitoring using validated, robust methods and is not aware of any circulating variants not susceptible to PEMGARDA at this time WALTHAM, Mass., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has re-issued an updated Emergency Use Authorization (EUA) Fact S

Independent evaluation of KP.3.1.1 and LB.1 variants shows in vitro pseudovirus neutralization potency of PEMGARDA in-line with prior variants testedProprietary, ongoing SARS-CoV-2 spike analyses demonstrate consistent structural stability of the pemivibart binding site to date, which has routinely predicted sustained pemivibart in vitro neutralization activity Potential emerging variants, such as XEC and LP.1, encode mutations that are distal from the pemivibart binding site, and, therefore, are also not expected to meaningfully alter pemivibart activity; routine neutralization analysis will follow in ordinary course to assess potential for epistasis or allostery WALTHAM, Mass., Sept. 2

Centers for Disease Control and Prevention (CDC) reports death rate due to COVID-19 has continued to increase throughout 2024 Immunocompromised patients at greatest risk for serious infections or even death due to COVID-19 PEMGARDA™ available under Emergency Use Authorization (EUA) for certain immunocompromised adults and adolescents; recommended by Infectious Disease Society of Americas (IDSA) guidelinesCovered by Medicare and Medicaid and has achieved rapid growth in commercial coverage across national and regional plans, including United Health Care, Aetna, Cigna, and Regional Blue Cross Blue Shield plansContinued neutralizing activity of PEMGARDA™ shown against dominant SARS-CoV-2 varian

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

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

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

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

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

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

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

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

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

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

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

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,

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