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)

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

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., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD) today announced that Marc Elia, Chairman of the Invivyd Board of Directors, will be presenting at the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The presentation is set to take place at 1:20 PM ET on Wednesday, February 12th. The live webcast link will be available in the investor section of the company's website at https://investors.invivyd.com and will be archived for approximately 90 days following the event. About InvivydInvivyd, Inc. (NASDAQ:IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd depl

Teaming up to raise awareness of the continuing toll of COVID-19 in America, an ongoing mass disabling event causing an American death approximately every 9 minutes with over 59,000 deaths and 665,000 hospitalizations in 2024, as well as a lifetime of unknown impact, despite widespread vaccinationIn life as in football, Coach Harbaugh believes in options, including for those who are immunocompromised and may continue to live in fear of COVID-19, such as people who have cancer, had an organ transplant, or are on certain medicationsProud to partner with a company driven to provide options for COVID-19, Coach Harbaugh encourages Americans, especially the immunocompromised, to learn more about t

Recruitment completed and all doses administered for VYD2311 ongoing Phase 1/2 clinical trial (40 subjects) evaluating 3 routes of administrationPhase 1/2 clinical data for VYD2311 to date are positive for both safety and pharmacokinetics, and are supported by antiviral activity data from Invivyd's standard virologic assessments Pooled, blinded adverse events (AEs) to date are mild or moderate and thus far deemed unrelated to study drug or largely related to injection site reaction or infusion reactionsAs of Day 65, serum concentrations remain high with half-life not yet reached, indicating potential long clinical dosing intervalIn vitro neutralization potency of VYD2311 assessed across cont

Preliminary Q4 2024 PEMGARDA™ (pemivibart) net product revenue of $13.8 million, 48% growth over Q3 2024 net product revenue of $9.3 millionPreliminary Q4 2024 total operating costs and expenses of approximately $32 million, 55% reduction compared to Q3 2024 operating costs and expenses of $71.6 millionPreliminary ending 2024 cash and cash equivalents of $69.3 million and $10.9 million of accounts receivableContinues to target near-term (by end of 1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of manufacturing expenses Further update to be provided on Q4 2024 earnings call anticipated in late March in conjunc

Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company's previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy startMost recent updated analysis provided to FDA, incorporating current dominant SARS-CoV-2 variant XEC neutralization data, demonstrated substantially higher pemivibart titers in the critical early phase post-dosing (Days 0-5) as compared to adintrevimab Data provided to FDA

New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA™ (pemivibart) against XEC Centers for Disease Control reports XEC and KP.3.1.1 (previously disclosed as susceptible to PEMGARDA) together constitute the majority of national SARS-CoV-2 variantsXEC data underscore continued pemivibart activity in the face of virus evolution including recently emerging types of structural changes to spike N-terminal domainData submitted to FDA, with timely update to PEMGARDA™ Fact Sheet for Healthcare Providers anticipatedContinued consistent activity for almost three years, with no meaningful change to pemivibart neutralization activity anticipated for the foreseeabl

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.

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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

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