Invivyd Inc

Invivyd, Inc. engages in the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The firm develops antibodies that can neutralize SARS-CoV-2, SARS-CoV-1, and additional emergent coronaviruses. It offers, ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses. The company was founded by Tillman U. Gerngross, Ren Russo and Laura Walker on June 3, 2020 and is headquartered in Waltham, MA.

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Invivyd Inc advances VYD222 for COVID-19, faces regulatory challenges

Invivyd Inc's progress with VYD222 for COVID-19 prevention is promising, supported by FDA clearance and financial stability.
While facing challenges in Phase III preparation and regulatory compliance, the company's strengths in neutralizing activity and biomarker research are notable.
Opportunities lie in market growth, regulatory pathways, and enhancing biomarker expectations for VYD222's success.

Invivyd reports robust Q2 earnings, poised for COVID-19 solution success

Invivyd Inc (IVVD) showcased a strong financial performance and promising progress in commercializing VYD222 during the Q2 2023 earnings call.
While facing challenges such as trial complexities and competitive landscape, the company's strengths in financial stability, positive trial results, and experienced management team position it well for future growth.
Opportunities abound in addressing the urgent need for COVID-19 protection, exploring commercial avenues, and establishing a strong market presence with VYD222.

Invivyd Inc reports robust Q3 performance and prepares for VYD222 launch

Invivyd Inc's Q3 2023 earnings call highlighted strong financial performance, progress in the CANOPY trial for VYD222, and strategic preparations for a potential market launch in 2024.
The company's focus on addressing the urgent need for monoclonal antibodies for immunocompromised individuals aligns with significant market opportunities and positions them for future success.
While facing challenges such as regulatory submissions and competitive pressures, Invivyd Inc remains optimistic about the potential impact of VYD222 and expresses gratitude for investor support.

Invivyd Inc reports strong cash position and FDA collaborations

Invivyd Inc focuses on addressing COVID-19 challenges with high efficacy antibodies.
The company's financials show strong cash position and potential for revenue growth.
Opportunities lie in FDA collaborations, clinical trials, and expanding treatment options.
Challenges include the need for revenue generation and uncertainties in product launch.

Invivyd reports solid Q3 earnings, aims for profitability amid FDA challenges

Invivyd Inc's Q3 2024 earnings call showcased strong commercial performance with $9.3 million in PEMGARDA net product revenue. The company faces challenges with FDA warnings but aims for profitability by June 2025. Opportunities in scaling COVID-19 protection and developing potent antibodies position Invivyd for future growth.

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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 the decision by the Board of Directors to eliminate the Chief Operating Officer role as part of its ongoing efforts to reallocate resources to support the launch of PEMGARDA, resulting in Jeremy Gowler's departure. In the ongoing transitional period, Invivyd's Chief Financial Officer, William Duke, Jr. will assume the role of Principal Executive Officer, and the Board of Directors will continue its ongoing search for a permanent Chief Executive Officer.

Invivyd Announces the Appointment of Timothy Lee as Chief Commercial Officer

WALTHAM, Mass., May 29, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will present preliminary, subset analyses from the CANOPY Phase 3 clinical trial of VYD222 (pemivibart) for pre-exposure prophylaxis of COVID-19 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and at the 2024 American Transplant Congress (ATC).

Invivyd to Present Data at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and 2024 American Transplant Congress (ATC)

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.

Invivyd Elects Two New Independent Members to its Board of Directors

WALTHAM, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that Marc Elia, Chairman of the Invivyd Board of Directors, is scheduled to present in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference on Monday, May 20, 2024 at 3:00 p.m. ET in New York, NY.

Invivyd to Participate at the H.C. Wainwright 2nd Annual BioConnect Investor Conference

Invivyd, Inc. (NASDAQ:IVVD ) Q1 2024 Results Conference Call May 9, 2024 4:30 PM ET Company Participants Scott Young - Vice President of Investor Relations & Corporate Communications Marc Elia - Chairman of Directors Bill Duke - Chief Financial Officer Jeremy Gowler - Interim CEO & Chief Operating & Commercial Officer Mark Wingertzahn - Senior Vice President of Clinical Development & Medical Affairs Robert Allen - Chief Scientific Officer Conference Call Participants Maxwell Skor - Morgan Stanley Patrick Trucchio - H.C. Wainwright & Co Evan Wang - Guggenheim Securities Jenna Li - Jefferies Operator Welcome to the Invivyd conference call.

Invivyd, Inc. (IVVD) Q1 2024 Earnings Call Transcript

Invivyd (NASDAQ: IVVD ) just reported results for the first quarter of 2024. Invivyd reported earnings per share of -38 cents.

IVVD Stock Earnings: Invivyd Meets EPS for Q1 2024

WALTHAM, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced financial results for the quarter ended March 31, 2024, and recent business highlights.

Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

WALTHAM, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced its intention to submit an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people utilizing a rapid immunobridging pathway. This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA. The immunobridging pathway for COVID-19 treatment is enabled by data from the Phase 2/3 clinical trial (STAMP) of adintrevimab, the prototype monoclonal antibody (mAb), for the treatment of COVID-191 and data from the ongoing CANOPY Phase 3 clinical trial of pemivibart for PrEP of COVID-19. The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible. Subsequent to the anticipated submission of an EUA request, Invivyd plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics (PK), and clinical virology.

Invivyd to Pursue Rapid Immunobridging Pathway to Potential EUA for Treatment of COVID-19 in Moderately to Severely Immunocompromised People, Based on U.S. FDA Feedback

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.

Invivyd to Host Conference Call Discussing First Quarter 2024 Financial Results and Business Highlights

WALTHAM, Mass., April 30, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to protection from serious viral infectious diseases, today announced that following a comprehensive strategic review, the company is improving its projected 2024 year-end cash position by approximately $20 million to $25 million. Invivyd now expects to end 2024 with at least $75 million in cash and cash equivalents.

Invivyd Announces $20 Million to $25 Million Improvement in Projected 2024 Year-End Cash Position

Product-specific Q Code (Q0224) facilitates product reimbursement for PEMGARDA; corresponding M Code (M0224) defines reimbursement for product administration Reimbursement through Medicare/Medicaid represents approximately 50% of covered lives in target population WALTHAM, Mass., April 15, 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 U.S. Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) Q code (Q0224) covering product reimbursement for PEMGARDA.

Invivyd Receives Healthcare Common Procedure Coding System (HCPCS) Reimbursement Codes from the U.S. Centers for Medicare & Medicaid Services (CMS) Covering PEMGARDA™

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.

Invivyd Announces CEO Transition

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.

Invivyd Provides PEMGARDA™ Launch Update and Announces 2024 Net Product Revenue Guidance in the Range of $150 Million to $200 Million

WALTHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced financial results for the full year ended December 31, 2023 and recent business highlights.

Invivyd Reports Full Year 2023 Financial Results and Recent Business Highlights

WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced interim exploratory COVID-19 clinical event data for VYD222, an investigational, monoclonal antibody (mAb) in development for the pre-exposure prophylaxis of COVID-19. The data announced today from the ongoing Phase 3 CANOPY clinical trial reflect and add further to the initial potential signal of clinical protection from symptomatic COVID-19 shared in December 2023, and may be useful in updating prior published work that analyzed the relationships between serum virus neutralizing antibody (sVNA) titers and protection in patients who had no prior exposure to vaccination or natural infection.1

Invivyd Announces Interim Exploratory Data on VYD222 from Ongoing CANOPY Clinical Trial

WALTHAM, Mass., March 22, 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™ (pemivibart), formerly VYD222, a half-life extended monoclonal antibody (mAb), has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

WALTHAM, Mass., Feb. 05, 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 David Hering, Chief Executive Officer of Invivyd, is scheduled to present in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Thursday, February 8, 2024 at 1:00 p.m. ET in New York, NY.

Invivyd to Participate at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference

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Invivyd, Inc. (IVVD) has been upgraded to a Zacks Rank #1 (Strong Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

All You Need to Know About Invivyd, Inc. (IVVD) Rating Upgrade to Strong Buy

Invivyd is developing an experimental antibody treatment to prevent COVID-19 in immunocompromised patients. An estimated 9 million immunocompromised patients in the U.S. don't respond strongly enough to today's COVID-19 vaccines.

Invivyd Stock More Than Doubled Last Week. Is It Too Late to Buy?

Invivyd (IVVD) reports positive initial data from the phase III CANOPY study on VYD222 for the prevention of symptomatic COVID-19. Stock shoots up on the news.

Invivyd (IVVD) Surges on Positive Data From COVID-19 Study

VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participants Data supportive of an immunobridging approach to the EVADE study of adintrevimab Overall favorable safety and tolerability profile of VYD222 including no study drug-related serious adverse events (SAEs) to date VYD222 demonstrates continued in-vitro neutralization activity against major SARS-CoV-2 variants, including against HV.1, the currently dominant variant in the U.S.    WALTHAM, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody candidate, for the prevention of symptomatic COVID-19.

Invivyd Announces Positive Initial Results from Ongoing CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of COVID-19

Invivyd, Inc. (NASDAQ:IVVD ) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET Corporate Participants Scott Young - SVP, Investor Relations and Corporate Communications Dave Hering - Chief Executive Officer Pete Schmidt - Chief Medical Officer Jeremy Gowler - Chief Operating and Commercial Officer Bill Duke - Chief Financial Officer Conference Call Participants Patrick Trucchio - H.C. Wainwright Jenna Li - Jefferies Maxwell Skor - Morgan Stanley Evan Wang - Guggenheim Securities Operator Welcome to the Invivyd Third Quarter 2023 Financial Results and Recent Business Highlights Call.

Invivyd, Inc. (IVVD) Q3 2023 Earnings Call Transcript

WALTHAM, Mass., Nov. 09, 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 financial results for the quarter ended September 30, 2023, and recent business highlights.

Invivyd Reports Third Quarter 2023 Financial Results and Recent Business Highlights

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.

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