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Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of antibody-based solutions for infectious diseases in the United States. The company's lead product candidate is the ADG20 (adintrevimab), a neutralizing antibody that is in Phase 3 clinical trials for the treatment and prevention of coronavirus disease. Adagio Therapeutics, Inc. has a collaboration agreement with Adimab, LLC for the discovery and optimization of proprietary antibodies; and the Scripps Research Institute to perform research activities to identify vaccine candidates for the prevention, diagnosis or treatment of influenza or beta coronaviruses. The company was incorporated in 2020 and is based in Waltham, Massachusetts.

Invivyd, Inc.

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WALTHAM, MASS., AUG. 14, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD) TODAY ANNOUNCED FINANCIAL RESULTS FOR THE QUARTER ENDED JUNE 30, 2025, AND PROVIDED RECENT BUSINESS HIGHLIGHTS.

INVIVYD REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

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 B COMPANY'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 ENROLLMENT PLANNED HEAD-TO-HEAD SAFETY EVALUATION WITH COVID-19 VACCINE, PENDING REGULATORY ALIGNMENT QUANTITIES OF VYD2311 POTENTIAL COMMERCIAL LAUNCH PRODUCT AVAILABLE WALTHAM, MASS., AUG. 14, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD) TODAY ANNOUNCED IT HAS RECEIVED AND IS ALIGNED WITH ADVICE FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) ON A COMPACT AND, THEREFORE, RAPID PATHWAY TO POTENTIAL BIOLOGICS LICENSE APPLICATION (BLA) APPROVAL FOR INVIVYD'S NOVEL MONOCLONAL ANTIBODY (MAB) CANDIDATE VYD2311, FOR THE PREVENTION OF COVID-19.

INVIVYD ALIGNS WITH U.S. FDA ON RAPID PATHWAY TO FULL APPROVAL (BLA) OF VACCINE ALTERNATIVE MONOCLONAL ANTIBODY VYD2311 TO PROTECT AMERICAN ADULTS AND ADOLESCENTS FROM COVID-19

WALTHAM, MASS., JULY 23, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD), TODAY ANNOUNCED THE ADDITION OF AKIKO IWASAKI, PH.D., PROFESSOR OF IMMUNOBIOLOGY AT YALE SCHOOL OF MEDICINE, TO THE SPEAR (SPIKE PROTEIN ELIMINATION AND RECOVERY) STUDY GROUP. THE SPEAR STUDY GROUP WAS LAUNCHED EARLIER THIS MONTH TO FOCUS ON THE BIOLOGY AND CLINICAL DISEASE OR INJURY ASSOCIATED WITH PERSISTENT PRESENCE OF SPIKE ANTIGEN FROM SARS-COV-2 VIRUS OR COVID-19 VACCINES.

SCIENTIST DR. AKIKO IWASAKI JOINS SPEAR STUDY GROUP TO INVESTIGATE MONOCLONAL ANTIBODIES FOR LONG COVID AND COVID-19 POST-VACCINATION SYNDROME

NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) GUIDELINES RECOMMEND MONOCLONAL ANTIBODIES FOR COVID-19 PREVENTION IN PEOPLE WITH CANCER; NEW DATA PUBLISHED

NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) GUIDELINES RECOMMEND MONOCLONAL ANTIBODIES FOR COVID-19 PREVENTION IN PEOPLE WITH CANCER; NEW DATA PUBLISHED IN JAMA ONCOLOGY UNDERSCORE SEVERE IMPACT OF COVID-19 ON THIS POPULATION

INVIVYD FORMS SPEAR (SPIKE PROTEIN ELIMINATION AND RECOVERY) STUDY GROUP WITH RESEARCHES TO ASSESS EFFECTS OF MONOCLONAL ANTIBODY THERAPY FOR LONG COVID

INVIVYD AND LEADING RESEARCHERS FORM SPEAR (SPIKE PROTEIN ELIMINATION AND RECOVERY) STUDY GROUP TO ASSESS THE EFFECTS OF MONOCLONAL ANTIBODY THERAPY FOR LONG COVID ANDCOVID-19 POST-VACCINATION SYNDROME

WALTHAM, MASS., JUNE 26, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD), TODAY ANNOUNCED FULL PHASE 1/2 CLINICAL DATA FOR VYD2311, A NEXT-GENERATION MONOCLONAL ANTIBODY (MAB) CANDIDATE DESIGNED TO PREVENT AND TREAT COVID-19.

INVIVYD ANNOUNCES POSITIVE FULL PHASE 1/2 CLINICAL DATA FOR VYD2311, A NEXT GENERATION COVID-19 MONOCLONAL ANTIBODY FOR POTENTIAL USE AS A NON-VACCINE PREVENTATIVE AND FOR TREATMENT OF ACTIVE INFECTION

WALTHAM, MASS., MAY 27, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD) TODAY ANNOUNCED THAT RESULTS FROM ITS CANOPY PHASE 3 CLINICAL TRIAL OF PEMIVIBART HAVE BEEN PUBLISHED ONLINE AS AN ADVANCE ARTICLE IN THE PEER-REVIEWED JOURNAL CLINICAL INFECTIOUS DISEASES (CID), AVAILABLE HERE.THE PUBLICATION, TITLED SAFETY AND EFFICACY OF PEMIVIBART, A LONG-ACTING MONOCLONAL ANTIBODY, FOR PREVENTION OF SYMPTOMATIC COVID-19: INTERIM RESULTS FROM A PHASE 3 RANDOMIZED CLINICAL TRIAL (CANOPY) HIGHLIGHTS ATTRACTIVE SAFETY, SUBSTANTIAL CLINICAL ANTIVIRAL ACTIVITY, THE IMMUNOBRIDGE BETWEEN CALCULATED SERUM VIRUS NEUTRALIZING ANTIBODY (SVNA) TITERS AND PEMIVIBART AND HISTORICAL CLINICAL EFFICACY DATA, AND NOMINALLY STATISTICALLY SIGNIFICANT AND CLINICALLY MEANINGFUL EFFICACY OF PEMIVIBART VERSUS PLACEBO IN A CONTEMPORARY U.S. POPULATION FACING, IMMUNE-EVASIVE OMICRON SARS-COV-2 VIRUSES.

INVIVYD ANNOUNCES PUBLICATION OF LANDMARK CANOPY PHASE 3 PEMGARDA (PEMIVIBART) CLINICAL TRIAL; RESULTS UNDERSCORE STRONG EFFICACY OF MONOCLONAL ANTIBODIES IN PREVENTING COVID-19 IN A MODERN U.S. POPULATION AGAINST RELEVANT, IMMUNE-EVASIVE SARS-COV-2 VIRUS

WALTHAM, MASS., MAY 23, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD), TODAY ANNOUNCED THAT PEMGARDA (PEMIVIBART), ITS INVESTIGATIONAL MONOCLONAL ANTIBODY, HAS BEEN ADDED TO THE NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) CLINICAL PRACTICE GUIDELINES IN ONCOLOGY FOR B-CELL LYMPHOMAS. NCCN JOINS THE INFECTIOUS DISEASE SOCIETY OF AMERICA (IDSA) THAT UPDATED ITS COVID-19 GUIDELINES IN AUGUST 2024 TO RECOMMEND THE USE OF PEMGARDA (PEMIVIBART) FOR PRE-EXPOSURE PROPHYLAXIS (PREP) IN MODERATELY TO SEVERELY IMMUNOCOMPROMISED ADULTS AND ADOLESCENTS (AGED 12 OR OLDER) AT RISK FOR PROGRESSION TO SEVERE COVID-19 WHEN PREDOMINANT REGIONAL VARIANTS ARE SUSCEPTIBLE TO PEMIVIBART.

INVIVYD ANNOUNCES INCLUSION OF PEMGARDA (PEMIVIBART) IN NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN)CLINICAL PRACTICE GUIDELINES IN ONCOLOGY FOR B-CELL LYMPHOMAS

FDA ACKNOWLEDGES THAT THE BENEFIT OF REPEAT DOSES OF COVID-19 VACCINE BOOSTERS FOR AMERICANS IS UNCERTAIN; THE UPDATED REGULATORY FRAMEWORK FOR COVID-19 VACCINES ARTICULATED BY THE AGENCY GENERALLY ALIGNS WITH RECENT INVIVYD CITIZEN PETITION REQUESTS IN CONTRAST TO VACCINE BOOSTERS, MONOCLONAL ANTIBODY (MAB) THERAPIES, INCLUDING PEMIVIBART, UNDERWENT CONTEMPORARY RANDOMIZED, PLACEBO-CONTROLLED TRIALS TO EVALUATE SAFETY, IMMUNOGENICITY, AND EXPLORATORY EFFICACY IN RELEVANT, MODERN AMERICANS, AGAINST RELEVANT, MODERN IMMUNE-EVASIVE SARS-COV-2 VIRUSES, AND OVER THE LONG-TERM INVIVYD PLANS TO ADVANCE NEXT GENERATION COVID-19 MABS TO IMPROVE PRODUCT SCALABILITY AND SYSTEM-FRIENDLINESS WHILE PRESERVING STRONG ANTICIPATED MAB PREVENTATIVE EFFICACY; ADDITIONAL DATA ON INVIVYD'S INVESTIGATIONAL MAB VYD2311 EXPECTED THIS QUARTER INVIVYD PLANS TO ENGAGE FDA SHORTLY ON AN EXPEDITED PATHWAY TO DEVELOP HIGH-QUALITY, SCALABLE COVID-19 PREVENTION AND TREATMENT OPTIONS URGENTLY NEEDED BY HIGH-RISK POPULATIONS IDENTIFIED BY THE FDA WALTHAM, MASS., MAY 21, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD), TODAY COMMENDS NEW U.S. FOOD AND DRUG ADMINISTRATION (FDA) LEADERSHIP ON TAKING IMPORTANT STEPS TO ACKNOWLEDGE AND RESOLVE THE SIGNIFICANT UNCERTAINTY SURROUNDING THE CONTEMPORARY COVID-19 VACCINE BOOSTER EFFICACY LANDSCAPE.

INVIVYD COMMENDS FDA FOCUS ON CONTEMPORARY EVIDENCE IN EVALUATING MEDICAL INTERVENTIONS TO PREVENT COVID-19

WALTHAM, MASS., MAY 15, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD) TODAY ANNOUNCED FINANCIAL RESULTS FOR THE QUARTER ENDED MARCH 31, 2025, AND PROVIDED RECENT BUSINESS HIGHLIGHTS.

INVIVYD REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

WALTHAM, MASS., MAY 14, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD) TODAY ANNOUNCED IT HAS SUBMITTED A CITIZEN PETITION WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) CALLING ON THE AGENCY TO EVOLVE FROM HISTORICAL APPROACHES TO THE DEVELOPMENT OF VACCINES AND MONOCLONAL ANTIBODIES (MABS) FOR COVID-19 PREVENTION, IN ORDER TO REBUILD AMERICAN'S TRUST IN SCIENTIFIC DATA, PUBLIC HEALTH RECOMMENDATIONS, AND PREVENTATIVES, INCLUDING MABS AND VACCINES, WHEN EFFECTIVE. AMERICANS WILL NEED A ROBUST ARSENAL TO MANAGE COVID-19 AND OTHER VIRAL INFECTIOUS DISEASE FOR DECADES TO COME.

INVIVYD FILES CITIZEN PETITION URGING FDA TO FOCUS ON MONOCLONAL ANTIBODIES FOR ENDEMIC-VIRUS-ERA COVID-19 PREVENTION, AND TO RE-ASSESS COVID-19 VACCINE EFFICACY

WALTHAM, MASS., MAY 13, 2025 (GLOBE NEWSWIRE) -- INVIVYD, INC. (NASDAQ: IVVD) TODAY ANNOUNCED THAT MANAGEMENT WILL PARTICIPATE IN A FIRESIDE CHAT AT THE H.C. WAINWRIGHT 3RD ANNUAL BIOCONNECT INVESTOR CONFERENCE ON TUESDAY, MAY 20, 2025, AT 11:00 A.M. ET IN NEW YORK, NY.

Invivyd, Inc.

IVVD

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Invivyd, Inc.

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