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Avidity Biosciences, Inc., a biopharmaceutical company, engages in the development of oligonucleotide-based therapies. It develops antibody oligonucleotide conjugates (AOC) that are designed to treat a range of serious diseases. The company's lead product candidate AOC 1001 is used for the treatment of myotonic dystrophy type 1, a rare monogenic muscle disease; AOC 1044 for the treatment of Duchenne Muscular Dystrophy; and AOC 1020 designed to treat facioscapulohumeral muscular dystrophy which are in preclinical stage. It also offers Lumizyme therapy for Pompe diseases. Avidity Biosciences, Inc. was incorporated in 2012 and is headquartered in San Diego, California.

Avidity Biosciences, Inc.

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ALIGNED WITH FDA ON DEL-BRAX ACCELERATED AND FULL APPROVAL PATHWAYS FOR FSHD, REPORTED POSITIVE TOPLINE DATA FROM PHASE 1/2 FORTITUDE TRIAL, AND INITIATED GLOBAL CONFIRMATORY PHASE 3 STUDY PLANNED DEL-ZOTA BLA SUBMISSION AT YEAR END 2025 FOR DMD44 ON TRACK TO BE AVIDITY'S FIRST BLA SUBMISSION ON TRACK FOR THREE POTENTIAL BLA SUBMISSIONS OVER A 12-MONTH PERIOD STRONG BALANCE SHEET AND CASH RUNWAY TO MID-2027 ENABLING GLOBAL COMMERCIAL LAUNCH READINESS; FIRST POTENTIAL COMMERCIAL LAUNCH IN U.S. IN 2026 SAN DIEGO , AUG. 7, 2025 /PRNEWSWIRE/ -- AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS) TO PROFOUNDLY IMPROVE PEOPLE'S LIVES, TODAY REPORTED FINANCIAL RESULTS FOR THE SECOND QUARTER ENDED JUNE 30, 2025 AND HIGHLIGHTED RECENT PROGRESS. "AVIDITY CONTINUES TO DELIVER ON ITS LEADERSHIP IN RNA THERAPEUTICS AS WE PREPARE FOR THREE POTENTIAL BLA SUBMISSIONS IN A 12-MONTH PERIOD WITH STRONG CLINICAL DATA, REGULATORY PROGRESS, AND OPERATIONAL EXECUTION," SAID SARAH BOYCE, PRESIDENT AND CHIEF EXECUTIVE OFFICER OF AVIDITY.

AVIDITY BIOSCIENCES REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS AND RECENT HIGHLIGHTS

--TOPLINE DATA READOUT FROM HARBOR STUDY ANTICIPATED IN Q2 2026 -- -- MARKETING APPLICATION SUBMISSIONS FOR DEL-DESIRAN INCLUDING IN U.S., EU AND JAPAN ANTICIPATED TO START IN H2 2026; ON TRACK TO POTENTIALLY BE THE FIRST GLOBALLY APPROVED DRUG FOR DM1-- -- ON TRACK TO SHARE UPDATES FROM ONGOING MARINA-OLE TRIAL OF DEL-DESIRAN INCLUDING LONG-TERM 4 MG/KG EFFICACY AND SAFETY DATA IN Q4 2025 -- SAN DIEGO , JULY 28, 2025 /PRNEWSWIRE/ -- AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS), TODAY ANNOUNCED THE COMPLETION OF ENROLLMENT IN THE ONGOING GLOBAL PHASE 3 HARBOR CLINICAL TRIAL OF DELPACIBART ETEDESIRAN (DEL-DESIRAN) FOR PEOPLE LIVING WITH MYOTONIC DYSTROPHY TYPE 1 (DM1). TOPLINE DATA FROM HARBOR, THE FIRST GLOBAL PHASE 3 CLINICAL TRIAL IN DM1, ARE ANTICIPATED IN THE SECOND QUARTER OF 2026.

AVIDITY BIOSCIENCES ANNOUNCES COMPLETION OF ENROLLMENT FOR HARBOR, THE FIRST GLOBAL PHASE 3 TRIAL OF DELPACIBART ETEDESIRAN (DEL-DESIRAN) FOR TREATMENT OF DM1 AND PROVIDES GUIDANCE ON REGULATORY SUBMISSION

-- ON TRACK FOR PLANNED BLA SUBMISSION FOR DEL-ZOTA AT YEAR END 2025 -- SAN DIEGO , JULY 23, 2025 /PRNEWSWIRE/ --AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS), TODAY ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS GRANTED BREAKTHROUGH THERAPY DESIGNATION TO DELPACIBART ZOTADIRSEN (DEL-ZOTA) FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PEOPLE LIVING WITH MUTATIONS AMENABLE TO EXON 44 SKIPPING (DMD44). DEL-ZOTA IS CURRENTLY BEING ASSESSED IN THE PHASE 2 EXPLORE44OPEN-LABEL EXTENSION (EXPLORE44-OLE)TRIAL FOR PEOPLE LIVING WITH DMD44 AND IS THE FIRST OF MULTIPLE AOCS THE COMPANY IS DEVELOPING FOR DMD.

AVIDITY BIOSCIENCES RECEIVES FDA BREAKTHROUGH THERAPY DESIGNATION FOR DELPACIBART ZOTADIRSEN (DEL-ZOTA) FOR THE TREATMENT OF DMD IN PEOPLE WITH MUTATIONS AMENABLE TO EXON 44 SKIPPING

-- FDA ALIGNMENT ON ACCELERATED AND FULL APPROVAL PATHWAYS FOR DELPACIBART BRAXLOSIRAN (DEL-BRAX) IN FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (FSHD) -- -- JEFFREY M. STATLAND, M.D.

AVIDITY BIOSCIENCES TO PRESENT TOPLINE DATA FROM PHASE 1/2 FORTITUDE TRIAL OF DEL-BRAX IN PEOPLE LIVING WITH FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY AT 32ND ANNUAL FSHD SOCIETY INTERNATIONAL RESEARCH CONGRESS

-- UNPRECEDENTED DATA FROM FORTITUDE DOSE ESCALATION COHORTS FOR DEL-BRAX TREATED PARTICIPANTS, COMPARED TO PLACEBO, DEMONSTRATE IMPROVEMENT IN FUNCTION, STRENGTH AND PROS AS WELL AS RAPID AND SIGNIFICANT REDUCTION IN BIOMARKERS -- -- DATA SUPPORT PLANNED ACCELERATED APPROVAL BLA SUBMISSION IN H2 2026 -- -- DATA BEING PRESENTED AT THE 32ND ANNUAL FSHD SOCIETY INTERNATIONAL RESEARCH CONGRESS (IRC); INVESTOR AND ANALYST WEBCAST EVENT TODAY, MONDAY, JUNE 9 AT 8:00 A.M. ET -- SAN DIEGO , JUNE 9, 2025 /PRNEWSWIRE/ -- AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS) TO PROFOUNDLY IMPROVE PEOPLE'S LIVES, TODAY ANNOUNCED POSITIVE TOPLINE DATA FROM THE DOSE ESCALATION COHORTS OF THE DELPACIBART BRAXLOSIRAN (DEL-BRAX) PHASE 1/2 FORTITUDE PROGRAM IN FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (FSHD).

AVIDITY BIOSCIENCES ANNOUNCES POSITIVE TOPLINE PHASE 1/2 FORTITUDE DATA DEMONSTRATING CONSISTENT IMPROVEMENT ACROSS MULTIPLE FUNCTIONAL MEASURES COMPARED TO PLACEBO IN DEL-BRAX TREATED FSHD PARTICIPANTS

-- PLANNING ACCELERATED APPROVAL BLA SUBMISSION IN H2 2026, FOLLOWING TOPLINE DATA FROMFORTITUDE BIOMARKER COHORT IN Q2 2026 -- -- INITIATED GLOBAL, CONFIRMATORY PHASE 3 FORWARD  STUDY OF DEL-BRAX 2MG/KG EVERY SIX WEEKS -- -- INVESTOR AND ANALYST WEBCAST EVENT TODAY, MONDAY, JUNE 9, 2025 AT 8 A.M. ET -- SAN DIEGO , JUNE 9, 2025 /PRNEWSWIRE/ --AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS) TO PROFOUNDLY IMPROVE PEOPLE'S LIVES, TODAY ANNOUNCED THE ACCELERATED APPROVAL REGULATORY PATHWAY IN THE UNITED STATES IS OPEN FOR DELPACIBART BRAXLOSIRAN (DEL-BRAX) IN THE TREATMENT OF FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (FSHD).

AVIDITY BIOSCIENCES ANNOUNCES THE ACCELERATED APPROVAL REGULATORY PATHWAY IN THE U.S. IS OPEN FOR DEL-BRAX AND INITIATES THE GLOBAL, CONFIRMATORY PHASE 3 FORWARD STUDY IN FSHD

SAN DIEGO , MAY 21, 2025 /PRNEWSWIRE/ -- AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS), TODAY ANNOUNCED THAT ON MAY 20, 2025, THE HUMAN CAPITAL MANAGEMENT COMMITTEE OF AVIDITY'S BOARD OF DIRECTORS GRANTED NON-QUALIFIED STOCK OPTION AWARDS TO PURCHASE AN AGGREGATE OF 71,000 SHARES OF ITS COMMON STOCK AND 35,000 RESTRICTED STOCK UNITS ("RSUS") TO SIXTEEN (16) NEW NON-EXECUTIVE EMPLOYEES UNDER THE AVIDITY BIOSCIENCES, INC. 2022 EMPLOYMENT INDUCEMENT INCENTIVE AWARD PLAN (THE "2022 INDUCEMENT PLAN"). THE AWARDS WERE GRANTED AS INDUCEMENTS MATERIAL TO THE EMPLOYEES ENTERING INTO EMPLOYMENT WITH AVIDITY IN ACCORDANCE WITHNASDAQ LISTING RULE 5635(C)(4).

AVIDITY BIOSCIENCES ANNOUNCES INDUCEMENT GRANTS UNDER NASDAQ LISTING RULE 5635(C)(4)

ON TRACK TO DELIVER KEY REGULATORY UPDATES FOR DEL-BRAX AND TOPLINE DATA FROM DOSE ESCALATION COHORTS IN THE FORTITUDE TRIAL IN THE SECOND QUARTER POSITIVE TOPLINE DEL-ZOTA DATA FURTHER SUPPORTS FIRST BLA SUBMISSION AT YEAR END 2025  CONTINUES TO HIGHLIGHT REPRODUCIBILITY AND CONSISTENCY ACROSS THREE LATE-STAGE CLINICAL TRIALS FOR DMD44, DM1 AND FSHD EXECUTING ON GLOBAL COMMERCIAL INFRASTRUCTURE DEVELOPMENT AND ON TRACK WITH PREPARATIONS FOR FIRST POTENTIAL COMMERCIAL LAUNCH IN U.S. IN 2026 STRONG BALANCE SHEET SUPPORTS EXECUTION ACROSS THREE LATE-STAGE CLINICAL PROGRAMS AND COMMERCIAL LAUNCH PREPARATIONS WITH CASH RUNWAY INTO MID-2027 SAN DIEGO , MAY 8, 2025 /PRNEWSWIRE/ -- AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS) TO PROFOUNDLY IMPROVE PEOPLE'S LIVES, TODAY REPORTED FINANCIAL RESULTS FOR THE FIRST QUARTER ENDED MARCH 31, 2025, HIGHLIGHTING RECENT PROGRESS. "WE CONTINUE TO BUILD ON THE CONSISTENT AND REPRODUCIBLE DATA READOUTS FROM OUR PLATFORM ACROSS ALL THREE OF OUR CLINICAL PROGRAMS FOR DMD44, DM1 AND FSHD, AND ARE EXECUTING ON OUR TRANSITION TO BECOME A GLOBAL COMMERCIAL ORGANIZATION.

AVIDITY BIOSCIENCES REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND RECENT HIGHLIGHTS

SAN DIEGO , MAY 6, 2025 /PRNEWSWIRE/ --AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS), TODAY ANNOUNCED THAT AVIDITY MANAGEMENT WILL PARTICIPATE IN A FIRESIDE CHAT DURING THE FOLLOWING INVESTOR CONFERENCE: BANK OF AMERICA SECURITIES 2025 HEALTH CARE CONFERENCEON TUESDAY, MAY 13, 2025, AT3:00P.M.PT/6:00P.M.

AVIDITY BIOSCIENCES TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCE

SAN DIEGO , APRIL 21, 2025 /PRNEWSWIRE/ -- AVIDITY BIOSCIENCES, INC. (NASDAQ: RNA), A BIOPHARMACEUTICAL COMPANY COMMITTED TO DELIVERING A NEW CLASS OF RNA THERAPEUTICS CALLED ANTIBODY OLIGONUCLEOTIDE CONJUGATES (AOCS), TODAY ANNOUNCED THAT ONAPRIL 20, 2025,THE HUMAN CAPITAL MANAGEMENT COMMITTEE OF AVIDITY'S BOARD OF DIRECTORS GRANTED NON-QUALIFIED STOCK OPTION AWARDS TO PURCHASE AN AGGREGATE OF 263,000 SHARES OF ITS COMMON STOCK AND 131,450 RESTRICTED STOCK UNITS ("RSUS") TO THIRTY-THREE (33) NEW NON-EXECUTIVE EMPLOYEES UNDER THE AVIDITY BIOSCIENCES, INC. 2022 EMPLOYMENT INDUCEMENT INCENTIVE AWARD PLAN (THE "2022 INDUCEMENT PLAN"). THE AWARDS WERE GRANTED AS INDUCEMENTS MATERIAL TO THE EMPLOYEES ENTERING INTO EMPLOYMENT WITH AVIDITY IN ACCORDANCE WITH NASDAQ LISTING RULE 5635(C)(4).

Avidity Biosciences, Inc.

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Avidity Biosciences, Inc.

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