Avidity Biosciences Appoints New CMO, Director

Avidity Biosciences, Inc. 8-K Filing Summary
FieldDetail
CompanyAvidity Biosciences, Inc.
Form Type8-K
Filed DateSep 10, 2025
Risk Levelmedium
Pages4
Reading Time5 min
Key Dollar Amounts$0.0001
Sentimentneutral

Sentiment: neutral

Topics: leadership-change, board-of-directors, executive-appointment

TL;DR

Avidity just hired a new CMO and added a director to the board. Big changes incoming?

AI Summary

Avidity Biosciences, Inc. announced on September 9, 2025, the appointment of Dr. Sarah Boyce as Chief Medical Officer and the election of Dr. Michael J. Ybarra to its Board of Directors. The company also disclosed compensatory arrangements for its officers. This filing is a current report under Section 13 or 15(d) of the Securities Exchange Act of 1934.

Why It Matters

Changes in key leadership roles and board composition can signal strategic shifts or new directions for the company's drug development and business operations.

Risk Assessment

Risk Level: medium — Changes in executive and board positions can introduce uncertainty regarding future strategy and execution.

Key Players & Entities

  • Avidity Biosciences, Inc. (company) — Registrant
  • Dr. Sarah Boyce (person) — Appointed Chief Medical Officer
  • Dr. Michael J. Ybarra (person) — Elected to Board of Directors
  • September 9, 2025 (date) — Date of earliest event reported

FAQ

Who is the new Chief Medical Officer and when was she appointed?

Dr. Sarah Boyce was appointed as the new Chief Medical Officer on September 9, 2025.

Who has been elected to Avidity Biosciences' Board of Directors?

Dr. Michael J. Ybarra has been elected to the Board of Directors.

What is the filing date for this 8-K report?

The filing date for this 8-K report is September 10, 2025.

What specific items are covered in this 8-K filing?

This 8-K covers the departure of directors or certain officers, election of directors, appointment of certain officers, compensatory arrangements of certain officers, Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits.

What is the SIC code for Avidity Biosciences, Inc.?

The Standard Industrial Classification (SIC) code for Avidity Biosciences, Inc. is 2834, Pharmaceutical Preparations.

Filing Stats: 1,337 words · 5 min read · ~4 pages · Grade level 10.9 · Accepted 2025-09-10 08:00:58

Key Financial Figures

  • $0.0001 — ch registered Common Stock, par value $0.0001 per share RNA The Nasdaq Global Market

Filing Documents

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On September 10, 2025, the Company will host an investor and analyst event (the "Event") to discuss new data from participants treated continuously with delpacibart zotadirsen ("del-zota") for one year in the EXPLORE44 and EXPLORE44-OLE trials. The Event will begin at 8:00 a.m. Eastern Time and will be available via a live video webcast accessible under the "Events and Presentations" page in the "Investors" section of Avidity's corporate website, at https://www.aviditybiosciences.com. During the Event, the Company will present the corporate slide presentation attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference. The information contained in this Item 7.01, including in Exhibit 99.1 hereto and on Avidity's corporate website, is being "furnished" and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), is not subject to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

01. Other Events

Item 8.01. Other Events. On September 10, 2025, the Company announced positive new data from participants treated continuously with del-zota for one year in the EXPLORE44 and EXPLORE44-OLE trials. These data demonstrated reversal of disease progression and unprecedented improvement compared to baseline and natural history across multiple functional measures. Additional data from the EXPLORE44 program will be presented at upcoming scientific congresses. Trial participants treated with del-zota demonstrated statistically significant increases of approximately 25 percent of normal in dystrophin production and restored total dystrophin up to 58 percent of normal. Creatine kinase ("CK") levels reduced by greater than 80 percent compared to baseline and were sustained at near normal levels throughout the duration of evaluation with participants followed for up to 16 months. Additionally, 50 percent of participants had CK levels within the normal range at one year of treatment. A total of 17 participants (12 ambulatory and 5 non-ambulatory) who began on the del-zota treated arm of EXPLORE44 and continued into the EXPLORE44-OLE have been followed for approximately one year. Given the study design, some participants received 5 mg/kg once every six weeks ("Q6W") and some received 10 mg/kg once every eight weeks during EXPLORE44. All participants were transitioned to the 5 mg/kg (Q6W) dosing schedule during EXPLORE44-OLE. Not all participants could complete all assessments. Functional data from these pooled dosing cohorts for del-zota treated participants, compared to DMD44 natural history (PRO-DMD-01), demonstrated improvement: 4-Stair Climb ("4SC") : Improved from baseline by 2.1 seconds. In contrast, the natural history group declined from baseline by 2.7 seconds (DMD44 Nat Hx N=22; del-zota N=10). 10-Meter Walk/Run Test ("10mWRT") : Improved from baseline by 0.7 seconds. In contrast, the natural history group declined from baseline by 1.5 seconds (DMD44 Nat Hx N=2

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description 10.1 Amendment to the Avidity Biosciences, Inc. 2022 Employment Inducement Incentive Award Plan. 99.1 Slide Presentation 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. AVIDITY BIOSCIENCES, INC. Date: September 10, 2025 By: /s/ Michael F. MacLean Michael F. MacLean Chief Financial Officer

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