[8-K] Avidity Biosciences, Inc. Reports Material Event

Rhea-AI Filing Summary

Avidity Biosciences (RNA) updated its regulatory timeline for del-zota. Following a pre-BLA meeting with the FDA, the company now plans to submit its Biologics License Application in the first quarter of 2026, revised from prior guidance of year end 2025. The change is intended to provide additional non-clinical data supporting the chemistry, manufacturing, and controls package.

The company also reiterated standard cautionary statements that outcomes depend on FDA feedback and the generation of the supplemental CMC data.

Insights

Biopharma regulatory analyst

Regulatory timeline shifts to Q1 2026 after FDA feedback.

Avidity Biosciences reported a schedule change for the del-zota BLA, moving from year end 2025 to Q1 2026. The driver is the FDA’s request for additional non-clinical data to bolster the CMC section, a common focus area for biologics filings.

The update reflects pre-filing alignment with the agency. Actual timing depends on generating the extra CMC data that meets FDA expectations. The company notes typical risks around data adequacy, safety/efficacy interpretation, and potential further FDA feedback.

The next concrete milestone is the planned BLA submission in Q1 2026. Subsequent disclosures would clarify if the added CMC data satisfies the agency and whether the filing proceeds as targeted.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 _________________________________________

FORM 8-K

  _________________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 13, 2025

  _________________________________________

AVIDITY BIOSCIENCES, INC. 

(Exact name of registrant as specified in its charter)

 _________________________________________

Delaware

001-39321

46-1336960

(State or other jurisdiction of incorporation or organization)

(Commission File Number)

(I.R.S. Employer Identification No.)

3020 Callan Road

San Diego, California 92121 92121

(Address of principal executive offices) (Zip Code)

(858) 401-7900

(Registrant’s telephone number, include area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

 _________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

RNA

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐ 

Item 8.01. Other Events.

On October 13, 2025, Avidity Biosciences, Inc. ("Avidity") announced that based on a pre-Biologics License Application ("BLA") meeting with the U.S. Food and Drug Administration ("FDA") regarding Avidity's planned BLA submission for del-zota, Avidity has updated its expected timing for submission of the BLA to the first quarter of 2026 from its previous guidance of year end 2025 in order to provide the FDA with additional non-clinical data to support the chemistry, manufacturing, and controls ("CMC") package.

Forward-Looking Statements

Avidity cautions readers that statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding Avidity's plans to provide the FDA with additional non-clinical CMC data and submit a BLA for del-zota and the timing thereof. The inclusion of forward-looking statements should not be regarded as a representation by Avidity that any of these plans will be achieved. Actual results may differ from those set forth in this Current Report on Form 8-K due to the risks and uncertainties inherent in Avidity's business and those beyond its control, including, without limitation: potential delays in generating the additional non-clinical CMC data and such data and other data and information to be included in a BLA for del-zota may not be satisfactory to the FDA; preliminary results of a clinical trial are not necessarily indicative of final results; further analysis of existing clinical data and analysis of new data may lead to conclusions different from those established as of the data cutoff dates in the clinical trial of del-zota, and such data may not meet Avidity's or the FDA's expectations; unexpected adverse side effects to, or inadequate efficacy of, del-zota that may delay or limit its development, regulatory approval and/or commercialization; later developments with the FDA that could be inconsistent with the feedback received to date regarding del-zota and which could delay its currently anticipated timelines; Avidity's approach to the discovery and development of product candidates based on its AOC™ platform is unproven; potential delays in the EXPLORE44-OLE study; Avidity's dependence on third parties in connection with clinical testing and product manufacturing; legislative, judicial and regulatory developments in the United States and foreign countries; Avidity could exhaust its available capital resources sooner than it currently expects; and other risks described in Avidity's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) and in subsequent filings with the SEC. Avidity cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that arise after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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: October 14, 2025						By:			/s/ Michael F. MacLean
									Michael F. MacLean
									Chief Financial Officer

FAQ

What did Avidity Biosciences (RNA) announce in this update?

The company plans to submit the del-zota BLA in Q1 2026, revised from prior guidance of year end 2025.

Why was the del-zota BLA timeline changed by Avidity (RNA)?

To provide the FDA with additional non-clinical CMC data following a pre-BLA meeting.

What product is affected by Avidity’s (RNA) timeline update?

The update pertains to del-zota and its planned BLA submission.

What role did the FDA play in Avidity’s (RNA) revised plan?

A pre-BLA meeting with the FDA informed the decision to add non-clinical CMC data before submission.

Does Avidity (RNA) mention risks related to the new timeline?

Yes. Risks include potential delays in generating the added CMC data and whether it will meet FDA expectations.

What is the next key milestone for Avidity (RNA) on del-zota?

The planned BLA submission in Q1 2026.