{"url_path":"/sec/dyn/8-k/2026-06-03/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-03","source_url":"https://www.sec.gov/Archives/edgar/data/1818794/0001193125-26-254597-index.html","accession_number":"0001193125-26-254597","cik":"0001818794","ticker":"DYN","issuer_name":"Dyne Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1818794/0001193125-26-254597-index.html","primary_entity_key":"0001818794","primary_entity_name":"Dyne Therapeutics, Inc."},"word_count":618,"has_tables":true,"body_markdown":"Item 8.01 Other Events.\n\n \n\nOn June 3, 2026, the Company issued a press release announcing full enrollment of the REC of its Phase 1/2 ACHIEVE trial of z-basivarsen in individuals with DM1 with 71 participants. Additionally, the Company announced the following key milestones for z-basivarsen:\n\n•\nTopline data from the ACHIEVE REC are planned for the first quarter of 2027 to support a potential Biologics License Application (“BLA”) for U.S. Accelerated Approval in the third quarter of 2027.\n\n•\nThe Company intends to use data from the REC and from the already enrolled participants in the multiple ascending dose (“MAD”) and ongoing long-term extension portions of the ACHIEVE trial to support a potential BLA submission for Accelerated Approval in the U.S.\n\n•\nThe Company expects a potential launch of z-basivarsen in the first half of 2028, assuming FDA grants Priority Review and approval is received on the anticipated timeline.\n\n•\nThe Company also continues to pursue approval pathways outside of the U.S. for z-basivarsen in DM1.\n\n \n\nCautionary Note Regarding Forward-Looking Statements\n\nThis Current Report on Form 8-K contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Current Report on Form 8-K, including statements regarding the Company’s strategy, future operations, prospects and plans, objectives of management, the potential of the FORCETM platform, the clinical potential of zeleciment basivarsen (“z-basivarsen,” also known as DYNE-101), the timing of planned data from the registrational expansion cohort, the content and timing of the planned submission of a Biologics License Application for U.S. Accelerated Approval, the timing and potential of U.S. launch of z-basivarsen for myotonic dystrophy type 1, as well as the pursuit of approval pathways outside of the U.S., constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the initiation, completion and success of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; the timing of and Dyne’s ability to enroll patients in clinical trials; uncertainties as to the FDA’s and other regulatory authorities’ interpretation of the data from Dyne's clinical trials and the regulatory approval process, including the availability of accelerated approval pathways; whether Dyne’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, including relative to anticipated product launch; as well as the risks and uncertainties identified in Dyne’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne’s views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views\n\n \n\n \n\nas of any date subsequent to the date hereof."}