Every 8-K that Dyne Therapeutics, Inc. (DYN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow DYN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full DYN filings page.
Dyne Therapeutics reported second quarter 2026 results and detailed progress across its neuromuscular pipeline. The FDA accepted the Biologics License Application for z-rostudirsen in exon 51 Duchenne muscular dystrophy with Priority Review, setting a PDUFA target action date of January 21, 2027, and a global confirmatory Phase 3 FORZETTO trial is underway. In myotonic dystrophy type 1, Dyne completed enrollment of 71 participants in the registrational expansion cohort of the ACHIEVE trial for z-basivarsen, began dosing in the Phase 3 HARMONIA trial, and plans ACHIEVE topline data in the first quarter of 2027. The FDA also cleared an Investigational New Drug application for DYNE-302 in facioscapulohumeral muscular dystrophy. Financing actions included expanding a senior secured term loan facility with Hercules Capital to up to $400 million and completing an underwritten public offering of 21,045,000 shares at $20.50 per share for gross proceeds of approximately $431 million, supporting an expected cash runway into the second quarter of 2028.
Cash, cash equivalents and marketable securities were $898.5 million as of June 30, 2026, before the estimated $405.0 million of net proceeds from the July 2026 offering. Research and development expenses were $152.2 million and general and administrative expenses were $29.5 million for the quarter, compared with $99.2 million and $16.6 million, respectively, a year earlier. Net loss was $178.6 million, or $1.08 per basic and diluted share, versus $110.9 million, or $0.97 per share, for the prior-year quarter.
Dyne Therapeutics entered into an underwriting agreement for an underwritten public offering of 18,300,000 shares of common stock at a public price of $20.50 per share, with underwriters purchasing at $19.27 per share. The company also granted the underwriters a 30‑day option to buy up to 2,745,000 additional shares at the public price less underwriting discounts and commissions.
The company estimates net proceeds of approximately $352.1 million, or approximately $405.0 million if the option is fully exercised, after underwriting discounts and estimated expenses. The offering is being made under an automatically effective shelf registration statement on Form S‑3, with closing expected on or about July 23, 2026, subject to customary conditions. Dyne believes these net proceeds, together with existing cash, cash equivalents and marketable securities and a $50.0 million term loan tranche borrowed from Hercules Capital in June 2026, will enable it to fund operating expenses, debt service obligations and capital expenditures into the second quarter of 2028, while cautioning that this forward‑looking runway estimate depends on various assumptions and risks.
Dyne Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted for review its biologics license application for zeleciment rostudirsen (z‑rostudirsen, also known as DYNE‑251) to treat individuals with Duchenne muscular dystrophy amenable to exon 51 skipping. The FDA granted Priority Review and set a Prescription Drug User Fee Act target action date of January 21, 2027.
The company stated it continues to expect a potential U.S. launch of z‑rostudirsen in the first quarter of 2027, assuming approval is received on this anticipated timeline. Dyne also emphasized that these expectations are forward‑looking and subject to substantial risks and uncertainties, including clinical, regulatory and financing factors described in its SEC reports.
Dyne Therapeutics appointed Barry E. Greene to its Board of Directors as a Class I director, with a term running until the 2027 annual meeting and continuation until a successor is elected or earlier departure.
The Board determined that Greene is an independent director under Nasdaq rules. Upon joining, he received a stock option for 57,463 shares at an exercise price of $20.87 per share, vesting in equal monthly installments over three years, with full acceleration upon a change in control. He will also receive $45,000 in annual cash compensation, additional annual equity grants under the non-employee director compensation program, and reimbursement of reasonable expenses related to Board meetings.
Dyne Therapeutics, Inc. amended its loan and security agreement with Hercules Capital, expanding its debt facility to an aggregate of up to $400.0 million and easing certain cash covenants.
Under the Second Amendment, Dyne immediately borrowed an additional $50.0 million tranche, bringing total outstanding principal under the loan agreement to $200.0 million. Three further term loan tranches totaling up to $125.0 million are available upon achieving specified clinical, regulatory and commercial milestones, plus a final tranche of up to $75.0 million subject to lender investment committee approval.
The amendment shifts the initial minimum cash covenant testing date to July 1, 2027 (with a potential extension to July 1, 2028 if financing milestones are met) and reduces the initial required cash level from 60% to 40% of then-outstanding obligations, tested only if Dyne’s market capitalization is less than $1.65 billion. The debt matures on July 1, 2030, bears interest at the Wall Street Journal prime rate (floor 7.50%) plus 2.45%, and is interest-only until July 1, 2029, with potential extension to maturity upon meeting milestones. The facility is secured by a first-priority security interest in substantially all company assets, including intellectual property.
Dyne Therapeutics, Inc. reported results from its 2026 annual stockholder meeting. Stockholders elected David Lubner, Brian Posner and Jason Rhodes as Class III directors to serve three-year terms ending at the 2029 annual meeting.
Stockholders approved, on a non-binding advisory basis, the compensation of the company’s named executive officers and ratified Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026. They also approved an amendment to increase authorized common shares from 200,000,000 to 400,000,000 and a separate amendment providing for officer exculpation, with both amendments effected by certificates of amendment filed on June 8, 2026.
Dyne Therapeutics announced completion of enrollment in the registrational expansion cohort of its Phase 1/2 ACHIEVE trial of z‑basivarsen for myotonic dystrophy type 1. The cohort includes 71 participants, providing the main data set to support potential regulatory submissions.
The company plans topline data from this cohort in the first quarter of 2027, aiming to use these results, along with multiple ascending dose and long‑term extension data, for a potential Biologics License Application seeking U.S. Accelerated Approval in the third quarter of 2027. Dyne anticipates a potential U.S. launch in the first half of 2028 if Priority Review is granted and approval is received, and it is also pursuing approval pathways outside the U.S.
Dyne Therapeutics reported first quarter 2026 results and highlighted progress in its Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) programs. Cash, cash equivalents and marketable securities were $972.2 million as of March 31, 2026, which the company expects will fund operations into the first quarter of 2028.
For the quarter ended March 31, 2026, research and development expenses were $100.9 million versus $106.4 million a year earlier, while general and administrative expenses rose to $24.4 million from $15.9 million, mainly to prepare for a potential z-rostudirsen launch. Net loss was $120.9 million, or $0.73 per share, compared with a net loss of $115.4 million, or $1.05 per share, in the prior-year period.
Clinically, Dyne completed a positive pre-BLA meeting with the FDA for z-rostudirsen in exon 51 DMD, remains on track to submit a BLA for U.S. Accelerated Approval in Q2 2026, and is planning a potential U.S. launch in Q1 2027. The company also reached its target of 60 participants in the registrational expansion cohort of the ACHIEVE trial for z-basivarsen in DM1, initiated the Phase 3 HARMONIA trial, and is planning data from the ACHIEVE cohort in Q1 2027 to support a potential BLA submission in early Q3 2027.
Dyne Therapeutics reported fourth quarter and full year 2025 results alongside major clinical progress in its neuromuscular pipeline. Year-end cash, cash equivalents and marketable securities were $1.1 billion, which the company expects will fund operations into the first quarter of 2028.
For 2025, research and development expenses were $398.3 million and general and administrative expenses were $69.9 million, leading to a net loss of $446.2 million, or $3.47 per share, compared with a $317.4 million loss in 2024. In the DELIVER trial for Duchenne muscular dystrophy, z‑rostudirsen achieved 5.46% of normal dystrophin at six months with statistically significant change from baseline and showed improvements on multiple functional measures with a favorable safety profile.
The company plans to submit a BLA for U.S. Accelerated Approval of z‑rostudirsen in Q2 2026 and targets a potential U.S. launch in Q1 2027, assuming Priority Review and approval. Dyne also advances z‑basivarsen in DM1 toward a Phase 3 trial in March 2026 and expects enrollment completion of the ACHIEVE registrational expansion cohort in Q2 2026.
Dyne Therapeutics, Inc. reported that it expects to disclose cash, cash equivalents and marketable securities of approximately $1.1 billion as of December 31, 2025. The company noted that its fourth-quarter and full-year 2025 financial results are not yet finalized and this cash figure is a preliminary, unaudited management estimate that remains subject to completion of normal closing procedures.
The company also made available an investor presentation on January 12, 2026, covering its current operations, future plans and other business updates. The presentation was filed as Exhibit 99.1 and is incorporated by reference, while the cash update and presentation are furnished for information purposes and are not deemed filed under securities laws unless specifically incorporated in other documents.
Dyne Therapeutics (DYN) furnished quarterly results. The company reported that it issued a press release announcing financial results for the quarter ended September 30, 2025, and made it available as Exhibit 99.1.
The disclosure is furnished under Item 2.02 and is not deemed “filed” under Section 18 of the Exchange Act, nor incorporated by reference into other filings unless specifically stated. The common stock trades on the Nasdaq Global Select Market under the symbol DYN.
Dyne Therapeutics appointed Brian Posner as a Class III director, with his term running until the 2026 annual stockholders’ meeting and subject to standard continuation conditions. The Board determined he qualifies as an independent director under Nasdaq rules and he is not serving on any Board committees.
Upon election, Posner received a stock option for 70,000 shares at an exercise price of $12.50 per share, vesting in equal monthly installments over three years, with full acceleration upon a change in control. He will also receive $45,000 in annual cash Board fees, additional annual equity grants under the non-employee director program, and reimbursement of reasonable travel and out-of-pocket Board-related expenses.
The company states there are no arrangements, family relationships, or related-party transactions involving Posner that require disclosure, and he will enter into Dyne’s standard indemnification agreement for directors.
Dyne Therapeutics (Nasdaq: DYN) filed an 8-K stating that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to its investigational antisense oligonucleotide DYNE-251 for Duchenne muscular dystrophy patients amenable to exon 51 skipping. BTD provides earlier, more frequent FDA interactions and eligibility for priority review, potentially shortening time to market if efficacy and safety are confirmed. The filing furnishes, but does not file, the related press release as Exhibit 99.1 and contains no financial statements, trial data, or updated guidance. Management characterizes the event as material under Regulation FD, signaling strategic importance to Dyne’s pipeline and future revenue prospects, but investors must note that DYNE-251 still requires successful pivotal studies and eventual FDA approval.