Dyne Therapeutics Q3 2026 loss widens to $194M
The FDA's target action date for z-rostudirsen is January 21, 2027, while Dyne expects its cash resources to fund operations into Q2 2028.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Dyne Therapeutics, Inc. (DYN) reported a third-quarter 2026 net loss of $193.552 million, compared with $108.041 million a year earlier. Research and development expense was $161.744 million versus $97.219 million, while general and administrative expense was $35.330 million versus $16.673 million. Cash, cash equivalents and marketable securities totaled $1,134.386 million as of September 30, 2026; Dyne expects those resources to fund operations into the second quarter of 2028.
The BLA for z-rostudirsen is under FDA priority review, with a PDUFA target action date of January 21, 2027; Dyne expects a potential U.S. launch in Q1 2027, assuming approval on the anticipated timeline. One-year data from a pooled dose group initially enrolled in the multiple ascending dose portion of Phase 1/2 ACHIEVE showed functional improvement versus baseline, placebo and a matched natural history cohort across multiple measures at 12 months. Topline data from the ACHIEVE registrational expansion cohort are planned for Q1 2027 to support a potential U.S. BLA submission in Q3 2027; Dyne expects a potential launch in H1 2028, assuming FDA grants Priority Review and approval is received on the anticipated timeline.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- None.
Negative
- Moderate pointQuarterly net loss was $193.552 million, compared with $108.041 million in Q3 2025.
8-K Event Classification
Key Figures
Key Terms
priority review regulatory
PDUFA target action date regulatory
Accelerated Approval regulatory
registrational expansion cohort medical
matched natural history cohort medical
Earnings Snapshot
Dyne expects cash, cash equivalents and marketable securities as of September 30, 2026, to fund operations into the second quarter of 2028.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What was DYN's net loss in Q3 2026?
How much cash did DYN have, and how long does it expect it to last?
When could the FDA act on DYN's z-rostudirsen application?
What are the next expected milestones for DYN's z-basivarsen program?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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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 (see General Instruction A.2. below):
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)) |
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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 2.02 Results of Operations and Financial Condition.
On [November 5], 2026, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Description |
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99.1 104 |
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Press Release issued by Dyne Therapeutics, Inc. on November 5, 2026 Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DYNE THERAPEUTICS, INC. |
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Date: November 5, 2026 |
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By: |
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/s/ John G. Cox |
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Name: |
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John G. Cox |
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President and Chief Executive Officer |
Exhibit 99.1
Dyne Therapeutics Reports Third Quarter 2026 Financial Results and Recent Business Highlights
- Biologics License Application (BLA) for z-rostudirsen in exon 51 Duchenne muscular dystrophy (DMD) under priority review by FDA; PDUFA target action date of January 21, 2027 -
- Additional one-year clinical data from Phase 1/2 ACHIEVE trial of z-basivarsen for myotonic dystrophy type 1 (DM1) presented at WMS and AANEM continued to support improvement at 6 months in video hand opening time (vHOT) as an early indicator of clinical benefit -
- Topline data from ACHIEVE registrational expansion cohort (REC) planned for Q1 2027 -
- Preclinical data presented at NMSG support the ongoing development of four investigational therapies for DMD amenable to skipping of exons 44, 45, 53, or 55 -
WALTHAM, Mass., November 5, 2026 – Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today reported financial results for the third quarter of 2026 and recent business highlights.
“As we work toward potential commercialization, we are investing across multiple programs with the goal of unlocking the full value of our FORCETM platform,” said John Cox, president and chief executive officer of Dyne. “This includes preparations for the potential U.S. launch of z-rostudirsen for exon 51 DMD, if approved, and topline data from the registrational expansion cohort of the ACHIEVE trial for z-basivarsen in DM1, both expected in the first quarter of 2027. At the same time, we are advancing HARMONIA, the only Phase 3 clinical trial in DM1 currently enrolling participants and progressing four preclinical DMD programs that have the potential to expand our reach to over one third of individuals living with Duchenne.”
Zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in DMD (Duchenne muscular dystrophy)
Key milestones for z-rostudirsen
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Zeleciment basivarsen (z-basivarsen, also known as DYNE-101) in DM1 (myotonic dystrophy type 1)
Additional one-year clinical data from Phase 1/2 ACHIEVE trial
Key milestones for z-basivarsen
Third Quarter Financial Results
Cash position: Cash, cash equivalents and marketable securities were $1.134 billion as of September 30, 2026. The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2026, will be sufficient to fund its operations into the second quarter of 2028.
Research and development (R&D) expenses: R&D expenses were $161.7 million for the three months ended September 30, 2026 compared to $97.2 million for the three months ended September 30, 2025. The increase in R&D expense was primarily due to increased manufacturing activity for z-rostudirsen and higher clinical trial costs related to conducting the ongoing FORZETTO and HARMONIA Phase 3 trials for z-rostudirsen and z-basivarsen, respectively.
General and administrative (G&A) expenses: G&A expenses were $35.3 million for the three months ended September 30, 2026 compared to $16.7 million for the three months ended September 30, 2025. The increase in G&A expenses was primarily due to preparation for the potential launch of z-rostudirsen, including an increase in headcount.
Net loss: Net loss for the three months ended September 30, 2026 was $193.6 million, or $1.06 per basic and diluted share. This compares with a net loss of $108.0 million, or $0.76 per basic and diluted share, for the three months ended September 30, 2025.
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About Dyne Therapeutics
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding: Dyne’s strategy, future operations, prospects, projections and plans; objectives of management; the potential of the FORCE platform; the potential of zeleciment basivarsen (z-basivarsen, also known as DYNE-101), zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251), DYNE-244, DYNE-245, DYNE-253, DYNE-255 and DYNE-302; the anticipated timelines for initiating additional clinical trials, reporting data from clinical trials, submitting applications for marketing approval and launching commercially; the availability of an expedited approval pathway for z-basivarsen; expectations regarding the potential timing and likelihood of regulatory approval and commercial launch; the outcome of interactions with regulatory authorities; and the sufficiency of Dyne’s cash resources for the period anticipated, 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. Dyne 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 and completion of clinical trials; uncertainties as to the availability and timing of results from clinical trials; uncertainties as to the timing of and Dyne’s ability to enroll patients in clinical trials; whether results from preclinical studies and data from clinical trials will be predictive of the final results of the clinical trials or other trials; whether data from clinical trials will support submission for regulatory approvals; uncertainties as to the FDA’s and other regulatory authorities’ interpretation of the data from Dyne's clinical trials and acceptance of Dyne's clinical programs; the regulatory approval process for Dyne’s product candidates; whether Dyne’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses, debt service obligations and capital expenditure requirements; 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
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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 Dyne’s views as of any date subsequent to the date of this press release.
Dyne Therapeutics, Inc. |
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Condensed Consolidated Statement of Operations |
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(in thousands, except share and per share data) |
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Three Months Ended |
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September 30, |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
161,744 |
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$ |
97,219 |
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General and administrative |
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35,330 |
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16,673 |
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Total operating expenses |
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197,074 |
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113,892 |
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Loss from operations |
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(197,074 |
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(113,892 |
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Other income, net |
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3,522 |
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5,851 |
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Net loss |
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$ |
(193,552 |
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$ |
(108,041 |
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Net loss per share, basic and diluted |
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$ |
(1.06 |
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$ |
(0.76 |
) |
Weighted average common shares outstanding, basic and diluted |
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181,765,918 |
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141,810,881 |
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4
Dyne Therapeutics, Inc. |
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Condensed Consolidated Balance Sheet Data |
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(in thousands) |
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September 30, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
1,134,386 |
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$ |
1,110,562 |
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Other assets |
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100,416 |
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76,396 |
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Total assets |
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$ |
1,234,802 |
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$ |
1,186,958 |
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Liabilities and Stockholders’ Equity |
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Liabilities |
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303,869 |
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214,829 |
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Stockholders’ equity |
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930,933 |
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972,129 |
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Total liabilities and stockholders’ equity |
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$ |
1,234,802 |
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$ |
1,186,958 |
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Contacts:
Investors
Mia Tobias
ir@dyne-tx.com
781-317-0353
Media
Stacy Nartker
media@dyne-tx.com
781-317-1938
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