Dyne Therapeutics (NASDAQ: DYN) details DMD and DM1 trial progress
Rhea-AI Filing Summary
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.
Positive
- None.
Negative
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Insights
Dyne advances DMD and DM1 programs while maintaining a sizable cash runway into early 2028.
Dyne Therapeutics ends Q1 2026 with $972.2 million in cash, cash equivalents and marketable securities, and expects this to fund operations into the first quarter of 2028. Operating expenses are concentrated in R&D at $100.9 million, with higher G&A of $24.4 million tied to launch preparation.
The company reported a quarterly net loss of $120.9 million, or $0.73/share, consistent with its clinical-stage status. Pipeline updates are central: a positive pre-BLA meeting for z-rostudirsen supports plans for a Q2 2026 BLA submission and possible U.S. launch in Q1 2027 under Accelerated Approval pathways.
In DM1, Dyne reached the 60-participant target in the ACHIEVE registrational expansion cohort and initiated the Phase 3 HARMONIA trial. An important planned catalyst is ACHIEVE data in Q1 2027, which the company intends to use, along with other ACHIEVE data, to support a potential BLA submission in early Q3 2027. Actual outcomes will depend on future clinical and regulatory results.
8-K Event Classification
Key Figures
Key Terms
Biologics License Application regulatory
Accelerated Approval regulatory
registrational expansion cohort financial
Phase 3 HARMONIA trial medical
FORCE platform technical
Duchenne muscular dystrophy medical
Earnings Snapshot
The company continues to expect its cash, cash equivalents and marketable securities as of March 31, 2026, will be sufficient to fund operations into the first quarter of 2028.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
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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 May 11, 2026, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 31, 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 May 11, 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: May 11, 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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Title: |
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President and Chief Executive Officer |
Exhibit 99.1
Dyne Therapeutics Reports First Quarter 2026 Financial Results and Recent Business Highlights
- Positive pre-BLA meeting completed with FDA for z-rostudirsen in exon 51 DMD; on track for BLA submission in Q2 2026 and potential launch in Q1 2027 -
- Positive cardiopulmonary results and long-term dystrophin data from Phase 1/2 DELIVER trial of z-rostudirsen in exon 51 DMD presented at MDA conference -
- Completion of enrollment in registrational expansion cohort of Phase 1/2 ACHIEVE trial of z-basivarsen in DM1 on track for Q2 2026; global confirmatory Phase 3 HARMONIA trial initiated -
- New preclinical data to be presented at ASGCT underscore differentiated capability of clinically validated FORCETM platform to cross the blood-brain barrier -
WALTHAM, Mass., May 11, 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 first quarter of 2026 and recent business highlights.
“Following positive topline data late last year, we continue to ramp up activities to support a potential launch of z-rostudirsen in DMD in the first quarter of 2027,” said John Cox, president and chief executive officer of Dyne. “We are grateful to the FDA for a collaborative pre-BLA meeting, where we aligned on the contents of our planned BLA submission for U.S. Accelerated Approval of z-rostudirsen, which is on track for this quarter.”
“In DM1, we have reached our target of 60 participants in the registrational expansion cohort of the ACHIEVE trial of z-basivarsen. Based on a recent acceleration in the number of participants in screening, we currently expect to exceed this target when we complete enrollment later this quarter. As we look toward the important expected readout in the first quarter of 2027, we continue to be driven by our goal to deliver functional improvement for individuals living with DM1. We remain committed to disciplined execution as we advance our two lead programs and broader pipeline and aim to maximize returns for our shareholders,” concluded Mr. Cox.
Zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in DMD (Duchenne muscular dystrophy)
Positive cardiopulmonary results and long-term dystrophin data from the DELIVER trial
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Key milestones for z-rostudirsen
Zeleciment basivarsen (z-basivarsen, also known as DYNE-101) in DM1 (myotonic dystrophy type 1)
Phase 3 HARMONIA trial underway
Key milestones for z-basivarsen
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New preclinical data showing robust central nervous system (CNS) activity in nonhuman primates with FORCE platform
First Quarter Financial Results
Cash position: Cash, cash equivalents and marketable securities were $972.2 million as of March 31, 2026. The Company continues to expect that its cash, cash equivalents and marketable securities as of March 31, 2026, will be sufficient to fund its operations into the first quarter of 2028.
Research and development (R&D) expenses: R&D expenses were $100.9 million for the three months ended March 31, 2026 compared to $106.4 million for the three months ended March 31, 2025. The decrease in R&D expense was primarily due to the timing of manufacturing batches of z-rostudirsen and z-basivarsen.
General and administrative (G&A) expenses: G&A expenses were $24.4 million for the three months ended March 31, 2026 compared to $15.9 million for the three months ended March 31, 2025. The increase in G&A expenses was primarily due to increased costs in preparation for the potential launch of z-rostudirsen.
Net loss: Net loss for the three months ended March 31, 2026 was $120.9 million, or $0.73 per basic and diluted share. This compares with a net loss of $115.4 million, or $1.05 per basic and diluted share, for the three months ended March 31, 2025.
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) and zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251); the anticipated timelines for initiating additional clinical trials, reporting data from clinical trials, enrolling registrational cohorts, submitting applications for marketing approval and launching commercially; the availability of expedited approval pathways for
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z-basivarsen and z-rostudirsen; expectations regarding the potential timing of regulatory approval, commercial launch and 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 and as to 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 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.
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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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March 31, |
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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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$ |
100,889 |
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$ |
106,447 |
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General and administrative |
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24,387 |
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15,925 |
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Total operating expenses |
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125,276 |
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122,372 |
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Loss from operations |
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(125,276 |
) |
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(122,372 |
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Other income, net |
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4,422 |
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7,011 |
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Net loss |
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$ |
(120,854 |
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$ |
(115,361 |
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Net loss per share, basic and diluted |
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$ |
(0.73 |
) |
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$ |
(1.05 |
) |
Weighted average common shares outstanding, basic and diluted |
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165,036,604 |
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109,911,628 |
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Dyne Therapeutics, Inc. |
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Condensed Consolidated Balance Sheet Data |
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(in thousands) |
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March 31, |
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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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$ |
972,156 |
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$ |
1,110,562 |
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Other assets |
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107,794 |
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76,396 |
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Total assets |
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$ |
1,079,950 |
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$ |
1,186,958 |
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Liabilities and Stockholders’ Equity |
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Liabilities |
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214,895 |
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214,829 |
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Stockholders’ equity |
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865,055 |
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972,129 |
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Total liabilities and stockholders’ equity |
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$ |
1,079,950 |
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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
snartker@dyne-tx.com
781-317-1938
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