Dyne Therapeutics Reports Third Quarter 2026 Financial Results and Recent Business Highlights

Research and development expenses rose to $161.7 million as manufacturing activity and Phase 3 trial costs increased.

Rhea-AI Summary

Dyne Therapeutics (Nasdaq: DYN) reported a third-quarter 2026 net loss of $193.6 million while advancing its neuromuscular disease programs. Loss per share widened to $1.06 from $0.76 a year earlier. Cash, cash equivalents and marketable securities totaled $1.134 billion; Dyne expects funding to last into Q2 2028.

Z-rostudirsen for exon 51 Duchenne muscular dystrophy is under FDA priority review, with a January 21, 2027 target action date. Dyne expects a potential Q1 2027 U.S. launch, assuming timely approval. Z-basivarsen showed functional improvement across multiple measures at 12 months in pooled ACHIEVE trial participants versus baseline, placebo and matched natural history controls. Dyne plans registrational expansion cohort results in Q1 2027 to support a potential Q3 2027 application for accelerated approval, and expects a potential H1 2028 launch, subject to priority review and timely approval.

8 points · 0 major

MixediHow this balance works

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.

How the balance worksHow Sentiment works

0 major · 7 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointZ-rostudirsen application is under FDA priority review, with a January 21, 2027 target action date.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Z-rostudirsen U.S. launch is expected potentially in Q1 2027, assuming timely approval.
• Moderate pointZ-basivarsen pooled ACHIEVE data showed 12-month functional improvement versus baseline, placebo and matched natural history controls.
• Moderate point. Forward-looking: it has not happened yet and may not happen.ACHIEVE registrational expansion cohort results are planned for Q1 2027, supporting a potential Q3 2027 approval application.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Z-basivarsen U.S. launch is expected potentially in H1 2028, assuming priority review and timely approval.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Cash, cash equivalents and marketable securities totaled $1.134 billion; Dyne expects funding into Q2 2028.

2 minor points

• Minor pointConfirmatory Phase 3 FORZETTO and HARMONIA trials are ongoing to support traditional approval and applications outside the U.S.
• Minor pointFour preclinical DMD candidates target exon skipping of 44, 45, 53 and 55.

Negative

• Moderate pointQuarterly net loss widened to $193.6 million, or $1.06 per share, from $108.0 million, or $0.76.
• Moderate pointWeighted average common shares outstanding increased to 181,765,918 from 141,810,881 in the prior-year quarter.
• Minor pointQuarterly research and development expenses rose to $161.7 million from $97.2 million a year earlier.
• Minor pointQuarterly general and administrative expenses rose to $35.3 million from $16.7 million a year earlier.
• Minor pointQuarterly other income, net declined to $3.522 million from $5.851 million a year earlier.

2 minor points

• Minor pointLiabilities increased to $303.869 million at September 30, 2026, from $214.829 million at December 31, 2025.
• Minor pointStockholders' equity declined to $930.933 million at September 30, 2026, from $972.129 million at December 31, 2025.

Key Figures

Cash, equivalents and marketable securities: $1.134 billion Cash runway: Into Q2 2028 PDUFA target action date: January 21, 2027 +5 more

Cash, equivalents and marketable securities

$1.134 billion

As of September 30, 2026

Cash runway

Into Q2 2028

Company expectation

PDUFA target action date

January 21, 2027

z-rostudirsen BLA under FDA priority review

ACHIEVE REC topline data

Q1 2027

z-basivarsen registrational expansion cohort

Potential BLA submission

Q3 2027

z-basivarsen; potential U.S. Accelerated Approval

R&D expenses

$161.7 million vs. $97.2 million

Three months ended September 30, 2026 vs. 2025

Net loss

$193.6 million vs. $108.0 million

Three months ended September 30, 2026 vs. 2025

Net loss per share

$1.06 vs. $0.76

Basic and diluted; three months ended September 30, 2026 vs. 2025

Previous Earnings Reports

1 past event · Latest: Jul 29

Same Type 1 event

1. Jul 29

   Quarterly results

   24h Move

   +2.5%

   BLA accepted for priority review, ACHIEVE cohort enrollment completed, and financing extended runway into Q2 2028.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

biologics license application, pdufa, multiple ascending dose, accelerated approval, +1 more

5 terms

biologics license application regulatory

"Biologics License Application (BLA) for z-rostudirsen"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

pdufa regulatory

"PDUFA target action date of January 21, 2027"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

multiple ascending dose medical

"multiple ascending dose (MAD) portion of the ongoing Phase 1/2 ACHIEVE"

A multiple ascending dose is a method used in testing new medicines where small groups of people receive gradually larger amounts of the drug over time. This approach helps researchers find the safest and most effective dose without causing too many side effects. For investors, it signals ongoing steps in drug development that can impact a company's potential success or approval prospects.

accelerated approval regulatory

"support a potential BLA submission for U.S. Accelerated Approval"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

video hand opening time medical

"improvement at 6 months in video hand opening time (vHOT)"

The video hand opening time is the measured interval, captured on video, from the moment a person or device begins to change hand posture until the fingers reach a fully open position. Investors see it as a simple, repeatable way to judge how well a therapy, assistive device or robotics system restores or speeds hand movement—much like timing a sprint—to assess product effectiveness, user benefit, and potential regulatory or market value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

- 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., Nov. 05, 2026 (GLOBE NEWSWIRE) -- 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 FORCE^TM 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

• Dyne’s BLA is under priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of January 21, 2027. 
• Dyne continues to expect a potential U.S. launch of z-rostudirsen in Q1 2027, assuming approval is received on the anticipated timeline.
• The ongoing confirmatory Phase 3 FORZETTO trial of z-rostudirsen is intended to support conversion of Accelerated Approval, if granted, to traditional approval in the U.S. and to support ex-U.S. marketing applications.
• In addition to z-rostudirsen, Dyne is advancing four development candidates (DYNE-244, DYNE-245, DYNE-253 and DYNE-255) for the potential treatment of DMD amenable to skipping of exons 44, 45, 53, and 55, respectively. Preclinical data supporting the ongoing development of these investigational therapies was recently presented at the 27^th Annual Neuromuscular Study Group (NMSG) Scientific Meeting.

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

• Dyne presented additional one-year efficacy data from the multiple ascending dose (MAD) portion of the ongoing Phase 1/2 ACHIEVE clinical trial of z-basivarsen at the 31^st Annual International Congress of the World Muscle Society (WMS) and the 2026 Annual Meeting of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM).
• Data from a pooled dose group of participants initially enrolled in the MAD portion of ACHIEVE showed functional improvement versus baseline, versus placebo and versus a matched natural history cohort across multiple measures at 12 months.

Key milestones for z-basivarsen

• Topline data from the ACHIEVE REC are planned for Q1 2027 to support a potential BLA submission for U.S. Accelerated Approval in Q3 2027.
  • Dyne intends to use data from the REC and from the already enrolled participants in the MAD and ongoing long-term extension portions of the ACHIEVE trial to support this potential BLA submission.
• Dyne expects a potential U.S. launch of z-basivarsen in H1 2028, assuming the FDA grants Priority Review and approval is received on the anticipated timeline.
• The ongoing confirmatory Phase 3 HARMONIA trial of z-basivarsen is intended to support conversion of Accelerated Approval, if granted, to traditional approval in the U.S. and to support ex-U.S. marketing applications.

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.

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 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.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
	Three Months Ended
	September 30,
	2026				2025
Operating expenses:
Research and development	$	161,744			$	97,219
General and administrative		35,330				16,673
Total operating expenses		197,074				113,892
Loss from operations		(197,074	)			(113,892	)
Other income, net		3,522				5,851
Net loss	$	(193,552	)		$	(108,041	)
Net loss per share, basic and diluted	$	(1.06	)		$	(0.76	)
Weighted average common shares outstanding, basic and diluted		181,765,918				141,810,881

Dyne Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
		September 30,					December 31,
		2026					2025
Assets
Cash, cash equivalents and marketable securities		$	1,134,386				$	1,110,562
Other assets			100,416					76,396
Total assets		$	1,234,802				$	1,186,958
Liabilities and Stockholders’ Equity
Liabilities			303,869					214,829
Stockholders' equity			930,933					972,129
Total liabilities and stockholders' equity		$	1,234,802				$	1,186,958

Contacts:

Investors

Mia Tobias
ir@dyne-tx.com
781-317-0353

Media

Stacy Nartker
media@dyne-tx.com
781-317-1938

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When is the FDA decision expected for Dyne Therapeutics' z-rostudirsen?

The FDA target action date for z-rostudirsen is January 21, 2027. The application for exon 51 Duchenne muscular dystrophy is under priority review. Dyne expects a potential U.S. launch in Q1 2027 if approval arrives on the anticipated timeline.

What were Dyne Therapeutics' third-quarter 2026 financial results?

Dyne reported a $193.6 million net loss, or $1.06 per basic and diluted share, compared with $108.0 million, or $0.76 per share, a year earlier. Research and development expenses were $161.7 million, while general and administrative expenses were $35.3 million.

Why did Dyne Therapeutics' expenses increase in the third quarter of 2026?

Dyne attributed higher expenses primarily to manufacturing, clinical trials and launch preparations. Research and development spending increased with z-rostudirsen manufacturing activity and costs for the FORZETTO and HARMONIA Phase 3 trials. General and administrative spending increased with preparations for a potential z-rostudirsen launch, including additional headcount.

What data does Dyne plan to use for its potential z-basivarsen approval application?

Dyne intends to combine ACHIEVE registrational expansion cohort data with data from already enrolled participants in the multiple ascending dose and ongoing long-term extension portions of ACHIEVE. These data would support a potential application for U.S. accelerated approval in Q3 2027.

What are Dyne Therapeutics' FORZETTO and HARMONIA trials intended to support?

The ongoing Phase 3 trials are intended to support conversion from accelerated to traditional U.S. approval, if accelerated approval is granted, and marketing applications outside the U.S. FORZETTO studies z-rostudirsen; HARMONIA studies z-basivarsen.