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  4. [8-K] Dyne Therapeutics, Inc. Reports Material Event

FDA Priority Review and Q2 loss shape Dyne Therapeutics (NASDAQ: DYN) outlook

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

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.

Positive

  • FDA Priority Review for z-rostudirsen’s Biologics License Application in exon 51 Duchenne muscular dystrophy, with a PDUFA target action date of January 21, 2027, advancing Dyne toward a first potential commercial product.
  • Extended cash runway into the second quarter of 2028, supported by $898.5 million in cash, cash equivalents and marketable securities plus approximately $405.0 million of net proceeds from a July 2026 equity offering.

Negative

  • None.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash, cash equivalents and marketable securities $898.5 million Balance as of June 30, 2026
Net loss $178.6 million Net loss for the quarter ended June 30, 2026
Net loss per share $1.08 Net loss per basic and diluted share for Q2 2026
R&D expenses $152.2 million Research and development expenses for Q2 2026; compared with $99.2 million for Q2 2025
G&A expenses $29.5 million General and administrative expenses for Q2 2026; compared with $16.6 million for Q2 2025
Equity offering gross proceeds $431 million Gross proceeds from July 2026 underwritten public offering of 21,045,000 shares at $20.50 per share
Equity offering net proceeds $405.0 million Estimated net proceeds from the July 2026 underwritten public offering
Term loan facility capacity $400 million Maximum size of amended non-dilutive senior secured term loan facility with Hercules Capital
Biologics License Application (BLA) regulatory
"Biologics License Application (BLA) for z-rostudirsen in exon 51 DMD accepted"
A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.
Priority Review regulatory
"BLA for z-rostudirsen accepted for review by FDA; Priority Review granted"
Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.
PDUFA target action date regulatory
"Priority Review granted; PDUFA target action date set for January 21, 2027"
The PDUFA target action date is the deadline set by the U.S. Food and Drug Administration (FDA) by which it aims to decide whether to approve or reject a new drug application. This date helps investors gauge when a company’s new medication might reach the market, potentially influencing sales and revenue expectations. It acts as a key milestone signaling progress in the drug approval process.
Investigational New Drug (IND) Application regulatory
"Investigational New Drug (IND) Application cleared by FDA for DYNE-302 in FSHD"
An investigational new drug (IND) application is a formal request submitted to a drug regulator asking permission to begin testing a new medicine in people. It compiles lab results, manufacturing details and proposed human trial plans so regulators can judge safety before human studies start; for investors, an accepted IND is a key milestone that opens the clinical development pathway and can materially change a company’s risk profile and potential value, like getting a license to road-test a prototype.
Accelerated Approval regulatory
"to support a potential BLA submission for U.S. Accelerated Approval in Q3 2027"
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.
multiple ascending dose (MAD) medical
"participants in the multiple ascending dose (MAD) and ongoing long-term extension"
Multiple ascending dose (MAD) is a research process used to test how a new medicine affects the body when given in increasing amounts over several doses. It helps researchers find the safest and most effective dose before the drug is widely used. For investors, understanding MAD studies is important because successful results can signal progress toward new treatments and potential future profits.
Net loss $178.6 million Compared with $110.9 million for the quarter ended June 30, 2025
R&D expenses $152.2 million Compared with $99.2 million for the quarter ended June 30, 2025
G&A expenses $29.5 million Compared with $16.6 million for the quarter ended June 30, 2025
Net loss per share, basic and diluted $1.08 Compared with $0.97 for the quarter ended June 30, 2025
Cash, cash equivalents and marketable securities $898.5 million As of June 30, 2026; the company also reported estimated net proceeds of approximately $405.0 million from the July 2026 underwritten public offering
Guidance

The company expects its cash, cash equivalents and marketable securities as of June 30, 2026, together with net proceeds from the July 2026 underwritten public offering, to fund operations into the second quarter of 2028.

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

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FAQ

What major FDA milestone did Dyne Therapeutics (DYN) report?
Dyne reported that the FDA accepted its BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy with Priority Review, setting a PDUFA target action date of January 21, 2027, a key step toward potential U.S. approval.

What were Dyne Therapeutics’ (DYN) key Q2 2026 financial results?
For Q2 2026, Dyne reported a net loss of $178.6 million, or $1.08 per share, and cash, cash equivalents and marketable securities of $898.5 million as of June 30, 2026, reflecting higher R&D and G&A spending.

How long does Dyne Therapeutics (DYN) expect its cash to last?
Dyne expects its cash, cash equivalents and marketable securities of $898.5 million as of June 30, 2026, together with $405.0 million of net proceeds from a July 2026 equity offering, to fund operations into the second quarter of 2028.

What financing steps did Dyne Therapeutics (DYN) take in 2026?
Dyne expanded its non-dilutive senior secured term loan facility with Hercules Capital to up to $400 million and completed an underwritten public offering of 21,045,000 shares at $20.50 per share for gross proceeds of approximately $431 million.

What is the status of Dyne Therapeutics’ (DYN) z-basivarsen program in DM1?
Dyne completed enrollment of 71 participants in the ACHIEVE registrational expansion cohort for z-basivarsen, began dosing in the Phase 3 HARMONIA trial, plans topline ACHIEVE data in Q1 2027, and is targeting a potential BLA submission in Q3 2027.

What development progress has Dyne Therapeutics (DYN) made with DYNE-302?
The FDA cleared Dyne’s IND for DYNE-302 in facioscapulohumeral muscular dystrophy in July 2026. Dyne plans a Phase 1 randomized, placebo-controlled, double-blind MAD trial in ambulatory adults, focusing on safety, pharmacokinetics and pharmacodynamics.
false000181879400018187942026-07-292026-07-29

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): July 29, 2026

 

Dyne Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

001-39509

36-4883909

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

 

 

 

1560 Trapelo Road

Waltham, Massachusetts

 

02451

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (781) 786-8230

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

 

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))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common stock, $0.0001 par value per share

DYN

Nasdaq Global Select Market

 

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 July 29, 2026, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 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

 

Exhibit No.

Description

 

 

 

99.1

104

Press Release issued by Dyne Therapeutics, Inc. on July 29, 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.

 

 

 

 

 

 

 

 

 

DYNE THERAPEUTICS, INC.

 

 

 

Date: July 29, 2026

By:

/s/ John G. Cox

 

 

Name:

John G. Cox

 

 

Title:

President and Chief Executive Officer

 

 

Exhibit 99.1

img259164492_0.gif

 

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

- Biologics License Application (BLA) for z-rostudirsen in exon 51 DMD accepted for review by FDA; Priority Review granted; PDUFA target action date set for January 21, 2027 -

- Completed enrollment of 71 participants in registrational expansion cohort of Phase 1/2 ACHIEVE trial of z-basivarsen in DM1; topline data planned for Q1 2027 -

- Investigational New Drug (IND) Application cleared by FDA for DYNE-302 in FSHD -

- Expected cash runway into Q2 2028 -


WALTHAM, Mass., July 29, 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 second quarter of 2026 and recent business highlights.

“We continue to make significant progress as we execute on our goal of delivering functional improvement for people living with genetically driven neuromuscular diseases,” said John Cox, president and chief executive officer of Dyne. “The FDA’s acceptance of our BLA for z-rostudirsen marks an important milestone for individuals living with DMD amenable to exon 51 skipping and a defining step in Dyne’s evolution toward becoming a commercial-stage company in the near future.”

“Across our portfolio, we have achieved key clinical and regulatory milestones, including completion of enrollment in the registrational expansion cohort of ACHIEVE, initiation of the global confirmatory Phase 3 HARMONIA and FORZETTO trials, and FDA clearance of our IND for FSHD, underscoring the breadth of opportunity enabled by our FORCE™ platform. With a potential U.S. approval of z-rostudirsen in January 2027, we are investing in the capabilities needed to support patients, execute successfully as a commercial organization and maximize long-term shareholder value.”

Zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in DMD (Duchenne muscular dystrophy)

Phase 3 FORZETTO trial underway

•
Dyne initiated the global confirmatory Phase 3 FORZETTO trial of z-rostudirsen in May 2026. Dyne has aligned with the U.S. Food and Drug Administration (FDA) on the Phase 3 trial design and protocol, which was presented at the 19th International Congress on Neuromuscular Diseases (ICNMD 2026).

 

Key milestones for z-rostudirsen

•
Dyne’s BLA was accepted for review by the FDA in July 2026, with Priority Review granted (Prescription Drug User Fee Act (PDUFA) target action date set for 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.
•
Dyne also continues to pursue approval pathways outside of the U.S. for z-rostudirsen in patients with DMD who are amenable to exon 51 skipping.

1

 

•
In addition to z-rostudirsen, Dyne is advancing four development candidates (DYNE-253, DYNE-245, DYNE-244 and DYNE-255) for the potential treatment of DMD amenable to skipping of exons 53, 45, 44, and 55, respectively.

 

Zeleciment basivarsen (z-basivarsen, also known as DYNE-101) in DM1 (myotonic dystrophy type 1)

Clinical trial execution progress

•
Dyne completed enrollment of 71 participants in the registrational expansion cohort (REC) of ACHIEVE in June 2026.
•
Dyne began dosing participants in the global confirmatory Phase 3 HARMONIA trial of z-basivarsen in July 2026.

 

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.
o
Dyne 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 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.
•
Dyne also continues to pursue approval pathways outside of the U.S. for z-basivarsen in DM1.

 

DYNE-302 in FSHD (facioscapulohumeral muscular dystrophy)

IND clearance and Phase 1 trial overview

•
Dyne received clearance from the FDA in July 2026 for its IND application to initiate a Phase 1 clinical trial for DYNE-302 in FSHD. DYNE-302 leverages the same FORCETM platform as Dyne’s first two clinical programs, z-rostudirsen in exon 51 DMD and z-basivarsen in DM1.
•
Dyne plans to evaluate DYNE-302 in a Phase 1 randomized, placebo-controlled, double-blind, MAD clinical trial in ambulatory adult individuals with FSHD. The primary endpoint will be safety and tolerability. The trial will also assess pharmacokinetics and pharmacodynamics, including change from baseline in muscle DUX4 transcriptome and plasma KHDC1L levels, which Dyne has independently identified as a DUX4-regulated biomarker in FSHD.
•
Dyne intends to pursue a traditional approval pathway in the U.S. for DYNE-302.

 

Financing Updates

•
Dyne entered into an amendment to its non-dilutive senior secured term loan facility with Hercules Capital, Inc. in June 2026, expanding its debt facility to up to $400 million.
•
Dyne completed an underwritten public offering of 21,045,000 shares of its common stock at a public offering price of $20.50 per share in July 2026. The gross proceeds from the offering before deducting underwriting discounts and commissions and offering expenses payable by Dyne were approximately $431 million.

2

 

 

 

 

Second Quarter Financial Results

Cash position: Cash, cash equivalents and marketable securities were $898.5 million as of June 30, 2026. In July 2026, the Company completed an underwritten public offering of 21,045,000 shares of its common stock for estimated net proceeds of approximately $405.0 million. The Company expects that its cash, cash equivalents and marketable securities as of June 30, 2026, together with the net proceeds from the July 2026 underwritten public offering, will be sufficient to fund its operations into the second quarter of 2028.

Research and development (R&D) expenses: R&D expenses were $152.2 million for the three months ended June 30, 2026 compared to $99.2 million for the three months ended June 30, 2025. The increase in R&D expense was primarily due to increased manufacturing activity and higher clinical costs related to z-rostudirsen and z-basivarsen during the three months ended June 30, 2026.

General and administrative (G&A) expenses: G&A expenses were $29.5 million for the three months ended June 30, 2026 compared to $16.6 million for the three months ended June 30, 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 June 30, 2026 was $178.6 million, or $1.08 per basic and diluted share. This compares with a net loss of $110.9 million, or $0.97 per basic and diluted share, for the three months ended June 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-253, DYNE-245, DYNE-244, 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 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

3

 

 

 

“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.

 

 

Dyne Therapeutics, Inc.

 

Condensed Consolidated Statement of Operations

 

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2026

 

 

2025

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

152,169

 

 

$

99,236

 

General and administrative

 

 

29,492

 

 

 

16,555

 

Total operating expenses

 

 

181,661

 

 

 

115,791

 

Loss from operations

 

 

(181,661

)

 

 

(115,791

)

Other income, net

 

 

3,105

 

 

 

4,934

 

Net loss

 

$

(178,556

)

 

$

(110,857

)

Net loss per share, basic and diluted

 

$

(1.08

)

 

$

(0.97

)

Weighted average common shares outstanding, basic and diluted

 

 

165,451,388

 

 

 

113,873,126

 

 

4

 

 

 

Dyne Therapeutics, Inc.

 

Condensed Consolidated Balance Sheet Data

 

(in thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2026

 

 

2025

 

Assets

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

898,475

 

 

$

1,110,562

 

Other assets

 

 

95,538

 

 

 

76,396

 

Total assets

 

$

994,013

 

 

$

1,186,958

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Liabilities

 

 

291,862

 

 

 

214,829

 

Stockholders’ equity

 

 

702,151

 

 

 

972,129

 

Total liabilities and stockholders’ equity

 

$

994,013

 

 

$

1,186,958

 

 

Contacts:
 

Investors


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

 

Media


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

5

 

 

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