Earnings summaries and quarterly performance for Dyne Therapeutics.
Executive leadership at Dyne Therapeutics.
Board of directors at Dyne Therapeutics.
Research analysts covering Dyne Therapeutics.
Recent press releases and 8-K filings for DYN.
Dyne Therapeutics Highlights Strong Financial Position and Clinical Pipeline Progress for DMD and DM1
DYN
Product Launch
New Projects/Investments
Guidance Update
- Dyne Therapeutics reported a strong financial position with ~$1.1 billion in cash as of December 31, 2025, providing an expected runway into Q1 2028.
- The company's lead program, z-rostudirsen for Duchenne muscular dystrophy (DMD), achieved positive topline results from its registrational cohort in December 2025, with a planned submission for U.S. Accelerated Approval in Q2 2026 and a potential U.S. launch in Q1 2027.
- Z-basivarsen, the second lead program for Myotonic Dystrophy Type 1 (DM1), demonstrated proof-of-concept and has a potential submission for U.S. Accelerated Approval in early Q3 2027, with a potential U.S. launch in Q1 2028.
- Dyne's FORCET™ platform is validated by z-rostudirsen's clinical results, enabling targeted delivery to muscle and CNS, and supports a broader pipeline including FSHD and Pompe.
1 day ago
Dyne Therapeutics Details Commercialization Plans and Clinical Data for DMD and DM1
DYN
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Dyne Therapeutics plans to submit its first BLA in Q2 2026 and aims to launch its first commercial product for Duchenne Muscular Dystrophy (DMD) in Q1 2027, with a Myotonic Dystrophy Type 1 (DM1) product launch anticipated in 2028.
- The company reported strong clinical validation for its FORCE platform, with zurastadersen for DMD showing a seven-fold increase in dystrophin and functional improvements, and zibasersen for DM1 demonstrating 33% DMPK knockdown, 25% splicing correction, and significant strength increases.
- Dyne holds a cash position of over $1 billion, wholly owns its assets, and is building a capital-efficient commercial infrastructure to support the launches of its high-priority DMD and DM1 programs.
- Enrollment for the DM1 ACHIEVE study's registrational cohort is on track to be completed in early Q2 2026.
1 day ago
Dyne Therapeutics Details Commercialization Strategy and Clinical Progress for DMD and DM1
DYN
Product Launch
New Projects/Investments
Guidance Update
- Dyne Therapeutics expects to submit data for accelerated approval of its DMD program (zurastadersen) in Q2 2026, targeting a Q1 2027 commercial launch. Clinical data showed a 7-fold increase in dystrophin and significant functional improvements across ambulatory and non-ambulatory patients.
- The company's DM1 program (Z-basophyrsin) is on track to complete registrational cohort enrollment in early Q2 2026, with a planned 2028 launch. Data indicated 33% DMPK knockdown, 25% splicing correction, and functional improvements including a 10-20% increase in muscle strength.
- Dyne aims to become a fully integrated commercial biotech company in 2026, supported by a cash position of over $1 billion. The company also plans to expand its DMD franchise to other exons, potentially tripling the market size, and anticipates FSHD as the next program to enter the clinic.
1 day ago
Dyne Therapeutics Provides Updates on DMD and DM1 Programs at J.P. Morgan Healthcare Conference
DYN
Product Launch
New Projects/Investments
Guidance Update
- Dyne Therapeutics reported a cash position of over $1 billion and wholly owns its assets, positioning it to fund its dual-priority pipeline.
- For its Duchenne Muscular Dystrophy (DMD) program, DYNE-251, the company plans to submit its first Biologics License Application (BLA) in Q2 2026 and anticipates a commercial launch in Q1 2027. Clinical data from the DELIVER trial showed a seven-fold increase from baseline in dystrophin levels and functional improvements across multiple measures.
- The Myotonic Dystrophy Type 1 (DM1) program, DYNE-101, is on track to complete enrollment of its registrational cohort in early Q2 2026, with a planned product launch in Q1 2028. The ACHIEVE study demonstrated 33% DMPK knockdown, 25% splicing correction, and significant functional improvements, including a 20% increase in muscle strength at 12 months.
- The company's FORCE platform has been clinically validated in humans for both DMD and DM1, with plans to expand its pipeline to other DMD exons, FSHD, and Pompe disease, aiming to triple the DMD market size through a franchise approach.
1 day ago
Dyne Therapeutics Reports Preliminary Q4 2025 Cash Position and Provides Pipeline Updates
DYN
Earnings
Guidance Update
Product Launch
- Dyne Therapeutics expects to report cash, cash equivalents and marketable securities of approximately $1.1 billion as of December 31, 2025, with an anticipated cash runway into Q1 2028.
- The company reported positive topline results for Z-rostudirsen (DYNE-251) in Duchenne muscular dystrophy (DMD) and is preparing for a potential U.S. launch in Q1 2027.
- For Z-basivarsen (DYNE-101) in Myotonic dystrophy type 1 (DM1), Dyne plans to submit for U.S. Accelerated Approval in early Q3 2027, with a potential U.S. launch in Q1 2028.
4 days ago
Dyne Therapeutics Announces Closing of Public Offering
DYN
- Dyne Therapeutics, Inc. (Nasdaq: DYN) announced the closing of its previously announced upsized underwritten public offering of common stock on December 11, 2025.
- The offering comprised 21,827,549 shares of common stock at a public offering price of $18.44 per share, which included 2,847,071 shares from the full exercise of the underwriters' option to purchase additional shares.
- The gross proceeds to Dyne from the offering totaled approximately $402.5 million, before deducting underwriting discounts and commissions and offering expenses, with all shares sold by Dyne.
Dec 11, 2025, 9:05 PM
Dyne Therapeutics Announces Pricing of Upsized Public Offering
DYN
- Dyne Therapeutics, Inc. announced the pricing of an upsized underwritten public offering of 18,980,478 shares of its common stock at a public offering price of $18.44 per share.
- The offering is expected to generate $350.0 million in gross proceeds for Dyne.
- The company estimates net proceeds of approximately $328.5 million, or approximately $377.9 million if the underwriters fully exercise their option to purchase an additional 2,847,071 shares.
- The offering is expected to close on or about December 11, 2025.
- These net proceeds, combined with existing cash, cash equivalents, marketable securities, and a $50.0 million term loan tranche, are projected to fund the company's operating expenses, debt service obligations, and capital expenditure requirements into the first quarter of 2028.
Dec 10, 2025, 9:22 PM
Dyne Therapeutics Prices Upsized Public Offering
DYN
- Dyne Therapeutics, Inc. has announced the pricing of an upsized underwritten public offering of 18,980,478 shares of its common stock.
- The shares are priced at $18.44 per share, with the offering expected to generate $350.0 million in gross proceeds for Dyne.
- All shares in the offering are being sold by Dyne, and the company has granted underwriters a 30-day option to purchase up to an additional 2,847,071 shares.
- The offering is anticipated to close on or about December 11, 2025.
Dec 10, 2025, 2:42 AM
Dyne Therapeutics Amends Loan Agreement and Borrows Additional Funds
DYN
Debt Issuance
New Projects/Investments
- On December 8, 2025, Dyne Therapeutics, Inc. entered into the First Amendment to its Loan and Security Agreement with Hercules Capital, Inc. and other lenders.
- This amendment allowed the company to borrow a second term loan tranche of $50.0 million.
- The company has access to an additional $125.0 million in potential future term loan tranches, with $75.0 million contingent on clinical, regulatory, and commercial milestones, and $50.0 million subject to lender approval.
- The loan has a Maturity Date of July 1, 2030, with an interest-only period until July 1, 2028, and bears a floating interest rate with a floor of 7.50% plus 2.45%.
- As collateral for the obligations, the company granted a first-priority security interest in substantially all of its property, including intellectual property.
Dec 8, 2025, 9:07 PM
Dyne Therapeutics Announces Proposed Public Offering of Common Stock
DYN
- Dyne Therapeutics, Inc. has commenced an underwritten public offering of $300,000,000 of its common stock.
- The company intends to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 of shares of common stock.
- All shares in the proposed offering are to be sold by Dyne.
- Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities are acting as joint book-running managers for the offering.
Dec 8, 2025, 9:02 PM
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