- Data from DELIVER and ACHIEVE Clinicals Trial to be Presented - - Presentation on ACHIEVE Trial in DM1 and Company Symposium to Feature Data on the Use of Splicing Correction as a Prognostic Biomarker of Functional Outcomes in DM1 - - Presentations Add Insights into the FORCE™ Platform’s Ability to Deliver Targeted Therapeutics to Muscle and the CNS - WALTHAM, Mass., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancin ...

Group 1 - Dyne Therapeutics, Inc. (DYN) has experienced significant selling pressure, resulting in a 10.4% decline in stock price over the past four weeks, but it is now considered to be in oversold territory, indicating a potential for recovery [1] - The Relative Strength Index (RSI) for DYN is currently at 29.98, suggesting that the stock is nearing a point of reversal due to the exhaustion of heavy selling [5] - Analysts have raised earnings estimates for DYN, with a 0.4% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [6] Group 2 - DYN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [7]

Core Insights - Dyne Therapeutics, Inc. is a clinical-stage company focused on developing innovative therapeutics for genetically driven neuromuscular diseases [3] Group 1: Company Overview - Dyne Therapeutics is dedicated to discovering and advancing life-transforming therapeutics for individuals with genetically driven neuromuscular diseases [3] - The company utilizes its FORCE™ platform to create targeted therapeutics aimed at improving delivery to muscle tissue and the central nervous system (CNS) [3] - Dyne has a diverse pipeline addressing various neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease [3] Group 2: Upcoming Events - Management is scheduled to present during a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 4:00 p.m. ET [1] - A live webcast of the presentation will be available on Dyne's website, with a replay accessible for 90 days following the event [2]

Core Viewpoint - Dyne Therapeutics, Inc. (DYN) has experienced a significant decline of 42.2% over the past four weeks, but it is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to determine if a stock is oversold, with a reading below 30 typically indicating oversold conditions [2] - DYN's current RSI reading is 18.47, suggesting that the heavy selling pressure may be exhausting, indicating a potential bounce back towards equilibrium [5] Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts that earnings estimates for DYN have increased by 0.4% over the last 30 days, which often correlates with price appreciation [6] - DYN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7]

Core Insights - Dyne Therapeutics has received Fast Track designation from the FDA for DYNE-101, aimed at treating myotonic dystrophy type 1 (DM1) [1][2] - The company plans to submit for U.S. Accelerated Approval in the first half of 2026 [1] Company Overview - Dyne Therapeutics is focused on developing therapeutics for genetically driven neuromuscular diseases, utilizing its FORCE™ platform [5] - The company is currently conducting a Phase 1/2 global clinical trial for DYNE-101 [3] Product Details - DYNE-101 is an investigational therapeutic designed to target muscle tissue and reduce toxic DMPK RNA, potentially halting or reversing disease progression [3] - The drug has received orphan drug designation from both the FDA and the European Medicines Agency for DM1 treatment [3] Disease Context - Myotonic dystrophy type 1 (DM1) is a rare genetic disease affecting over 40,000 people in the U.S. and 74,000 in Europe, with no approved disease-modifying therapies available [4]

Core Insights - Dyne Therapeutics, Inc. has revealed new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101 for myotonic dystrophy type 1 (DM1) and plans to initiate a global Registrational Expansion Cohort to support U.S. Accelerated Approval submission in H1 2026 [1][4][5] Group 1: Trial Data - Efficacy data from the 6.8 mg/kg Q8W cohort (n=8) showed significant splicing correction at 3 months, linked to improvements in multiple functional endpoints at both 3 and 6 months [2][3] - Analysis of muscle biopsy data indicated a substantial knockdown of DMPK RNA levels, with robust splicing correction at 3 months supporting CASI-22 as a surrogate endpoint for potential U.S. Accelerated Approval [7] Group 2: Safety and Tolerability - Safety data from 56 patients indicated that most treatment-emergent adverse events were mild or moderate, with no serious treatment-emergent adverse events identified [4] - Early and sustained improvement in myotonia was observed, particularly in the 6.8 mg/kg Q8W cohort, with functional measures showing clinical benefits [7] Group 3: Future Plans - Dyne anticipates completing enrollment in the Registrational Expansion Cohort by mid-2025 and aims to submit for U.S. Accelerated Approval in H1 2026 [5]

Company Overview - Dyne Therapeutics is a clinical-stage company focused on developing innovative therapeutics for genetically driven neuromuscular diseases [3] - The company leverages its FORCE™ platform to design targeted therapeutics that address delivery challenges to muscle tissue and the central nervous system [3] - Dyne has a broad pipeline including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), as well as a preclinical program for facioscapulohumeral muscular dystrophy (FSHD) [3] Upcoming Event - Dyne Therapeutics' president and CEO John Cox is scheduled to present at the 43rd Annual J P Morgan Healthcare Conference on January 15, 2025 at 10:30 a m PT (1:30 p m ET) [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for 30 days following the event [2]

WALTHAM, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced it plans to report new clinical data from the Phase 1/2 ACHIEVE clinical trial on January 10, 2025, and to host a webcast at 8:00 a.m. ET. The company intends to issue a press release prior to the start of the event. Investor Conference Call and ...

Exhibit 99.1 Dyne Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update - IND Application for DYNE-101 for DM1 Cleared by FDA - - New Clinical Data from DYNE-101 ACHIEVE Trial Expected in Early January 2025 - - Enrolling Registrational Cohort of DYNE-251 DELIVER Trial in DMD - WALTHAM, Mass., November 12, 2024 – Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-39509 Dyne Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delawa ...