Group 1 - Dyne Therapeutics, Inc. announced a public offering of 24,242,425 shares of common stock at a price of $8.25 per share, aiming for gross proceeds of $200 million before expenses [1] - The offering is expected to close around July 2, 2025, pending customary closing conditions [1] - Dyne has granted underwriters a 30-day option to purchase an additional 3,636,363 shares at the public offering price [1] Group 2 - The offering is conducted under a shelf registration statement filed with the SEC on March 5, 2024, which became effective upon filing [3] - A preliminary prospectus supplement has been filed with the SEC, and a final prospectus will also be filed [3] Group 3 - Dyne Therapeutics focuses on developing therapeutics for genetically driven neuromuscular diseases, including myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) [5] - The company is also advancing preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease [5]

- $100 million funded upfront; additional $175 million tied to milestones provides strategic flexibility through key inflection points - WALTHAM, Mass., June 30, 2025 (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 announced it has entered into a $275 million non-dilutive senior secured term loan facility with Hercules Capital, Inc. (NYSE: HTGC), a leader i ...

Core Viewpoint - DJS Law Group is investigating Dyne Therapeutics for potential violations of securities laws following a significant drop in share price after the company announced revised trial protocols [1][2]. Investigation Details - The investigation centers on whether Dyne Therapeutics made misleading statements or failed to disclose critical information to investors [2]. - Following a June 17, 2025 announcement regarding feedback from the FDA and new efficacy data, Dyne's shares fell by over 19.4% during intraday trading on the same day [2]. Company Background - DJS Law Group specializes in enhancing investor returns through legal advocacy, focusing on securities class actions, corporate governance litigation, and M&A appraisals [4].

Group 1 - Dyne Therapeutics is under investigation by Pomerantz LLP for potential securities fraud or unlawful business practices involving its officers and directors [1] - On June 17, 2025, Dyne announced a delay in filing for FDA approval of its experimental therapy DYNE-101 for myotonic dystrophy type 1, revising its enrollment timeline for the Phase 1/2 global ACHIEVE trial [3] - Following the announcement of the delay, Dyne's stock price dropped by $2.96, or 21.42%, closing at $10.86 per share [4] Group 2 - The revised schedule for the ACHIEVE trial indicates that Dyne now aims to complete enrollment in the fourth quarter of 2025, with data readout expected in mid-2026 and a potential Accelerated Approval submission in late 2026 [3]

Core Viewpoint - Dyne Therapeutics is facing an investigation regarding potential securities fraud or unlawful business practices following a delay in FDA approval for its experimental therapy DYNE-101 for myotonic dystrophy type 1 [1][2]. Group 1: Company Developments - On June 17, 2025, Dyne Therapeutics announced a delay in filing for FDA approval of DYNE-101, which is an experimental therapy for myotonic dystrophy type 1 [2]. - The company revised its protocol for the Phase 1/2 global ACHIEVE trial for DYNE-101 after a Type C meeting with the FDA, with the revised protocol submitted in June [2]. - Dyne now plans to complete enrollment in the Registrational Expansion Cohort by the fourth quarter of 2025, aiming for a data readout in mid-2026 and a potential Accelerated Approval submission in late 2026 [2]. Group 2: Market Reaction - Following the announcement of the delay, Dyne's stock price fell by $2.96 per share, representing a decline of 21.42%, closing at $10.86 per share on June 17, 2025 [3].

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in the biotech sector and has compiled detailed reports on more than 1,000 companies [1]

Core Viewpoint - Dyne Therapeutics is facing an investigation regarding potential securities fraud and unlawful business practices following a delay in FDA approval for its experimental therapy DYNE-101 for myotonic dystrophy type 1 [1][3]. Group 1: Company Developments - On June 17, 2025, Dyne Therapeutics announced a delay in filing for FDA approval of DYNE-101, which is intended for treating myotonic dystrophy type 1 [3]. - The company revised its protocol for the Phase 1/2 global ACHIEVE trial after a Type C meeting with the FDA, with the new enrollment goal set for the fourth quarter of 2025 and a potential data readout in mid-2026 [3]. - The previous timeline aimed for enrollment completion in mid-2025 and regulatory submission in the first half of 2026, indicating a significant shift in the project timeline [3]. Group 2: Market Reaction - Following the announcement of the delay, Dyne's stock price dropped by $2.96 per share, or 21.42%, closing at $10.86 per share on June 17, 2025 [4].

Summary of Dyne Therapeutics (DYN) Conference Call on June 17, 2025 Company Overview - **Company**: Dyne Therapeutics - **Focus**: Development of DYME-one hundred one for Myotonic Dystrophy Type one (DM1) Key Industry Insights - **Regulatory Progress**: - Dyne Therapeutics received Breakthrough Therapy Designation from the FDA for DYME-one hundred one, indicating significant unmet medical need in DM1 and strong clinical data supporting potential clinical benefits [6][7] - The company is pursuing accelerated approval by revising the protocol for the ongoing registrational expansion cohort of the ACHIEVE trial, with VHOD as the primary endpoint [8][9] Core Points and Arguments - **Clinical Data**: - New long-term clinical data show robust improvement in VHOD as early as three to six months, with strength measured by QMT improving by approximately 10% at six months and 20% at twelve months [11][12] - The updated clinical plan includes increasing the registrational cohort to 60 patients to enhance statistical power [10][18] - Sustained improvements across multiple clinical endpoints were observed, reinforcing the efficacy of DYME-one hundred one [20][21] - **Regulatory Strategy**: - The switch from using CASI-twenty two as a primary endpoint to VHOD is seen as a pragmatic decision based on FDA feedback, allowing for a more straightforward path to accelerated approval [15][19] - The company plans to submit data from the registrational expansion cohort for potential accelerated approval in late 2026 [12][34] - **Safety Profile**: - The safety profile of DYME-one hundred one remains favorable, with no serious treatment-emergent adverse events reported [28][29] Additional Important Insights - **Market Need**: Approximately 40,000 Americans are living with DM1, highlighting the significant unmet need for effective treatments [12] - **Future Plans**: Dyne Therapeutics is preparing for potential launches of DYME-one hundred one and DYNE-two fifty one in 2027, with a focus on leveraging synergies in marketing to healthcare providers [35][36] - **Financial Guidance**: The company has narrowed its cash runway guidance to the fourth quarter of 2026, indicating improved financial projections [37] Conclusion - Dyne Therapeutics is advancing its clinical development of DYME-one hundred one with a clear regulatory strategy aimed at accelerated approval, supported by promising clinical data and a favorable safety profile. The company is also preparing for future product launches, addressing significant unmet needs in the neuromuscular disease space.

Clinical Trial & Regulatory Strategy - Dyne and the FDA have agreed on the next step toward Accelerated Approval, which involves submitting the revised protocol for the Registrational Expansion Cohort of the ACHIEVE trial with vHOT as the primary endpoint[9] - The FDA has granted Breakthrough Therapy Designation for DYNE-101 in DM1 following a Type C Meeting[9] - Data from the Registrational Expansion Cohort are planned for mid-2026 to support a potential U S Accelerated Approval submission in late 2026[9] - The company is planning to initiate a confirmatory Phase 3 clinical trial in Q1 2026[54] DYNE-101 Efficacy Data - New data from the ACHIEVE trial demonstrate robust and sustained functional improvement across multiple measures at 6 and 12 months at the registrational dose of 6 8 mg/kg Q8W[9] - Data support vHOT improvement as an early indicator of clinical benefit with DYNE-101[9, 22, 24, 27, 41, 48] - At 6 months, the DYNE-101 6 8 mg/kg Q8W group showed a -3 0 second change from baseline in vHOT Middle Finger, a -39% change from baseline, compared to a +0 4 second change and +5% change from baseline in the placebo group[30] - At 12 months, the DYNE-101 6 8 mg/kg Q8W group showed a -2 9 second change from baseline in vHOT Middle Finger, a -38% change from baseline[30] - At 6 months, the DYNE-101 6 8 mg/kg Q8W group showed a 10 3 %p change from baseline in Quantitative Muscle Testing (QMT) Total Score, a 20 1% change from baseline, compared to a -2 0 %p change and -3 9% change from baseline in the placebo group[32] - At 12 months, the DYNE-101 6 8 mg/kg Q8W group showed a 5 2 %p change from baseline in Quantitative Muscle Testing (QMT) Total Score, a 10 1% change from baseline[32] - At 6 months, the DYNE-101 6 8 mg/kg Q8W group showed a -1 5 second change from baseline in the 5 Times Sit to Stand Test, a -14 5% change from baseline, compared to a +0 5 second change and +5 2% change from baseline in the placebo group[34] - At 12 months, the DYNE-101 6 8 mg/kg Q8W group showed a -1 2 second change from baseline in the 5 Times Sit to Stand Test, a -12 4% change from baseline[34] - At 6 months, the DYNE-101 6 8 mg/kg Q8W group showed a -0 4 second change from baseline in the 10-Meter Walk/Run Test, a -9 0% change from baseline, compared to a +0 1 second change and +4 3% change from baseline in the placebo group[34] - At 12 months, the DYNE-101 6 8 mg/kg Q8W group showed a -0 3 second change from baseline in the 10-Meter Walk/Run Test, a -7 2% change from baseline[34] - At 6 months, the DYNE-101 6 8 mg/kg Q8W group showed a -12 3 change from baseline in the Myotonic Dystrophy Health Index (MDHI) Total Score, a -46 5% change from baseline, compared to a +1 9 change and +10% change from baseline in the placebo group[37] - At 12 months, the DYNE-101 6 8 mg/kg Q8W group showed a -11 7 change from baseline in the Myotonic Dystrophy Health Index (MDHI) Total Score, a -44% change from baseline[37] Safety Profile - DYNE-101 has demonstrated a continued favorable safety profile[9, 22, 23, 27, 41] - Approximately 1000 doses of the study drug have been administered to date, representing 93 patient-years of follow-up[45] Financial Position - The company has a strong financial position with $677 5 million in cash as of March 31, 2025, with an expected runway into Q4 2026[62]

Core Viewpoint - Dyne Therapeutics has received Breakthrough Therapy Designation from the FDA for DYNE-101, aimed at treating myotonic dystrophy type 1 (DM1), and has outlined a revised plan for U.S. Accelerated Approval based on new long-term functional data [1][2][10]. Group 1: FDA Designations and Approvals - The FDA granted Breakthrough Therapy Designation to DYNE-101 for DM1, which expedites development and review for drugs showing substantial improvement over existing therapies [10]. - Dyne is pursuing U.S. Accelerated Approval for DYNE-101, with a revised protocol submitted to the FDA following a Type C meeting [6][5]. Group 2: Clinical Trial Updates - The ongoing Registrational Expansion Cohort of the ACHIEVE trial will enroll 60 participants, with video hand opening time (vHOT) as the primary endpoint for potential Accelerated Approval [6][5]. - New long-term data from the ACHIEVE trial indicate that DYNE-101 led to a 3.3 seconds improvement in vHOT at 6 months compared to placebo, with sustained improvements observed at 12 months [12]. - The trial's secondary endpoints include various measures of muscle strength and performance, with a reported 20% improvement in strength at 12 months relative to baseline [12]. Group 3: Financial Guidance - As of March 31, 2025, Dyne reported cash, cash equivalents, and marketable securities totaling $677.5 million, expected to fund operations into Q4 2026 [7]. Group 4: Future Plans - Dyne plans to complete enrollment in the Registrational Expansion Cohort by Q4 2025, with data expected in mid-2026 to support a potential U.S. Accelerated Approval submission in late 2026 [6]. - A confirmatory Phase 3 clinical trial is anticipated to begin in Q1 2026 [6].