Shares of Dyne Therapeutics, Inc. (DYN) , a clinical-stage muscle disease company, tumbled 30.7% on two key announcements. The company announced that some of its senior executives have stepped down from their respective positions. Earlier, DYN reported mixed data from its ongoing phase I/II study, the DELIVER trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD). Year to date, Dyne has surged 155.8% against the industry's 2.9% decline. Image Source: Zacks Investment Research Dyne Reports New ...

Core Insights - Dyne Therapeutics is advancing its clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) while preparing for commercialization and expedited approval pathways [1][2] Leadership Changes - Doug Kerr has been appointed as the new Chief Medical Officer (CMO), bringing over 25 years of experience in clinical development, particularly in neurology [2][3] - Johanna Friedl-Naderer joins as Chief Commercial Officer (CCO), with over 20 years of experience in global commercialization and product launches in rare diseases [3][4] - Lucia Celona has been appointed as Chief Human Resources Officer (CHRO), contributing over 30 years of experience in organizational design and talent management [4][5] - The company announced the departure of Susanna High (COO) and Jonathan McNeill (CBO) to pursue other opportunities [5][6] Company Strategy - The leadership team aims to leverage their extensive experience in launching therapies for rare diseases to enhance Dyne's operational success and prepare for the potential registration and commercialization of its clinical programs [2][3] - Dyne Therapeutics utilizes its proprietary FORCE™ platform to develop oligonucleotide therapeutics targeting muscle diseases, with a robust pipeline that includes clinical programs for DM1 and DMD, as well as a preclinical program for facioscapulohumeral muscular dystrophy (FSHD) [7]

- Initiating Registrational Cohorts with Update on Path to Registration by Year-End 2024 - - Virtual Investor Event Today at 8:00 a.m. ET - WALTHAM, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced new clinical data from its ongoing Phase 1/2 DELIVER trial of DYNE-251 in patients with Duchenne muscular dystr ...

Core Insights - Dyne Therapeutics reported significant clinical data from the ACHIEVE trial for DYNE-101 in myotonic dystrophy type 1 (DM1) and the DELIVER trial for DYNE-251 in Duchenne muscular dystrophy (DMD), indicating strong potential for both therapies [2][3][4] - The company successfully completed a public offering, raising approximately $374 million, which extends its cash runway into at least the second half of 2026 [1][8] Clinical Trials and Data - The ACHIEVE trial for DYNE-101 showed robust muscle delivery and dose-dependent splicing correction, with improvements in myotonia, muscle strength, and functional tests based on data from 40 adult DM1 patients [3] - The DELIVER trial for DYNE-251 demonstrated dose-dependent exon skipping and dystrophin expression, with levels exceeding those of the current standard of care, using a 12-fold lower dose [4][5] - Both trials are designed to be registrational, and the company is pursuing expedited approval pathways, with updates expected by the end of 2024 [6] Financial Performance - As of June 30, 2024, the company reported cash, cash equivalents, and marketable securities totaling $778.8 million, which is expected to fund operations through at least the second half of 2026 [9] - Research and development expenses for Q2 2024 were $62.3 million, compared to $59.1 million in Q2 2023, while general and administrative expenses increased to $9.7 million from $7.6 million [10] - The net loss for Q2 2024 was $65.1 million, or $0.70 per share, slightly higher than the net loss of $64.9 million, or $1.08 per share, in the same quarter of the previous year [10][13] Pipeline and Future Prospects - Dyne's FORCE™ platform demonstrated potential in delivering enzyme replacement therapy in preclinical models for Pompe disease and showed robust DUX4 suppression in facioscapulohumeral muscular dystrophy (FSHD) [7] - The company plans to present data from its clinical trials at the 2024 World Muscle Society Annual Congress in October [7]

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 June 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) Delaware 36 ...

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Below, we take a look at Dyne Therapeutics, Inc. (DYN) , a company that currently holds a Momentum Style Score of B. We also talk about price change and earnings estimate revisions, two of the main aspects of the Momentum Style Score. You can see the current list of Zacks #1 Rank Stocks here >>> While any stock can see a spike in price, it takes a real winner to consistently outperform the market. Over the past quarter, shares of Dyne Therapeutics, Inc. Have risen 66.05%, and are up 269.37% in the last year ...

The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive. However, it's not enough to look at the price change for around three months, as it doesn't reflect any trend reversal that might have happened in a shorter time frame. It's important for a potential winner to maintain the price trend ...

WALTHAM, Mass., June 24, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced new preclinical data in a Pompe disease model demonstrating the potential of the FORCE™ platform to deliver enzyme replacement therapy to cardiac and skeletal muscle and the central nervous system (CNS). The data were presented at the New Directions in ...

Core Findings - FSHD is a severe muscle disorder caused by aberrant expression of the DUX4 gene, leading to progressive muscle wasting and skeletal muscle loss [1] - DYNE-302, developed using the FORCE platform, consists of a fragment antibody (Fab) that binds to transferrin receptor 1 (TfR1) and is conjugated to an siRNA designed to reduce DUX4 expression [1] - DYNE-302 demonstrated robust and durable DUX4 suppression and functional benefit in FSHD preclinical models, with effects lasting up to three months [4][7] FORCE™ Platform - The FORCE platform is designed to develop targeted oligonucleotide therapeutics for serious muscle diseases, leveraging TfR1's role in muscle biology [5] - The platform overcomes current limitations in delivering therapeutics to muscle tissue, aiming to stop or reverse disease progression [5] - Dyne links therapeutic payloads to its TfR1-binding Fab to create targeted treatments for muscle diseases [5] DYNE-302 Preclinical Data - In hTfR1/iFLExD mouse models, a single intravenous dose of DYNE-302 resulted in dose-dependent and robust reduction of the DUX4 transcriptome (D4T) [4] - DYNE-302 also showed high in vitro potency in FSHD patient-derived myotubes [4] - The data highlight the modularity of the FORCE platform to conjugate different oligonucleotides and target underlying disease mechanisms [4] FSHD Overview - FSHD is a rare, progressive genetic disease caused by a mutation in the DUX4 gene, leading to muscle weakness, wasting, and limited mobility [11] - An estimated 16,000-38,000 individuals in the US and approximately 35,000 in Europe are affected by FSHD, with no currently approved therapies [11] Company Overview - Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative therapeutics for genetically driven diseases [6] - The company has a broad pipeline, including clinical programs for DM1 and DMD, and a preclinical program for FSHD [6]