Dyne Therapeutics, Inc. develops investigational therapies for genetically driven neuromuscular diseases using its FORCE platform, which is designed to deliver payloads to muscle tissue and the central nervous system. Company news centers on clinical programs in Duchenne muscular dystrophy and myotonic dystrophy type 1, including z-rostudirsen, z-basivarsen, the DELIVER, ACHIEVE and HARMONIA studies, and preclinical work in additional neuromuscular diseases.
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Dyne Therapeutics (Nasdaq: DYN) announced today the FDA has granted Fast Track designation for DYNE-251, targeting Duchenne muscular dystrophy (DMD) mutations suited for exon 51 skipping. This designation aims to expedite DYNE-251's development, which is currently evaluated in the Phase 1/2 DELIVER trial. Results are anticipated in H2 2023, focusing on safety, tolerability, and dystrophin levels. DYNE-251 aims to address a critical need in DMD treatment, enhancing access to therapies with potentially transformative effects in muscle signaling and function.
Dyne Therapeutics (DYN) presented preclinical data for its Duchenne muscular dystrophy (DMD) programs at the World Muscle Society Congress. Key findings from the DYNE-251 candidate include robust exon skipping and dystrophin expression in animal models. Notably, dystrophin levels reached 90% in the diaphragm and 77% in the heart. The FORCE platform targets exon skipping for DMD mutations, with additional conjugates for other exons. Dyne anticipates reporting clinical data from the Phase 1/2 DELIVER trial in H2 2023, focusing on safety, tolerability, and dystrophin levels.
Dyne Therapeutics, a clinical-stage company focused on muscle diseases, will participate in a fireside chat at Chardan’s 6th Annual Genetic Medicines Conference on October 4, 2022, at 8:00 a.m. ET. The event will provide insights into Dyne's innovative therapeutics for genetically driven diseases, including myotonic dystrophy, Duchenne muscular dystrophy, and facioscapulohumeral muscular dystrophy. A live webcast will be available on the company's website, with a replay accessible for 90 days post-event.
Dyne Therapeutics held a virtual event on Sept 12, 2022, discussing its clinical trials for DYNE-101 in myotonic dystrophy type 1 (DM1) and DYNE-251 in Duchenne muscular dystrophy (DMD). Experts shared insights into the unmet needs in these diseases. Both trials aim to report data in the second half of 2023. Dyne is extending its focus on these programs while deferring the investigational application for a program in facioscapulohumeral muscular dystrophy. As a result, the company expects its cash runway to last through 2024.
Dyne Therapeutics (Nasdaq: DYN) announced its participation in the Morgan Stanley 20th Annual Global Healthcare Conference on September 12, 2022, at 2:15 p.m. ET. The event will feature a fireside chat with management, focusing on the company’s innovative therapeutics for muscle diseases. A live webcast will be available on Dyne's website, with a replay accessible for 90 days post-event. Dyne Therapeutics specializes in developing oligonucleotide therapies targeting serious muscle disorders, utilizing its proprietary FORCE™ platform.
Dyne Therapeutics has initiated the ACHIEVE Phase 1/2 clinical trial for DYNE-101 to treat myotonic dystrophy type 1 (DM1). The trial includes a 24-week multiple ascending dose (MAD) period, followed by open-label and long-term extensions, enrolling around 64 adult patients. Key endpoints are safety, tolerability, and splicing measures. First patient dosing is expected in September 2022, with data anticipated in the latter half of 2023. A virtual event discussing the trial and pipeline is scheduled for September 12.
Dyne Therapeutics, a clinical-stage company, has initiated its Phase 1/2 DELIVER trial evaluating DYNE-251 for Duchenne muscular dystrophy (DMD) mutations amenable to exon 51 skipping. The trial aims to enroll 46 participants aged 4 to 16 and includes a 24-week placebo-controlled period followed by open-label extensions. Dyne expects to report data on safety and dystrophin levels in late 2023. Additionally, Dyne will host a virtual event on September 12, 2022, to discuss its pipeline and clinical programs, with a focus on DMD and myotonic dystrophy type 1.
Dyne Therapeutics (Nasdaq: DYN) announces the appointment of Dr. Francesco Bibbiani as senior vice president, head of development. Dr. Bibbiani brings over 20 years of experience in drug development, particularly focusing on rare neuromuscular diseases like Duchenne muscular dystrophy (DMD). His expertise in operationalizing clinical trials will be crucial as Dyne’s clinical programs advance. The company leverages its FORCE™ platform to develop oligonucleotide therapeutics for serious muscle diseases. This leadership change aims to enhance Dyne's capabilities and advance its investigational therapies.
Dyne Therapeutics (Nasdaq: DYN) has published preclinical data demonstrating the effectiveness of its FORCE™ platform for Duchenne muscular dystrophy (DMD) in mdx mice. The study, featured as a 'Breakthrough Article' in Nucleic Acids Research, reports significant dystrophin expression levels, achieving up to 90% in the diaphragm and 77% in the heart. DYNE-251, targeting exon 51 skipping, is set for a Phase 1/2 clinical trial beginning summer 2022. This publication reinforces Dyne's position in advancing therapies for muscle diseases.
Dyne Therapeutics (DYN) announced progress in its clinical trials, with patient dosing for DYNE-251 in Duchenne muscular dystrophy and DYNE-101 in myotonic dystrophy type 1 expected to begin in mid-2022. The company reported a Q2 2022 net loss of $52.3 million ($1.01 per share), compared to a net loss of $30 million ($0.58 per share) in Q2 2021. However, cash, cash equivalents, and marketable securities stood at $291.8 million, projected to fund operations into 2024.