Dyne Therapeutics, Inc. Stock Price, News & Analysis

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.

Dyne Therapeutics (DYN) has received regulatory clearance from New Zealand to initiate its Phase 1/2 multiple ascending dose clinical trial for DYNE-101, targeting myotonic dystrophy type 1 (DM1). The company plans to start dosing patients in mid-2022, with additional clearances expected globally. The trial will enroll 60 to 70 adult patients to assess safety, tolerability, and muscle function. DM1 affects over 40,000 people in the U.S., and DYNE-101 aims to address this unmet medical need.

Dyne Therapeutics has announced the FDA's clearance of its Investigational New Drug (IND) application, allowing the initiation of a Phase 1/2 clinical trial for DYNE-251 targeting Duchenne muscular dystrophy (DMD) amenable to skipping exon 51. Dosing is expected to begin in mid-2022, enrolling 30 to 50 male participants aged 4 to 16. The trial aims to assess safety, tolerability, and muscle function. Dyne is also expanding its DMD program with additional therapies for other exon mutations.

Dyne Therapeutics announced management's participation in a fireside chat at the Jefferies Global Healthcare Conference on June 9, 2022, at 3:00 p.m. ET. This event will be held in New York, NY, and a live webcast will be accessible via the company’s website. Additionally, a replay will be available for 90 days post-event. Dyne Therapeutics focuses on developing life-transforming therapeutics for genetically driven muscle diseases using its proprietary FORCE™ platform.

Dyne Therapeutics (Nasdaq: DYN) announced the initiation of dosing in a clinical trial for DYNE-101, targeting myotonic dystrophy type 1 (DM1). New in vivo data showcased substantial RNA knockdown in cardiac and skeletal muscles with low monthly doses. The treatment demonstrated a favorable safety profile in preclinical studies. DYNE-101 represents a potential disease-modifying therapy for DM1, a rare genetic disorder affecting over 40,000 people in the U.S. No approved therapies currently exist for DM1, enhancing the significance of DYNE-101's potential impact.

Dyne Therapeutics (DYN) has initiated plans for patient dosing in multiple ascending dose clinical trials for DYNE-251 in Duchenne muscular dystrophy (DMD) and DYNE-101 in myotonic dystrophy type 1 (DM1). The company expects to submit its response to the FDA regarding the clinical hold letter for DYNE-251 and regulatory filings for DYNE-101 in mid-2022. As of March 31, 2022, Dyne reported cash reserves of $323.2 million to fund operations into H2 2024, with a net loss of $35.6 million for Q1 2022.