Dyne Therapeutics

Dyne Therapeutics, Inc. engages in developing innovative life-transforming therapies for genetically driven muscle diseases. It develops a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1, Duchenne muscular dystrophy, and facioscapulohumeral muscular dystroph. The company was founded by Jason P. Rhodes and Romesh R. Subramanian on December 1, 2017 and is headquartered in Waltham, MA.

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- Initiation of Dosing in Multiple Ascending Dose Clinical Trial of DYNE-101 in Patients with DM1 On Track for Mid-2022 -

Dyne Therapeutics Announces Clearance of Clinical Trial Application for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1

Dyne Therapeutics Inc (NASDAQ: DYN) shares are trading lower by 5.42% to $6.81 after the company announced FDA clearance of its Investigational New Drug application for DYNE-251 for the treatment of Duchenne muscular dystrophy. Dyne says the company plans to evaluate DYNE-251 in a global,.

What's Going On With Dyne Therapeutics Shares Today?

- Initiation of Dosing in Multiple Ascending Dose Clinical Trial in Patients with Mutations Amenable to Skipping Exon 51 On Track for Mid-2022 -

Dyne Therapeutics Announces FDA Clearance of IND Application for DYNE-251 for the Treatment of Duchenne Muscular Dystrophy

- Initiation of Dosing in Multiple Ascending Dose Clinical Trial for DYNE-101 in Patients with Myotonic Dystrophy Type 1 Anticipated in Mid-2022 -

Dyne Therapeutics Presents New In Vivo Data from DYNE-101 at ASGCT Annual Meeting Demonstrating Low Monthly Dosing Leads to Robust DMPK RNA Knockdown

- Initiation of Patient Dosing in Multiple Ascending Dose Clinical Trials for DYNE-251 in DMD and DYNE-101 in DM1 Anticipated in Mid-2022 -

Dyne Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights

SAN RAMON, CA / ACCESSWIRE / March 17, 2022 / Grid Dynamics Holdings, Inc. (NASDAQ:DYN) (Grid Dynamics), a leader in enterprise-level digital engineering services and solutions, today announced it has launched a fully transactional B2B and B2C commerce application for selfologi, a Dubai-based digital platform aiming to become the number one cosmetic treatment destination in the Middle East. Key Takeaways: In partnership with Grid Dynamics, commercetools, and other partners, Dubai-based digital platform selfologi launches a fully transactional B2B and B2C content and commerce marketplace selfologi's cosmetic treatment site was built on an accelerated timeline with a composable commerce architecture, leveraging best-of-breed advanced technologies including microservices, APIs, cloud-native SaaS, and headless Grid Dynamics was chosen for its deep experience in designing and developing transactional web applications and deep data science and engineering expertise Grid Dynamics is the lead digital technology consulting partner on the project, bringing together best-of-breed capabilities from additional providers including commercetools, Algolia, Amplience, Emarsys, and Yotpo.

selfologi Chooses Digital Technology Consulting Partner Grid Dynamics to Launch Its Cosmetic Treatment Platform

- Response to FDA for DYNE-251 IND in DMD on Track for Submission in the Second Quarter of 2022 - - Initiation of Patient Dosing in Multiple Ascending Dose Clinical Trials for DYNE-251 in DMD and DYNE-101 in DM1 Planned in Mid-2022 -

Dyne Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Highlights

WALTHAM, Mass., March 03, 2022 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced the appointment of Carlo Incerti, M.D., to its Board of Directors. Dr. Incerti has more than three decades of experience in the biopharmaceutical industry, including in rare disease drug development.

Dyne Therapeutics Appoints Carlo Incerti, M.D., to its Board of Directors

A clinical hold regarding one of the company's therapies brought Dyne's shares to a 52-week low.

Why Shares of Dyne Therapeutics Dropped 18.1% on Tuesday

The FDA has placed a clinical hold on Dyne Therapeutics Inc's (NASDAQ: DYN) investigational New Drug (IND) application to initiate a clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD) amenable to skipping exon 51.  Dyne received a clinical hold letter from the FDA on Friday, January 14, requesting additional clinical and non-clinical information for DYNE-251.

FDA Issues Clinical Hold On Dyne's IND For Duchenne Muscular Dystrophy Program

WALTHAM, Mass., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed on clinical hold its Investigational New Drug (IND) application to initiate a clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD) amenable to skipping exon 51. Dyne received a clinical hold letter from the FDA on Friday, January 14, 2022 requesting additional clinical and non-clinical information for DYNE-251. The Company expects to submit to the FDA its response with data from existing and ongoing studies in the second quarter of 2022, and if satisfactory to the FDA, to be dosing patients in a Phase 1/2 multiple ascending dose (MAD) clinical trial of DYNE-251 by mid-2022 in accordance with its current guidance. Dyne will work closely with the FDA to resolve the clinical hold as promptly as possible.

Dyne Therapeutics Announces FDA Clinical Hold on IND Application for DYNE-251 in Duchenne Muscular Dystrophy

WALTHAM, Mass., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that Joshua Brumm, president and chief executive officer, is scheduled to present during the virtual 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 2:15 p.m. ET.

Dyne Therapeutics to Present at the 40th Annual J.P. Morgan Healthcare Conference

Dyne Therapeutics (DYN) files an investigational new drug application in the United States for a clinical study on its investigational candidate DYNE-251 to address Duchenne Muscular Dystrophy.

Dyne Therapeutics (DYN) Submits IND to FDA for DMD Candidate

- DYNE-251, Dyne's First DMD Program, is Being Developed for Patients with Mutations Amenable to Skipping Exon 51 -

Dyne Therapeutics Announces Submission of IND Application to Initiate Clinical Trial of DYNE-251 for Duchenne Muscular Dystrophy

- Robust In Vivo Data Presented at Scientific Meetings Support Advancement of Dyne's Co-lead Candidates into the Clinic -

Dyne Therapeutics Reports Third Quarter 2021 Financial Results and Business Highlights

- Investigational New Drug (IND) Submissions Anticipated for DYNE-251 in DMD During the Fourth Quarter of 2021 and for DYNE-101 in DM1 During the First Quarter of 2022 -

Dyne Therapeutics Highlights Preclinical Data and Clinical Development Plans for DMD and DM1 Programs at Inaugural R&D Day

Dyne Therapeutics Inc (NASDAQ: DYN) has announced new data presented today during the 2021 Muscle Study Group Annual Scientific Meeting for its Duchenne muscular dystrophy (DMD) program. DMD is a rare disease caused by mutations in the gene that encodes for dystrophin, a protein critical for the normal function of muscle cells.

Dyne Therapeutics Highlights New Preclinical Data For Duchenne Muscular Dystrophy Program

- Dystrophin Restoration of 90% of Wild-Type Levels Observed in the Diaphragm and 78% in the Heart with ~80% Dystrophin-Positive Fibers After a Single Dose in mdx Mouse Model -

Dyne Therapeutics Presents New In Vivo Data for its Duchenne Muscular Dystrophy Program During Muscle Study Group Annual Scientific Meeting Demonstrating Robust and Durable Exon Skipping and Dystrophin Expression

- “The Muscle to Move to the Clinic” Event Will Highlight Preclinical Data Supporting Advancement of Dyne's DM1 and DMD Programs Toward Clinical Trials and Anticipated Timelines, and Feature Leading Experts in Both Disease Areas -

Dyne Therapeutics to Host Virtual Research and Development Day on Wednesday, October 13, 2021

WALTHAM, Mass., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that management is scheduled to present during Chardan's Virtual 5th Annual Genetic Medicines Conference.

Dyne Therapeutics to Present at Chardan's Virtual 5th Annual Genetic Medicines Conference

- New In Vivo Data Also Show Sustained Knockdown of Toxic Human Nuclear DMPK RNA and Foci Reduction -

Dyne Therapeutics Presents New In Vivo Data for its Myotonic Dystrophy Type 1 Candidate (DYNE-101) Demonstrating Robust Splicing Correction During World Muscle Society 2021 Virtual Congress

- On Track to Submit INDs for DM1, DMD and FSHD Programs Between the Fourth Quarter of 2021 and the Fourth Quarter of 2022 - - New In Vivo Data from DM1 and DMD Programs to be Presented at Scientific Meetings this Fall -

Dyne Therapeutics Reports Second Quarter 2021 Financial Results and Business Highlights

- FORCE™ platform enables targeted muscle delivery with lead FSHD program candidate demonstrating potent suppression of DUX4 biomarkers in patient cell line -

Dyne Therapeutics Presents Preclinical Data from its Facioscapulohumeral Muscular Dystrophy Program During the FSHD Society International Research Congress

- Co-founder Romesh Subramanian, Ph.D., stepping down as chief scientific officer and will serve as an advisor after leading successful R&D and pipeline-building efforts -

Dyne Therapeutics Announces Chief Scientific Officer Transition

Dyne Therapeutics Inc (NASDAQ: DYN) has announced new preclinical data from its myotonic dystrophy type 1 (DM1) program, including results demonstrating sustained knockdown of toxic human nuclear DMPK RNA, the genetic basis of the disease. Data were presented at the American Society of Gene & Cell Therapy Annual Meeting.

News for Dyne Therapeutics Stock (DYN)