Business
Dyne Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Highlights
- 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
About this update from Dyne Therapeutics, Inc.
[{"type":"text","content":"- 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 - WALTHAM, Mass., March 10, 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 reported financial results for the fourth quarter and full year 2021 and recent business highlights. “In 2021 we made significant achievements throughout the business. We generated platform-validating preclinical data across our programs, including demonstrating sustained knockdown of toxic nuclear DMPK RNA and correction of splicing in DM1 and robust exon skipping and dystrophin expression in DMD. We also submitted our first IND for DYNE-251 in DMD in the fourth quarter, further strengthened our leadership team with multiple key hires, and completed a $168 million financing at the start of the year, extending our cash runway into the second half of 2024,” said Joshua Brumm, president and chief executive officer of Dyne. “We begin 2022 laser focused on advancing our programs into the clinic. We are on track to submit our response to the FDA for our DYNE-251 IND in DMD in the second quarter. In addition, as part of our global clinical development strategy, we now anticipate submitting regulatory filings in multiple countries for DYNE-101 in DM1 in the second quarter, with the goal of initiating patient dosing in clinical trials for both DYNE-251 and DYNE-101 in mid-2022. We believe we have the team, platform and pipeline in place to execute on our mission of delivering life-transforming therapies for people living with serious muscle diseases.” Recent Highlights In December 2021, Dyne submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD) amenable to skipping exon 51. As previously announced, Dyne received a clinical hold letter from the FDA on January 14, 2022 requesting additional clinical and non-clinical information for DYNE-251. The Company expects to submit its response to the FDA in the second quarter of 2022 with data from e...