CureDuchenne was an early investor in Dyne Therapeutics in 2020, and congratulates the company for receiving Breakthrough Therapy Designation from the US FDA for DYNE-251, their exon 51-skipping agent for the treatment of Duchenne.
Why is this important:
The FDA grants Breakthrough Therapy Designations to speed up the development and review of drugs for serious conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over an available therapy on clinically significant endpoints. This designation offers several benefits to Dyne, including enhanced interactions with key senior-level staff the FDA, as well as Rolling and Priority Review eligibility, which will can significantly reduce the time the FDA uses for making an approval decision.
What’s next:
Dyne is expecting data from the DELIVER trial in late 2025, and is planning to submit materials to the FDA for consideration for accelerated approval in early 2026.
Link to press release: https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-announces-fda-breakthrough-therapy-0
Community letter attached
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