Dyne Therapeutics has reported new data from Phase I/II studies in myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy that it believes can position each candidate for US accelerated approval with best-in-class potential, and analysts see as validating the Waltham, MA-based company’s platform for oligonucleotide therapeutic.
Dyne Hopes DM1 And DMD Mid-Stage Data Can Lead To Accelerated Approval
Phase I/II data for its ADC candidates in myotonic dystrophy type 1 and Duchenne muscular dystrophy indicate potential for biomarker-based accelerated approval in both diseases, Dyne asserts.
More from Strategy
• By
Plus deals involving GV20/Mitsubishi Tanabe, Kaken/Alumis, AstraZeneca/Alteogen and deal terminations involving Clover/Gavi Alliance and Rhythm/RareStone.
• By
The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.
• By
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
• By
Plus deals involving Relmada/Trigone, Alvotech/Xbrane, OPKO Health/Entera, iOncologi/TargImmune and more.
More from Business
• By
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
• By
Plus deals involving Relmada/Trigone, Alvotech/Xbrane, OPKO Health/Entera, iOncologi/TargImmune and more.
• By
With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.