The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.
The firm will seek accelerated approval for WVE-N531 in DMD amenable to exon 53 skipping based on FDA feedback and Phase II data.
WVE-N531, an oligonucleotide, elicited significant functional benefit and reversal of muscle damage in the Phase II ...
Wave Life plans a 2026 NDA filing for WVE-N531 after positive Phase 2 data in Duchenne muscular dystrophy, showing functional gains and biomarker improvements.
Avidity Biosciences, Inc.'s innovative AOC platform and promising clinical programs make it a high-risk, high-reward ...
As it gears up to submit an approval application next year, Wave Life Sciences has presented fresh phase 2 data showing its ...
Shares of Wave Life Sciences Ltd . (NASDAQ: WVE) rose 14% today, following the company’s announcement of positive results from its FORWARD-53 clinical trial in Duchenne muscular dystrophy (DMD), which ...
New study results presented at the European Lung Cancer Congress (ELCC) 2025, March 26 to 29, demonstrate the role of AstraZeneca's TAGRISSO® (osimertinib), as monotherapy and as the backbone for ...
Entrada Therapeutics has secured authorisation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and ...
Entrada Therapeutics (NASDAQ:TRDA) said on Monday that it has received approval from the U.K.'s Medicines and Healthcare ...
Entrada Therapeutics (TRDA) has received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency and ...
Entrada Therapeutics Inc. has received authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and research ethics committee to initiate a phase I/II study of ENTR-601 ...
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