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What Does the FDA's NDA Acceptance Mean for Mineralys Therapeutics

2 months ago

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Sarepta Announces FDA Acceptance of sNDAs for AMONDYS 45® and VYONDYS 53®

Sarepta's sNDAs for AMONDYS 45 and VYONDYS 53 were accepted by the FDA, potentially expanding label indications for Duchenne muscular dystrophy treatments.

SRPT

Stock News•3 weeks ago

Corcept Resubmits New Drug Application for Relacorilant as a Treatment for Patients with Cushing's Syndrome

Corcept resubmitted its NDA for relacorilant to the FDA for Cushing's syndrome, following a prior FDA request. The resubmission could determine market access for the therapy.

CORT

Stock News•3 weeks ago

DiaMedica Receives FDA Feedback on DM199 Preeclampsia Nonclinical Program

DiaMedica received FDA feedback requiring additional nonclinical reproductive toxicity data for DM199 in preeclampsia, which could delay the program's timeline.

DMAC

Stock News•2 months ago

Mineralys Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

Mineralys Therapeutics announced the FDA accepted its New Drug Application for lorundrostat to treat hypertension in adults. The agency assigned a PDUFA target action date of December 22, 2026, markin...

MLYS