The U.S. Food and Drug Administration (FDA) has once again declined to approve Supernus Pharmaceuticals' SPN-830, a drug-device combination aimed at treating the movement-related symptoms of Parkinson's disease, marking the third rejection for the product. The FDA issued a Complete Response Letter (CRL) highlighting two main areas of concern: product quality and the master file for the infusion device. Following the announcement, Supernus Pharmaceuticals' stock saw a decrease of 9% in early trading and was down 7.5% pre-market. In parallel, the FDA has agreed to review a rare disease drug from another developer, a decision that was long-awaited by the company and could have led to the shelving of further work on the drug if the FDA had not agreed to review it.
FDA swats away Supernus’ Parkinson’s disease infusion pump for 3rd time https://t.co/A7LsuW3gRz
Supernus Pharmaceuticals said on Monday the U.S. FDA declined to approve its drug-device combination to treat movement-related symptoms of Parkinson's disease, sending its shares down 9% in early trade. https://t.co/7QP0pXJeqF https://t.co/7QP0pXJeqF
US FDA declines to approve Supernus' Parkinson's combination again https://t.co/bkyX76iJpX https://t.co/Cr3MSr8bOG
Will be an interesting case for FDA - ELAMIPRETIDE for Barth Syndrome - .. the Tazpower trial - in the RCT phase - clearly was a bust - .. even with the FDA favorite cross-over design to max the stats power w/ small N trial data - .. all these folks have been based on the OLE…
$SUPN (-7.5% pre) Supernus Pharma (SUPN) Provides Regulatory Update for SPN-830, FDA Issues CRL - SI https://t.co/33rrwF4xnl
The U.S. Food and Drug Administration (FDA) declined to approve Supernus Pharmaceuticals' drug-device combination to treat movement-related symptoms of Parkinson's disease, the drugmaker said on Monday. https://t.co/crJoAUbDLe https://t.co/crJoAUbDLe
The FDA has agreed to review a rare disease drug developed by a small company that planned to shelve further work if the agency did not take this long-sought step. https://t.co/szQ7bVWuXu
FDA agrees to review a rare disease drug that its developer was about to give up on.. https://t.co/I38X1oxbkP #pharma #biotech #FDA #RareDisease
$SUPN FDA issues CRL for the NDA for SPN-830. The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA. First relates to product quality. Second relates to the master file for the infusion device which is…
TACT2 Trial #LBCT #ACC24 🫀does chelation heals postMI patients with DM? 🫀27% 💃🏻 but diverse population 🫀68% complete all 40 infusion 🫀No difference in primary outcome of MI, stroke, 🏥, or revasc ⁉️differ from tact1: blood levels ⤵️ over time. Is this why? https://t.co/7TBWmTlje6