Sarepta’s Elevidys Phase 3 Study Raises Concerns: Kapoor Issues Sell Rating Amid Market Applicability and Control Group Disparities
Mitchell Kapoor, an analyst from H.C. Wainwright, reiterated the Sell rating on Sarepta Therapeutics (SRPT – Research Report). The associated ...
Sarepta could be down on patient death in FDA database, says RBC Capital
RBC Capital analyst Brian Abrahams says shares of Sarepta (SRPT) could be trading lower today on an FDA database update that ...
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Roche Looks Forward to Itovebi Approval in Europe Amid Steady Q4 Revenue Growth
The firm will share new overall survival data from the INAVO120 trial with regulators to support the breast cancer drug's approval.
F. Hoffmann-La Roche Ltd: Roche reports strong 2024 results with 7% sales growth; fourth quarter marks third straight quarter of 9% growth
Group sales grew by 7%1 at constant exchange rates (CER; 3% in CHF), driven by strong demand for both medicines and diagnostics.Excluding COVID-19, Group sales increased by 9%.
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Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...