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FDA panel rejects UroGen's bladder cancer drug UGN-102, citing efficacy concerns, leading to stock decline.
UroGen Pharma's bladder cancer drug, UGN-102, faced a setback after an FDA panel voted against its approval due to concerns about its efficacy, causing the stock to drop.
Analyst Raghuram Selvaraju downgraded the stock from "Buy" to "Neutral," though he may reassess if the drug gets approval with conditions.
UroGen has sufficient funds to operate through late 2026, and the Phase 3 trial for its next drug, UGN-103, is expected to complete enrollment by mid-2025.
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El panel de la FDA rechaza el medicamento contra el cáncer de vejiga de UroGen UGN-102, citando preocupaciones de eficacia, lo que lleva a la disminución de las existencias.