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Urogen Pharma’s UGN-102 Faces Crucial Test: Durability of Response Key to Drug’s Approval Prospects

Urogen Pharma’s UGN-102 Faces Crucial Test: Durability of Response Key to Drug’s Approval Prospects

Urogen Pharma (URGN) has disclosed a new risk, in the Innovation / R&D category.

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Urogen Pharma faces a significant business risk concerning their investigational drug UGN-102, which has successfully met its primary endpoints in the ATLAS and ENVISION Phase 3 trials. However, there is uncertainty surrounding the upcoming evaluation of the secondary endpoint—duration of response—in the ENVISION trial slated for 2024. Should UGN-102 fall short in demonstrating a satisfactory duration of response or if new data emerges challenging its efficacy and safety, Urogen Pharma’s prospects for regulatory approval might be negatively impacted, potentially derailing commercialization efforts for this treatment.

Overall, Wall Street has a Strong Buy consensus rating on URGN stock based on 3 Buys and 1 Hold.

To learn more about Urogen Pharma’s risk factors, click here.

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