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

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.

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.

Related Articles
TheFlyUroGen Pharma price target raised to $64 from $60 at H.C. Wainwright
TheFlyUroGen Pharma announces FDA acceptance of new drug application for UGN-102
TheFlyUroGen Pharma initiated with a Buy at EF Hutton
Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App