UroGen Pharma Ltd. (NASDAQ:URGN ) Q4 2024 - Earnings Conference Call March 10, 2025 10:00 AM ET Company Participants Vincent Perrone - Head of IR Liz Barrett - President and CEO Mark Schoenberg - CMO David Lin - CCO Chris Degnan - CFO Conference Call Participants Michael Schmidt - Guggenheim Raghuram Selvaraju - H.
Urogen Pharma (URGN) came out with a quarterly loss of $0.80 per share versus the Zacks Consensus Estimate of a loss of $0.74. This compares to loss of $0.72 per share a year ago.
PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced results from the subgroup analyses of the pivotal ENVISION study evaluating the impact of tumor burden and focality on the response to UGN-102, an investigational drug in development for treatment of LG-IR-NMIBC. Analyses of pre-specified subgroups showed comparable CR rates and DOR pa.
UroGen's Jelmyto, a gel-based mitomycin product for LG-UTUC, achieved $25.2mn in Q3 2024, marking a 20% YoY increase. Lead candidate UGN-102 shows promise in treating low-grade intermediate risk NMIBC, with significant clinical trial success and a PDUFA date set for June 13, 2025. Financially, UroGen has a market cap of $464mn and a cash runway of 8-9 quarters, despite facing patent challenges from Teva.
PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the presentation of the Phase 3 ENVISION trial's efficacy and safety results at the Society of Urologic Oncology (SUO) annual meeting in Dallas, TX. These results, published online in the Journal of Urology in October, demonstrate that treatment with investigational therapy UGN-102, a.
The mean of analysts' price targets for Urogen Pharma (URGN) points to a 209.9% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
Urogen's UGN-102 for bladder cancer presents a $5 billion market opportunity, prompting a continued "Strong Buy" rating despite past misjudgments. FDA approval by 06/2025 is crucial, with UGN-102 potentially being the first FDA-approved treatment for low-grade intermediate-risk NMIBC. Urogen's financials show a cash runway of over 2 years, with additional borrowing contingent on timely FDA approval.
UroGen Pharma Ltd. (NASDAQ:URGN ) Q3 2024 Earnings Call Transcript November 6, 2024 10:00 AM ET Company Participants Vincent Perrone - Head of IR Liz Barrett - President and CEO Mark Schoenberg - CMO David Lin - CCO Chris Degnan - CFO Conference Call Participants Tara Bancroft - TD Cowen Ram Selvaraju - H.
PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder.
PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will participate in fireside chats at the following investor conferences in September: H.C. Wainwright 26th Annual Global Investment Conference – September 9-11th, 2024 Fireside Chat: September 9th, 2024 at 9:00am ET Location: New York, NY Webcast Registration Link: Here 2024 C.