Urogen Pharma Ltd. (URGN)
UroGen Pharma: Lessons Learned And Future Outlook
UroGen Pharma's FDA approval for UGN-102 removes existential risk and validates a contrarian investment stance, driving a sharp stock price recovery. A key investment thesis now hinges on UGN-102's commercial uptake, as physician adoption versus entrenched surgical standards remains uncertain. UroGen's financial runway is limited, with high cash burn and royalty obligations, raising the likelihood of future capital raises or non-dilutive financing.
US FDA approves Urogen's bladder cancer drug
The U.S. Food and Drug Administration has approved Urogen Pharma's drug to treat a type of bladder cancer, the regulator said on Thursday.
UroGen: Despite ODAC Vote, Hope Remains With Targeting Of Other Cancer Subpopulation
PDUFA date of June 13th 2025 by which FDA will decide upon whether or not UGN-102 should be approved for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The 7 major bladder cancer markets are expected to reach $5.4 billion by 2034. Company is developing anti-CTLA4 antibody UGN-301 in a phase 1 study either alone as a monotherapy or in combination to target patients with recurrent high-grade non-muscle invasive bladder cancer.
UroGen Pharma Stock Receives Downgrade As Analyst Cites FDA Panel Setback For Key Bladder Cancer Drug
HC Wainwright & Co. analyst Raghuram Selvaraju downgraded the rating on UroGen Pharma Ltd. URGN from Buy to Neutral.
UroGen Pharma: ODAC Decision Puts Drug Approval In Limbo, But It's Not Over, Either
UroGen Pharma Ltd.'s investment thesis hinges on FDA approval of UGN-102, a minimally invasive bladder cancer treatment with a June 13 decision date. ODAC narrowly voted against approval, citing insufficient comparative data, but a split panel and urologist support leave room for a positive FDA surprise. URGN faces significant financial risk, with only 4-5 quarters of cash and inability to fund another confirmatory trial if required by the FDA.
UroGen Pharma Ltd. (URGN) Q1 2025 Earnings Call Transcript
UroGen Pharma Ltd. (NASDAQ:URGN ) Q1 2025 Earnings Conference Call May 12, 2025 10:00 AM ET Company Participants Vincent Perrone - Senior Director, Investor Relations Liz Barrett - President and Chief Executive Officer Mark Schoenberg - Chief Medical Officer David Lin - Chief Commercial Officer Chris Degnan - Chief Financial Officer Conference Call Participants Tara Bancroft - TD Cowen Kelsey Goodwin - Guggenheim Leland Gershell - Oppenheimer Raghuram Selvaraju - H.
Urogen Pharma (URGN) Reports Q1 Loss, Lags Revenue Estimates
Urogen Pharma (URGN) came out with a quarterly loss of $0.92 per share versus the Zacks Consensus Estimate of a loss of $0.83. This compares to loss of $0.97 per share a year ago.
Urogen Pharma (URGN) Moves 14.1% Higher: Will This Strength Last?
Urogen Pharma (URGN) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.
UroGen: June 13 PDUFA For Potential Bladder Cancer Blockbuster Sets Up Strong Buy
I maintain a "Strong Buy" rating on UroGen Pharma despite a ~20% drop, emphasizing the high-risk nature of early-stage biotechs in today's volatile market. UroGen's ~$0.43 billion market cap undervalues its potential, especially with the upcoming FDA decision on UGN-102 for low-grade intermediate-risk non-muscle invasive bladder cancer. UGN-102's pivotal trial results show promising data, with an 80.6% duration of response at 18 months, making a strong case for FDA approval.
UroGen Pharma Ltd. (URGN) Q4 2024 Earnings Call Transcript
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) Reports Q4 Loss, Lags Revenue Estimates
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.
UroGen: Upcoming PDUFA, Some Concerns Remain
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.
