Bitcoin price today: gains to $120k, near record high on U.S. regulatory cheer
Scotiabank (TSX:BNS) raised its price target on UroGen Pharma (NASDAQ:URGN) to $47.00 from $23.00 on Friday, while maintaining a Sector Outperform rating following FDA approval of the company’s bladder cancer treatment. The stock has already responded positively, surging over 50% in the past week, with analyst targets ranging from $3 to $41.
The FDA approved UroGen’s UGN-102, marketed as ZUSDURI, for the treatment of recurrent, low-grade, intermediate risk, non-muscle invasive bladder cancer (LG-IR-NMIBC), despite a previously mixed outcome from the FDA’s Oncologic Drugs Advisory Committee (ODAC). According to InvestingPro data, the company maintains impressive gross profit margins of nearly 90% and holds more cash than debt on its balance sheet.
Scotiabank noted that the FDA’s decision highlights the agency’s view of the drug’s positive benefit/risk profile as demonstrated in the single-arm ENVIISON trial, which aligns with supportive commentary from practicing urologists on the ODAC panel.
The investment bank increased its likelihood of FDA approval from 60% to 100% following the regulatory decision, citing the drug’s market potential in the bladder cancer space.
Scotiabank estimates ZUSDURI has a peak market opportunity of approximately $1 billion in low-grade NMIBC alone, though specific details on drug pricing have not yet been announced.
In other recent news, UroGen Pharma Ltd. has received FDA approval for ZUSDURI, a medication for recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This marks the first FDA-approved intravesical medication for this condition, impacting an estimated 59,000 U.S. patients annually. ZUSDURI, which combines mitomycin with UroGen’s RTGel delivery platform, demonstrated a 78% complete response rate in Phase 3 trials. The treatment is expected to provide a non-surgical alternative to the standard tumor removal procedures, potentially reducing the need for repeated surgeries. Meanwhile, Oppenheimer has adjusted its price target for UroGen Pharma to $10, down from $36, while maintaining an Outperform rating, reflecting a revised financial model as the company approaches a regulatory milestone for its UGN-102 therapy. UroGen Pharma’s UGN-102 is under FDA review, with a decision expected by June 13, 2025, following a favorable advisory committee vote. The ongoing ENVISION trial results have shown promising data for UGN-102, suggesting it could offer a new treatment option for bladder cancer patients. UroGen Pharma’s developments are closely watched by investors, as FDA decisions could significantly influence the company’s future prospects.
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