UroGen Pharma Stock Scores Bullish Price Target Revisions Up To $47 Following FDA Nod For Zusduri

Shares of UroGen Pharma gained momentum after the U.S. FDA approved Zusduri, a therapy for recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer, prompting a flurry of bullish analyst revisions and heightened interest from retail investors.

UroGen Pharma shares jumped 8.6% to $12.03 on Friday, hitting a three-month high, and edged up further to $12.06 in after-hours trading.

Goldman Sachs

Goldman Sachs raised its price target to $16 from $3, noting the stock’s 22% post-approval rally surprised most investors, given the negative ODAC vote and briefing document that had flagged an unfavorable benefit-risk profile. 

In a note, analyst Paul Choi reminded investors that FDA approvals following negative oncology advisory panels are “exceedingly rare.” 

The firm remains ‘Neutral’ on the stock despite the unexpected regulatory success.

Oppenheimer

Oppenheimer raised its target to $31 from $10, reiterating an ‘Outperform’ rating and emphasizing a key update from Friday’s conference call—a $21,500 per-dose list price for Zusduri. 

Analyst Leland Gershell expects clarity on UGN-103's path to approval will help preserve franchise exclusivity beyond 2031, adding that sales could reach $1 billion over time. 

He also said he would “take advantage of any near-term weakness to buy UroGen shares.”

Scotiabank

Scotiabank lifted its target to $47 from $23, increasing its FDA approval probability from 60% to 100%. 

The firm continues to rate the stock ‘Outperform,’ citing a $1 billion peak market opportunity for Zusduri and revising valuation models accordingly.

Guggenheim and D. Boral also reaffirmed bullish views on UroGen Pharma, calling the FDA's early approval of Zusduri a 'surprise decision' that bypassed further trial requirements and validated regulatory flexibility in high-unmet-need cancer settings.

The drug, a combination of mitomycin and sterile hydrogel, is administered once weekly for six weeks via catheter, offering a non-surgical alternative to transurethral resection of bladder tumors, the current standard of care.

On Stocktwits, retail sentiment was ‘extremely bullish’ amid ‘extremely high’ message volume.

The stock has risen 12.4% so far in 2025.

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