Thinly traded UroGen (URGN -5.5%) slips on almost triple normal volume, albeit on turnover of only 608K shares, on the heels of updated data on candidates UGN-101 and UGN-102 presented during its Investor Day today.
Final results from the Phase 3 OLYMPUS study evaluating UGN-101 (mitomycin gel) in patients with low-grade upper tract urothelial cancer showed a 59% (n=42/71) complete response rate. 89% of patients experienced sustained responses at month 6 and 84% at month 12. Median time to recurrence was 13.0 months.
Investors appear to be reacting to the safety profile. 67% (n-48/71) of treated patients experienced an adverse event involving the renal/urinary tract. Of these, 50% (n=24/48) required temporary ureteral stent placement, 23% (n=11/48) required a long-term ureteral stent and 4% (n=2/48) required a nephroureterectomy (removal of the renal pelvis, kidney, ureter and bladder cuff).
The company plans to complete its U.S. marketing application next quarter and expects approval in H1 2020.
Preliminary data from the Phase 2b OPTIMA trial evaluating UGN-102 (mitomycin gel) for intravesical instillation in patients with intermediate-risk low-grade non-muscular invasive bladder cancer showed a 63% (n=20/32) complete response rate. A Phase 3 study should launch in 2020 after discussions with the FDA.
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