Urogen Pharma, Inc.

Revolo Biotherapeutics' ‘1104, derived from Mycobacterium tuberculosis, targets antigen-presenting cells to shift the immune system from a pro-inflammatory to a homeostatic state, potentially providing remission for allergic diseases. It acts upstream in the inflammatory response, reducing IL-4 and IL-13 signaling via SHP-1 activation, and increases regulatory T and B cells. This upstream approach contrasts with traditional therapies, offering potential for more durable disease control and fewer side effects. Preclinical and clinical findings support its broad-spectrum efficacy across Th2-driven conditions like eosinophilic esophagitis, asthma, and atopic dermatitis, with potential for less frequent dosing and long-term remission.

UroGen submitted an NDA for UGN-102, a potential first FDA-approved treatment for LG-IR-NMIBC, showing a 79.6% CR rate in Phase III trials. It offers a non-surgical option, with a 82.3% 12-month DOR. Common side effects were mild-to-moderate. FDA approval is anticipated by early 2025.

Goldman Sachs' Paul Choi maintains a Hold rating on Urogen Pharma with a $22 price target, citing promising UGN-102 Phase 3 results but uncertainty over replacing TURBT surgery. Acknowledges potential for priority review and 2025 launch, yet cautious on treatment practice shifts. Choi, a 4-star analyst, focuses on healthcare stocks.

UGN-102, a hydrogel-based mitomycin formulation, showed promise in phase 3 trials (ATLAS and ENVISION) for treating low-grade, intermediate-risk non–muscle invasive bladder cancer without surgery. It reduced recurrence risk by 55% vs TURBT alone, with 64.8% and 79.2% CR rates at 3 months in respective trials, aiming for FDA approval.

UGN-102, a bladder-administered treatment, shows promise for low-grade, intermediate-risk non-muscle invasive bladder cancer, improving disease-free survival and reducing progression or death risk. Phase 3 trials ATLAS and ENVISION highlight its potential as a non-surgical option, with significant complete response rates. UroGen Pharma plans FDA submission in 2024.

UGN-102 (mitomycin) showed improved disease-free survival in low-grade, intermediate-risk NMIBC patients, with a 55% reduced risk of recurrence, progression, or death compared to TURBT alone. The phase 3 ATLAS and ENVISION trials met primary endpoints, with ENVISION showing a 79.2% complete response rate. UGN-102, a non-surgical treatment, may change the treatment paradigm, with FDA submission expected in 2024.