Urogen Pharma Stock Price, News & Analysis

UroGen Pharma Ltd. (Nasdaq: URGN) has initiated a Phase 3b study of UGN-102 in patients with low-grade non-muscle invasive bladder cancer. This study aims to evaluate the feasibility of administering treatment at home, potentially enhancing access for patients, often elderly and medically complex. The study will enroll up to ten patients, with the first dose already administered. The primary endpoint is the safety profile of UGN-102.

With 80,000 annual bladder cancer cases, patient demand for less invasive options is critical, as current surgical methods are burdensome.

UroGen Pharma Ltd. (Nasdaq: URGN) announced the issuance of inducement restricted stock units (RSUs) to 13 new employees to support the commercial launch of Jelmyto® and ongoing pipeline development. A total of 53,000 shares will be available upon vesting over three years, contingent on continued employment. This grant aligns with UroGen’s 2019 Inducement Plan and complies with Nasdaq Rule 5635(c)(4). UroGen focuses on innovative solutions for specialty cancers and urologic diseases, utilizing RTGel™ technology aimed at enhancing local treatment effectiveness.

UroGen Pharma Ltd. (URGN) reported a net product revenue of $11.4 million for Q3 2021, marking over 200% growth year-over-year. The company announced a shift to a single-arm Phase 3 study for UGN-102 in bladder cancer, aiming for a NDA submission in 2024. New patient starts surged by 60% in September and October compared to prior months. Despite gains, UroGen reported a net loss of $30.2 million, with cash equivalents totaling $110.3 million as of September 30, 2021. Full-year revenue guidance ranges from $47 million to $51 million.

UroGen Pharma Ltd. (Nasdaq: URGN) announced its participation in two virtual healthcare conferences in November: the Stifel 2021 Virtual Healthcare Conference on November 17 at 9:20 a.m. ET and the Jefferies London Healthcare Conference with an on-demand Fireside Chat available starting November 18 at 3:00 a.m. ET. Webcasts for these events will be accessible via UroGen's website for 30 days. UroGen focuses on developing novel treatments for urothelial and specialty cancers, leveraging its RTGel™ technology for enhanced therapeutic profiles.

UroGen Pharma Ltd. (Nasdaq: URGN) announces plans for a single-arm Phase 3 study of UGN-102 to treat low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC), expected to start in early 2022. Approximately 220 patients will be enrolled across 90 sites, with the study intended to support a New Drug Application (NDA) by 2024. The company will halt enrollment in its ATLAS trial but will allow current participants to complete it. UroGen also discussed its pipeline, including immunotherapy candidates UGN-301 and UGN-201, during its virtual Spotlight Event.

UroGen Pharma Ltd. (NASDAQ: URGN) is hosting a virtual ‘Spotlight Event’ on November 10, 2021, at 11:00 AM ET to discuss UGN-102 and its innovative early-stage pipeline programs, including UGN-301 and UGN-302. The event will feature presentations from executives, including Chairman Arie Belldegrun, along with a Key Opinion Leader panel on NMIBC treatment. The third quarter 2021 financial results will be reported on November 15, 2021, followed by a conference call at 10:00 AM ET.

UroGen Pharma announced promising results from the Phase 2b OPTIMA II trial for UGN-102, a non-surgical treatment for low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The trial showed a 65% complete response rate at three months, with 61% of patients maintaining complete response at 12 months. The data supports ongoing Phase 3 development, indicating UGN-102's potential as a primary therapy for this patient demographic, which currently relies heavily on surgical interventions.

UroGen Pharma Ltd. (URGN), a biopharmaceutical company focused on specialty cancers and urologic diseases, will present at the Cantor Fitzgerald 2021 Virtual Global Healthcare Conference on September 30, 2021, at 3:20 p.m. ET. A live webcast will be accessible on UroGen’s website, with a replay available for 30 days. UroGen is known for its proprietary RTGel™ technology, aimed at enhancing drug delivery in urology. The company’s initial product, UGN-102, targets low-grade non-muscle invasive bladder cancer through non-surgical means.

UroGen Pharma Ltd. (NASDAQ: URGN) announced key results from the Phase 2b OPTIMA II trial of UGN-102, where 65% of patients with low-grade intermediate risk NMIBC achieved complete response at three months. Additionally, the Phase 3 OLYMPUS trial of Jelmyto revealed a 58% complete response rate in low-grade upper tract urothelial cancer patients, with an 81.8% durability rate at 12 months. Both trials were presented at the AUA Annual Meeting and highlight UroGen's focus on non-surgical treatments for urinary cancers.