UroGen Pharma Ltd. Ordinary Shares - URGN STOCK NEWS

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.

UroGen Pharma Ltd. (Nasdaq: URGN) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on-demand starting at 7:00 a.m. ET on September 13, 2021, through the conference portal and UroGen's website. UroGen focuses on developing innovative treatments for specialty cancers and urologic diseases, with its proprietary RTGel™ technology enhancing drug delivery to the urinary tract. Its investigational product, UGN-102, targets low-grade non-muscle invasive bladder cancer.

UroGen Pharma Ltd. (Nasdaq: URGN) announced the grant of inducement restricted stock units (RSUs) to 19 new employees. This initiative supports the ongoing launch of Jelmyto® for pyelocalyceal solution, UroGen's first approved product, and the development of its pipeline. A total of 94,800 shares of common stock are issuable upon the vesting of these RSUs, which will vest equally over three years. The RSUs comply with Nasdaq Rule 5635(c)(4) and are part of the company's 2019 Inducement Plan.

UroGen Pharma Ltd. (Nasdaq: URGN) reported financial results for Q2 2021, highlighting strong revenue growth from its product Jelmyto, which generated $13.0 million, a 70% increase from Q1 2021. The company has activated 407 treatment sites, a 29% rise since May. UGN-102's pivotal Phase 3 ATLAS trial continues with nearly 100 sites enrolled. UroGen's net loss was $26.2 million with a cash position of $129.3 million as of June 30, 2021. The company anticipates operating expenses between $155 to $165 million for the year.

UroGen Pharma Ltd. (Nasdaq: URGN) has entered into an exclusive licensing agreement with Neopharm to market Jelmyto (mitomycin) in Israel, pending regulatory approval. Jelmyto is the first FDA-approved treatment for low-grade upper tract urothelial cancer (LG-UTUC). Neopharm will handle the regulatory processes, supported by successful Phase 3 OLYMPUS trial results. UroGen aims to expand Jelmyto's availability beyond the U.S., emphasizing Israel's significance due to its foundational ties and local clinical trial contributions.