UroGen Pharma Ltd. Ordinary Shares - URGN STOCK NEWS

UroGen Pharma announced promising results from the Phase 3 ENVISION study of UGN-102 for treating low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The study showed an 82.3% duration of response at 12 months in patients achieving complete response. The trial met its primary endpoint with a 79.6% complete response rate at three months. UroGen completed its NDA submission to the FDA with a PDUFA date of June 13, 2025. The treatment demonstrated mild-to-moderate side effects, consistent with previous trials.

UroGen Pharma (Nasdaq: URGN) announced FDA acceptance of its New Drug Application (NDA) for UGN-102, an investigational drug for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA set a PDUFA goal date of June 13, 2025. If approved, UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC.

The NDA is supported by data from three clinical trials, including the ENVISION trial, which met its primary endpoint with a 79.6% complete response rate at three months. The trial also showed an 82.3% 12-month duration of response by Kaplan-Meier estimate in patients who achieved a complete response at 3 months. Common adverse events included dysuria, hematuria, and urinary tract infection.

UroGen's CEO, Liz Barrett, emphasized the potential of UGN-102 to expand treatment options for LG-IR-NMIBC patients, addressing unmet needs in this space.

UroGen Pharma (Nasdaq: URGN) has appointed Chris Degnan as its new Chief Financial Officer, succeeding Don Kim. Degnan brings extensive experience as a publicly traded biotech CFO, with expertise in financial strategy, investor relations, SEC reporting, accounting, and compliance. He joins UroGen from previous roles at Galera Therapeutics and Verrica Pharmaceuticals.

As part of his appointment, Degnan received an inducement grant of restricted stock units covering 13,450 ordinary shares and a stock option to purchase up to 74,142 ordinary shares at an exercise price of $13.11. These awards will vest over three years, subject to Degnan's continued service with UroGen.

UroGen's CEO, Liz Barrett, expressed confidence in Degnan's ability to contribute to the company's growth, particularly as they prepare to launch UGN-102, a potential first-in-class product for the treatment of low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).

UroGen Pharma (Nasdaq: URGN) has announced the dosing of the first patient in the Phase 3 clinical trial of UGN-103, a next-generation mitomycin-based formulation for treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The UTOPIA study aims to enroll 87 patients, evaluating the efficacy and safety of UGN-103.

Key points:

• UGN-103 uses UroGen's proprietary RTGel® platform technology
• The FDA accepted the Investigational New Drug Application for UGN-103 in April 2024
• UroGen completed the New Drug Application submission for UGN-102 ahead of schedule
• Potential FDA approval for UGN-102 is expected in early 2025, pending acceptance and priority review

The UTOPIA study will assess the complete response rate at the three-month visit, with patients receiving 75 mg of UGN-103 via intravesical instillation once a week for 6 weeks.

UroGen Pharma (Nasdaq: URGN) has received a Notice of Allowance from the USPTO for a patent application covering its RTGel® technology combined with medac's lyophilized mitomycin formulation. This patent, set to expire in December 2041, will protect UroGen's UGN-103 and UGN-104 development programs for treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), respectively.

The company believes this combination has potential advantages in production, cost, supply, and patient convenience. UroGen recently entered a licensing agreement with medac for these programs, and the FDA has accepted the IND application for UGN-103. Clinical sites are being onboarded for the UGN-103 study, with a similar study for UGN-104 expected to commence in early 2025.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancers, has announced the granting of inducement restricted stock units (RSUs) to 19 new employees. These RSUs, convertible into up to 71,800 ordinary shares of UroGen, are designed to support the commercialization of Jelmyto® and the company's pipeline development. The RSUs will vest equally over three years, with one-third vesting annually, contingent on continued employment. Granted under UroGen's 2019 Inducement Plan and in compliance with Nasdaq Listing Rule 5635(c)(4), these RSUs serve as an inducement for new hires joining the company.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancers, has announced its participation in two upcoming investor conferences. The company will engage in fireside chats at:

1. The H.C. Wainwright 26th Annual Global Investment Conference on September 9th, 2024, at 9:00am ET in New York, NY.

2. The 2024 Cantor Global Healthcare Conference on September 18, 2024, at 3:40pm ET, also in New York, NY.

Webcasts of both events will be accessible through UroGen's website investor section, with replays available for approximately 90 days. This participation provides investors an opportunity to gain insights into UroGen's innovative cancer treatment solutions and business strategies.

UroGen Pharma (Nasdaq: URGN) has submitted a New Drug Application (NDA) for UGN-102, a potential first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The company anticipates possible FDA approval in early 2025, pending acceptance and priority review. The NDA is supported by the Phase 3 ENVISION study, which demonstrated a 79.6% complete response rate at three months and an 82.3% 12-month duration of response. UGN-102 aims to provide an alternative to repeated surgeries, offering potential quality of life benefits and clinically meaningful recurrence-free intervals for patients with this challenging disease.

UroGen Pharma (NASDAQ: URGN) reported Q2 2024 financial results and business highlights. Key points include:

• UGN-102 NDA submission ahead of schedule, with potential FDA decision by Q1 2025
• JELMYTO Q2 2024 net product revenues of $21.8 million
• Cash position of $241.3 million as of June 30, 2024
• UGN-102 Phase 3 ENVISION trial showed 82.3% Duration of Response at 12 months
• Net loss of $33.4 million or ($0.91) per share in Q2 2024

The company is preparing for potential UGN-102 approval and launch, targeting a $5 billion market opportunity in low-grade intermediate-risk non-muscle invasive bladder cancer.