Urogen Pharma Stock Price, News & Analysis

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.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancers, has announced it will release its second quarter 2024 financial results on Tuesday, August 13, 2024, before the stock market opens. The company will host a live audio webcast and conference call at 10:00 AM Eastern Time on the same day to discuss the results. Investors can access the webcast through UroGen's Investor Relations website, where a replay will be available for approximately 30 days after the event. This announcement provides an opportunity for stakeholders to gain insights into UroGen's financial performance and future outlook.

UroGen Pharma (Nasdaq: URGN) announced the pricing of an underwritten public offering of 5,000,000 ordinary shares at $17.50 per share, alongside pre-funded warrants for 1,142,857 shares at $17.499 per warrant. The gross proceeds are expected to be around $107.5 million before deductions. Underwriters have a 30-day option to buy an additional 921,428 shares. The offering is set to close on June 20, 2024, pending customary conditions. TD Cowen and Guggenheim Securities are joint book-running managers, with Oppenheimer & Co., Ladenburg Thalmann, and H.C. Wainwright & Co. also involved. The offering is based on a shelf registration statement filed with the SEC, effective since November 29, 2022.

UroGen Pharma (Nasdaq: URGN), a biotech firm focused on treating urothelial and specialty cancers, announced the start of an underwritten public offering of its ordinary shares and pre-funded warrants. The offering's completion and terms depend on market conditions. UroGen plans to grant underwriters a 30-day option to buy an additional 15% of the total shares offered, including pre-funded warrants. TD Cowen and Guggenheim Securities will act as joint book-running managers, while Oppenheimer & Co. and Ladenburg Thalmann will serve as lead and co-managers, respectively. The offering is being made under a shelf registration statement filed with the SEC, effective as of November 29, 2022. Copies of related documents can be obtained from TD Securities or Guggenheim Securities.

UroGen Pharma announced that its Phase 3 ENVISION trial for UGN-102, targeting low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), achieved an 82.3% duration of response (DOR) at 12 months. The trial showed a complete response (CR) rate of 79.6% at three months. The Kaplan-Meier estimates for DOR at 15 and 18 months were both 80.9%. The safety profile was consistent with previous trials, with common side effects including dysuria, hematuria, and urinary tract infection. UroGen has initiated a New Drug Application (NDA) to the FDA, aiming for a decision by Q1 2025. A virtual event discussing these results is scheduled for today at 11:00 AM ET.

UroGen Pharma (Nasdaq: URGN) has announced the grant of inducement restricted stock units (RSUs) and an option to 15 new employees, including Chief Commercial Officer David Lin. Up to 52,500 shares will be issued upon vesting for 14 employees, and up to 13,041 shares plus 71,942 shares upon the exercise of an option will be issued for Lin. RSUs and options vest over three years, contingent on continued employment. The exercise price for the option is set at $13.13, the closing price on June 3, 2024. These grants are under UroGen's 2019 Inducement Plan, following Nasdaq Listing Rule 5635(c)(4), to support the commercialization of Jelmyto and pipeline development.

UroGen Pharma (Nasdaq: URGN) will host a virtual event on June 13, 2024, at 11:00 a.m. ET, to present the 12-month durability response results from its Phase 3 ENVISION trial. This trial assesses UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The focus will be on patients who showed a complete response at three months after six weekly doses. The event will include insights from Key Opinion Leaders and a panel discussion. A replay will be available on the company's website after the event.

UroGen Pharma (Nasdaq: URGN) announced its participation in the 45th Annual Goldman Sachs Global Healthcare Conference. The event will occur in Miami, FL, from June 10-13, 2024, and UroGen's management will present on June 11 at 3:20 PM ET. The presentation will be in a fireside chat format. A webcast will be available live and for replay for approximately 90 days on the company's investor relations website.