Urogen Pharma Stock Price, News & Analysis

UroGen Pharma (Nasdaq: URGN) reports new data from a long-term follow-up study of the OLYMPUS trial, showing a median duration of response (DOR) of 47.8 months for patients who achieved complete response with JELMYTO (mitomycin) for pyelocalyceal solution. JELMYTO is FDA approved for treating low-grade, upper tract urothelial cancer (LG-UTUC) in adults. The study, published in the Journal of Urology, included 41 patients from the OLYMPUS trial with a median follow-up of 28.1 months. Notably, 20 of these patients entered the long-term follow-up study. The data suggests robust durability in maintaining cancer control. The study's limitations include its post-hoc nature and selection bias. Further research is ongoing through the JELMYTO uTRACT Registry, with 19 sites activated and 191 patients enrolled as of July 10.

UroGen Pharma reported Q3 2024 financial results, highlighting FDA acceptance of UGN-102's New Drug Application with a PDUFA date of June 13, 2025. JELMYTO achieved net product sales of $25.2 million in Q3 2024, up from $20.9 million in Q3 2023. The company reported a net loss of $23.7 million ($0.55 per share) and maintained a strong cash position of $254.2 million. The Phase 3 ENVISION trial for UGN-102 showed a 79.6% complete response rate and 82.3% 12-month duration of response in treating low-grade intermediate-risk non-muscle invasive bladder cancer.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancer treatments, has announced its participation in the Guggenheim Securities Healthcare Innovation Conference. The company will engage in a fireside chat on November 12, 2024, at 3:00 PM ET in Boston, MA. The event will include one-on-one investor meetings and will be accessible via public webcast through UroGen's Investor Relations website, with replay available for 90 days.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancer treatments, will release its 2024 third quarter financial results on Wednesday, November 6, 2024, before market open. The company will host a conference call and live audio webcast at 10:00 AM ET on the same day. The webcast will be accessible through UroGen's Investor Relations website, with a replay available for approximately 30 days afterward.

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.