UROGEN PHARMA LTD

At the Cantor Fitzgerald conference, UroGen reported a robust early launch of its bladder cancer therapy Zusduri, with sales rising from $29.8m in Q1 to $50m in Q2 2025 and insured access exceeding 95%. The company sees a conservative peak sales potential of around $1.2bn and holds $180m in cash, which management says should be sufficient to reach profitability. UroGen is expanding its sales team and focusing on physician training and reimbursement, but still faces challenges in education, competitive pressure and converting initial momentum into sustainable growth. In parallel, UroGen is advancing follow-on programs such as UGN-103, UGN-104 and UGN-501; an NDA for UGN-103 has been submitted and an FDA decision is expected by mid‑June 2026. » Mere på de.investing.com

At the Wells Fargo Healthcare Conference, UroGen reported growing commercial momentum for ZUSDURI after the assignment of a permanent J-code and 96% payer coverage. The company cites 450 prescribing physicians, roughly 1,500 activated treatment centers, and reiterates a peak sales potential of $1.2 billion for low- to intermediate-grade NMIBC, with a total upside of more than $2 billion if expanded to high-grade tumors. UroGen highlights ZUSDURI’s strong clinical profile, plans to expand into office-based practices, and is advancing next-generation candidates such as UGN-103, UGN-104 and UGN-501, as well as a collaboration with IntraGel to extend the product lifecycle. » Mere på de.investing.com

IntraGel has entered into an equity investment as well as options and research license agreement with UroGen for up to $7 million to fund the Phase 2 development of TumoCure, a local cisplatin therapy for advanced head and neck cancer based on the SRGel platform. UroGen obtains an exclusive option on worldwide development and commercialization rights after completion of the Phase 2 study, as well as access to the SRGel platform and options to license up to three additional oncology programs. Phase 1b data showed good tolerability, low systemic cisplatin exposure and initial signs of antitumor activity, including in cisplatin-resistant patients. » Mere på de.investing.com

UroGen Pharma’s stock rose to a 52-week high of $49.69 and is trading near record levels. Over the past year the share gained 158.56% and is up 109% year-to-date. In Q2 2026 revenue increased to $72.5 million, driven by the launch of ZUSDURI ($50.4 million) and Jelmyto ($22.0 million); the full-year guidance remains $97–101 million. Despite a net loss of $14.4 million, analysts including Guggenheim raised price targets and maintained buy ratings. » Mere på de.investing.com

UroGen has submitted a New Drug Application to the FDA for UGN-103, a mitomycin formulation to treat recurrent, non–muscle-invasive bladder cancer (NMIBC) with low to intermediate risk. The filing is based on the single-arm, multicenter Phase 3 UTOPIA study with 99 patients, which showed a complete response rate of 77.8% at three months and a durability of response of 94.5% at six months. UGN-103 uses RTGel technology with an improved manufacturing process and longer shelf life after reconstitution, and is based on a licensing agreement with medac; relevant patent protection is expected to extend until July 2044. » Mere på de.investing.com