UroGen Pharma (URGN) Update / Briefing June 13, 2025 08:30 AM ET Speaker0 Good day, and thank you for standing by. Welcome to the UroGen Pharma Zasturi Approval Investor Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perrone, Head of Investor Relations. Please go ahead. Speaker1 ...

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for allegedly making false statements regarding its lead product UGN-102 and its clinical study design, which may have misled investors [1][3]. Company Overview - UroGen Pharma Ltd. focuses on developing and commercializing solutions for specialty cancers, with its lead product being UGN-102, an intravesical solution for treating low-grade intermediate risk non-muscle invasive bladder cancer [2]. Allegations in the Lawsuit - The lawsuit claims that UroGen's ENVISION clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined the evidence of the product's effectiveness [3]. - It is alleged that UroGen ignored FDA warnings regarding the study design, leading to a significant risk that the NDA for UGN-102 would not be approved [3][4]. - Following the FDA's briefing document release on May 16, 2025, which criticized the study design, UroGen's stock price dropped nearly 26% [4]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, resulting in a further stock price decline of nearly 45% [5].

Policy Developments - The National Medical Products Administration (NMPA) held a meeting on May 28 to discuss the "Clearing Source" action in the drug distribution sector, emphasizing strict enforcement of regulations and collaboration across departments to ensure drug quality and safety [2]. Drug and Device Approvals - Novartis announced on May 28 that its anti-VEGF monoclonal antibody, Brolucizumab, has been approved by the NMPA for the treatment of diabetic macular edema (DME), allowing for injections every three months after the loading phase [4]. - On the same day, the NMPA accepted the new drug application (NDA) for Rocbrutinib, a fourth-generation BTK inhibitor developed by LuPeng Pharmaceutical, which is intended for adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitor treatment [5]. Capital Market Activities - Zhenmai Bio completed a C+ round financing of 280 million yuan on May 28, with participation from multiple investors, aiming to focus on "commercial ecosystem construction" and "global expansion" [7]. Industry Events - On May 27, Anmai Bio announced a global licensing agreement with Juri Biosciences for the development of KLK2 and CD3 T-cell engaging molecules for metastatic prostate cancer, with potential payments up to 210 million USD [9]. - Eli Lilly announced on May 27 that it will acquire SiteOne Therapeutics, a startup focused on developing sodium channel inhibitors for pain management, with a total deal value of up to 1 billion USD [10]. Regulatory and Compliance Issues - ST Longjin announced on May 28 that it received a decision from the Shenzhen Stock Exchange to terminate its stock listing, effective June 27, 2025, due to non-compliance with listing rules [12]. - ST Jiyuan's stock will be delisted on May 29, 2025, after failing to maintain a closing price above 1 yuan for 20 consecutive trading days [14]. - ST Suwu reported on May 28 that it is under investigation by the China Securities Regulatory Commission (CSRC) for information disclosure violations, but its daily operations remain normal [15]. - Jiaying Pharmaceutical announced on May 28 that it is under investigation by the CSRC for suspected information disclosure violations and will cooperate with the regulatory body [16].