On Wednesday, UroGen Pharma (NASDAQ:URGN) shares received a reaffirmed Outperform rating and a steady price target of $40.00 from Oppenheimer. The endorsement comes as the U.S. Food and Drug Administration (FDA) accepted UGN-102's New Drug Application (NDA) for review, with an action date set for June 13, 2025.
UroGen Pharma announced the FDA's acceptance of the NDA for UGN-102, a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The action date is a deadline by which the FDA will make a decision on the drug's approval. The analyst from Oppenheimer expressed a positive outlook for UGN-102, projecting over $1 billion in U.S. sales over time, contingent upon its approval.
The analyst also indicated that while an advisory committee (ad comm) meeting may be forthcoming, they do not view it as a cause for concern due to UGN-102's robust efficacy and safety data. The lack of a Priority Review designation, which would have expedited the approval process to February, was noted as a potential reason for any share price decline on Wednesday. Nonetheless, the analyst recommended taking advantage of any such weakness in UroGen Pharma's stock.
Oppenheimer's continued support for UroGen Pharma is based on the anticipation of UGN-102's approval for treating LG-IR-NMIBC. The analyst highlighted the strong support for the drug's efficacy and safety, suggesting confidence in its market potential and recommending UroGen Pharma as a top pick in the sector.
In other recent news, UroGen Pharma Ltd. has seen a series of notable developments. The U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for UGN-102, a potential treatment for low-grade intermediate-risk non-muscle invasive bladder cancer.
The company's financial position has been bolstered, with a 16% sequential increase and 3% year-on-year growth in net product revenue for JELMYTO, totaling $21.8 million. To support the launch of UGN-102, UroGen secured a $25 million loan and raised approximately $116.2 million in a public offering.
The company has also undergone significant executive changes, with Chris Degnan taking over as Chief Financial Officer from Don Kim. Degnan brings extensive experience from his previous roles at Galera Therapeutics (OTC:GRTX) and Verrica Pharmaceuticals (NASDAQ:VRCA). Analysts from H.C. Wainwright and EF Hutton have maintained their Buy ratings for UroGen Pharma, reflecting confidence in the company's direction.
UroGen Pharma has also been granted a US patent for its RTGel® technology combined with a mitomycin formulation, which is expected to last until December 2041. However, the company also saw the resignation of board member Fred E. Cohen, M.D., D.Phil. These are all recent developments within the company.
InvestingPro Insights
UroGen Pharma's financial health and market position offer additional context to the FDA's acceptance of UGN-102's NDA. According to InvestingPro data, the company's market capitalization stands at $516.32 million, reflecting investor expectations for its future prospects. Despite the positive outlook from Oppenheimer, it's worth noting that UroGen is currently not profitable, with a negative P/E ratio of -4.56 over the last twelve months as of Q2 2024.
However, UroGen demonstrates impressive gross profit margins of 89.87%, indicating strong pricing power for its existing products. This could bode well for the potential commercialization of UGN-102, supporting Oppenheimer's projection of over $1 billion in U.S. sales.
InvestingPro Tips highlight that UroGen holds more cash than debt on its balance sheet, which could provide financial flexibility as the company navigates the regulatory process for UGN-102. Additionally, the company's liquid assets exceed short-term obligations, potentially allowing it to focus on long-term growth strategies.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips for UroGen Pharma, providing deeper insights into the company's financial position and market outlook.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.