H.C. Wainwright has maintained a Buy rating and a $60.00 price target for UroGen Pharma (NASDAQ: URGN). The firm's affirmation follows UroGen Pharma's recent announcement about the progression of its investigational drug, UGN-103 (mitomycin), which has now entered a Phase 3 trial.
This trial is significant as it is aimed at treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
UroGen Pharma reported on Tuesday that the first patient received a dose in the pivotal study of UGN-103. This drug candidate is a next-generation formulation that leverages UroGen's proprietary RTGel platform technology.
This technology is expected to enhance the delivery and effectiveness of the drug by providing a sustained release of the active ingredient, potentially improving treatment outcomes for patients.
The U.S. Food and Drug Administration (FDA) had previously accepted the Investigational New Drug (IND) Application for UGN-103 in April 2024. This acceptance allows for the investigational use of the drug in adult patients diagnosed with LG-IR-NMIBC. UGN-103 is anticipated to be a follow-up treatment to UGN-102, also based on mitomycin for the intravesical solution, which is awaiting potential FDA approval and commercial launch for the same indication.
The analyst from H.C. Wainwright cited these developments while reiterating the firm's positive stance on UroGen Pharma's stock. In the statement, the analyst expressed confidence in the drug's progress and its alignment with the company's strategic objectives, emphasizing the reiteration of the Buy rating and the 12-month price target of $60.
In other recent news, UroGen Pharma has secured a $25 million loan and is eyeing FDA approval for its new drug, UGN-102. The company has also reported a 16% sequential increase and a 3% year-on-year growth in net product revenue for JELMYTO, totaling $21.8 million in Q2 2024. In addition, UroGen Pharma raised approximately $116.2 million in a public offering to support the launch of UGN-102.
The company also recently obtained a US patent for its RTGel® technology combined with a mitomycin formulation, which is expected to last until December 2041. This technology is anticipated to treat specific low-grade urothelial cancers.
Lastly, Fred E. Cohen, M.D., D.Phil., a board member of UroGen Pharma, has resigned from his position. His departure was not due to any disagreements with the company's operations, policies, or practices. These are all recent developments within the company.
InvestingPro Insights
To complement the analysis of UroGen Pharma's (NASDAQ:URGN) clinical progress, let's examine some key financial metrics and insights from InvestingPro. Despite the company's promising drug pipeline, InvestingPro data reveals that UroGen is not currently profitable, with a negative P/E ratio of -4.68 over the last twelve months as of Q2 2024. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.
However, it's worth noting that UroGen's revenue growth stands at 17.22% over the last twelve months, suggesting ongoing commercial development. Additionally, the company boasts impressive gross profit margins of 89.87%, which is highlighted as an InvestingPro Tip. This high margin could be crucial for funding further research and development of drugs like UGN-103.
Investors should be aware that UroGen's stock is trading at a high Price / Book multiple of 17.48, which may reflect market optimism about its pipeline potential, including the Phase 3 trial for UGN-103. For those interested in a deeper dive into UroGen's financial health and market position, InvestingPro offers 8 additional tips that could provide valuable insights for investment decisions.
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