Latest news with #UGN102
Associated Press
23-05-2025
- Business
- Associated Press
Kaplan Fox is Investigating Potential Securities Law Violations against UroGen Pharma Ltd. (URGN)
NEW YORK, NY - May 23, 2025 ( NEWMEDIAWIRE ) - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ: URGN). CLICK HERE TO RECEIVE MORE INFORMATION ABOUT THIS INVESTIGATION If you are a UroGen investor and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing [email protected] or by calling (212) 329-8571. On May 16, 2025, in advance of a meeting of the U.S. Food and Drug Administration's ('FDA') Oncologic Drugs Advisory Committee ('ODAC'), the FDA published the Combined FDA and Applicant ODAC Briefing Document concerning UroGen's new drug application ('NDA') for investigational drug UGN-102 (mitomycin) for intravesical solution for the treatment of recurrent of low-grade intermediate-risk non-muscle invasive bladder cancer ('Briefing Document'). The Briefing Document stated that 'the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret' as the Phase 3 ENVISION trial 'lacked a concurrent control arm.' The FDA stated that it was 'unclear whether the observed DOR can be attributed to the investigational product or instead reflects the natural history of the disease.' Following this news, the price of UroGen stock declined from a closing price on May 15, 2025 of $9.85 per share, to close at $7.31 per share on May 16, 2025, a decline of $2.54 per share, or nearly 26%, on heavy trading volume. Then, on May 21, 2025, the ODAC conducted a public meeting to discuss the NDA and then voted 4 to 5 that the benefit/risk of UGN-102 (mitomycin) for intravesical solution was favorable for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. On May 21, 2025, the price of UroGen stock declined from a closing price on May 20, 2025 of $7.54 per share to close at $4.17 per share, a decline of $3.37 per share, or over 44%, on heavy trading volume. WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey. With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand. Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. If you have any questions about this investigation, please contact: CONTACT: Jeffrey P. Campisi KAPLAN FOX & KILSHEIMER LLP 800 Third Avenue, 38th Floor New York, New York 10022 (212) 329-8571 [email protected] Laurence D. King KAPLAN FOX & KILSHEIMER LLP 1999 Harrison Street, Suite 1560 Oakland, California 94612 (415) 772-4704 [email protected] Contacting or submitting information to Kaplan Fox & Kilsheimer LLP does not create an attorney-client relationship, nor an obligation on the part of Kaplan Fox to retain you as a client.
Yahoo
12-03-2025
- Business
- Yahoo
UroGen Pharma Ltd (URGN) Q4 2024 Earnings Call Highlights: Strategic Advances and Financial ...
Release Date: March 10, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. UroGen Pharma Ltd (NASDAQ:URGN) submitted a new drug application for UGN 102 ahead of schedule, with FDA review underway and a target date set for June 13th. The Envision phase 3 trial for UGN 102 demonstrated a compelling complete response rate of 79.6% at 3 months and an 82.3% duration of response at 12 months. UroGen Pharma Ltd (NASDAQ:URGN) reported a strong balance sheet with $241.7 million in cash equivalents and marketable securities, positioning them well for future growth. The company achieved a 12% year-over-year increase in sales for their commercial product, Jelmyto, indicating strong market demand. UroGen Pharma Ltd (NASDAQ:URGN) is expanding its sales force from 52 to 83 representatives in anticipation of the UGN 102 launch, demonstrating a commitment to commercial preparedness. UroGen Pharma Ltd (NASDAQ:URGN) reported a net loss of $126.9 million for the full year 2024, an increase from the $102.2 million loss in 2023. Research and development expenses increased significantly to $57.1 million in 2024 from $45.6 million in 2023, driven by manufacturing and regulatory expenses. SG&A expenses rose to $121.2 million in 2024 from $93.3 million in 2023, primarily due to commercial preparation activities for UGN 102. The company anticipates using a miscellaneous J code for UGN 102 initially, which may complicate reimbursement processes for providers. UroGen Pharma Ltd (NASDAQ:URGN) faces potential challenges in market access and reimbursement during the initial launch period of UGN 102 due to the generic J code. Warning! GuruFocus has detected 4 Warning Signs with URGN. Q: You noted on the call that you anticipate approval in the recurrent setting. Do you anticipate that UGN 102 could still be used in the about 10% of patients or so that are ineligible for surgery, which would be the frontline setting, and would this then require it to be used off label? A: Liz Barrett, CEO: Yes, that would be considered off-label, so we wouldn't be able to promote there. It would be up to the physician to work with their insurance company to ensure payment. This doesn't change our revenue projections, as we still believe UGN 102 will generate over a billion dollars in revenue. Physicians have expressed a desire to make this choice, and we are considering whether to conduct clinical work in this space. Q: On UGN 102, as you think about the potential FDA approval later this summer, how should investors think about the initial launch trajectory, perhaps relative to Gelido or other potential benchmarks? A: David Lynn, Chief Commercial Officer: We intend to continue educating our physician provider universe and maintaining support. The overall shape of the launch curve is modeled similarly to Gelido, although the absolute numbers will be larger due to the patient population. We are considering pricing in the $18,000 to $19,000 per dose range. Q: With respect to UGN 102 and the projected reimbursement environment, can you provide additional granularity regarding the difference in reimbursement level and market access during the period immediately after launch with a generic J code versus a specific J code? A: David Lynn, Chief Commercial Officer: Initially, we anticipate using a miscellaneous J code, which may result in a longer reimbursement process of about 50 to 60 days. This will improve with a permanent J code expected by January 2026. We will support accounts through this period, similar to our approach with Jamio. Q: Regarding the pipeline development activities, can you give us an update on how enrollment kinetics appear to be progressing in the UGN 103 program and if you still expect to report data from that trial either next year or in 2027? A: Mark Schoenberg, Chief Medical Officer: We anticipate completing enrollment for the Utopia trial this year, with data expected in 2026 and potential approval in 2027. The trial is progressing well, and we are optimistic about maintaining this timeline. Q: Given the impressive durability that the Envision data has shown, have you stress-tested potentially higher pricing for UGN 102, and what are your payer reactions? A: Liz Barrett, CEO: We are revisiting our pricing strategy due to the impressive durability data. We believe there is an opportunity to increase pricing slightly and are conducting research to refine our assumptions. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
