UroGen Pharma Ltd., a biotechnology company, engages in the development and commercialization novel solutions for specialty cancers and urothelial diseases. It offers RTGel, a polymeric biocompatible and reverse thermal gelation hydrogel to improve therapeutic profiles of existing drugs; and Jelmyto for pyelocalyceal solution. The company's lead product candidate is UGN-102 for the treatment of several forms of non-muscle invasive urothelial cancer that include low-grade upper tract urothelial carcinoma and low-grade non-muscle invasive bladder cancer. It is also developing UGN-301 for the treatment of high-grade non-muscle invasive bladder cancer. Agenus Inc. to develop, make, use, sell, import, and commercialize products of Agenus for the treatment of cancers of the urinary tract via intravesical delivery; and strategic research collaboration with MD Anderson to advance investigational treatment for NMIBC. UroGen Pharma Ltd. was incorporated in 2004 and is based in Princeton, New Jersey.

UroGen Pharma Ltd.

(RTTNews) - UroGen Pharma Ltd. (URGN), Monday announced results of a five-year long-term extension study of the Phase 2b OPTIMA II trial, evaluating ZUSDURI for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer.
Of the total 41 patients who achieved complete response at three months post-treatment with ZUSDURI, 25 remained in CR at 12 months and 17 entered the long-term follow-up study. Among those 17, the median duration of response was 3.5 years by Kaplan-Meier estimate.
Notably, these results build upon previously published 12-month DOR data, showing ZUSDURI's potential to deliver meaningful, lasting event-free periods.
Chief Medical Officer Mark Schoenberg commented, "For recurrent patients facing repeated surgeries, it offers a non-surgical approach that can empower patients and providers to choose a path that best fits individual needs and preferences."
In the pre-market hours, URGN is trading at $15.50, up 1.51 percent on the Nasdaq.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

UroGen Pharma Announces Data Of Phase 2b Of Bladder Cancer Study

(RTTNews) - UroGen Pharma Ltd. (URGN) announced that the U.S. Food and Drug Administration has approved ZUSDURI (mitomycin) for Intravesical Solution as the first and only medication indicated for the treatment of recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer or LG-IR-NMIBC.
The approval is based on the positive results from the Phase 3 ENVISION trial that demonstrated ZUSDURI delivers 78% complete response (CR) for patients at 3 months, and of those patients 79% remained event-free 12 months later.
ZUSDURI is expected to be available in the U.S. on or around July 1, 2025, for the treatment of adults with recurrent LG-IR-NMIBC.
URGN closed Thursday's regular trading at $11.08 up $3.78 or 51.78%. In the after-hours trading, the stock further gained $0.91 or 8.21%.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
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FDA Oks UroGen's ZUSDURI For Recurrent Low-Grade Intermediate-Risk Bladder Cancer Treatment;stock Up

(RTTNews) - UroGen Pharma Ltd. (URGN) announced encouraging safety data from the Phase 1 dose-escalation study for UGN-301 (zalifrelimab) intravesical solution, an investigational drug in development for the treatment of recurrent non-muscle invasive bladder cancer (NMIBC).
The company noted that UGN-301 demonstrated tolerability across all dose levels, with no dose-limiting toxicities or adverse events resulting in treatment discontinuation. The formulation of UGN-301 in a reverse thermal gel enabled sustained bladder exposure.
Additionally, some patients treated with UGN-301 (zalifrelimab) intravesical solution exhibited clinical activity during the week 12 disease assessment. These findings were presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

UroGen Pharma Reports Positive Phase 1 Results For UGN-301 In Non-Muscle Invasive Bladder Cancer

(RTTNews) - UroGen Pharma Ltd. (URGN) posted a fourth quarter net loss of $37.5 million compared to a loss of $26.0 million, a year ago. Net loss per ordinary share was $0.80 compared to a loss of $0.72. Analysts on average expected the company to report a loss per share of $0.72, for the quarter. Analysts' estimates typically exclude special items.
Revenue increased to $24.57 million from $23.53 million, last year. Underlying demand revenue increased 15% year-over-year.
The company expects full-year 2025 net product revenues from JELMYTO to be in the range of $94 to $98 million. This implies a year-over-year growth rate of approximately 8% to 12%.
Shares of UroGen Pharma are down 4% in pre-market trade on Monday.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

UroGen Pharma Posts Wider Loss In Q4 - Quick Facts

The following companies are expected to report earnings prior to market open on 03/10/2025. Visit our Earnings Calendar for a full list of expected earnings releases.
Franco-Nevada Corporation (FNV)is reporting for the quarter ending December 31, 2024. The gold mining company's consensus earnings per share forecast from the 5 analysts that follow the stock is $0.89. This value represents a 1.11% decrease compared to the same quarter last year. The last two quarters FNV had negative earnings surprises; the latest report they missed by -3.61%. Zacks Investment Research reports that the 2024 Price to Earnings ratio for FNV is 46.17 vs. an industry ratio of -1.90, implying that they will have a higher earnings growth than their competitors in the same industry.
BioNTech SE (BNTX)is reporting for the quarter ending December 31, 2024. The biomedical (gene) company's consensus earnings per share forecast from the 8 analysts that follow the stock is $0.57. This value represents a 72.20% decrease compared to the same quarter last year. Zacks Investment Research reports that the 2024 Price to Earnings ratio for BNTX is -32.41 vs. an industry ratio of -4.00.
UroGen Pharma Ltd. (URGN)is reporting for the quarter ending December 31, 2024. The biomedical (gene) company's consensus earnings per share forecast from the 3 analysts that follow the stock is $-0.74. This value represents a 2.78% decrease compared to the same quarter last year. The "days to cover" for this stock exceeds 18 days. Zacks Investment Research reports that the 2024 Price to Earnings ratio for URGN is -3.31 vs. an industry ratio of -4.00, implying that they will have a higher earnings growth than their competitors in the same industry.
Telos Corporation (TLS)is reporting for the quarter ending December 31, 2024. The information technology services company's consensus earnings per share forecast from the 4 analysts that follow the stock is $-0.21. This value represents a 75.00% decrease compared to the same quarter last year. In the past year TLS has beat the expectations every quarter. The highest one was in the 3rd calendar quarter where they beat the consensus by 12%. Zacks Investment Research reports that the 2024 Price to Earnings ratio for TLS is -4.25 vs. an industry ratio of 28.50.
Aligos Therapeutics, Inc. (ALGS)is reporting for the quarter ending December 31, 2024. The biomedical (gene) company's consensus earnings per share forecast from the 3 analysts that follow the stock is $-2.50. This value represents a 54.55% increase compared to the same quarter last year. Zacks Investment Research reports that the 2024 Price to Earnings ratio for ALGS is -1.30 vs. an industry ratio of -4.00, implying that they will have a higher earnings growth than their competitors in the same industry.
DarioHealth Corp. (DRIO)is reporting for the quarter ending December 31, 2024. The medical instruments company's consensus earnings per share forecast from the 1 analyst that follows the stock is $-0.31. This value represents a 24.39% increase compared to the same quarter last year. In the past year DRIO has beat the expectations every quarter. The highest one was in the 3rd calendar quarter where they beat the consensus by 28.57%. Zacks Investment Research reports that the 2024 Price to Earnings ratio for DRIO is -0.62 vs. an industry ratio of 5.00.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Pre-Market Earnings Report for March 10, 2025 : FNV, BNTX, URGN, TLS, ALGS, DRIO

(RTTNews) - UroGen Pharma Ltd. (URGN) said that the U.S. Food and Drug Administration accepted the New Drug Application or NDA for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025.
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently under regulatory review for approval in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer. The U.S. market for low-grade intermediate-risk non-muscle invasive bladder cancer that UGN-102 can address, if approved, is valued at about $5 billion.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

UroGen Pharma: FDA Accepts UGN-102 NDA For Treatment Of Low-Grade Bladder Cancer

(RTTNews) - Biotech company UroGen Pharma Ltd. (URGN) announced that Chris Degnan has been appointed Chief Financial Officer. Degnan succeeds Don Kim, who is leaving UroGen to pursue other opportunities.
Degnan joins UroGen with extensive experience as a publicly traded biotech CFO, most recently at Galera Therapeutics and Verrica Pharmaceuticals. Degnan has broad expertise in financial strategy, investor relations, SEC reporting, accounting and compliance.
Earlier in his career, Degnan held senior positions at Endo International plc. Before joining Endo, Degnan spent more than 10 years at biopharmaceutical company AstraZeneca plc.
In connection with his appointment as CFO, Degnan received an inducement grant of restricted stock units covering 13,450 ordinary shares of UroGen and an inducement grant of a stock option to purchase up to 74,142 ordinary shares of UroGen. The exercise price of the Inducement Option is $13.11.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

UroGen Pharma Appoints Chris Degnan To Succeed Don Kim As CFO

Exelixis (EXEL) came out with quarterly earnings of $0.84 per share, beating the Zacks Consensus Estimate of $0.37 per share. This compares to earnings of $0.31 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of 127.03%. A quarter ago, it was expected that this drug developer would post earnings of $0.28 per share when it actually produced earnings of $0.17, delivering a surprise of -39.29%.
Over the last four quarters, the company has surpassed consensus EPS estimates two times.
Exelixis, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $637.18 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 36.09%. This compares to year-ago revenues of $469.85 million. The company has topped consensus revenue estimates just once over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Exelixis shares have lost about 2% since the beginning of the year versus the S&P 500's gain of 8.7%.
What's Next for Exelixis?
While Exelixis has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Exelixis: mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is $0.40 on $482.98 million in revenues for the coming quarter and $1.39 on $1.88 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Urogen Pharma (URGN), another stock in the same industry, has yet to report results for the quarter ended June 2024. The results are expected to be released on August 13.
This company is expected to post quarterly loss of $0.82 per share in its upcoming report, which represents a year-over-year change of +20.4%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Urogen Pharma's revenues are expected to be $23.69 million, up 12% from the year-ago quarter.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Exelixis (EXEL) Tops Q2 Earnings and Revenue Estimates

BioMarin Pharmaceutical (BMRN) came out with quarterly earnings of $0.96 per share, beating the Zacks Consensus Estimate of $0.57 per share. This compares to earnings of $0.54 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of 68.42%. A quarter ago, it was expected that this rare disease biopharmaceutical would post earnings of $0.60 per share when it actually produced earnings of $0.71, delivering a surprise of 18.33%.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
BioMarin, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $712.03 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 7.80%. This compares to year-ago revenues of $595.28 million. The company has topped consensus revenue estimates two times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
BioMarin shares have lost about 12.7% since the beginning of the year versus the S&P 500's gain of 12.1%.
What's Next for BioMarin?
While BioMarin has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for BioMarin: mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is $0.74 on $692.17 million in revenues for the coming quarter and $2.87 on $2.72 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 36% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
One other stock from the same industry, Urogen Pharma (URGN), is yet to report results for the quarter ended June 2024.
This company is expected to post quarterly loss of $0.82 per share in its upcoming report, which represents a year-over-year change of +20.4%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Urogen Pharma's revenues are expected to be $23.69 million, up 12% from the year-ago quarter.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

BioMarin Pharmaceutical (BMRN) Q2 Earnings and Revenues Surpass Estimates

(RTTNews) - UroGen Pharma Ltd. (URGN) announced the pricing of an underwritten public offering of 5 million ordinary shares at a price to the public of $17.50 per ordinary share, and, to certain investors in lieu of issuing ordinary shares, pre-funded warrants to purchase 1.14 million ordinary shares at a purchase price of $17.499 per pre-funded warrant, which equals the public offering price per ordinary share less the $0.001 per share exercise price for each pre-funded warrant.
The company expects gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, to be approximately $107.5 million.
In addition, UroGen granted the underwriters a 30-day option to purchase up to an additional 921,428 ordinary shares at the public offering price, less underwriting discounts and commissions.
The offering is expected to close on June 20, 2024.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

UroGen Pharma Ltd.

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