Key Takeaways ONDS won a $4.8M SOUTHCOM and SMX contract for a three-month maritime awareness mission.World View will deploy stratospheric balloon systems for persistent ISR in maritime security operations.Ondas said its ISR platform combines sensing, autonomy, AI data fusion and communications. Ondas Inc. (ONDS - Free Report) recently announced that its wholly owned subsidiary, World View Enterprises, has been selected by the U.S. Naval Forces Southern Command (SOUTHCOM), U.S. 4th Fleet and SMX to provide high-altitude balloon capabilities for an operational Maritime Domain Awareness (MDA) program. The initiative supports counter-narcotics operations and efforts to combat illegal, unreported and unregulated (IUU) fishing across SOUTHCOM’s area of responsibility.
The initial contract is valued at approximately $4.8 million over a three-month mission period, with World View set to begin immediate deployment of its high-altitude balloon systems to deliver persistent intelligence, surveillance and reconnaissance (ISR) capabilities for maritime security missions.
The program aligns with SOUTHCOM’s broader strategy to expand the use of autonomous, semi-autonomous and unmanned technologies throughout the region. By integrating advanced systems across multiple domains, SOUTHCOM aims to strengthen regional security cooperation, enhance operational effectiveness and disrupt illicit maritime activities.
Management highlighted that the selection validates the growing importance of stratospheric ISR solutions in providing persistent, wide-area awareness across complex maritime environments. Also, management stated that combining World View’s high-altitude platforms with Ondas’ autonomous systems portfolio supports the development of a layered, multi-domain intelligence architecture designed to improve decision-making and operational responsiveness.
As part of Ondas Autonomous Systems, World View extends the company’s multi-domain ISR capabilities into the stratosphere. Ondas believes the combination of persistent sensing, autonomous systems, AI-enabled data fusion and mission-critical communications creates a differentiated platform for defense, homeland security, allied government and critical infrastructure customers worldwide.
Ondas is benefiting from strong demand for its ISR and counter-UAS solutions, rising defense spending, growing investor support and expanding market opportunities. The company is seeing increased demand for its proven ISR platforms, while acquisitions such as World View, BIRD Aerosystems and Mistral have strengthened its ISR capabilities, expanded its customer reach and enhanced its multi-domain surveillance and reconnaissance offerings. The partnership with Palantir is also supporting the development of layered ISR and ISR-as-a-service opportunities.
Taking a Look at ONDS Competitors’Draganfly (DPRO - Free Report) is benefiting from growing demand for military drone solutions, defense modernization programs, and expanding opportunities with military and government customers. During the first quarter of 2026, the company secured orders from the U.S. Army, international military customers, and special operations units, while also advancing partnerships with defense organizations such as Global Ordnance and Babcock.
On the last earnings call, the company highlighted increasing demand for interoperable drone platforms capable of supporting multiple missions, including ISR, surveillance, communication and networking, targeting, logistics and autonomous operations. Draganfly also stated that strong engagement with Canadian and U.S. defense initiatives, positioning its ISR and multi-drone platform capabilities to support evolving military requirements and future procurement programs.
Red Cat Holdings, Inc. (RCAT - Free Report) is gaining from rising defense spending, accelerating demand for unmanned systems, expanding military procurement programs and growing adoption of ISR and autonomous drone technologies. On the last earnings call, the company highlighted strong demand for its Black Widow ISR drone, which is deployed in multiple operational theaters and is being evaluated across U.S. military branches, Ukraine, Japan, the Philippines and Taiwan. Red Cat also noted opportunities tied to Drone Dominance initiatives, where ISR drones such as Black Widow are used as sensor platforms to support sensor-shooter operations.
Additional growth drivers include increasing demand for unmanned surface vessels (USVs), international defense contracts, expanding production capacity, integration with platforms such as Anduril’s Lattice and advancements in swarm robotics, autonomous operations and battlefield communications.
ONDS’ Price Performance, Valuation and EstimatesShares of ONDS have surged 676% in the past year against the Zacks Wireless-National industry’s decline of 7.9%.
Image Source: Zacks Investment Research
Valuation-wise, ONDS seems overvalued, as suggested by the Value Score of F. In terms of the forward 12-month Price/Sales ratio, ONDS is trading at 12.91, considerably higher than the industry’s multiple of 1.72.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for ONDS’ earnings for the current year has been unchanged over the past 60 days.
Image Source: Zacks Investment Research
ONDS currently has a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Ondas reported Q1 revenue of $50.1 million, up 1,079% year-over-year, matching its entire FY2025 revenue base. Pro forma backlog surged to $457 million, while Q2-to-date orders exceeded $110 million, supporting revenue visibility. Gross margin expanded to 49% from 35% a year ago as software-driven revenue increasingly complements hardware sales.
Key Takeaways Ondas reported a $4.3B opportunity pipeline across over 45 programs, spanning ISR, drones, UGVs and security.ONDS sees $500M annual revenue potential; it also has a $450M backlog.ONDS raised 2026 revenue outlook to at least $390M. Ondas Inc (ONDS - Free Report) is witnessing a rapidly expanding opportunity pipeline. On the first-quarter 2026 earnings call, the company disclosed an active pipeline of approximately $4.3 billion in opportunities across more than 45 global program submissions, highlighting strong demand for its autonomous defense, robotic, ISR (intelligence, surveillance, and reconnaissance), and security capabilities.
Regionally, Europe and the United States account for the largest share, with roughly $2 billion and more than $1.8 billion in opportunities, respectively. It is advancing in other markets such as Israel. Management noted that the current pipeline represents more than $500 million in potential annualized revenue opportunity.
The pipeline spans multiple operational domains, including aerial security, ISR, and unmanned ground vehicles (UGVs). The company is also targeting large-scale defense initiatives such as the LASSO program, which alone represents a potential opportunity nearing $1 billion. These efforts position Ondas to compete for complex, multi-domain programs that require integrated technology platforms.
The company has already secured positions in strategic programs with a potential value exceeding $1.6 billion. Ondas has also accumulated a backlog exceeding $450 million following the acquisitions of World View and Mistral. Management increased 2026 revenue guidance to at least $390 million.
While execution remains key, the scale and diversification of Ondas’ $4.3 billion pipeline suggest it may have secured multi-year growth in the fast-growing autonomous defense market. However, the autonomous space is witnessing increasing competition as both established players and new players double down on capturing the market share.
Mapping the Competitive TerrainDraganfly (DPRO - Free Report) is a Canada-based drone solutions and systems developer. The company does not explicitly mention backlog and pipeline metrics. Increasing presence in the military vertical is a major tailwind. At the beginning of the first quarter, DPRO secured orders for FPV drones from the U.S. Army and for Commander 3 XLs from international military customers. It was recently selected by the Department of War, along with F4 Defense International, to develop a multi-layered, modular and rapidly deployable counter-UAS (C-UAS) system.
Draganfly is also building strong strategic partnerships. The alliance with Prime Global Ordnance positions the company as a supplier in the growing military drone and munition ecosystem supporting Ukraine. Meanwhile, the partnership with Babcock strengthens access to Indo-Pacific defense markets. Management is of the idea that future military operations will require fleets of interoperable drones rather than isolated single-use platforms. Draganfly cites that its core advantage lies in the interoperability and modularity.
Red Cat Holdings (RCAT - Free Report) also does not break out a backlog metric but has emphasized a “large opportunity pipeline for 2026” around its Black Widow platform on the last earnings call. This pipeline spans multiple customers, including the U.S. Army (with a pending LRIP contract), Marines, Air Force, Philippines, Ukraine, Japan and Taiwan. The opportunity pipeline for the Teal Black Widows is nearly $700 million, added Red Cat. The company has the capacity and inventory to support up to $220 million worth of Black Widows, reinforcing readiness to convert pipeline into revenues.
Red Cat delivered $15.5 million in revenues in the first quarter, marking an 849% year-over-year increase. The company expects $150 million to $180 million in annual revenues in the near to medium term. The gross margins expected to approach 30% over time.
ONDS’ Price Performance, Valuation and EstimatesShares of ONDS have gained a whopping 25.5% in the past six months against the Zacks Wireless-National industry’s decline of 1.8%
Image Source: Zacks Investment Research
In terms of the forward 12-month Price/Sales ratio, ONDS is trading at 11.02, considerably higher than the industry’s multiple of 1.66.
Image Source: Zacks Investment Research
For ONDS, earnings estimates for the current year have remained unchanged in the past 60 days.
Image Source: Zacks Investment Research
ONDS currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Key Takeaways ONDS shares rose 23.7% in six months, backed by strong orders, a $4.3B pipeline and over $450M backlog.Ondas is expanding via acquisitions and partnerships, with growth driven by defense tech demand.ONDS faces rising costs, integration risks and profitability challenges in the near term. Ondas Inc. (ONDS - Free Report) has delivered a 23.7% gain in the past six months, but the underlying business momentum appears far stronger, marked by explosive revenue growth, expanding backlog and an ambitious strategic roadmap.
Price Performance
Image Source: Zacks Investment Research
This raises a key question for investors: is the market underestimating Ondas’ potential, or are execution risks too significant to ignore?
Let’s do a deep dive.
What Favors ONDS?Ondas is rapidly transforming from a niche unmanned systems player into a scaled, multi-domain defense technology platform. Ondas Autonomous Systems (“OAS”) has quickly become a multi-domain autonomy platform spanning Intelligence, Surveillance, Reconnaissance or ISR, Counter-UAS, loitering munitions/strike systems, unmanned ground vehicles and stratospheric sensing via World View acquisition.
The company has accomplished this broad portfolio through focused M&A activity. In the first quarter alone, the company completed five acquisitions (World View, INDO Earth, Rotron Aerospace, Bird Aero and Mistral Inc).
ONDS announced an agreement to acquire Omnisys Ltd., adding AI-powered battlefield orchestration software to its autonomous defense systems portfolio. In the past year, it has acquired Sentrycs, Apeiro Motion and Zickel, among others. Ondas now operates in more than 45 countries with over 1,000 employees globally.
This expanding reach is complemented by a rapidly growing opportunity set, including a $4.3 billion active pipeline and more than $1.6 billion in strategic program potential, as highlighted by management on the last earnings call. Regionally, Europe and the United States account for the largest share, with roughly $2 billion and more than $1.8 billion in opportunities, respectively. It is advancing in other markets such as Israel. Management noted that the current pipeline represents more than $500 million in potential annualized revenue opportunity.
The pipeline spans multiple operational domains, including aerial security, ISR and unmanned ground vehicles (UGVs). The company is also targeting large-scale defense initiatives such as the LASSO program, which alone represents a potential opportunity nearing $1 billion. Ondas has also accumulated a backlog exceeding $450 million following the acquisitions of World View and Mistral.
Against this backdrop, Ondas recently announced that it has secured more than $30 million in new orders during May 2026 and has surpassed $110 million in total orders quarter to date. Strong order momentum signals growing market acceptance, and the company's transformation into a diversified defense technology platform is gaining traction.
Management increased 2026 revenue guidance to at least $390 million. A key factor will be the integration and monetization of recent acquisitions, particularly World View and Mistral, which are expected to contribute more meaningfully as the year progresses.
With substantial cash reserves and minimal debt, the company is well-positioned to continue investing in growth, pursue acquisitions and navigate market uncertainties.
ONDS: Execution Overhang, Competition and So OnDespite the impressive growth story, Ondas carries substantial risks. Extensive M&A amplifies risks, as so many acquisitions in such a short period can create integration overload and execution risks, as achieving targets depends on timely integration and conversion of backlog into revenues.
Profitability remains concerning. Ondas faces rising operating costs as it invests in personnel and infrastructure capabilities to capture additional market opportunities. First-quarter operating expenses rose substantially to $67 million from $11.8 million reported in the prior-year quarter. This led to an operating loss of $42.7 million, which widened from $10.3 million year over year. Consolidated adjusted EBITDA loss was $10.9 million, wider than a loss of $7.5 million in the first quarter of 2025.
Amid rising costs, management expects adjusted EBITDA losses to stay elevated in the second quarter of 2026, likely marking the peak loss period. Beyond that, ONDS expects improvement throughout the year, driven by higher revenues, gross profit and operational scale.
Notably, management pulled forward the OAS EBITDA profitability target to the first quarter of 2027 — roughly six months ahead of the earlier target. Expectations for company-wide adjusted EBITDA profitability were unchanged, with the target being the first quarter of 2028. The key factor driving this is the company’s progress at the product level.
Image Source: Zacks Investment Research
Nonetheless, the path to profitability remains heavily dependent on flawless execution. Any delays in integration and order conversion could push the profitability timeline further out. Increasing competition in the already crowded drone space is another headwind.
The drone industry is experiencing rapid growth, with the unmanned aerial vehicle drones market expected to witness a CAGR of 9.3% from 2026 to 2031, according to a report from Mordor Intelligence. Competition has intensified with drone companies such as Red Cat Holdings (RCAT - Free Report) , Kratos Defense & Security Solutions (KTOS - Free Report) and Draganfly (DPRO - Free Report) vying to capture a larger share.
Heavy reliance on OAS for revenue growth in the increasingly crowded drone space is also concerning.
Given these factors, analysts have kept their earnings estimates unchanged for ONDS’ second quarter over the past 30 days.
ONDS Stock vs. PeersNot just ONDS, but other drone tech players have also seen their stocks perform poorly in the past three months.
KTOS and DPRO have lost 25% and 12.1%, respectively, over the same time frame, while RCAT is up 48.6%.
ONDS: Sky High Valuation Complexes Investment CaseONDS is trading at a forward 12-month price-to-sales ratio of 9.75X, a premium compared with the Zacks Wireless National industry’s 1.61X.
Image Source: Zacks Investment Research
The forward 12-month price/sales multiple for KTOS, DPRO and RCAT stand at 5.75X, 1.16X and 6.85X, respectively.
What Does the Second Half Hold for ONDS?At present, ONDS carries a Zacks Rank #3 (Hold).
Ondas is moving forward with strong momentum in orders and backlog, but much depends on its ability to execute and integrate recent acquisitions effectively.
While the long-term opportunity remains compelling, the sky-high valuation and near-term profitability issues justify a balanced, wait-and-watch stance.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BBAI stock is moving. See the chart and price action here. BigBear.Ai is the most established of the group, with a contract backlog that grew 14% quarter-over-quarter to $281.9 million in Q1 2026, including a $53 million classified sole-source military award.
The company reorganized specifically to lean into defense, security, and government — a strategic bet that the Pentagon’s AI modernization budget isn’t slowing down.
BigBear.Ai hauled in roughly $75 million in new Q1 national security and trade and travel contract wins and is guiding to approximately 17% revenue growth for 2026.
According to Benzinga Pro, the stock has a market cap of $1.43 billion — fairly modest relative to the backlog.
Palladyne AI – PDYN Palladyne AI on Monday announced a strategic partnership with Israel Aerospace Industries to manufacture, integrate, and market IAI’s HARPY, HAROP, and Mini HARPY loitering munition systems to the U.S. Department of War.
PDYN shares are trading at $6.46 with a market cap of $251 million, meaning the market hasn’t fully priced in what could be a transformative contract vehicle.
Palladyne AI posted 107% year-over-year Q1 revenue growth to $3.5 million and reaffirmed full-year 2026 guidance of $24 million to $27 million. The company appointed two retired generals to its Defense Advisory Board last week and presented at the Jefferies 2026 Defense Tech Summit.
The autonomous swarming demonstrations via its IntelliSwarm and SwarmOS platforms are exactly the kind of capability the Department of War has been writing large checks for.
Ondas – ONDS Ondas is the growth story of the three, raising its full-year 2026 revenue target to at least $390 million after Q1 revenue surged more than 10-fold year-over-year to $50.1 million.
The company is building a multi-domain autonomous defense platform — drones, ground robotics, AI-at-the-edge — and secured an $80 million-plus cluster of active demining programs and a $68 million military engineering order in recent months.
None of these stocks are risk-free bets — each carries execution risk, unprofitable balance sheets and sensitivity to government budget cycles.
But in a market where every AI narrative runs through the cloud, the defense angle offers something different: signed contracts, growing backlogs and a spending tailwind that transcends the AI hype cycle.
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During the Lightning Round of CNBC’s Mad Money, Jim Cramer adopted a more defensive stance, characterizing the broader market as “turned ugly.” One of his strongest warnings was reserved for Ondas Holdings (NASDAQ:ONDS), one of 2026’s hottest drone and counter-drone stocks.
The Ondas “Meme Stock” Call Asked about Ondas, Cramer was blunt: “This is a meme stock. It’s just a meme stock that it’s about the autonomous system meme. And I can’t get behind a meme stock. This market’s too horrible. I mean meme stock could rip your lungs out.”
Ondas has been one of the year’s most striking stories, with management reporting Q1 FY2026 revenue of $50.12 million, up 1,079.8% year over year, and a pro forma backlog that swelled to $457 million after five acquisitions closed in Q1 2026 alone. CEO Eric Brock raised full-year revenue guidance to at least $390 million in the company’s May 14 earnings release.
Pulling Back on a Favorite: Nebius The more revealing call was on AI cloud infrastructure player Nebius Group (NASDAQ:NBIS | NBIS Price Prediction). Cramer admitted, “Until this market turned ugly, Nebius is one of my favorite stocks. Now, I got to pull back because the facts of this entire market have changed.”
AI Disruption: Thomson Reuters On Thomson Reuters (NASDAQ:TRI), Cramer gave a structural rejection: “I understand why you think that Wall Street is wrong. But the problem is that this is media, and media has been decimated by all things AI. And I can’t get behind it.”
Despite Thomson Reuters’ CoCounsel AI growth story and Q1 2026 revenue of $2.09 billion, up 10% year over year, Cramer sees AI as a secular headwind for media and information businesses broadly. For him, valuation is not enough to overcome the bucket the stock sits in.
The Takeaway Across the segment, Cramer rejected speculative momentum (Ondas), trimmed a former favorite (Nebius), and avoided an AI-disrupted sector (media via Thomson Reuters). Lightning Round calls are rapid-fire opinions, and the “ugly market” framing is Cramer’s read of the broader market. The consistent thread across all these takes is that in this environment, risk management is doing more work than stock picking.
Avalo Therapeutics (NASDAQ: AVTX - Get Free Report) and Silence Therapeutics (NASDAQ: SLN - Get Free Report) are both small-cap medical companies, but which is the superior stock? We will contrast the two businesses based on the strength of their analyst recommendations, valuation, dividends, risk, profitability, earnings and institutional ownership. Insider and Institutional Ownership 87.1% of Avalo
Shares of Silence Therapeutics PLC Sponsored ADR (NASDAQ:SLN – Get Free Report) have received an average recommendation of “Moderate Buy” from the seven brokerages that are presently covering the stock, MarketBeat reports. Two investment analysts have rated the stock with a sell rating, four have issued a buy rating and one has assigned a strong buy rating to the company. The average 12-month price target among analysts that have issued ratings on the stock in the last year is $34.50.
Several research analysts have issued reports on SLN shares. HC Wainwright reaffirmed a “buy” rating and set a $75.00 price objective on shares of Silence Therapeutics in a report on Friday, March 13th. William Blair reiterated an “outperform” rating on shares of Silence Therapeutics in a research report on Monday, March 2nd. Jefferies Financial Group raised Silence Therapeutics to a “strong-buy” rating in a report on Wednesday, March 18th. Finally, Weiss Ratings restated a “sell (d-)” rating on shares of Silence Therapeutics in a research report on Thursday, January 22nd.
Read Our Latest Stock Report on Silence Therapeutics
Silence Therapeutics Stock Performance Shares of NASDAQ SLN opened at $5.94 on Friday. The business has a fifty day moving average of $5.43 and a two-hundred day moving average of $5.88. Silence Therapeutics has a 52-week low of $1.97 and a 52-week high of $7.91. The stock has a market cap of $280.55 million, a PE ratio of -3.18 and a beta of 1.33.
Silence Therapeutics (NASDAQ:SLN – Get Free Report) last issued its quarterly earnings data on Friday, March 6th. The company reported ($0.25) earnings per share for the quarter, topping the consensus estimate of ($0.32) by $0.07. Silence Therapeutics had a negative net margin of 15,851.88% and a negative return on equity of 101.71%. The firm had revenue of $0.03 million for the quarter, compared to analysts’ expectations of $2.19 million. Analysts predict that Silence Therapeutics will post -1.77 earnings per share for the current year.
Institutional Inflows and Outflows A number of institutional investors have recently bought and sold shares of SLN. Seven Fleet Capital Management LP acquired a new position in shares of Silence Therapeutics in the 4th quarter valued at $897,000. XTX Topco Ltd acquired a new position in Silence Therapeutics in the 4th quarter worth $71,000. Quadrature Capital Ltd bought a new position in Silence Therapeutics during the 4th quarter worth about $331,000. Opaleye Management Inc. acquired a new stake in shares of Silence Therapeutics in the 4th quarter valued at about $480,000. Finally, Millennium Management LLC lifted its holdings in shares of Silence Therapeutics by 121.0% in the fourth quarter. Millennium Management LLC now owns 659,592 shares of the company’s stock valued at $4,010,000 after purchasing an additional 361,080 shares in the last quarter. Institutional investors and hedge funds own 98.73% of the company’s stock.
About Silence Therapeutics (Get Free Report)
Silence Therapeutics plc is a clinical-stage biotechnology company focused on the discovery and development of ribonucleic acid interference (RNAi) therapeutics. Leveraging its proprietary EnCore lipid nanoparticle delivery platform, the company aims to silence disease-causing genes in the liver and other tissues. Silence’s technology is designed to enhance targeted delivery of small interfering RNA (siRNA) molecules, with the goal of achieving durable therapeutic effects and improved safety profiles compared with traditional drug modalities.
The company’s lead product candidates include SLN360, an siRNA therapeutic designed to reduce lipoprotein(a) levels for cardiovascular risk reduction, and SLN124, aimed at treating hereditary hemochromatosis and beta-thalassemia by modulating iron metabolism.
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Silence Therapeutics PLC Sponsored ADR (SLN - Free Report) shares rallied 19% in the last trading session to close at $7.28. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 11.4% loss over the past four weeks.
Silence Therapeutics’s stock price gain can be attributed to increasing investor confidence in recent pipeline developments. SLN continues to advance its siRNA pipeline with multiple near-term catalysts. Its lead candidate, divesiran for polycythemia vera (PV), has seen accelerated timelines, with phase II SANRECO topline data expected in the third quarter 2026 due to faster enrollment. The company’s zerlasiran, targeting elevated lipoprotein(a), is Phase III–ready and could attract a development partner. In earlier stages, SLN365 for cholesterol and SLN098 for obesity are showing encouraging preclinical progress, underscoring the potential of its mRNAi GOLD platform, with multiple updates anticipated throughout 2026.
This company is expected to post quarterly loss of $0.33 per share in its upcoming report, which represents a year-over-year change of +45%. Revenues are expected to be $6 million, up 4185.7% from the year-ago quarter.
While earnings and revenue growth expectations are important in evaluating the potential strength in a stock, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
For Silence Therapeutics, the consensus EPS estimate for the quarter has remained unchanged over the last 30 days. And a stock's price usually doesn't keep moving higher in the absence of any trend in earnings estimate revisions. So, make sure to keep an eye on SLN going forward to see if this recent jump can turn into more strength down the road.
The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>
Silence Therapeutics belongs to the Zacks Medical - Drugs industry. Another stock from the same industry, Guardian Pharmacy Services (GRDN - Free Report) , closed the last trading session 1.9% lower at $37.09. Over the past month, GRDN has returned 10.9%.
For Guardian Pharmacy, the consensus EPS estimate for the upcoming report has remained unchanged over the past month at $0.24. This represents a change of +14.3% from what the company reported a year ago. Guardian Pharmacy currently has a Zacks Rank of #1 (Strong Buy).
LONDON--(BUSINESS WIRE)---- $SLN #SenseofSilence--Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Company”), a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, today reported its financial results for the first quarter ended March 31, 2026, and provided an update on recent business achievements. “The Silence team continues to advance research supporting the broad potential of our mRNAi GOLD™ platform, and we remain well positioned as we approach a significant company mile.
LONDON--(BUSINESS WIRE)---- $SLN #SenseofSilence--Silence Therapeutics plc (Nasdaq: SLN), a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, today announced that Curtis Rambaran, MD, Chief Medical Officer of Silence Therapeutics, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on Tuesday, May 19, 2026 at 2:00 p.m. ET. The live webcast can be accessed in the Investors section of the Silence website at www.silence-therapeutics.com. An archiv.
LONDON--(BUSINESS WIRE)---- $SLN #SenseofSilence--Silence Therapeutics plc (Nasdaq: SLN), a global clinical-stage biotechnology company developing novel siRNA (short interfering RNA) therapies, today announced that management will participate in an analyst-led fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 3, 2026 at 4:55 p.m. ET. A live webcast can be accessed in the Investors section of the Silence website at www.silence-therapeutics.com. An archived replay of the webcast will be avail.
It has been about a month since the last earnings report for Paramount Skydance (PSKY - Free Report) . Shares have added about 1.1% in that time frame, underperforming the S&P 500.
But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Paramount Skydance due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.
PSKY Q1 Earnings & Revenues Beat Estimates, Q2 Outlook SoftParamount Skydance Corporation reported first-quarter 2026 results, wherein both the top and bottom lines surpassed the Zacks Consensus Estimate.
The quarter reflected continued momentum across the company's ongoing transformation, with Direct-to-Consumer growth, a studio recovery and disciplined cost management driving outperformance on both revenue and profitability.
On the revenue front, PSKY posted total revenues of $7.35 billion, beating the Zacks Consensus Estimate by 1.4%. Revenues grew 2.16% year over year, reflecting continued momentum in streaming and a double-digit rebound at the studio, partially offset by structural headwinds in linear television.
PSKY reported adjusted earnings per share of 23 cents per share, beating the Zacks Consensus Estimate by 53.33%. The first-quarter 2026 results include $103 million in transaction-related costs associated with the pending Warner Bros. Discovery merger.
PSKY's Financial Performance OverviewGAAP operating income totaled $616 million in the first quarter of 2026 compared with $550 million in the first quarter of 2025, with the current period including $103 million in transaction-related costs associated with the pending WBD merger, excluded from the company's adjusted profitability measure.
Adjusted EBITDA reached $1.16 billion in the first quarter of 2026, rising 59% year over year from $732 million and translating to a 15.8% margin. The result reflected strong cost discipline across the business, with expenses coming in lighter than planned on slower hiring pacing and favorable content spend timing.
On the advertising front, total company ad revenues declined 3% year over year, an improvement from the fourth-quarter 2025 trajectory, with the DTC advertising business returning to growth driven by improved fill rates across both Paramount+ and Pluto TV.
PSKY's Q1 Segment Performance DetailsThe DTC segment posted revenues of $2.40 billion, up 11% year over year. Paramount+ revenues grew 17% year over year to $1.97 billion, driven by a 14% increase in ARPU reflecting the January price increase and an improved subscriber mix. The platform ended the quarter with 79.6 million paid subscribers, adding 700,000 on a reported basis and approximately 2 million on an underlying basis, partially offset by the deliberate exit of over 1 million uneconomic international hard-bundle subscribers. DTC Adjusted EBITDA improved to $251 million (10% margin) from a loss of $4 million in the first quarter of 2025, reflecting subscription and advertising growth as well as a content expense benefit from the Skydance accounting basis change. Pluto TV saw VOD hours per user rise 60% year over year, with 65% of U.S. viewing minutes now coming from registered users.
The TV Media segment reported revenues of $3.67 billion, down 6% year over year, with both advertising and affiliate revenues declining 6% each, reflecting international exits and continued pay-TV subscriber erosion. Despite the revenue pressure, cost discipline drove TV Media Adjusted EBITDA to $1.1 billion (29% margin), up from a 24% margin in the first quarter of 2025. CBS held 13 of the top 20 primetime series and delivered the most-watched Masters final-round broadcast in over a decade.
The Studios segment revenues grew 11% year over year to $1.28 billion, led by Scream 7 — which surpassed $200 million globally — and the consolidation of Skydance licensing revenues. Studios Adjusted EBITDA reached $164 million (13% margin), up from $82 million in the first quarter of 2025. The film slate has doubled to 15 releases in 2026 from 8 in 2025.
PSKY's Q1 Balance Sheet and Cash Flow DetailsAs of March 31, 2026, cash and cash equivalents totaled $1.94 billion, down from $3.27 billion at Dec. 31, 2025, primarily reflecting a $2.8 billion advance consideration payment for the WBD acquisition funded via a $2.15 billion revolving credit facility draw, partially offset by $347 million in debt repayments.
Gross debt stood at $15.48 billion as of March 31, 2026, up from $13.66 billion at Dec. 31, 2025, with $86 million in debt maturities remaining for the balance of 2026.
Operating cash flow was $185 million in the first quarter, broadly in line with $180 million in the year-ago period. Free cash flow was $96 million compared with $123 million in the first quarter of 2025, reflecting higher capital expenditures of $89 million versus $57 million in the prior-year period.
PSKY Offers Q2 and Full-Year 2026 OutlookFor the second quarter of 2026, PSKY expects total revenues between $6.75 billion and $6.95 billion (flat to down 1% year over year). The outlook reflects a difficult comparison against Mission: Impossible — The Final Reckoning theatrical revenues in the second quarter of 2025 and the lapping of NCAA Final Four and Championship ad revenue.
Paramount+ subscriber growth is expected to be flattish quarter over quarter due to the planned exit of approximately 2 million additional international hard-bundle subscribers.
Adjusted EBITDA is guided to $900 million to $1 billion (13.9% margin at midpoint). The company also anticipates transformation costs of several hundred million dollars in the second quarter, which will weigh on reported free cash flow.
DTC segment margins are expected to face additional pressure in the third and fourth quarters as the content slate ramps through the second half of 2026.
For 2026, PSKY reaffirmed its target of $30 billion in total revenue (+4% year over year) and $3.8 billion in Adjusted EBITDA (12.7% margin), representing approximately 16% profitability growth year over year. Free cash flow conversion is expected at approximately 5% before roughly $800 million in transformation costs. The efficiency program remains on track to deliver more than $2.5 billion in run-rate efficiencies by year-end 2026 and at least $3 billion through 2027.
On the technology and operations front, PSKY remains on track to unify its streaming services, BET+, Pluto TV and Paramount+, onto a single tech stack by mid-2026, with Pluto TV set to receive its most significant product update in a decade this summer.
The WBD acquisition remains on track to close by the end of the third quarter of 2026, with $10 billion in permanent financing secured and $49 billion in bridge financing syndicated to 18 global financial institutions.
How Have Estimates Been Moving Since Then?It turns out, fresh estimates have trended upward during the past month.
The consensus estimate has shifted -19.94% due to these changes.
VGM ScoresCurrently, Paramount Skydance has a subpar Growth Score of D, though it is lagging a bit on the Momentum Score front with an F. However, the stock has a score of B on the value side, putting it in the second quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been broadly trending upward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Paramount Skydance has a Zacks Rank #4 (Sell). We expect a below average return from the stock in the next few months.
The Six-Year Deal Delivers All UFC Numbered Event Main Cards Exclusively to Paramount+ Subscribers Nationwide
TORONTO--(BUSINESS WIRE)--Paramount, a Skydance Corporation (NASDAQ: PSKY), and UFC, the world’s premier mixed martial arts organization, today announced an expansion of their media rights partnership that makes Paramount+ the exclusive home of UFC Numbered Event main cards in Canada for the next six years beginning in 2027.
UFC Numbered Events (traditionally known as Pay-Per-Views) typically feature championship bouts on the main cards and showcase UFC’s biggest stars. This new partnership with Paramount will provide UFC fans across Canada with exclusive access to all 13 marquee UFC Numbered Event main cards live, at no additional cost to Paramount+ subscribers. This announcement expands on Paramount’s landmark seven-year, multi-territory UFC media rights partnership announced in 2025, and reaffirms Paramount+ as the premier destination for UFC fans in North America, Latin America and Australia*.
“Beginning in 2027, Paramount+ subscribers in Canada will get every UFC Numbered Event main card live, at no additional cost,” said UFC President and CEO Dana White. “Paramount has been an incredible partner that understands the power of UFC, and together we’re going to make it easier than ever for fans in Canada to watch the biggest fights in the sport. I love Canada and I’m very excited for the fans to be able to enjoy the Paramount experience.”
"UFC is one of the most dynamic live sports properties in the world and we are thrilled to bring Paramount+ subscribers in Canada into the Octagon in 2027 for no additional cost,” said Rodrigo Mazón, Paramount+’s Head of Direct-To-Consumer in Latin America and Canada. “Expanding our partnership into Canada lets us serve a deeply engaged MMA audience, while reinforcing what Paramount+ is built for: premium live sports and globally relevant entertainment."
Details on the first UFC events to stream live on Paramount+ in Canada will be announced later this year.
The debut of UFC on Paramount+ in the U.S. and Latin America earlier this year was the service’s biggest exclusive live event in history. To date, over 10 million households have watched more than 100 million hours of UFC programming on Paramount+—delivering viewership more than 15x the average pay-per-view event over the past two years.
Since debuting in Canada with UFC 83 in 2008, UFC has held 37 premier sporting events across 11 cities in the Great White North. Canadian cards have featured legendary athletes like Georges St-Pierre, Jon Jones, Jose Aldo, Valentina Shevchenko and Max Holloway.
About UFC®
UFC® is the world's premier mixed martial arts (MMA) organization, with more than 700 million fans and approximately 363 million social media followers. The organization produces more than 40 live events annually in some of the most prestigious arenas around the world, while distributing programming to an estimated 1 billion broadcast and digital households across 210 countries and territories. UFC's athlete roster features the world's best MMA athletes, representing more than 75 countries. The organization's digital offerings include UFC FIGHT PASS®, one of the world's leading streaming services for combat sports. UFC is part of TKO Group Holdings (NYSE: TKO) and is headquartered in Las Vegas, Nevada. For more information, visit UFC.com and follow UFC at Facebook.com/UFC and @UFC on X, Snapchat, Instagram, and TikTok.
About Paramount, a Skydance Corporation
Paramount, a Skydance Corporation (Nasdaq: PSKY) is a leading, next‑generation global media and entertainment company, comprised of three business segments: Studios, Direct-to-Consumer, and TV Media. The Company's portfolio unites legendary brands, including Paramount Pictures, Paramount Television, CBS, CBS News, CBS Sports, Nickelodeon, MTV, BET, Comedy Central, SHOWTIME®, Paramount+, Pluto TV, Skydance Animation, Film, Television, and Interactive/Games, and the newly established Paramount Sports Entertainment. For more information, please visit www.paramount.com.
*In the U.S. and Latin America, Paramount+ offers subscribers all 13 UFC Numbered Events and 30 Fight Nights.
*In Australia, it includes all 30 UFC Fight Nights and prelims for all UFC Numbered Events.
*In Canada, it includes all 13 UFC Numbered Event Main Cards.
Paramount and the UFC, which kicked off a splashy rights deal last January, have agreed to expand their partnership to Canada.
The expansion covers 13 UFC “numbered events,” which have traditionally been known as pay-per-views. Under the Paramount deal, UFC action is included for all subscribers to Paramount+, with no extra charge. typically feature championship bouts on the main cards and showcase UFC’s biggest stars.
“Together we’re going to make it easier than ever for fans in Canada to watch the biggest fights in the sport,” UFC CEO Dana White said in a statement. “I love Canada and I’m very excited for the fans to be able to enjoy the Paramount experience.”
Rodrigo Mazón, Paramount+’s head of direct-to-consumer in Latin America and Canada, said the expansion “lets us serve a deeply engaged MMA audience, while reinforcing what Paramount+ is built for: premium live sports and globally relevant entertainment.”
Details on the first UFC events streaming on Paramount+ in Canada will be announced later this year, the companies said.
In 2025, soon after closing its merger with Skydance, Paramount clinched a 7-year deal with the UFC as the mixed martial arts circuit was wrapping its deal with ESPN. The $7.7 billion agreement, spanning the U.S. and Latin America, signaled to Hollywood and the sports world that the David Ellison-led Paramount, which now is looking to close a far bigger merger with Warner Bros. Discovery, was a major new player on the media scene.
While Paramount+ has grown steadily and in some ways punched above its weight, the streaming service remains on the second tier, lagging behind Netflix, Disney+, Prime Video and HBO Max. Ellison is making a number of aggressive moves designed to boost the company’s standing in streaming.
The UFC has been the top live draw on Paramount+ since the streams began at the start of 2026. Paramount says more than 10 million households have watched more than 100 million hours of UFC programming on Paramount+. Because the prior deal with ESPN required an extra pay-per-view fee, on top of an ESPN+ subscription, viewership on the comparatively cheaper Paramount+ setup has been more than 15 times the average for pay-per-views over the past two years, the company said.
A Paramount logo is shown on the top of a building in Hollywood in Los Angeles, California, U.S., August 5, 2025. REUTERS/Mike Blake Purchase Licensing Rights, opens new tab
CompaniesJune 4 (Reuters) - Paramount Skydance (PSKY.O), opens new tab and the Ultimate Fighting Championship on Thursday announced a six-year deal, under which UFC's numbered event main cards in Canada will be streamed exclusively on Paramount+ starting next year.
The deal is the latest step in Paramount's push to become a live sports streaming destination, as media companies bet on live events to boost viewership and drive subscriber growth in a mature streaming market.
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The agreement builds on the $7.7 billion deal in August last year, under which Paramount secured exclusive U.S. broadcast rights to the UFC, allowing it to carry the full U.S. slate of 13 numbered events and 30 "Fight Nights".
The UFC was one of the earliest bets by David Ellison after he became Paramount CEO following the company's merger with his production studio Skydance.
Under the expanded deal, all 13 UFC numbered events that traditionally feature championship bouts and the sport's biggest stars will stream live on Paramount+ each year. The deal ends UFC's traditional pay-per-view model in Canada.
Since the UFC debuted on Paramount's platforms in the U.S. and Latin America, over 10 million households have watched more than 100 million hours of UFC programming on Paramount+, the company said.
TKO Group Holdings-owned (TKO.N), opens new tab UFC is a mixed martial arts organization that produces more than 40 live events annually. Specific events to launch the service in Canada will be announced later in 2026.
The expansion to Canada comes as the media giant prepares to complete its $110 billion acquisition of Warner Bros Discovery (WBD.O), opens new tab, whose live sports portfolio includes TNT Sports' Major League Baseball and NASCAR rights.
Reporting by Anhata Rooprai in Bengaluru; Editing by Diti Pujara
Our Standards: The Thomson Reuters Trust Principles., opens new tab
LAS VEGAS & MIAMI--(BUSINESS WIRE)--Certerra, a leading provider of technology-enabled testing, inspection, and certification (“TIC”) services for critical infrastructure, today announced the acquisition of Paramount Consulting & Engineering, a provider of building envelope consulting, inspection, and specialized testing services in South Florida.
“Over the past 15 years, we've earned a reputation for technical rigor, longstanding client partnerships, & deep expertise in complex building envelope systems. We are excited to build on that legacy as part of Certerra." - Cesar Soto, Paramount Founder
Share This acquisition strengthens Certerra’s presence in the South Florida market, one of the most active and technically demanding building envelope markets in the U.S. driven by stringent durability and performance requirements. The addition of Paramount Consulting & Engineering expands Certerra’s capabilities across the built environment and reinforces its position as the partner of choice in materials engineering and the earth sciences.
For more than 15 years, Paramount Consulting & Engineering has delivered comprehensive building envelope solutions across the Greater Miami and South Florida markets, including glass and glazing inspection, waterproofing, forensic investigation, and special inspections. With a portfolio of 1,500+ active projects, Paramount Consulting & Engineering serves a diverse client base of developers, architects, general contractors, and property managers.
“The acquisition of Paramount Consulting & Engineering brings a highly specialized team with deep expertise in building envelope consulting, forensic engineering, and code-driven inspection services to our Southeast and Building Envelope Divisions," said Ed Lyon, CEO of Certerra. "Paramount Consulting & Engineering's technical depth and proven track record in South Florida position us as a full-lifecycle TIC provider, offering services from the ground up through the roof."
"Joining the Certerra platform is a natural next step for our team and a tremendous opportunity to bring our building envelope expertise to a national scale," said Cesar Soto, P.E., Founder of Paramount Consulting & Engineering. “Over the past 15 years, we have earned a reputation for technical rigor, longstanding client partnerships, and deep expertise in complex building envelope systems, and we are excited to build on that legacy as part of Certerra."
Womble Bond Dickinson, LLP, acts as legal advisor to Certerra. Cassel Salpeter & Co. provides advisory services, and J2 Advisory Group serves as legal advisor to Paramount Consulting & Engineering.
About Certerra
Certerra is a leading provider of technology-enabled testing, inspection, and certification (“TIC”) services in materials engineering and the earth sciences. Certerra helps assure the quality and advance innovation in the delivery of critical infrastructure—from the ground up. Since 2021, Certerra has unified over 20 businesses into a national platform that combines local expertise with specialized capabilities and scaled resources. With a team of 1,800+ engineers, technicians, and scientists across 65+ offices and laboratory facilities, Certerra is the partner of choice for infrastructure asset owners, contractors, design professionals, and manufacturers. Together with its clients, Certerra helps ensure that communities are built to last. Certerra is a portfolio company of OceanSound Partners. For more information, please visit www.certerra.com.
About Paramount Consulting & Engineering
Paramount Consulting & Engineering is a leading provider of building envelope consulting, inspection, and specialized testing services, offering comprehensive solutions backed by more than 15 years of industry experience. Paramount provides a full suite of services, including consulting and design, glass and glazing inspection, waterproofing, forensic investigation, and special inspections, serving developers, architects, general contractors, and property managers across South Florida. For more information, please visit https://paramountce.com/.
SummaryCompaniesAG says his office has central role in protecting Hollywood jobsBehavioral remedies not always adequate to protect competition, AG saysParamount has said deal will create jobsJune 5 (Reuters) - California Attorney General Rob Bonta will soon decide whether to sue to block Paramount's (PSKY.O), opens new tab $110 billion acquisition of Warner Bros (WBD.O), opens new tab, he told Reuters in an interview, adding that in general he views any corporate promises to address antitrust concerns as better when backed up by potential divestitures.
Bonta's office has been reviewing the deal for potential violations of U.S. antitrust law, as movie theater owners, Hollywood actors and others have expressed concerns that it would decrease competition across the industry, leading to lower wages, higher prices and fewer options for consumers and content buyers.
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Antitrust authorities in Europe are set to decide by early July whether to clear the deal, while the U.S. Department of Justice is likely to reach a decision soon, according to a source familiar with the matter. The deal could close once it clears those reviews, putting time pressure on Bonta's office, which is seen as the most likely enforcement agency to challenge the deal.
"There's not a lot of time left before we will need to act if that's what we decide to do," Bonta said in an interview in Oakland, California.
The combination of two major U.S. film studios has elicited angst in Hollywood over the potential for fewer productions. Bonta said his office has heard from many workers in the industry and that their concerns have raised "even more red flags."
Antitrust enforcers can challenge mergers that would significantly harm competition, including competition among employers for specialized labor.
"We think we have a central role in being able to protect jobs in Hollywood with respect to the Paramount-Warner Brothers proposed merger," Bonta said.
A Paramount spokesperson said the company has "every economic incentive" to expand production after the merger in order to grow streaming service subscriptions. Paramount CEO David Ellison has vowed that the combined company will release 30 movies per year in theaters. The company views theatrical releases as key to marketing its streaming offerings, it recently said in court papers.
Asked whether Paramount should be required to spin off any parts of its business to protect competition, Bonta said that behavioral remedies, where companies agree to take particular actions, are not always adequate.
"Can they be part of a solution? Maybe. Should they be backed, if they're even pursued at all, by a structural remedy consequence if they're not adequate? I'd say so. That's kind of the way I'm thinking about it," he said.
Item 1 of 2 California Attorney General Rob Bonta speaks during an interview with Reuters in Oakland, California, U.S., June 4, 2026. REUTERS/Nathan Frandino
[1/2]California Attorney General Rob Bonta speaks during an interview with Reuters in Oakland, California, U.S., June 4, 2026. REUTERS/Nathan Frandino Purchase Licensing Rights, opens new tab
Paramount Chief Legal Officer Makan Delrahim said in a statement that the company is "always prepared to remedy legitimate and articulated violations of the antitrust laws," but that it believes the deal presents none.
STATES TEAM UP TO TAKE ON ANTITRUSTCalifornia's Department of Justice has the largest antitrust division in the country, with just under 50 people. And the state is adding eight more attorneys this year along with eight support staff, Bonta said. California Governor Gavin Newsom has proposed adding $14.3 million to Bonta's budget for antitrust work.
A number of other states are talking to California about a joint challenge to the deal, two people familiar with the matter said.
However, there was no indication that the states have come to an agreement on their approach. The potential costs involved if California hires an outside lawyer could be a factor for states, the sources said.
"The full range of options are on the table and available and are fully resourced, no matter what we decide," Bonta said when asked if the state was prepared to take action on its own.
California has worked with both Democratic and Republican-led states on major antitrust cases in the past, including a recent win against Live Nation.
Working together is more important now that the Trump administration is "picking winners and losers based on who their friends are," Bonta said.
But antitrust cases often cost tens of millions of dollars, raising questions about how many major lawsuits the states can bring without their federal partners.
"We will find a way, either we'll go back and ask for more money, we'll all pitch in enough resources, we'll hire outside counsel, whatever it takes," Bonta said. "I think the people of our states and the people of this country want that, and I know they deserve that."
Reporting by Jody Godoy in New York, Nathan Frandino in Oakland and Dawn Chmielewski in Los Angeles; Editing by Christopher Cushing
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Jody Godoy reports on tech policy and antitrust enforcement, including how regulators are responding to the rise of AI. Reach her at [email protected]
Item 1 of 3 The Warner Bros. Water Tower is pictured at Warner Bros. Studios in Burbank, California, U.S. February 27, 2026. REUTERS/Daniel Cole
[1/3]The Warner Bros. Water Tower is pictured at Warner Bros. Studios in Burbank, California, U.S. February 27, 2026. REUTERS/Daniel Cole Purchase Licensing Rights, opens new tab
SummaryCompaniesCalifornia, New York among the states preparing to sueLawsuit expected in coming weeksParamount has promised shareholders payments if closing delayed past SeptemberJune 5 (Reuters) - California, New York and other U.S. states are preparing a lawsuit to block Paramount Skydance's (PSKY.O), opens new tab $110 billion acquisition of Warner Bros (WBD.O), opens new tab, sources familiar with the matter told Reuters on Friday.
The lawsuit is expected to be filed in the coming weeks, the sources said. It was not immediately clear which other states would join the lawsuit, which would mark the boldest move yet by the states in their effort to be at the forefront of U.S. antitrust enforcement.
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California Attorney General Rob Bonta on Thursday criticised what he called President Donald Trump's "abdication" of federal antitrust agencies with more resources than the state governments. Bonta, a Democrat, has led the charge among states concerned about the deal, promising a probe soon after Paramount announced it would acquire Warner Bros, after beating a bid by streaming giant Netflix.
On Friday, a spokesperson for Bonta's office said California's investigation remains active but declined to comment further.
Shares of Warner Bros fell after Reuters first reported the news, and were down 3.6% on Friday afternoon. Paramount shares added to losses and were down 6.7%.
Not all lawsuits seeking to block mergers succeed. But they can delay the consummation of deals by months if a judge issues an order pausing the merger while the case plays out.
Paramount has agreed to pay shareholders a fee starting in October if the deal has not closed. Those fees add up to around $6.9 million per day, the company said recently.
Analysts have said Paramount's political connections and other factors should give it an easier road to regulatory clearance from federal antitrust watchdogs in the U.S. Paramount CEO David Ellison's father, billionaire Oracle co-founder Larry Ellison, has cultivated ties with Trump.
The U.S. Department of Justice is likely to reach a decision on the deal soon, according to a source familiar with the matter. The DOJ sent subpoenas in late March seeking information on how the merger would affect studio output, content rights, streaming competition and movie theaters.
A Paramount spokesperson said the deal would bring greater competition, and opposing it "means giving entrenched incumbents like Netflix an advantage they do not deserve."
"We will continue to fight against any attempt to derail a deal that plainly benefits consumers, creators, and the industry as a whole," the spokesperson said.
Paramount has pledged to maintain both studios, and produce a minimum of 30 theatrical films annually after the deal closes.
The deal, which would combine two of Hollywood's four major studios, has drawn criticism from actors, writers and others in Hollywood who fear job losses. Theater owners also oppose the combination of the storied Warner Bros movie studio, maker of the "Harry Potter" and "Superman" films, with Paramount Pictures, arguing it will give cinemas fewer movies to choose from, eroding competition.
Reporting by Jody Godoy in New York; editing by Chris Sanders, Chizu Nomiyama and David Gregorio
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Jody Godoy reports on tech policy and antitrust enforcement, including how regulators are responding to the rise of AI. Reach her at [email protected]
A group of states, including California and New York, are preparing a lawsuit to block Paramount Skydance’s $110 billion acquisition of Warner Bros., two sources familiar with the matter told Reuters on Friday.
The lawsuit is expected to be filed in the coming weeks, the sources said. The case would mark the boldest move yet by the states in their effort to be at the forefront of US antitrust enforcement, as their better-funded counterpart agencies in the Trump administration take a more business-friendly view of enforcement.
Analysts have also viewed Paramount as facing an easier road to regulatory clearance from federal antitrust watchdogs in the US in part because of its political connections. Paramount CEO David Ellison’s father, billionaire Oracle co-founder Larry Ellison, has cultivated ties with President Trump.
A group of states, including California and New York, are preparing a lawsuit to block Paramount Skydance’s $110 billion acquisition of Warner Bros.,sources told Reuters. Getty Images Shares of Warner Bros fell after the news, and were down 3%. Paramount shares added slightly to losses and were down 7%.
A Paramount spokesperson said the deal would bring greater competition, and opposing it “means giving entrenched incumbents like Netflix an advantage they do not deserve.”
“We will continue to fight against any attempt to derail a deal that plainly benefits consumers, creators, and the industry as a whole,” the spokesperson said.
It was not immediately clear which other states would join the lawsuit. A spokesperson for California Attorney General Rob Bonta’s office said California’s investigation remains active but declined to comment further.
The proposed transaction has faced pushback from actors, writers and others in Hollywood over its potential to eliminate jobs.
Shares of Warner Bros. and Paramount fell on the news. Getty Images for Warner Bros. Discovery Hollywood and Wall Street have been closely watching the high-stakes deal, which would bring together some of the entertainment industry’s most enduring franchises.
The new Paramount Games Studio will be helmed by Tony Driscoll as president. The studio will roll together Skydance's existing gaming outfits, Skydance Interactive and Skydance New Media.
Warner Bros. Discovery (WBD 1.24%), global media and entertainment company with film, television, and streaming services, closed Friday at $26.24, down 2.81%. The stock moved lower during Friday’s regular session as investors reacted to reports that multiple U.S. states are preparing antitrust lawsuits to block its planned Paramount Global acquisition. Investors are now watching how growing legal challenges could reshape the deal’s terms and timing.
The company’s trading volume reached 48.1 million shares, about 122% above its three-month average of 21.6 million shares.
How the markets moved todayThe S&P 500 (^GSPC 1.62%) fell 2.63% to 7,383.74 on Friday, while the Nasdaq Composite (^IXIC 1.98%) dropped 4.18% to 25,709. Within entertainment, industry peer Walt Disney (DIS 0.42%) closed at $99.71, up 0.37%, underscoring how deal-specific regulatory risk is distinguishing individual media stocks.
What this means for investorsWarner Bros. Discovery shares fell following reports that several U.S. states, led by California and New York, are preparing to sue to block Paramount Skydance’s planned $110 billion acquisition. Although shareholders have approved the merger, these reports introduce additional regulatory uncertainty as the deal still requires U.S. and European approval.
California’s review is significant because state officials may seek structural remedies, such as divestitures, if they find behavioral commitments insufficient to protect competition. Key forthcoming developments will include whether state attorneys general file suit and whether regulators impose conditions that could impact the timing or value of Paramount Skydance’s planned acquisition.
Eric Trie has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Walt Disney and Warner Bros. Discovery. The Motley Fool has a disclosure policy.
SummaryCompaniesWorkers, unions and politicians voice concerns over job losses and industry consolidationCalifornia and New York prepare lawsuit to block deal, citing antitrust and labor concernsEntertainment job losses have hit California especially hardRegulators in US and Europe reviewing merger, with EU decision expected by July 7LOS ANGELES, June 6 (Reuters) - As he spoke at a gathering on Saturday to protest Paramount Skydance's (PSKY.O), opens new tab proposed acquisition of Warner Bros. Discovery (WBD.O), opens new tab, stand-up comedian Adam Conover framed the ongoing media consolidation as an existential threat to an industry that made the United States a cultural power.
"It's about to die, and that's why I feel so passionately about this issue," he said.
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Conover was a featured speaker on Saturday at an event billed as the first stop in a three-city “Main Street vs. The Merger” tour bringing together entertainment workers, small business owners and politicians who oppose Paramount Skydance's plan to absorb Warner Bros. Discovery in a $110 billion transaction.
About 100 people gathered at Lumiere Music Hall in Los Angeles for the event, which was organized by advocacy groups, the Writers Guild of America and industry workers who wanted to voice their concerns about the merger.
U.S. antitrust regulators appear poised to approve the combination, amid assurances from Paramount Skydance that the deal would not hurt other studios or creative talent. CEO David Ellison has pledged that the combined Paramount and Warner studios would stay productive by releasing at least 30 films a year.
A Paramount spokesperson issued a statement saying the merged companies would have "every economic incentive" to expand production of the quality content that consumers demand.
"Opposing this deal means opposing expanded consumer choice, new opportunities for creators and workers, and greater competition throughout the creative ecosystem — the opposite of what antitrust law is meant to achieve," the spokesperson said in a statement.
But a group of U.S. states including California and New York are preparing a lawsuit to block the deal, sources familiar with the matter told Reuters on Friday.
Conover knows firsthand the toll of cost-cutting from media mergers. After AT&T's 2018 acquisition of Time Warner, his TruTV show "Adam Ruins Everything" was canceled, putting employees, "countless" contractors and more than 100 others out of work.
The job losses reflect an entertainment industry where employment has declined since its peak in late 2022.
California has been especially hard hit, shedding 17,234 positions from 2019 through 2023, according to the Milken Institute. It concluded that a combination of factors — including shrinking television ad revenue and stagnating streaming growth — convinced studios to look for less-expensive places to make movies and series.
The occupancy rate in Hollywood’s sound stages has fallen to 62% in the first half of 2025, down from nearly full occupancy in 2016, according to Film LA, the non-profit organization that coordinates filming in greater Los Angeles. The International Alliance of Theatrical Stage Employees, which represents 170,000 behind-the-scenes professionals, has said its members worked about 36% fewer hours than in 2022.
Matt Radecki, a co-founder of the Different by Design post-production facility in Los Angeles, fears a Paramount Skydance-Warner Bros. Discovery merger will result in fewer buyers for documentary films such as the Oscar-winning "Navalny," which was produced by two Warner units, HBO Max and CNN Films.
"This is the biggest thing that we've faced," Radecki told attendees on Saturday. "The places we work with are closed ... They're gone, and they're never coming back, and we don't want to see that happen to HBO or CNN or CNN Films."
Former Federal Trade Commissioner Alvaro Bedoya expressed optimism that California Attorney General Rob Bonta could block the merger. Bonta could argue that the Paramount Skydance-Warner deal lessens competition among film studios, thereby indirectly affecting workers.
But it is also possible in the U.S. to block a merger by arguing it would decrease competition for specific types of labor. Antitrust authorities did so once before, in the case of publisher Penguin Random House's bid to buy rival Simon & Schuster in 2022.
California could point to that precedent in any labor-focused challenge, said Ioana Marinescu, a University of Pennsylvania economist who wrote the Biden-era Justice Department's guidelines on labor market issues.
"For some workers it could be that jobs at these two companies are really special, and this is really what they want," she said. "And there isn't necessarily a very close substitute. And those are the people for whom it's going to make an adverse impact."
(This June 6 story has been repeated without any changes to the text.)
Reporting by Dawn Chmielewski in Los Angeles and Jody Godoy in New York; Editing by Edmund Lee, Sergio Non, Franklin Paul and Nick Zieminski
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Jody Godoy reports on tech policy and antitrust enforcement, including how regulators are responding to the rise of AI. Reach her at [email protected]
Marlon Wayans, Craig Wayans and Maurice Mo Hill in "Scary Movie."
Paramount Pictures
The Wayans Bros.’ Scary Movie opened at No. 1 with an estimated $55 million in domestic ticket sales over the weekend, and thanks to its studio Paramount Pictures’ new theatrical-to-streaming window, audiences will get a bit longer to see the film on the big screen.
The sixth film in the Scary Movie franchise opened in theaters on Friday. It marks a reboot of the hit comedy franchise, which kicked off in 2000 with Scary Movie and ended in 2013 with Scary Movie 5. Directed by Michael Tiddes, the new Scary Movie stars Damon Wayans Jr., Marlon Wayans, Shawn Wayans, Anna Faris and Regina Hall.
Forbes‘Scary Movie’ Rotten Tomatoes Reviews Slice And Dice Wayans Bros. SpoofBy Tim Lammers
Like previous releases in the franchise, the new Scary Movie is a send-up of modern horror hits, including M3GAN, Terrifier, Get Out, Weapons, Sinners, Longlegs and Scream, among others.
The new film is written by Marlon Wayans, Shawn Wayans, Keenen Ivory Wayans, Craig Wayans and Rick Alvarez.
Marlon Wayans in "Scary Movie."
Paramount Pictures/Quantrell Colbert
MORE FOR YOU
Paramount Pictures Announced A New 45-Day Theatrical-To-Streaming Window At CinemaConAt the 2026 CinemaCon convention of theater owners in mid-April, Paramount and Skydance CEO David Ellison announced that effective immediately, the studio was going to implement a 45-day window from the time Paramount Pictures’ films open in theaters to the day they arrive on digital streaming via premium video on demand.
Prior to the announcement, Paramount’s films were made available as soon as a month after they opened in theaters. So, for example, the studio’s hit slasher thriller Scream 7, which opened in theaters on Feb. 27, pivoted to PVOD just over a month later, on March 31.
Forbes‘Backrooms’ Drops 70% In Business At Weekend 2 Box OfficeBy Tim LammersAs such, Scary Movie will likely follow Paramount’s new window, which would peg the film for a July 14 release on PVOD, since new releases on digital streaming typically arrive on Tuesdays. New PVOD releases are generally available on such digital platforms as Apple TV, Fandango at Home, Prime Video and YouTube Movies & TV to purchase for anywhere between $19.99 and $29.99 and as a 48-hour rental for anywhere between $14.99 and $24.99.
While Scary Movie will likely follow Paramount Pictures’ new streaming strategy, there is a remote chance that it could debut a little later than July 14. However, a longer theatrical window is rare for the studio, and generally has been reserved for mega-blockbuster releases from the likes of Tom Cruise, who champions the big-screen experience and has the clout to demand longer theatrical engagments.
Forbes‘Mandalorian And Grogu’ Tumbles Out Of Top 5 After 59% Drop At Box OfficeBy Tim LammersFor example, it took Cruise’s Mission: Impossible – The Final Reckoning 88 days from the day it opened in theaters on May 23, 2025, to its release on PVOD on Aug. 19, 2025.
Marlon Wayans in "Scary Movie."
Paramount Pictures/Quantrell Colbert
‘Scary Movie’ Will Make Its Streaming Video On Demand Premiere On Paramount+Since Scary Movie is a Paramount Pictures release, the Pay-1 window for the film on subscription streaming services belongs to Paramount+.
Prior to Paramount Pictures’ implementation of its new 45-day theatrical-to-PVOD window, it would take about a month after the studio’s films debut on PVOD to arrive on Paramount+. However, since Scary Movie is the first major release under Paramount’s new theatrical-to-PVOD strategy, a new theatrical-to-SVOD pattern has yet to be established.
Forbes‘Supergirl’ Tracking To Open At $55 Million, Less Than Half Of ‘Superman’s’ First WeekendBy Tim LammersShould Paramount tack on 15 days to create a month window between Scary Movie’s PVOD and SVOD releases, then the film could possibly arrive on Paramount+ on Aug. 20.
However, the May 28 release date for Scream 7 on Paramount+ may be a telling sign that Paramount has quietly implemented a 90-day theatrical-to-SVOD window since the film was released on the big screen on Feb. 27. Should Scary Movie follows that same pattern, it could arrive on SVOD on Paramount+ as late as Sept. 3.
Rated R, Scary Movie is new in theaters.
More From ForbesForbes‘Mortal Kombat II’ Arrives On Streaming This Week As Film Reaches $128 MillionBy Tim LammersForbesWhy He-Man’s History Won’t Help ‘Masters Of The Universe’ Opening WeekendBy Tim LammersForbesWhy ‘Masters Of The Universe’ Streaming Release Will Likely Echo ‘Project Hail Mary’By Tim LammersForbes‘Obsession’ Streaming Date Skipped In Favor Of Longer Theatrical-To-PVOD WindowBy Tim Lammers
Paramount Skydance (PKSY) shares have fallen 50% from last year's all-time high as it and Netflix (NFLX) saw a months-long clash to acquire Warner Bros. Discovery (WBD).
Proxy adviser ISS on Monday urged Warner Bros Discovery shareholders to vote against executive pay and exit packages for CEO David Zaslav and other top executives tied to the company's merger with Paramount Skydance.
Item 1 of 2 Paramount sign outside their offices at 1515 Broadway in New York City, U.S., February 17, 2026. REUTERS/Adam Gray
[1/2]Paramount sign outside their offices at 1515 Broadway in New York City, U.S., February 17, 2026. REUTERS/Adam Gray Purchase Licensing Rights, opens new tab
CompaniesJune 9 (Reuters) - Britain's competition regulator said on Tuesday it has formally started its review of Paramount Skydance's (PSKY.O), opens new tab planned $110 billion acquisition of Warner Bros Discovery (WBD.O), opens new tab, after ending the first part of its information gathering process.
The first phase of the review has a deadline of August 7, after which the Competition and Markets Authority (CMA) will decide whether to clear the deal or refer it for a more in-depth probe.
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Here are details on the deal and the subsequent review:
Under the so-called phase 1 enquiry, the CMA will look into whether a deal may harm competitiveness in an industry or region within the UK.
Its invitation to comment, where interested parties had a chance to tell the regulator how the proposed transaction would impact competition, had run from April 13 until April 27.
Paramount outbid Netflix (NFLX.O), opens new tab in February after a drawn-out bidding war to buy Warner Bros, combining major studios and networks such as CNN and CBS in an effort to compete with streaming platforms more aggressively.
The deal has already received some regulatory scrutiny across North America and Europe, as industry players including writers, actors, filmmakers and cinema operators voiced concerns about the impact it could have on the entertainment industry and consumers.
Last week, sources told Reuters that California, New York and other U.S. states were preparing a lawsuit to block the deal.
“Today’s milestone is consistent with our expected timeline. We look forward to continuing to work constructively with the Competition and Markets Authority and all regulatory agencies as they advance their review process," a Paramount spokesperson said in an emailed response to Reuters.
Warner Bros declined to comment.
Reporting by Prerna Bedi in Bengaluru; additional reporting by Tuhina; Editing by Harikrishnan Nair and Devika Syamnath
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Bari Weiss, editor of Common Sense and host of "Honestly" podcast speaks at the 2022 Milken Institute Global Conference in Beverly Hills, California, U.S., May 3, 2022. REUTERS/Mike Blake Purchase Licensing Rights, opens new tab
June 9 (Reuters) - Paramount Skydance (PSKY.O), opens new tab is scouting candidates to oversee the business side of operations, who would work alongside CBS News' editor-in-chief Bari Weiss, Axios reported on Tuesday, citing two sources familiar with the matter.
If Paramount's acquisition of Warner Bros Discovery (WBD.O), opens new tab goes through, Weiss would manage editorial across CBS News and CNN, and her potential counterpart would manage business operations at both, the report said.
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Paramount did not immediately respond to a request for comment. Reuters could not independently verify the report.
The search follows a recent purge at "60 Minutes", CBS' flagship Sunday news magazine, where more than half a dozen people have departed over internal clashes, including correspondent Scott Pelley, whose contract was terminated last week.
Since becoming editor-in-chief in October under the Free Press-Paramount deal, Weiss has been reshaping the newsroom by adding commentators who offer observations about news, politics and culture to CBS as part of a push to bring a "streaming mentality" to the network.
Among the candidates being considered for the business role are NBCUniversal News Group chairman Cesar Conde, CNN Worldwide CEO Mark Thompson and former NBC News president Noah Oppenheim, the report said.
Paramount has also considered Daily Beast CEO and former ABC News president Ben Sherwood and former CBS News president and current Sky News executive chairman David Rhodes, Axios reported, citing a source.
Axios reported Weiss' position is secure despite a report by media outlet Puck stating Paramount executives were looking for ways to limit her purview over linear coverage.
While the companies wait for regulatory approval for the $110 billion merger, no Paramount executives can have conversations with any Warner Bros executives, including Thompson, Axios reported.
Wendy McMahon, former president and CEO of CBS News, resigned in May 2025, telling staffers that she and the company have differing views on the path forward.
Reporting by Anhata Rooprai in Bengaluru; Editing by Vijay Kishore
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Paramount Skydance Corporation is rated Buy with a $12.32 12-month price target, driven by operational inflection and merger potential. Q1 adjusted EBITDA surged 59% on just 2% revenue growth, highlighting emerging operating leverage and cost discipline across PSKY's diversified media assets. Streaming momentum is accelerating, with Paramount+ reaching 79.6 million subscribers and platform unification expected to further boost engagement and margins.
The main gate of Paramount Pictures Studios in Los Angeles, California, U.S., February 27, 2026. REUTERS/Mario Anzuoni Purchase Licensing Rights, opens new tab
CompaniesBRUSSELS, June 10 (Reuters) - Paramount Skydance Corp's (PSKY.O), opens new tab takeover of Warner Bros Discovery (WBD.O), opens new tab, backed by Gulf, opens new tab sovereign wealth funds, is under European Union subsidy scrutiny, according to a European Commission filing.
The U.S. entertainment giant sought EU approval under its Foreign Subsidies Regulation, which targets unfair foreign state aid, on Tuesday.
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The Commission, which acts as the EU competition enforcer, will decide by July 14 whether to clear the deal or open a full-scale 90 working day investigation.
Saudi Arabia's Public Investment Fund (PIF), Abu Dhabi-based L'imad Holding Company, and Qatar Investment Authority (QIA) are backing the deal, which is also being reviewed under EU merger rules.
The subsidy review is expected to be easier than the merger one where the companies will likely have to offer concessions such as divesting a children's channel to address EU competition concerns, sources have previously told Reuters.
Reporting by Foo Yun Chee;Editing by Elaine Hardcastle
Our Standards: The Thomson Reuters Trust Principles., opens new tab
An agenda-setting and market-moving journalist, Foo Yun Chee is a 21-year veteran at Reuters. Her stories on high profile mergers have pushed up the European telecoms index, lifted companies' shares and helped investors decide on their next move. Her knowledge and experience of European antitrust laws and developments helped her break stories on Microsoft, Google, Amazon, Meta and Apple, numerous market-moving mergers and antitrust investigations. She has previously reported on Greek politics and companies, when Greece's entry into the eurozone meant it punched above its weight on the international stage, as well as on Dutch corporate giants and the quirks of Dutch society and culture that never fail to charm readers.
Paramount Skydance CEO David Ellison has prioritized putting streaming services on one tech platform. Jonathan Raa/NurPhoto via Reuters Connect; Valerie Macon / AFP via Getty Images; Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images Paramount Skydance is preparing to move around some streaming staffers as David Ellison's company wraps up its long-term project of unifying the tech platforms of Paramount+ and free streamer Pluto TV.
This so-called "convergence" project has been a top priority for Paramount. Two high-level streaming employees recently said that convergence is on pace to meet the company's stated goal of a "mid-year launch." While Paramount is planning to keep Paramount+ and Pluto TV as separate services, the hope is that having a single tech platform will save resources and improve recommendations across each app, which could drive higher engagement.
Once convergence is complete, Paramount is planning to reassign staffers who've worked on it, streaming leaders told employees during a quarterly meeting on Wednesday morning.
Paramount said it will "organize our teams against thematic pillars" like monetization, content, and live & video, according to a screenshot of the presentation viewed by Business Insider.
Streaming staffers also learned that some employees "will be utilized to create select additional Solutions Teams" focused on advertising formats, user experience for the short-form video feed on Paramount+, and video playback.
A person familiar with Paramount's streaming strategy said these changes are about "redeploying" product employees after convergence is finished. They said most streaming staff won't be affected by these changes and that no associated layoffs were planned.
Boosting tech beyond convergenceSince Ellison became Paramount's CEO in August, the company has prioritized technology by shaking up teams, making key hires, and adding new streaming features.
Paramount merged some technical streaming teams in March, Business Insider reported. The company said that putting the Paramount+ Global Quality Engineering group and Pluto TV's Software Test Engineering team under one roof helped facilitate "AI enablement and automated testing."
Ellison's company has also emphasized data by expanding the role of EVP Jason Kim, who, since January, has overseen data and insights across all of Paramount, not just streaming.
Paramount has made several key hires. They include former Google AI executive Barak Turovsky as head of consumer AI; fellow former Google executive Hugh Williams as an EVP; and former Amazon ad sales leader Danielle Carney as head of its US ad sales group. Ellison has also brought over product chief Dane Glasgow from Meta and revenue chief Jay Askinasi from Roku.
Paramount has had key departures as well, including former tech chief Phil Wiser in May and former head of streaming product and tech Vibol Hou in January.
Besides marrying the tech stacks of Paramount+ and Pluto TV, Paramount hopes to boost streaming engagement by adding vertical video clips and interactive features, such as a shopping tool. The company is exploring adding video podcasts; rival Netflix recently made a major move into licensed podcasts.
Paramount's most transformative change would be buying Warner Bros. Discovery, which would give it control of the Warner Bros. Studio, HBO, HBO Max, and cable networks like CNN. The merger still needs regulatory approval in the US and abroad, which the company hopes to get by the end of September.
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72.2% Probability of Remaining Event-Free at 24 Months by Kaplan-Meier Analysis After Achieving Complete Response at Three Months (79.6%)
PRINCETON, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the publication of results from the pivotal Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution in The Journal of Urology. ZUSDURI is indicated for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The publication reports a 72.2% probability of remaining event-free at 24 months after complete response (CR) (95% CI: 64%, 79%) as determined by Kaplan-Meier analysis. The CR rate at three months was 79.6%. The median follow-up time after three-month CR was 23.7 months, and the median DOR was not reached.
“The publication of these long-term data in The Journal of Urology provides important peer-reviewed validation of the durability of ZUSDURI treatment observed in the ENVISION trial,” said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, New Jersey, and Principal Investigator of the ENVISION trial. “For patients who achieved a complete response, the likelihood of remaining event-free through two years was substantial, underscoring the potential of ZUSDURI to change the long-term management of this highly recurrent disease with a six-week induction treatment alone without maintenance. For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy.”
The existing standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates, patients, who are often elderly with multiple comorbidities, may require repeated TURBT procedures over their lifetime, which can negatively impact quality of life and may be associated with increased health risks. An estimated 59,000 patients with LG-IR-NMIBC experience recurrence annually in the United States.
“Now that the 24-month duration of response data from ENVISION are published in a leading urology journal, we’re seeing even stronger validation of ZUSDURI’s clinical impact,” said Mark Schoenberg, Chief Medical Officer, UroGen. “As the first and only approved treatment for recurrent LG-IR-NMIBC, ZUSDURI gives patients a real chance at meaningful, recurrence-free periods. These results suggest we may finally be able to break the long-standing cycle of repeated recurrences and surgeries that has defined care for patients with recurrent LG-IR-NMIBC.”
The most common (≥10%) adverse reactions, including laboratory abnormalities, observed in patients treated with ZUSDURI were dysuria, hematuria, urinary tract infection, increased creatinine, increased potassium, decreased hemoglobin, decreased lymphocytes, decreased neutrophils, increased eosinophils, and increased liver enzymes (AST and ALT). Adverse reactions were primarily mild to moderate in severity. Serious adverse reactions occurred in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%).
About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product, ZUSDURI (mitomycin) for intravesical solution, is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.
APPROVED USE FOR ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working.
IMPORTANT SAFETY INFORMATION
You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.
Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:
have kidney problemsare pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.
Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.
How will I receive ZUSDURI?
You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving ZUSDURI:
ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential long-term benefits of ZUSDURI, including its potential to provide meaningful recurrence-free periods; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “can,” “estimate,” “likely,” “may,” “potential,” “will” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to UroGen’s products; the ability to maintain regulatory approval; labeling limitations; competition in UroGen’s industry; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 2, 2026, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
PRINCETON, N.J., April 08, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the launch of its “LG-UTUC Luminaries” initiative, recognizing clinicians and institutions demonstrating leadership, expertise, and a commitment to advancing low‑grade upper tract urothelial cancer (LG‑UTUC) care.
LG‑UTUC is a rare form of cancer affecting an estimated 6,000-7,000 patients each year in the U.S., which represents approximately 40% of patients diagnosed in the U.S. annually with UTUC. While typically noninvasive, it often recurs and may require repeated endoscopic procedures or radical surgery to remove the kidney and ureter, underscoring a continued need for guideline-recommended kidney‑sparing care approaches.
“Through the LG-UTUC Luminaries initiative, we are honored to recognize the clinicians and institutions redefining what is possible for patients living with LG-UTUC,” said Liz Barrett, President and Chief Executive Officer of UroGen. “By elevating these leaders, we aim to inspire broader adoption of evidence-based, kidney-sparing care, strengthen collaboration across the urology community, and accelerate progress toward a future where patients with this highly recurrent disease have better outcomes and a better care experience.”
The LG-UTUC Luminaries initiative recognizes clinicians and institutions working to achieve excellence in LG-UTUC care. Honorees have extensive experience with LG-UTUC and are actively involved in treatment, research, and peer-to-peer education. Institutional recipients are distinguished by established, guideline-aligned care pathways spanning diagnosis, treatment, and long-term surveillance, as well as strong commitments to physician training, research participation, and comprehensive patient support.
UroGen recognizes Saum Ghodoussipour, MD, Director, Bladder and Urothelial Cancer Program, Rutgers Cancer Institute, and Associate Professor of Surgery, Rutgers Robert Wood Johnson Medical School, as the first recipient of this flagship LG-UTUC Luminaries recognition—an honor that will continue to be presented to physicians and institutions dedicated to helping shape the future of kidney-sparing management in LG-UTUC.
“I’m truly honored to receive this recognition,” said Dr. Saum Ghodoussipour, Director of the Bladder and Urothelial Cancer Program at Rutgers Cancer Institute and Associate Professor of Surgery at Rutgers Robert Wood Johnson Medical School, NJ. “This distinction reflects the dedication of our entire multidisciplinary team at Rutgers Cancer Institute, whose commitment to advancing education, research, and patient-centered care continues to drive progress for individuals living with LG-UTUC. I’d especially like to recognize Dr. Vignesh Packiam, Director of Clinical and Translational Research in Urologic Oncology and Associate Professor of Surgery at Rutgers Robert Wood Johnson Medical School, whose leadership and contributions have been instrumental in shaping our program. Together, we remain committed to improving outcomes through collaboration, innovation, and a steadfast focus on our patients.”
About the LG-UTUC Luminaries Initiative
The LG-UTUC Luminaries initiative is UroGen’s effort to recognize and collaborate with leading clinicians and institutions advancing care for patients with low-grade upper tract urothelial cancer. By highlighting clinical leadership and fostering collaboration across the urology community, the initiative supports continued progress in kidney-sparing care and efforts to improve outcomes in this rare and highly recurrent disease.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.
INVESTOR CONTACT:
Vincent Perrone [email protected]
(609) 460-3588 Ext. 1093
MEDIA CONTACT:
Cindy Romano [email protected]
(609) 460-3566 Ext. 1083
PRINCETON, N.J., April 29, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report first quarter 2026 financial results on Wednesday, May 6th, 2026, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.
A live public webcast of the earnings conference call can be accessed on UroGen’s Investor Relations website. Following the live webcast, a replay will be available on the site for approximately 30 days.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.
ZUSDURI™ generated revenue of $29.2 million in Q1 2026, representing 109% quarter-over-quarter growth, reflecting broader utilization with the permanent J Code effective January 1, 2026JELMYTO achieved $21.7 million in revenue in Q1 2026, representing year-over-year growth of 7%Continued advancement of next-generation pipeline, UGN-103 on track for NDA submission in the second half of 2026; six-month durability data expected in mid-2026UroGen to host Key Opinion Leader (KOL) panel highlighting real-world experience with ZUSDURI at the American Urological Association (AUA) annual meeting on May 17th at 8:30 AM ETConference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., May 06, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2026, and provided an overview of recent developments.
“2026 is off to a strong start, with expanding usage of ZUSDURI™ (mitomycin) for intravesical solution and clear acceleration across key commercial indicators, including prescriber trial and adoption,” said Liz Barrett, President and Chief Executive Officer of UroGen. “These trends reflect growing clinical confidence in ZUSDURI as a primary, non-surgical therapy for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The early launch momentum is now translating into meaningful revenue growth, providing early validation of our commercial model and reinforcing the blockbuster potential for ZUSDURI. In parallel, we continue to advance our broader pipeline, including next generation products UGN-103 in LG-IR-NMIBC and UGN-104 in low-grade upper tract urothelial carcinoma (LG-UTUC), as well as UGN-501, our investigational, potentially best-in-class, next-generation oncolytic virus. With this momentum, we are well positioned to execute our long-term growth strategy and continue to expand our leadership position in uro-oncology.”
Q1 2026 and Recent Business Highlights:
ZUSDURI (mitomycin) for intravesical solution:
Commercial launch of ZUSDURI continues to accelerate, following its U.S. FDA-approval as the first and only FDA-approved medicine for adults with recurrent LG-IR-NMIBC.The permanent Healthcare Common Procedure Coding System Level II J Code (J9282) became effective on January 1, 2026 and has enabled broader adoption by improving reimbursement clarity and confidence across both hospital and community settings.ZUSDURI achieved net product revenue of $29.2 million in the first quarter of 2026, representing 109% quarter-over-quarter growth. The accelerating growth trend in prescribers, particularly repeat prescribers, reflects increasing health care provider confidence and successful integration of ZUSDURI into routine urology practice. As of March 31, 2026, UroGen reported: 972 activated sites of care256 unique ZUSDURI prescribers103 repeat ZUSDURI prescribers Updated results from the Phase 3 ENVISION trial evaluating ZUSDURI were published online ahead of print in the Journal of Urology. The publication reported that patients who achieved a complete response (CR) three months after the first instillation of ZUSDURI had a 72.2% probability of remaining event-free 24 months after CR (95% CI: 64.1%, 78.8%) as determined by Kaplan-Meier analysis.
JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC:
Generated net product revenue of $21.7 million in the quarter ended March 31, 2026, an increase of approximately 7% over the $20.3 million reported for first quarter of 2025.
Next-generation novel mitomycin-based formulations for urothelial cancer
UroGen plans to submit a New Drug Application (NDA) for UGN-103 (mitomycin) for recurrent LG-IR-NMIBC in the second half of 2026 with potential FDA approval in 2027. The FDA has agreed with the Company’s regulatory plan to submit the NDA based on the data from the Phase 3 UTOPIA trial. Top line results from UTOPIA were reported in November 2025, demonstrating a 77.8% three-month CR rate (95% CI, 68.3%, 85.5%). For more information on the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.UGN-103 is a next-generation mitomycin product designed to offer improvements over ZUSDURI, including a shorter manufacturing process and simplified reconstitution procedure. It combines UroGen’s RTGel® technology with a novel mitomycin formulation licensed from medac. UroGen continues to evaluate lifecycle management and pipeline expansion opportunities, including potential applications in high-grade NMIBC settings and adjuvant use of UGN-103 in IR-NMIBC patients.The Phase 3 clinical trial to explore the safety and efficacy of UGN-104 is ongoing and is expected to be fully enrolled by the end of 2026. UGN-104 is a next-generation mitomycin product for LG-UTUC. For more information on the UGN-104 Phase 3 trial (UT002), refer to https://clinicaltrials.gov/study/NCT06774131.
UGN-501 (investigational next-gen oncolytic virus) for use in high-grade non-muscle invasive bladder cancer
UGN-501 is a potent and fast-replicating investigational next-generation oncolytic virus being developed as a locally administered cancer treatment. Investigational New Drug (IND)-enabling studies are nearing completion, and UroGen plans to submit an IND in the second quarter of 2026 and initiate a Phase 1 clinical trial in NMIBC by year end. Nonclinical data to date demonstrate cytotoxic activity across a panel of bladder cancer cell lines representing a broad range of tumor stages and grades. The Phase 1 trial will initially evaluate aqueous intravesical administration of UGN-501, and UroGen plans to evaluate delivery using its proprietary RTGel technology, which may enable prolonged dwell time and enhanced local activity. The initial focus is bladder cancer with the potential to expand into additional tumor types beyond the genitourinary system.
Expanded Debt Facility with Pharmakon Advisors
In February 2026, UroGen entered into an amended and restated loan agreement with Pharmakon Advisors for two additional tranches of senior secured term loans. The first tranche of $200 million was funded at closing to refinance the existing $125 million loan facility and provide additional non-dilutive capital. A second tranche of $50 million may be drawn at the Company's option no later than June 30, 2027, subject to customary conditions. All outstanding loans with Pharmakon Advisors will accrue interest at a fixed rate of 8.25% and be repaid in four equal quarterly payments commencing in the second quarter of 2030. All outstanding loans with Pharmakon Advisors can be prepaid in whole at UroGen's discretion at any time, subject to prepayment premiums, make-whole amounts, as applicable, and fees.
American Urological Association Key Opinion Leader Panel to Showcase Real-World Experience with ZUSDURI
UroGen will host a KOL panel at the upcoming AUA Annual Meeting focused on real-world experience with ZUSDURI, including patient selection, workflow integration, treatment patterns, and patient outcomes. The event will feature leading urologists highlighting the role of ZUSDURI as a primary, non-surgical treatment option in recurrent low-grade intermediate-risk NMIBC and will be webcast and accessible through the Company’s website. To register click here.
First quarter 2026 Financial Results
Revenue: Total revenue was $51.0 million in the first quarter ended March 31, 2026, compared with $20.3 million in the first quarter of 2025. Year-over-year revenue growth of 152% was primarily driven by the commercial launch of ZUSDURI and JELMYTO revenue growth.
Research and Development (R&D) Expenses: R&D expenses were $15.6 million in the first quarter of 2026, including non-cash share-based compensation expense of $0.8 million. This compares to $19.9 million, including non-cash share-based compensation expense of $0.6 million, for the same period in 2025. The decrease in R&D expenses was primarily attributable to the acquisition of UGN-501 in the first quarter of 2025 and ZUSDURI manufacturing costs, which were recognized as R&D expense in the first quarter of 2025 prior to receiving FDA approval.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $51.5 million in the first quarter of 2026, including non-cash share-based compensation expense of $3.9 million. This compares to $35.0 million, including non-cash share-based compensation expense of $2.5 million, for the same period in 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, an increase in overall commercial operation costs, and higher advisory costs, including fees associated with the Pharmakon Advisors debt refinancing in the first quarter of 2026.
Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.5 million in the first quarter of 2026 compared with $4.6 million in the same period in 2025.
Interest Expense on Long-term Debt: Interest expense related to long-term debt was $4.2 million in the first quarter of 2026, compared to $4.1 million in the same period in 2025. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, offset by the lower interest rate.
Net Loss: UroGen reported a net loss of $23.6 million or ($0.47) per basic and diluted share in the quarter ended March 31, 2026, compared with a net loss of $43.8 million or ($0.92) per basic and diluted share in the first quarter of 2025.
Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, cash, cash equivalents and marketable securities totaled $140.3 million.
2026 JELMYTO Revenue and Company Operating Expense Guidance: The Company continues to expect 2026 net product revenue for JELMYTO to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over the $94 million of JELMYTO revenue reported in 2025. The Company is not providing full-year 2026 revenue guidance for ZUSDURI at this time, as the product remains in the early stages of its commercial launch. The Company continues to expect full-year 2026 operating expenses to be in the range of $240 million to $250 million, including non-cash share-based compensation expense of $20 million to $24 million.
Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.
The live webcast can be accessed by visiting the Investors section of the Company’s website at http://investors.UroGen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.
UROGEN PHARMA LTD.SELECTED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands)(Unaudited) March 31, 2026 December 31, 2025Cash and cash equivalents and marketable securities $140,274 $120,456 Total assets $253,690 $200,455 Total liabilities $377,943 $305,929 Total shareholders' deficit $(124,253) $(105,474) UROGEN PHARMA LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(U.S. dollars in thousands, except share and per share data)(Unaudited) Three months ended March 31, 2026 2025 Revenue$50,959 $20,254 Cost of revenue 4,139 2,330 Gross profit 46,820 17,924 Operating expenses: Research and development expenses 15,597 19,871 Selling, general and administrative expenses 51,486 34,967 Total operating expenses 67,083 54,838 Operating loss (20,263) (36,914)Financing on prepaid forward obligation (4,506) (4,583)Interest expense on long-term debt (4,185) (4,068)Interest and other income, net 608 2,114 Loss before income taxes$(28,346) $(43,451)Income tax benefit (expense) 4,772 (392)Net loss$(23,574) $(43,843)Net loss per ordinary share, basic and diluted$(0.47) $(0.92)Weighted average shares outstanding, basic and diluted 50,182,758 47,422,119 About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means.
APPROVED USE FOR ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove a tumor that did not work or is no longer working.
IMPORTANT SAFETY INFORMATION
You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.
Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:
have kidney problems.are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.
Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.
How will I receive ZUSDURI?
You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving ZUSDURI:
ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:
are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.JELMYTO is given to your kidney through a tube called a catheter.During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.JELMYTO may cause serious side effects, including:Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first product to treat LG-UTUC and second product (mitomycin) for intravesical solution for adults with recurrent LG-IR-NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X, @UroGenPharma.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential for ZUSDURI as a primary, non-surgical therapy for adults with recurrent LG-IR-NMIBC; ZUSDURI’s accelerating commercial uptake and growing rates of prescriber trial and adoption; the belief that growing clinical confidence in ZUSDURI will continue to drive commercial momentum and that the early launch trajectory provides validation of UroGen's commercial model; the belief in the significant commercial opportunity for ZUSDURI and UroGen’s ability to fully capitalize on it; the potential benefits and opportunities for UroGen’s product candidates, including UGN-103, UGN-104 and UGN-501; UroGen’s planned and ongoing clinical trials and IND-enabling studies and the timing for regulatory submissions and potential regulatory approvals for its product candidates, including the ongoing Phase 3 UTOPIA clinical trial of UGN-103, the ongoing Phase 3 clinical trial of UGN-104 and the IND-enabling studies of UGN-501, the planned NDA submission for UGN-103 and the potential regulatory approval thereof and the planned IND submission for UGN-501 and the potential Phase 1 trial thereof; the potential of UGN-501 to expand into additional tumor types beyond the genitourinary system; the expectation that UroGen’s next-generation medicines will enhance supply, improve manufacturing and preparation efficiencies and provide opportunity for lifecycle extensions; 2026 JELMYTO revenue and company operating expense guidance; the expected timeline of UroGen’s expanded debt facility with Pharmakon Advisors; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin and as a viable platform for local delivery of complex immunotherapies; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “can,” “continue,” “estimate,” “expect,” “may,” “on track,” “plan,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to UroGen’s products; risks related to UroGen’s and its licensors’ ability to protect their respective patents and other intellectual property, including that UroGen’s or its licensors’ pending patent applications may not be successful, and in such event, the duration of intellectual property protection would be more limited; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; the data from the UTOPIA trial may not be sufficient to support approval of UGN-103; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 2, 2026, as well as in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q being filed with the SEC later today, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
Urogen Pharma (URGN - Free Report) came out with a quarterly loss of $0.47 per share versus the Zacks Consensus Estimate of a loss of $0.56. This compares to a loss of $0.92 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +16.44%. A quarter ago, it was expected that this company would post a loss of $0.66 per share when it actually produced a loss of $0.54, delivering a surprise of +18.18%.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Urogen Pharma, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $50.96 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 16.96%. This compares to year-ago revenues of $20.25 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.
Urogen Pharma shares have added about 1.8% since the beginning of the year versus the S&P 500's gain of 6%.
What's Next for Urogen Pharma?While Urogen Pharma 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 Urogen Pharma was favorable. 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 #2 (Buy) for the stock. So, the shares are expected to outperform 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 the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.48 on $55.25 million in revenues for the coming quarter and -$1.45 on $249.47 million 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 bottom 40% 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, Guardant Health (GH - Free Report) , is yet to report results for the quarter ended March 2026. The results are expected to be released on May 7.
This provider of oncology testing services is expected to post quarterly loss of $0.47 per share in its upcoming report, which represents a year-over-year change of +4.1%. The consensus EPS estimate for the quarter has been revised 0.8% higher over the last 30 days to the current level.
Guardant Health's revenues are expected to be $278.52 million, up 36.9% from the year-ago quarter.
PRINCETON, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will participate in the following investor conferences in May.
Bank of America Health Care Conference 2026Date / Time:May 13th, at 11:15 AM ETFormat:1x1’sLocation:Las Vegas, NVWebcast Link:Here
HC Wainwright 4th Annual BioConnect Investor ConferenceDate / Time:May 19th, at 10:30 AM ETFormat:1x1’sLocation:New York, NYWebcast Link:Here
TD Cowen 7th Annual Oncology Innovation SummitDate / Time:May 26th, at 10:30 AM ETLocation:VirtualWebcast Link:Here
The webcasts from the conference will also be available on UroGen’s Investor Relations website. A replay will be available for approximately 90 days.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first product to treat LG-UTUC and second product (mitomycin) for intravesical solution for adults with recurrent LG-IR-NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X, @UroGenPharma.
UroGen Pharma is reaffirmed as a Strong Buy, with a 12-month price target raised to $39/share, reflecting robust Q1 2026 results. Zusduri sales more than doubled QoQ to $29.2M, driven by the January J-code assignment, validating the trajectory toward profitability by 2027. URGN's path to profitability is underpinned by >91% gross margins, disciplined expense control, and a realistic break-even threshold of $305M annual revenue.
From a technical perspective, Urogen Pharma (URGN - Free Report) is looking like an interesting pick, as it just reached a key level of support. URGN's 50-day simple moving average crossed above its 200-day simple moving average, which is known as a "golden cross" in the trading world.
A golden cross is a technical chart pattern that can signify a potential bullish breakout. It's formed from a crossover involving a security's short-term moving average breaking above a longer-term moving average, with the most common moving averages being the 50-day and the 200-day, since bigger time periods tend to form stronger breakouts.
Golden crosses have three key stages that investors look out for. It starts with a downtrend in a stock's price that eventually bottoms out, followed by the stock's shorter moving average crossing over its longer moving average and triggering a trend reversal. The final stage is when a stock continues the upward climb to higher prices.
This kind of chart pattern is the opposite of a death cross, which is a technical event that suggests future bearish price movement.
Shares of URGN have been moving higher over the past four weeks, up 36.3%. Plus, the company is currently a #3 (Hold) on the Zacks Rank, suggesting that URGN could be poised for a breakout.
The bullish case solidifies once investors consider URGN's positive earnings outlook. For the current quarter, no earnings estimate has been cut compared to 3 revisions higher in the past 60 days. The Zacks Consensus Estimate has increased too.
With a winning combination of earnings estimate revisions and hitting a key technical level, investors should keep their eye on URGN for more gains in the near future.
64.5% Probability of Remaining Event-Free at Three Years by Kaplan-Meier Analysis After Achieving Complete Response at Three MonthsFirst and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer PRINCETON, N.J., May 13, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced a 36-month duration of response (DOR) of 64.5% (95% CI, 54.6% - 72.8%) by Kaplan-Meier estimate in patients who achieved a complete response (CR) at three months (79.6%) in the pivotal Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution. At a median follow-up of 35.5 months, the median DOR had not been reached. These data demonstrate that a substantial proportion of complete responders remained disease-free at three years, and durable outcomes were achieved without the need for maintenance therapy.
“This update from the pivotal ENVISION trial shows that many patients who achieve a complete response with ZUSDURI remain disease-free through three years,” said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. “Among patients who achieved a complete response, the event rate over time has remained stable. Importantly, ZUSDURI’s durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing ongoing treatment burden for patients.”
As a non-surgical, in-office treatment, ZUSDURI offers patients an opportunity to achieve meaningful disease- and treatment-free living without the burden of repeated TURBT procedures under general anesthesia. The current standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates following surgery, patients often undergo multiple TURBTs over their lifetime, leading to a cycle of repeat procedures that can impact quality of life and increase cumulative risk, particularly in older patients with comorbidities. An estimated 59,000 patients with LG-IR-NMIBC recur annually.
“The ENVISION 36-month DOR data reinforce ZUSDURI’s potential to shift the treatment paradigm for recurrent LG-IR-NMIBC,” said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. “By delivering durable responses without maintenance therapy, ZUSDURI provides an opportunity to move beyond the cycle of repeated surgical interventions and toward a more durable, lower-burden treatment approach over time.”
The most common (≥ 10%) adverse reactions (ARs), including laboratory abnormalities, that occurred in patients were dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. ARs were mainly mild to moderate. Serious ARs occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%).
About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.
About ENVISION
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter pivotal study evaluating the efficacy and safety of ZUSDURI (mitomycin) for intravesical solution as a chemoablative therapy in adult patients with recurrent LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of ZUSDURI. The primary endpoint evaluated the CR rate three months after the first instillation, and the key secondary endpoint evaluates durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat low-grade upper tract urothelial cancer and our second product, ZUSDURI (mitomycin) for intravesical solution for adult patients with recurrent LG-IR-NMIBC, are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel.
Visit www.UroGen.com to learn more or follow us on X (Twitter), @UroGenPharma.
APPROVED USE FOR ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working.
IMPORTANT SAFETY INFORMATION
You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.
Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:
have kidney problemsare pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.
Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.
How will I receive ZUSDURI?
You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving ZUSDURI:
ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential benefits of ZUSDURI, including as an outpatient treatment option, its potential to provide durable CRs without maintenance therapy and clinically meaningful disease- and recurrence-free intervals; the potential of ZUSDURI to shift the treatment paradigm and provide a compelling non-surgical alternative to TURBT for the treatment of recurrent LG-IR-NMIBC; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the ongoing Phase 3 ENVISION trial; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “can,” “estimate,” “likely,” “may,” “potential,” “will” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to UroGen’s products; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q being filed with the SEC on May 6, 2026, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
PRINCETON, N.J., May 15, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) durability of response (DOR) at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial of UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The six-month results from UTOPIA are generally consistent with the 91.9% (95% CI: 86.9, 95.0) six-month DOR observed with ZUSDURI™ (mitomycin) for intravesical therapy in its pivotal ENVISION trial. ZUSDURI is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for adult patients with recurrent LG-IR-NMIBC.
Based on the consistency of UTOPIA data with the results of the ENVISION trial studying ZUSDURI in patients meeting the same eligibility criteria and alignment with the FDA, UroGen remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026.
“The durability of response observed at six months with UGN-103 in the UTOPIA trial is generally consistent with that observed in the pivotal ENVISION trial of ZUSDURI, and highlights the potential to further advance care for adult patients with recurrent LG-IR-NMIBC,” said Abishek Srivastava, MD, Urologic Oncologist at Atlantic Urology Clinics, Myrtle Beach, SC, START Center for Cancer Research, Carolinas and lead investigator of the UTOPIA trial. “UGN-103 builds on a proven therapeutic approach with meaningful innovations that could help enhance how we deliver this therapy in clinical practice.”
UGN-103 is designed to build on the clinical and commercial foundation of ZUSDURI. The benefits of UGN-103 include a more streamlined manufacturing process and simplified reconstitution, while preserving the innovative and proven RTGel® technology that enables sustained drug exposure at tumor sites in the bladder.
“These clinical data reinforce the potential of UGN-103 to become a new standard of care for adult patients with recurrent LG-IR-NMIBC,” said Liz Barrett, President and Chief Executive Officer of UroGen. “With FDA alignment on our regulatory path, we are advancing with urgency toward NDA submission. We believe UGN-103 represents a significant opportunity to build on our leadership in uro-oncology, expand our commercial portfolio, and drive long-term growth.”
UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property protection expected to extend into December 2041.
About UTOPIA
The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in 99 patients across global sites. Enrolled patients received 75 mg of UGN-103 via intravesical instillation in an outpatient setting once weekly for six weeks. The primary endpoint is CR rate at three months, with responders entering a follow-up phase of up to 12 months to assess DOR. For more information on the UTOPIA study, please visit https://clinicaltrials.gov/study/NCT06331299.
About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC. UGN-103 is designed to reinforce and extend the clinical and commercial profile of ZUSDURI, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. The program maintains UroGen’s innovative and proven RTGel technology, enabling sustained mitomycin exposure in the bladder, while incorporating next-generation enhancements, including a more streamlined manufacturing process and simplified reconstitution to support improved ease of use in clinical practice. UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property protection expected to extend into December 2041.
About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about NMIBC at www.BladderCancerAnswers.com.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product, ZUSDURI (mitomycin) for intravesical solution, is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.
About medac CDMO
The belief that health is humanity’s most valuable resource drives medac group. Since 1970, the mission of medac has been to improve patients’ quality of life worldwide by making the best medical treatments available. Since 2000, medac has been dedicated to improving patient outcomes globally by supporting pharmaceutical companies in bringing the best medical treatments to market. As a trusted Contract Development and Manufacturing Organization (CDMO), headquartered in Germany, medac CDMO is specialised in providing customised, high-quality services to customers and worldwide markets.
With a team of over 2,000 highly skilled professionals, medac CDMO offers comprehensive solutions tailored to the needs of clients worldwide. The cutting-edge facilities of medac group in Germany and the Czech Republic are equipped with the latest technologies to ensure precision, efficiency and compliance with the most stringent industry standards. From early-stage development to large-scale commercial production, medac CDMO is committed to foresight, progress, reliability and creative thinking which makes them a solution ahead.
The deep expertise, commitment to quality and flexible manufacturing capabilities enable medac CDMO to serve as a trusted partner for pharmaceutical and biotech companies looking to scale their operations and bring life-changing treatments to patients around the globe.
For more information, please visit www.medac-cdmo.com.
APPROVED USE FOR ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working.
IMPORTANT SAFETY INFORMATION
You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.
Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:
have kidney problemsare pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.
Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.
How will I receive ZUSDURI?
You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving ZUSDURI:
ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential for the Phase 3 UTOPIA trial to support an NDA submission for UGN-103 and the planned timing thereof; the potential path toward approval of UGN-103 and potential approval thereof; the potential of UGN-103 to advance care for and provide benefits to adult patients with recurrent LG-IR-NMIBC and become a new standard of care; the potential of UGN-103 to build on UroGen’s leadership in uro-oncology, expand its commercial portfolio, and drive long-term growth; the potential benefits of UGN-103 as compared to ZUSDURI, including its streamlined manufacturing and reconstitution processes and expected intellectual property protection; the expected duration of intellectual property protection for UGN-103; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “believe,” “can,” “estimated,” “expect,” “may,” “plan,” “potential,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary clinical results may not be indicative of results that may be observed in the future; potential safety and other complications related to UroGen’s products and product candidates; risks related to our and our licensors’ ability to protect our respective patents and other intellectual property, including the fact that UroGen’s or our licensors’ pending patent applications may not be successful, and in such event, the duration of intellectual property protection would be more limited; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and UroGen’s products and product candidates may not perform as expected; the data from the UTOPIA trial may not be sufficient to support approval of UGN-103; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 6, 2026, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
PRINCETON, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced that management will present at the Goldman Sachs 47th Annual Global Healthcare Conference to take place on June 8-10, 2026.
Goldman Sachs 47th Annual Global Healthcare Conference
Date / Time:June 10, 2026, at 8:40 AM ETFormat:Fireside chat and 1x1 investor meetingsLocation:Miami Beach, FLWebcast Link:here
The webcast from the conference will also be available on UroGen’s corporate website, under Events & Presentations. A replay will be available for approximately 90 days.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X, @UroGenPharma.
Agreement reinforces the value of UroGen’s innovation and reflects the strength of the Company’s intellectual property portfolioTeva will be granted a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA PRINCETON, N.J., June 02, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has entered into a settlement and license agreement (the “Agreement”’) with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals, USA, Inc. (collectively, “Teva”). This Agreement resolves the patent litigation UroGen initiated in response to Teva’s submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (“FDA”) seeking approval to market a generic version of JELMYTO® (mitomycin) for pyelocalyceal solution prior to the expiration of the relevant Company patents. Please note, that the Teva ANDA has not received tentative approval from the FDA, according to the Agency’s public database.
Under the terms of the Agreement, UroGen will grant Teva a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will ask the court to dismiss the pending patent litigation with prejudice.
“We believe this resolution underscores the innovation behind our RTGel® technology and the strength of our intellectual property portfolio,” said Liz Barrett, President and Chief Executive Officer of UroGen. “We look forward to continuing to execute on our mission to transform paradigms in uro-oncology with our innovative treatments.”
JELMYTO has regulatory exclusivity through April 15, 2027, and is covered by Orange Book-listed patents expiring on January 20, 2031. The negotiated license date preserves nearly all of this patent protection period, reflecting the strength of the Company’s intellectual property.
As required by law, the companies will submit the Agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for review.
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel approved for the treatment of adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through a nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
About Upper Tract Urothelial Cancer
Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as UTUC. In the U.S., there are approximately 6,000 - 7,000 new or recurrent LG-UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often have multiple comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). Treatment with endoscopic surgery can be associated with a high rate of recurrence and relapse.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:
are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?
Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.JELMYTO is given to your kidney through a tube called a catheter.During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines. After receiving JELMYTO:
JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water. Clothing that comes in contact with urine should be washed right away and washed separately from other clothing. JELMYTO may cause serious side effects, including:
Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.
Forward-Looking Statements
This statement contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without
limitation, statements regarding: the anticipated dismissal of the pending patent litigation with prejudice; UroGen’s ability to transform paradigms with its solutions; the strength of UroGen’s intellectual property portfolio and the value of UroGen’s innovation; the potential for UroGen to transform urothelial cancer treatments; the strength of UroGen’s patents and UroGen’s plans to vigorously defend its intellectual property rights; the patient population for UTUC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words and phrases such as “believe,” “can” “expected,” “if,” “look forward to,” “may,” “plans to” “potential,” “will,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: uncertainties related to whether UroGen’s patent-infringement lawsuit against Teva will be successful; the ability obtain and maintain adequate intellectual property rights and adequately protect and enforce such rights; the costs and outcome of legal proceedings to enforce such intellectual property rights, including the lawsuit against Teva; competition in UroGen’s industry, including the potential approval and introduction of generic or branded products that compete with UroGen’s product or product candidates; and the ability to maintain regulatory approval; complications associated with commercialization activities; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the timing and success of clinical trials and potential safety and other complications thereof; the size and growth of the market(s) for UroGen’s product and product candidates and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; UroGen’s RTGel technology may not perform as expected; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; UroGen’s ability to attract or retain key management, members of the board of directors and personnel; and UroGen’s financial condition and need for additional capital in the future.. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Annual Report on Form 10-Q for the first quarter ended March 31, 2026, filed with the SEC on May 6, 2026, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
PRINCETON, N.J., June 05, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 21 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of JELMYTO® (mitomycin) for pyelocalyceal solution and ZUSDURITM (mitomycin) for intravesical solution, UroGen’s only approved products, and the continued development of UroGen’s pipeline.
Up to 102,700 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs. The RSUs will vest equally over three years, with one-third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.
The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder. The RSUs were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq Listing Rule 5635(c)(4).
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first commercial product is approved to treat low-grade upper tract urothelial cancer, and UroGen’s second product is the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Both medicines are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, New Jersey with operations in Israel. To learn more, visit www.urogen.com or follow us on X, @UroGenPharma.
JELMYTO®, RTGel®, ZUSDURI™ and UroGen® are registered trademarks of UroGen Pharma Ltd.
INVESTOR CONTACT:
Vincent Perrone [email protected]
(609) 460-3588 Ext. 1093
MEDIA CONTACT:
Cindy Romano [email protected]
(609) 460-3566 Ext. 1083
ACNT is now a pure-play specialty chemicals company. They've replaced their mixed tubing-and-chemicals operations with a leaner industrial specialty chemicals focus. 2025 was mixed as revenues declined, but gross profit, gross margin, and adjusted EBITDA improved materially. In my view, this suggests that ACNT's leaner business model is strengthening despite the expected initial transition friction.
