logo
With Rick Perry's backing and $50 million from the state, Texas set to become a leader in psychedelics research

With Rick Perry's backing and $50 million from the state, Texas set to become a leader in psychedelics research

Yahooa day ago

As Texas sets to crack down on the recreational use of cannabis, state leaders are opting to invest $50 million in another plant with purported medicinal benefits – a psychedelic called ibogaine.
For several years, people have silently traveled to clinics in Mexico to take ibogaine. The extract of an ancient African shrub has been used across the Texas border to alleviate addiction and brain trauma.
Texas Gov. Greg Abbott is set to sign Senate Bill 2308 on Wednesday, creating a consortium of universities, hospitals, and drug developers to conduct clinical trials on an ibogaine drug, with the hopes of receiving U.S. Food and Drug Administration approval. Lawmakers approved $50 million in taxpayer dollars to support this effort, making Texas the global leader in psychedelic research investment.
Since Texas is trying to be the first to develop the drug, the legislation ensures Texas retains control of the research and development process. The goal of this investment is to ensure Texans reap the economic benefits from an ibogaine treatment program, not a pharmaceutical company. The investment entitles Texas to at least 20% of any successful ibogaine drug resulting from the trials, with a quarter of that revenue allocated to a fund for state veterans.
After a failed attempt in Kentucky to start a state-funded ibogaine drug, Texas has picked up the effort under the leadership of a familiar statewide figure-turned psychedelics cheerleader — former Gov. Rick Perry.
'None of this is possible without Perry,' said Bryan Hubbard, the former chair of the Kentucky Opioid Abatement Advisory Commission and current executive director of the American Ibogaine Initiative. 'He made it happen in Texas. That is a big deal and catches the attention of the nation.'
Ibogaine is an illegal drug that has found itself in a unique position where Republicans champion it. This comes as some of them, led by Lt. Gov. Dan Patrick, have made it a mission this session to ban recreational use of THC, which awaits Abbott's approval.
Katharine Neill Harris, a drug policy fellow at Rice University's Baker Institute for Public Policy, said it's easy for Republicans to sign on to ibogaine because the intent of it is to medicinally treat addiction.
'Also, this bill doesn't grant public access to ibogaine, and there's nothing in the bill that could really be construed as soft on drugs,' she said.
For that reason seemingly, Patrick has publicly thrown his support toward ibogaine as he fends off critics from the left and right for his hardline views on THC. Patrick did not respond to a request for a comment for this story.
Harris said Texas' investment in ibogaine could kickstart a trend across states to invest in drug research to address addiction, as private funds have become inconsistent.
'In 2024, the FDA rejected a proposal to approve MDMA-assisted therapy for PTSD. MDMA-assisted therapy for PTSD is one of the more studied alternative psychedelic treatment protocols, and the FDA rejection was a huge blow to private industry, likely leading some to rethink investment in this area,' she said.
It was early 2022, and the only thing former Army Ranger Chase Rowan could think about was killing himself.
Sixteen years prior, his parachute failed to fully deploy during a nighttime training exercise as his body careened toward the ground at 60 miles per hour. To cope through the pain from the severe brain injury that resulted, the Lubbock resident turned to opioids which morphed into a fentanyl addiction that eventually dissolved his family.
'I was stuck alone. I had no money and no vehicle, just white knuckling sobriety,' Rowan said.
When Rowan got to Mexico to test out a novel drug called ibogaine in August of 2022, he wasn't scared, but determined to heal.
Upon taking the ibogaine pill, Rowan started seeing images — one of a devil with wings and another of roads leading to childhood memories. The psychedelic journey on his first night opened his eyes to past trauma and the pain he caused to those around him, like a movie.
He woke up the next day feeling the happiest he had been in 20 years.
'It felt like a weight was lifted off of me,' he said. 'I got that stuff out of me.'
What Rowan was dealing with is a particular high that comes from ibogaine that is often referred to as a 'spiritual awakening' or a greater sense of self.
Stanford Medicine conducted a study in 2024 that found 'ibogaine, when combined with magnesium to protect the heart, safely and effectively reduces PTSD, anxiety and depression and improves functioning in veterans with' traumatic brain injury.
Hubbard sees no threat of ibogaine becoming recreationally used or abused since it does not provide an enjoyable high and leaves the user in a state of temporary paralysis. Because of this, most never go back for another dose.
'There is no street economy for this drug,' Hubbard said.
Ibogaine also comes with potential dangers. Harris calls it one of the 'more complicated psychedelics to administer' because it brings risks of cardiac issues and sudden death. The risks make it more expensive to study and to provide as a treatment, drawing out the years that ibogaine becomes more widely available, Harris said.
'If the FDA were to approve ibogaine for opioid use disorders or other disorders…the treatment could be quite costly,' Harris said.
Since leaving his two-year stint as U.S. Energy Secretary during the first Trump administration, Perry has thrown the weight of his reputation behind psychedelics, becoming one of the most high-profile advocates of its research nationally.
But the journey to this point started when he still occupied the Governor's Mansion in Austin.
'It's the question I hear the most,' Perry said with a laugh. 'What is a right-wing anti-drug governor doing associated with psychedelics?'
In 2006, Perry became close with Navy SEAL veteran Marcus Luttrell who struggled from a brain injury, PTSD and addiction, without access to effective treatments. He recalls Luttrell sleeping with the TV and lights on, trying to comfort his battered mind.
When Luttrell told him he was planning to go to Mexico with several other veterans to try ibogaine, Perry was skeptical.
'I remember the first time he told me, and I looked at him the same way a dog does when they hear a funny noise. I remember telling him to be careful with that because I still had my beliefs on drugs at the time, but at the same time, people that I trusted were going to Mexico for this, I had to listen,' Perry said.
The data was indisputable to Perry. He unequivocally believes ibogaine takes away addiction and he is ready to tell anyone who will ask him about it. He has since gone on to the Joe Rogan podcast to wax poetic about the drug and other psychedelic treatments. He is a scheduled speaker for a psychedelic conference in Denver. He is also planning to reach out to officials in Israel and Ukraine to initiate ibogaine treatment programs there.
'I have always been open to new knowledge. The same thing with criminal justice reform and in-state tuition, as a Republican, I have my beliefs, but I am willing to change them once looking at the data and science,' Perry said.
Hubbard cautioned that ibogaine is not a drug to be taken without medical supervision and Texas is probably at least six years away from seeing any movement on FDA approval for clinical trials.
However, he is hopeful that the drug qualifies for a Breakthrough Therapy designation, a pathway that accelerates the regulatory review of drugs showing early promise in treating severe conditions. As of June 30, 2024, the FDA has only granted 587 designations out of the 1,516 requested since 2012.
Hubbard believes the current presidential administration will see the momentum in Texas and help expedite the process with the FDA.
'If Texas can create a treatment plan for ibogaine, it might be the most significant achievement in modern medicine for nearly a century,' said Hubbard.
Disclosure: Rice University and Rice University's Baker Institute for Public Policy have been financial supporters of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.
Big news: 20 more speakers join the TribFest lineup! New additions include Margaret Spellings, former U.S. secretary of education and CEO of the Bipartisan Policy Center; Michael Curry, former presiding bishop and primate of The Episcopal Church; Beto O'Rourke, former U.S. Representative, D-El Paso; Joe Lonsdale, entrepreneur, founder and managing partner at 8VC; and Katie Phang, journalist and trial lawyer.
Get tickets.
TribFest 2025 is presented by JPMorganChase.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Playbook PM: Reconciliation, rescissions roil Republicans
Playbook PM: Reconciliation, rescissions roil Republicans

Politico

time41 minutes ago

  • Politico

Playbook PM: Reconciliation, rescissions roil Republicans

Presented by THE CATCH-UP BIG IMMIGRATION NEWS: The Trump administration today will tell hundreds of thousands of Cubans, Haitians, Nicaraguans and Venezuelans who immigrated here legally under humanitarian parole that their legal status is being terminated, CNN's Priscilla Alvarez scooped. That will leave them vulnerable to deportation, after the Supreme Court green-lit the policy for now. … But the administration seems to have paused its plans to begin mass transfers of detained immigrants to Guantanamo Bay, POLITICO's Myah Ward and Nahal Toosi report. RECONCILABLE DIFFERENCES: Republicans have averted one small blow-up on the Hill — Sen. Rand Paul (R-Ky.) is invited to today's White House congressional picnic after all. President Donald Trump announced it, and Paul posted a photo of his grandson in a MAGA hat (though Rep. Thomas Massie (R-Ky.) said he too had his tickets withheld). But much more challenging clashes still loom for both the reconciliation megabill and today's House vote on rescissions. Miller time: White House deputy chief of staff Stephen Miller met with Senate Republicans today to advocate for border/immigration enforcement funding in the reconciliation bill, per ABC's Allison Pecorin. But things got tense between Miller and deficit hawks who want to pare back spending, including what sources tell Punchbowl's Andrew Desiderio was a 'shouting match' with Sen. Ron Johnson (R-Wis.) on the budget math. Axios' Stef Kight reports that Sen. Roger Marshall (R-Kan.) was peeved at Miller, while an absent Paul loomed large. Kicking the can down the road: A decision on the state and local tax deduction number won't be included in the Senate Finance bill text yet, Sen. Chuck Grassley (R-Iowa) told Semafor's Burgess Everett. Sen. Markwayne Mullin (R-Okla.) told reporters he's working with House members to try to land a SALT deal. 'I hope they modify it in a very small way,' Speaker Mike Johnson said, holding up prayer hands. By the numbers: The latest CBO report offers a neat encapsulation of the messaging wars likely to come between Democrats and Republicans on the bill. The analysis finds that the reconciliation package — including tax cuts, Medicaid cuts and SNAP cuts — would bolster the average American household's resources from 2026 to 2034. But it would increase inequality, hurting low-income families' resources while benefiting the middle class and wealthy. Specifically, the nonpartisan scorekeeper says low-income households would suffer a $1,600 annual hit on average, middle-income households would gain $500 to $1,000, and high-income households would romp with a whopping $12,000 boost, per POLITICO's Jennifer Scholtes. WHAT TO WATCH TODAY: The House is barreling toward a 3 p.m. vote on enshrining Department of Government Efficiency cuts to foreign aid and public broadcasting, with the outcome potentially still up in the air. Johnson said he feels confident Republicans have the votes to claw back $9 billion in funding. But POLITICO's Meredith Lee Hill reports that it's not a done deal yet: Leadership hasn't been able to flip seven GOP holdouts, and they 'may have to rely on Dem absences.' At stake: The consequences of this vote are enormous. Republicans see it as a way to start institutionalizing DOGE cuts and ax spending for organizations they dislike. But decimating funding for PEPFAR could threaten HIV treatment and prevention programs that have saved 25 million lives in 22 years, even as the White House claims it'll keep lifesaving work going. Humanitarian groups say the future of foreign aid looks very bleak, though the Senate may try to scale back some of the cuts, NOTUS' Helen Huiskes reports. Meanwhile, cuts to PBS and NPR have public media stations, especially in rural areas, fearing they may not survive, POLITICO's Aaron Pellish reports. Good Thursday afternoon. Thanks for reading Playbook PM. Drop me a line at eokun@ 8 THINGS YOU NEED TO KNOW 1. CONSTITUTIONAL CRISIS WATCH: Defense Secretary Pete Hegseth today refused to confirm that the administration would comply with a potential court ruling barring the deployment of Marines to support ICE operations in Los Angeles, POLITICO's Joe Gould reports. He deflected lawmakers' questions and said only that 'we should not have local judges determining foreign policy or national security policy.' The California clash: Ahead of this afternoon's court hearing, California Gov. Gavin Newsom continued to go after Trump for deploying troops to anti-ICE protests. On NYT's 'The Daily,' Newsom outright questioned the president's mental acuity after Trump claimed he talked to the governor Monday: 'Maybe he actually believed he said those things, and he's not all there. I mean that.' But he also distanced himself from sanctuary policies and said he'd work with ICE. Indeed, many Democrats are hoping to refocus the political conversation here away from immigration policy and onto Trump pushing the legal limits of his power, POLITICO's Dustin Gardiner and Natalie Fertig report from San Francisco. Behind the escalation: Before the LA situation, there was a monthslong history of planning within the administration to use the military more to support domestic immigration enforcement, CNN's Priscilla Alvarez and Natasha Bertrand report. And on the flip side, far-left groups that advocate for violence have encouraged agitators to escalate beyond peaceful protests, especially at night — part of a pattern from other cities in recent years, NBC's Rich Schapiro and Andrew Blankstein report. Wait, what? Apparently having heard from farming and hospitality advocates, Trump posted on Truth Social today to indicate that he doesn't want aggressive deportations to target their workforce. That message may not have gotten through to his vast immigration enforcement apparatus: Border czar Tom Homan told Semafor's Ben Smith that coming soon, 'worksite enforcement operations are going to massively expand.' The other military hubbub: The latest AP/NORC poll shows Americans have mixed feelings about Trump's military parade on his birthday this Saturday. The median opinion seems to be something like: Seems fine, but wish we weren't spending money on it. U.S. adults overall say they approve of the parade, 40 percent to 31 percent, but don't think it's a good use of government funds, 60 percent to 38 percent. 2. PAGING NUUK: 'I just want to help you out, because people try to twist your words,' Rep. Mike Turner (R-Ohio) said to Hegseth on the Hill today. 'You are not confirming in your testimony today that at the Pentagon, there are plans for invading or taking by force Greenland, correct?' But Hegseth wouldn't go there: 'The Pentagon has plans for any number of contingencies,' he said. 'We look forward to working with Greenland to ensure that it is secured from any potential threats.' 3. MIDDLE EAST LATEST: Top Israeli officials are expected to travel tomorrow to meet with special envoy Steve Witkoff, POLITICO's Nahal Toosi reports. That will be an opportunity for Jerusalem to clarify what its plans are toward Iran, amid a flurry of reports that U.S. officials expect an Israeli attack on Iran could be imminent. 'I don't want to say imminent, but it is something that could very well happen,' Trump said of a potential Israeli strike. But Witkoff has warned senators that Iran's response might be a mass casualty event in Israel, Axios' Barak Ravid scooped. 4. MAN OF STEEL: 'Trump Says US Government Will Get 'Golden Share' in US Steel,' by Bloomberg's Josh Wingrove and Mario Parker: 'Trump's comment was the first public confirmation by the administration that it was seeking a golden share. The White House has not yet spelled out what that would mean, including — as is typically the case — whether that would include an equity stake.' 5. TRADING PLACES: Trade talks between the U.S. and India have hit some speed bumps as both sides dig in on crucial demands, including whether New Delhi will allow genetically modified crops in, Bloomberg's Shruti Srivastava reports. Meanwhile, despite Trump touting the latest framework agreement with China this week, Beijing is very much playing the long game and learning how to stall the U.S. repeatedly, NYT's David Pierson and Berry Wang report. 'While Trump seeks quick deals done directly with top leaders, [Chinese President Xi Jinping] favors a framework led by his lieutenants that wards against being blindsided,' Bloomberg writes. 'Such haggling could drag on for years.' 6. WITH FRIENDS LIKE THESE: Despite Trump's alliance with Salvadoran President Nayib Bukele, ProPublica's T. Christian Miller and Sebastian Rotella reveal that San Salvador impeded a yearslong U.S. investigation into whether its government had quietly struck a deal with MS-13. Bukele allies have also refused to extradite gang members to the U.S. who could have been witnesses. At the same time, Bukele's growing relationship with Trump has emboldened what experts say is a growing authoritarian crackdown on dissent at home, AP's Megan Janetsky and Marcos Alemán report. Longtime Bukele opponents say there's been 'an inflection point' in recent weeks, as the U.S. Embassy hasn't said anything. 7. LOOK WHO'S BACK: Sen. Bernie Sanders (I-Vt.) is hitting the road again with his record-breaking 'Fighting Oligarchy' tour, which has rejuvenated progressives deep into red territory. His stops next weekend will take a similar approach, from the Rio Grande Valley to Tulsa, Oklahoma, to Johnson's hometown of Shreveport, Louisiana. 8. BUYER'S REMORSE: 'Trump's travel ban fuels despair and disgust with politics among Arab Americans in Michigan,' by AP's Isabella Volmert in Dearborn: 'It came as a particular shock to many Yemeni Americans … While it may not elicit the same protests as 2017, many Yemeni and Arab Americans in the all important battleground state see it as yet another offense contributing to enormous dissatisfaction with both major political parties.' TALK OF THE TOWN Winsome Earle-Sears' old Google/Yelp reviews for her business show that she often got into it with displeased customers. Abraham Lincoln-signed copies of the Emancipation Proclamation and the 13th Amendment are going up for auction, potentially fetching several million dollars. Noah Wyle was on the Hill today to advocate for mental health care for health care workers. PLAYBOOK REAL ESTATE SECTION — 'This D.C. real estate agent is closing huge deals with Trump-world elite,' by Axios' Mimi Montgomery: 'Over the years, [Daniel] Heider, 38, has become known in Washington for selling ginormous, ultra-lux estates — positioning him perfectly for catering to the enormously wealthy cast of players moving into President Trump's Gilded Age D.C. … He doesn't see himself as simply a real estate agent. He's more of a white-glove concierge meets sociologist meets therapist, he tells Axios.' OUT AND ABOUT — SPOTTED at Walmart's U.S. manufacturing reception yesterday at its Navy Yard office, capping the company's two-day Hill fly-in: Reps. Nick LaLota (R-N.Y.), Sarah Elfreth (D-Md.), Bill Foster (D-Ill.), Darrell Issa (R-Calif.), Brad Knott (R-N.C.), Mariannette Miller-Meeks (R-Iowa), Brad Schneider (D-Ill.), Nick Langworthy (R-N.Y.) and Beth Van Duyne (R-Texas) and Resident Commissioner Pablo José Hernández (D-P.R.). — SPOTTED at the Aspen Institute's Philosophy and Society/Wisdom of Crowds salon with Francis Fukuyama at Damir Marusic's residence last night: Shadi Hamid, Samuel Kimbriel, Christine Emba, Jason Willick, Freddy Gray, Freddie Hayward, Jordan Castro, Rachel Rizzo, Kelly Chapman, Harry Stein, Jamie Kirchick, Diana Brown, Mana Afsari, Santiago Ramos, Kristina Tabor, Samuel Goldman, Jon Purves, Chris Griswold, Peter Catapano, Chris McCaffery, Sadev Parikh and John Hudson. TRANSITIONS — Ronald Rowe Jr. is joining the Chertoff Group as a senior adviser. He previously was acting director of the Secret Service. … Reservoir Communications Group is adding Patrick 'Pat' Kannan as CFO and Ashley Flint as an SVP. Kannan previously was CFO at OPEXUS. Flint previously was a principal at Avalere Health. Send Playbookers tips to playbook@ or text us on Signal here. Playbook couldn't happen without our editor Zack Stanton, deputy editor Garrett Ross and Playbook Podcast producer Callan Tansill-Suddath.

Conservative Josh Hawley introduces bill to raise federal minimum wage to $15 an hour
Conservative Josh Hawley introduces bill to raise federal minimum wage to $15 an hour

USA Today

timean hour ago

  • USA Today

Conservative Josh Hawley introduces bill to raise federal minimum wage to $15 an hour

Conservative Josh Hawley introduces bill to raise federal minimum wage to $15 an hour Show Caption Hide Caption Lawmakers advance bill to lower pay for trainees Florida lawmakers are advancing bills that would allow employers to pay certain workers in training below the minimum wage for up to 12 months. Fox - 35 Orlando WASHINGTON - Ultraconservative Missouri Sen. Josh Hawley introduced a bill on June 10 with Democratic Vermont Sen. Peter Welch to raise the federal minimum wage to $15 an hour, making him one of the few Republicans to support the cause. The bill, dubbed the 'Higher Wages for American Workers Act,' would raise the minimum wage starting in January 2026 and allow it to increase on the basis of inflation in subsequent years. The federal minimum wage is currently $7.25 per hour and it's been unchanged since 2009. It is unclear whether the legislation will be taken up for a vote. Members of Congress have previously tried to raise the minimum wage, but to no avail. In 2021, Democratic lawmakers tried to tack a $15 per hour minimum wage provision in former President Joe Biden's $1.9 trillion coronavirus package, but a Senate official ruled that the measure couldn't be included in the bill. President Donald Trump said in December 2024 that he would 'consider' raising the minimum wage. However, he revoked a 2024 executive order that set the minimum wage for federal contractors at $17.75. 'For decades, working Americans have seen their wages flatline," Hawley said in a statement. One major culprit of this is the failure of the federal minimum wage to keep up with the economic reality facing hardworking Americans every day." Welch, a member of the Senate Finance Committee, echoed a similar sentiment. 'Every hardworking American deserves a living wage that helps put a roof over their head and food on the table–$7.25 an hour doesn't even come close,' he said. The Employment Policies Institute, a think tank dedicated to researching employment growth, opposed Hawley and Welch's push, arguing that it would result in a loss of jobs. 'Sen. Hawley should know better,' Rebekah Paxton, research director of the institute, said in a news release. 'This proposal would more than double the minimum wage and slash over 800,000 jobs. An overwhelming majority of economists agree that drastic minimum wage hikes cut employment, limit opportunities for workers, and shutter businesses.' The nonpartisan Congressional Budget Office found in an analysis that raising the minimum wage would 'raise the earnings and family income of most low-wage workers' but would cause other low-income workers to lose their jobs and their family income to fall. Hawley in February teamed up with progressive firebrand Vermont Sen. Bernie Sanders to introduce a bill capping credit card interest rates at 10%, saying it would "provide meaningful relief to working people." He's also been a vocal critic of Medicaid cuts.

U.S. FDA Approves UroGen's ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
U.S. FDA Approves UroGen's ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

Yahoo

timean hour ago

  • Yahoo

U.S. FDA Approves UroGen's ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

ZUSDURI (formerly known as UGN-102) is a localized medication designed for potent tumor ablation delivered by innovative RTGel® technology. Approval supported by pivotal Phase 3 ENVISION trial demonstrating 78% of patients achieved complete response (CR) at 3 months, and 79% of those responders maintained complete response at 12 months after the 3-month visit (DOR). Manageable safety profile characterized primarily by mild to moderate lower urinary tract symptoms. An estimated 59,000 LG-IR-NMIBC patients in the U.S. recur each year and face repeat surgeries. Conference call and webcast to be held on June 13, 2025, at 8:30 AM ET PRINCETON, N.J., June 12, 2025--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. ZUSDURI consists of mitomycin and sterile hydrogel, using UroGen's proprietary sustained release RTGel® technology. ZUSDURI has been designed for potent tumor ablation. This landmark approval is based on the positive results from the Phase 3 ENVISION trial that demonstrated ZUSDURI delivers 78% complete response (CR) for patients at 3 months, and of those patients 79% remained event-free 12 months later. "The approval of ZUSDURI represents a significant step forward for our company and for the treatment of recurrent LG-IR-NMIBC," said Liz Barrett, President and CEO of UroGen. "For the first time, the estimated 59,000 U.S. patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine. This historic achievement is a bold leap forward in our mission to redefine uro-oncology and bring innovation to patients who need it most. We are deeply grateful to the FDA for their collaboration and to the investigators, patients, and caregivers whose commitment made this milestone possible. Their contributions have been essential in bringing meaningful innovation to the bladder cancer community." The existing standard of care for LG-IR-NMIBC is a surgical procedure typically performed under general anesthesia called transurethral resection of bladder tumor (TURBT). Due to high recurrence rates of LG-IR-NMIBC, repeat TURBTs may be necessary. "ZUSDURI marks a breakthrough in uro-oncology, offering a new alternative for recurrent LG-IR-NMIBC patients who can live for many years with the disease but often endure multiple resections, under general anesthesia," said Dr. Sandip Prasad, MD, Director of Genitourinary Surgical Oncology at Morristown Medical Center/Atlantic Health System, NJ, and principal investigator of the ENVISION trial. "For decades, TURBT has been the standard approach for bladder cancer treatment. That's why innovative treatments like ZUSDURI are essential, especially for those adult patients with recurrent low-grade, intermediate-risk NMIBC." The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. Serious adverse reactions occurred in 12% of patients who received ZUSDURI, including, urinary retention (0.8%) and urethral stenosis (0.4%). Product Availability ZUSDURI is expected to be available in the U.S. on or around July 1, 2025, for the treatment of adults with recurrent LG-IR-NMIBC. In the interim, patients can visit (available soon). UroGen Patient Support UroGen is committed to helping patients access ZUSDURI. UroGen Support may help identify appropriate financial assistance programs for eligible patients with commercial, Medicare or Medicaid coverage, as well as those with no insurance coverage. These programs are for eligible patients who have been prescribed ZUSDURI and who need help managing the cost of treatment. The appropriate program will depend on the patient's insurance coverage. Visit (available soon) or contact UroGen Support at 1-833-UROGEN-1 (1-833-876-4361) for additional information. Post-Marketing Commitment As a post-marketing commitment, UroGen has agreed with the FDA to complete the ongoing ENVISION trial to further characterize the clinical benefit of ZUSDURI for the treatment of patients with recurrent LG-IR-NMIBC. In addition, UroGen committed to provide the FDA annual updates on duration of response (DOR) for all patients with ongoing complete responses. The annual updates will continue until all ongoing patients experience a recurrence of LG-IR-NMIBC; progression; death; loss to follow-up; or reach 63 months after the first instillation as planned in the protocol, whichever occurs first. Conference Call & Webcast Information Members of UroGen's management team will host a live conference call and webcast on June 13, 2025 at 8:30 AM Eastern Time to review ZUSDURI approval details and commercialization plans. The live webcast can be accessed by visiting the Investors section of the Company's website at 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. An archive of the webcast will be available on the Company's website. 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. 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 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 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 ZUSDURI (mitomycin) for intravesical solution, UroGen's first product to treat recurrent LG-IR-NMIBC are both designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit 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 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 who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last 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 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. ZUSDURI™ is a trademark and UroGen® is a registered trademark of UroGen Pharma, Ltd. Copyright©2025 UroGen Pharma, Inc. All rights reserved. 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 estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential benefits to patients and opportunities for ZUSDURI; 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," "expect," "may," "plan," "potential," "target," "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: 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; and UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology. 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, 2025, filed with the SEC on May 12, 2025. 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. View source version on Contacts INVESTOR CONTACT:Vincent PerroneSenior Director, Investor 609-460-3588 ext. 1093 MEDIA CONTACT:Cindy RomanoDirector, Corporate 609-460-3583 ext. 1083

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store