On June 2, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported key Revuforj (revumenib) data that was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago, including the oral presentation of new data from the post hematopoietic stem cell transplant (HSCT) setting. Revuforj is the first and only menin inhibitor that is FDA approved for patients one year and older with relapsed/refractory (R/R) acute leukemia with a KMT2A translocation or R/R acute myeloid leukemia (AML) with a susceptible NPM1 mutation (NPM1m) who have no satisfactory alternative treatment options.

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"The selection of the revumenib post-transplant data for oral presentation at ASCO (Free ASCO Whitepaper) underscores the clinical importance of this dataset and the potential for revumenib to advance the treatment paradigm," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "Building on the data presented at ASCO (Free ASCO Whitepaper) and other ongoing trials, we look forward to pioneering further research in the post-transplant setting, including the planned MenTain study, the first randomized, placebo-controlled trial specifically focused on evaluating revumenib as post-transplant maintenance."

"We are encouraged by the long-term outcomes observed among a cohort of 24 heavily pretreated patients with KMT2Ar, NPM1m, or NUP98r acute leukemia who resumed revumenib as maintenance after stem cell transplantation," said Ghayas C. Issa, M.D., Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center. "Among this population at high-risk for relapse and poor outcomes, we observed a 2-year overall survival rate of 90%, almost double the historical rate observed prior to the introduction of revumenib. While the sample size is small, these results are promising and strongly support further evaluation of revumenib as post-transplant maintenance."

Overview of key revumenib data presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract title: Revumenib as maintenance for AML following allogeneic stem cell transplantation
Abstract #: 6505

Pooled analysis of 24 patients (13 adults and 11 children) who resumed revumenib as maintenance after receiving a HSCT. 71% (17/24) had KMT2A-rearranged, 25% (6/24) had NPM1 mutated, and 4% (1/24) had NUP98-rearranged acute myeloid leukemia. This was a heavily pretreated cohort with a median of 3 prior lines of therapy (range: 1-11); 54% (13/24) had undergone prior HSCT. At current HSCT, 25% (6/24) of patients were in first complete remission (CR1) and 75% (18/24) were in second complete remission or beyond (CR2+).
Median time to initiate revumenib post-HSCT was 82 days (range: 42 – 174 days). Median duration of revumenib therapy post-HSCT was 10 months (range: 0.5 – 36 months). At last follow-up, 29% (7/24) of patients remained on revumenib.
With a median follow-up of 21 months, median overall survival (OS) and event-free survival from the time of HSCT were not reached.
In this single-arm study, a 2-year overall survival (OS) rate of 90% was observed in the overall population. In contrast, in a historical cohort of patients with the same genetic subtypes of acute leukemia treated prior to the advent of revumenib, a 2-year OS rate of 51% was observed.
The 1-year cumulative relapse rate was 0% and 17% among patients transplanted in CR1 and CR2+, respectively. In contrast, in a historical cohort of patients, the 1-year cumulative relapse rate was 12% and 40% among patients transplanted in CR1 and CR2+, respectively.
The most common any grade adverse event was thrombocytopenia, leading to dose modification in 46% (11/24) and discontinuation in 13% (3/24) of patients. No other significant toxicities were observed.
Outcomes appear favorable compared to historical cohorts, supporting prospective evaluation of revumenib as maintenance in the post-HSCT setting.

Abstract title: Pharmacokinetic (PK) assessment of revumenib in patients with relapsed/refractory (R/R) acute leukemias harboring a KMT2A rearrangement (KMT2Ar) or NPM1 mutation (NPM1m): Impact of food and concomitant medications
Abstract #: 6528

PK data were obtained from 335 patients (286 adults and 49 children) with acute leukemia, including those with KMT2Ar and NPM1m, who were enrolled in the Phase 1/2 AUGMENT-101 trial.
Results highlight differentiating aspects of revumenib’s PK profile, including the ability to:
Administer revumenib with commonly prescribed gastric acid reducing agents, such as proton pump inhibitors, without the risk of reduced exposure and efficacy
Maintain optimal exposure in the presence of strong CYP3A4 inhibitors using a clear revumenib dose adjustment strategy
Administer revumenib with a low-fat meal or under a fasted state

About Revuforj (revumenib)

Revuforj (revumenib) is the first and only menin inhibitor that is FDA approved for the treatment of adult and pediatric patients one year and older with relapsed or refractory (R/R) acute leukemia with a KMT2A translocation as determined by an FDA-authorized test or R/R acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

Revuforj (revumenib)

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES

Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

QTc prolongation and Torsades de Pointes have occurred in patients receiving Revuforj. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate Revuforj in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension.

In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.

QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes.

Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation. QTc prolongation occurred in 21% of the 34 patients less than 17 years old, 35% of the 146 patients 17 years to less than 65 years old, and 46% of the 61 patients 65 years or older. One patient had a fatal outcome of cardiac arrest, and one patient had non-sustained Torsades de Pointes.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and throughout treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.

Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower-dose level after the QTcF interval returns to ≤480 msec
Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia

Embryo-Fetal Toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 9 (4%) patients who received Revuforj, including 4 with sudden death, 2 with differentiation syndrome, 2 with hemorrhage, and 1 with cardiac arrest.

Serious adverse reactions were reported in 184 (76%) patients. The most frequent serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).

The most common adverse reactions (≥20%) including laboratory abnormalities, were phosphate increased (51%), hemorrhage (48%), nausea (48%), infection without identified pathogen (46%), aspartate aminotransferase increased (44%), alanine aminotransferase increased (40%), creatinine increased (38%), musculoskeletal pain (37%), febrile neutropenia (37%), electrocardiogram QT prolonged (36%), potassium decreased (34%), parathyroid hormone intact increased (34%), alkaline phosphatase increased (33%), diarrhea (29%), bacterial infection (27%), triglycerides increased (27%), phosphate decreased (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).

DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

Strong CYP3A4 inhibitors: reduce Revuforj dose
Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj
QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec

SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.

Pregnancy and testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: no overall differences were observed in the effectiveness of Revuforj between patients who were 65 years and older, and younger patients. Compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.

To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including BOXED WARNINGS.

(Press release, Syndax, JUN 2, 2026, View Source [SID1234666372])

On June 2, 2026 Personalis, Inc. (Nasdaq: PSNL) reported clinical data from the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting establishing the clinical importance of ultrasensitive MRD detection across six solid tumor types, led by the VICTORI colorectal cancer and TRACERx lung cancer studies.

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"Our ASCO (Free ASCO Whitepaper) data continues to build on a compelling body of evidence, including recent landmark publications, that show ultrasensitive MRD detection with NeXT Personal enables early detection of patients at risk for relapse, across a broad set of solid tumor types," said Richard Chen, MD, MS, President and Chief Medical Officer of Personalis. "These data, along with our recent Medicare approvals, further our mission to provide cancer patients with the precision MRD testing they need to help guide clinical management."

Key clinical themes and data presented at the meeting included:

Exceptional Performance in Colorectal Cancer

The prospective VICTORI study (Abstract #396), led by the University of British Columbia, monitored over 100 Stage I-IV resectable CRC patients with NeXT Personal. Highlights from the interim analysis include:

100% sensitivity for cancer relapse during surveillance, ahead of imaging: NeXT Personal successfully detected 100% of all patient relapses in the cohort ahead of clinical imaging, including all distant metastases in historically difficult-to-detect regions like the lung.
82% landmark sensitivity at 4 weeks after surgery: Just four weeks after surgery, the test detected 82% of patients who later relapsed, providing clinicians with a highly reliable early signal of cancer to inform treatment pathways.
Importance of Sub-10 ppm Sensitivity in Lung Cancer

In an oral podium presentation (Abstract #8017), investigators from University College London utilized the landmark TRACERx cohort to analyze 431 Stage IA-IIIB non-small cell lung cancer (NSCLC) patients using NeXT Personal. The study demonstrated the clinical utility of detecting ctDNA at ultra-low thresholds:

Consistent Ultra-Low Limits of Detection: NeXT Personal demonstrated consistent detection of ctDNA at ultra-low levels in this study, achieving a median limit of detection (LOD) of 1.66 ppm.
Prevalence of Sub-10 ppm Detections: Building on prior NeXT Personal publications showing approximately 40% of TRACERx detections were in the ultrasensitive range (<100 ppm), this additional analysis showed that a significant portion of detections are found at the lowest limits of detection less than 10ppm. Approximately 21% of pre-operative adenocarcinoma and 18% of post-operative landmark detections were below 10 ppm—thresholds frequently missed by less sensitive assays.
Clinical importance: The clinical importance of detecting these ultra-low levels was established. Patients with post-operative landmark detections below 10 ppm (within 10–120 days post-surgery) experienced a 3-fold increased risk of recurrence compared to patients with undetectable ctDNA, potentially enabling much earlier clinical intervention.
Growing Breadth of Evidence Across Diverse Solid Tumors

Beyond colorectal and lung cancers, ASCO (Free ASCO Whitepaper) presentations highlighted the ultrasensitive performance of NeXT Personal in a broad array of additional tumor types:

Ovarian Cancer (Abstract #233): In collaboration with MD Anderson Cancer Center, 72 patients with high-grade epithelial ovarian cancer were evaluated following frontline chemotherapy and surgery. ctDNA detection correlated with a 3.5-fold risk increase for progression. Overall, NeXT Personal showed comparable sensitivity and specificity to second-look laparoscopy (SLL), suggesting its potential as a non-invasive SLL alternative.
Endometrial Cancer (Abstract #277): MD Anderson investigators found that ctDNA clearance post-treatment in 99 Stage I-IV patients reduced recurrence risk 29-fold. Notably, 46% of detections were in the ultrasensitive range, reinforcing the need for high-sensitivity testing.
Melanoma (Abstract #288): A NeXT Personal study from the University Medical Center Hamburg-Eppendorf (UKE) on 98 unresectable and resected melanoma patients demonstrated that ctDNA clearance and on-treatment dynamics predicted response. The unresectable melanoma cohort demonstrated 100% pre-treatment baseline ctDNA detection in first-line patients, with early on-therapy ctDNA decreases associated with a reduced risk of progression. The resected melanoma cohort demonstrated that increasing ctDNA during adjuvant therapy was associated with an approximately 5-fold higher risk of distant metastasis, and ultrasensitive monitoring identified recurrences a median of 212 days prior to imaging.
Renal Cell Carcinoma (Abstract #30): Investigators from the Instituto de Investigación Sanitaria (IDIS) demonstrated that ultrasensitive ctDNA detection and molecular clearance serve as robust prognostic markers in advanced renal cell carcinoma. NeXT Personal demonstrated a high pre-treatment baseline ctDNA detection rate of 84%. Patients who failed to achieve molecular ctDNA clearance (mCR) during first-line therapy experienced significantly worse outcomes, including a more than 7-fold increase in the risk of progression and a nearly 4-fold increase in the risk of death.

(Press release, Personalis, JUN 2, 2026, View Source [SID1234666388])

On June 2, 2026 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the Goldman Sachs 47th Annual Healthcare Conference, being held at the Loews Miami Beach Hotel, in Miami Beach, Florida on June 8-10, 2026. The fireside chat is scheduled to take place on Tuesday, June 9, 2026, at 2:00 PM ET.

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A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

(Press release, TG Therapeutics, JUN 2, 2026, View Source [SID1234666373])

On June 2, 2026 Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), reported that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), as an adjuvant treatment for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II and III breast cancer. The FDA is expected to make a decision on the approval by November 30, 2026.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "The FDA’s filing acceptance brings us closer to delivering a new standard-of-care with the potential to fundamentally change the treatment paradigm for people with early-stage disease."

The filing acceptance is based on the Phase III lidERA Breast Cancer study results, which showed adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death (iDFS) by 30% compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI]: 0.57-0.87, p=0.0014). At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the SoC ET arm. The iDFS benefit was consistent across all clinically relevant subgroups. Overall survival (OS) data were immature at the time of this analysis, but a clear positive trend was observed. Follow-up for OS will continue to the next analysis. Giredestrant was well tolerated; adverse events were manageable and consistent with its known safety profile. The treatment discontinuation rate for giredestrant was 5.3% versus 8.2% with SoC ET.

Additional analyses from the giredestrant program were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Congress. This growing body of evidence continues to reinforce the clinical benefit profile of giredestrant and its potential to meaningfully improve outcomes across ER-positive early-stage and advanced breast cancer.

The U.S. FDA recently accepted the NDA for giredestrant in combination with everolimus for those with ESR1-mutated, ER-positive advanced breast cancer based on the evERA results, with a decision expected in December 2026.

Genentech’s expanding giredestrant clinical development program spans distinct treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

Globally, 2.3 million people are diagnosed with breast cancer each year. ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage. Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence.

About the lidERA Breast Cancer study

lidERA Breast Cancer [NCT04961996] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Over 4,100 patients were enrolled in the study.

The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers). Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety.

About giredestrant

Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)
About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

(Press release, Genentech, JUN 2, 2026, View Source [SID1234666389])

On June 2, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported 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.

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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.

(Press release, UroGen Pharma, JUN 2, 2026, View Source [SID1234666374])