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])

On June 2, 2026 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved the expanded use of PD-L1 IHC 22C3 pharmDx, Code GE006, for use on the Dako Omnis platform to aid in identifying patients in the United States with esophageal squamous cell carcinoma (ESCC)3, triple-negative breast cancer (TNBC)4, cervical cancer5, and gastric or gastroesophageal junction (GEJ) adenocarcinoma6, who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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This approval expands access to PD-L1 testing across four additional tumor types beyond the previously approved non-small cell lung cancer (NSCLC)7 and head and neck squamous cell carcinoma (HNSCC)8. Until now, these FDA-approved PD-L1 IHC 22C3 pharmDx indications have been available on Autostainer Link 48 (ASL48) as the only platform and are now also approved for the Dako Omnis platform. This enables pathology laboratories to consolidate PD-L1 testing across more tumor types within a single automated Dako Omnis workflow, supporting increased automation and operational efficiency.

Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: "Pathology laboratories are increasingly looking to standardize testing on automated platforms that fit seamlessly into daily workflow. By expanding PD-L1 IHC 22C3 pharmDx on Dako Omnis for additional FDA-approved indications, we’re helping labs deliver PD-L1 results more conveniently and efficiently, supporting clinicians as they identify patients who may be eligible for immunotherapy."

To support expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis, Agilent conducted a multisite external platform performance comparison study evaluating concordance of PD-L1 IHC 22C3 pharmDx results across staining platforms (Code SK006 on the ASL48 platform and Code GE006 on Dako Omnis) for the four additional indication specimens. Study results met acceptance criteria to demonstrate inter-platform concordance for these specimens when assessed at the appropriate CPS cutoffs.

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Agilent, JUN 2, 2026, View Source [SID1234666390])

On June 2, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported the publication of results from the Company’s randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer, which the Company first announced in December 2024, in The Lancet Oncology, one of the world’s leading peer-reviewed oncology journals (impact factor 35.9).

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"Localized prostate cancer remains an area of significant unmet need, with many patients experiencing disease recurrence after definitive radiotherapy. Innovation in this setting has been limited over the past two decades, making these peer-reviewed data particularly important for patients with intermediate- to high-risk localized prostate cancer," said Dr. Mark Garzotto, Professor of Urology and Radiation Medicine, School of Medicine, Oregon Health & Science University, and Chief of Urology at the Portland VA Medical Center. "The publication of these findings in The Lancet Oncology provides important peer-reviewed validation of the clinical significance of the results observed with aglatimagene in combination with radiotherapy."

The manuscript, titled "Aglatimagene besadenovec (CAN-2409) with radiotherapy for patients with localized prostate cancer: a phase 3, multicentre, randomised, double-blind, placebo-controlled trial," reports results from a pivotal phase 3 clinical trial (NCT01436968) evaluating aglatimagene plus valacyclovir in combination with standard-of-care radiotherapy administered with curative intent. The trial enrolled 745 patients and met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in DFS compared with radiotherapy alone.

The publication reports:

30% improvement in DFS in the aglatimagene arm, compared to placebo (hazard ratio 0.70; 95% confidence interval (CI) 0.52-0.94; p=0.016)
38% improvement in prostate cancer-specific DFS (prostate cancer recurrence or prostate cancer related death) (hazard ratio 0.62; 95% confidence interval 0.44-0.87; p=0.0046)
Aglatimagene improved pathological complete response rate in a post-hoc blinded review of biopsies collected two years after completion of radiotherapy, with 80% (167/209) of patients in the aglatimagene treatment arm observed with negative biopsies, versus 63% (62/98) observed in the placebo group (p=0.0018)
A generally favorable safety profile, with the most common treatment-related adverse events (chills, flu-like symptoms, fatigue, pyrexia, pollakiuria, and nausea) observed to be grades 1-2 and self-limited
While the study was not statistically powered to establish benefit in subgroups, exploratory descriptive analyses suggested clinical benefit of aglatimagene compared to placebo, independent of radiation therapy regimen and independent of androgen deprivation therapy use

The Company recently presented extended follow-up data from this phase 3 trial at the American Urological Association 2026 Annual Meeting, showing a 39% improvement in prostate cancer-specific DFS after an additional 20 months of follow-up (updated median follow-up, as of March 15, 2026, was 58 months). These data also showed consistently favorable trends across secondary and exploratory endpoints, including, time to biochemical failure, time to and incidence of metastasis, and time to salvage anti-cancer treatment in the aglatimagene arm compared with the placebo arm.

"The statistically significant increase in pathological complete response rates — observed in prostate biopsies obtained approximately two years after aglatimagene treatment and reported today in The Lancet Oncology — is particularly meaningful because biopsy findings after radiotherapy have previously been shown to predict later biochemical failure and metastasis with longer follow-up," said Garrett Nichols, M.D., Chief Medical Officer of Candel. "Together, these data strengthen our confidence that earlier tumor control, reflected in biopsy-based DFS events, may translate into durable and clinically meaningful benefit for patients."

"The publication of this pivotal phase 3 trial in The Lancet Oncology provides important peer-reviewed validation of the significance of these findings for patients with localized prostate cancer," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "Patients who elect to undergo radical treatment for localized prostate cancer do so with the goal of increasing their chance of living free from cancer while reducing the risk of recurrence and the need for future anti-cancer therapies that may carry additional toxicity and affect quality of life. These data showed a clinically meaningful reduction in disease recurrence in patients treated with aglatimagene in combination with radiotherapy. The primary endpoint findings were supported by sensitivity analyses and reinforced by secondary and exploratory endpoints and together provide a comprehensive and internally consistent body of evidence that supports the therapeutic potential of aglatimagene in localized prostate cancer."

The published manuscript is available online at The Lancet Oncology

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use.

(Press release, Candel Therapeutics, JUN 2, 2026, View Source [SID1234666375])

On June 2, 2026 Foundation Medicine, Inc., a global, patient-focused precision medicine company, reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant. Itovebi is a therapy developed by Genentech, a member of the Roche group, which is approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. This decision from the FDA follows the approval of FoundationOneLiquid CDx, Foundation Medicine’s blood-based comprehensive genomic profiling (CGP) test, for the same therapy combination and indication in October 2024.

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Of all breast cancer cases, approximately 70% are HR-positive, HER2-negative.2 Within this patient population, PIK3CA is mutated in approximately 40% of patients.3 An analysis of the agreement of identified PIK3CA mutation status between the FoundationOne CDx and FoundationOne Liquid CDx tests for patients in the INAV0120 trial demonstrated high concordance between the two assays.

"The prevalence of PIK3CA mutations found in HR-positive, HER2-negative breast cancer makes it extremely important to have high quality, FDA-approved tests to match patients to the most effective therapy options in a timely manner," said Todd Druley, M.D., Ph.D., chief medical officer at Foundation Medicine. "While actionable genomic alterations like PIK3CA may be identified by blood-based biopsy, some patients’ tumors may not be shedding adequate levels of tumor DNA into the blood for these alterations to be detected. In these cases, confirmatory tissue testing may help match more breast cancer patients to this therapy."

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. With this most recent approval, Foundation Medicine has eight FDA-approved companion diagnostic indications for breast cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company.1,4

"When someone is diagnosed with metastatic breast cancer or experiences a recurrence of their disease, making decisions about treatment can feel extremely overwhelming," said Jean A. Sachs, MSS, MLSP, chief executive officer at Living Beyond Breast Cancer. "Having two high quality FDA-approved biomarker tests to detect PIK3CA mutations using different sample types opens more doors to help match patients to this targeted treatment regimen in the first line setting."

(Press release, Foundation Medicine, JUN 2, 2026, View Source [SID1234666391])

On June 2, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven precision oncology company, reported clinical data and updates in the form of a presentation from its ongoing Phase 2 HARMONIC trial (NCT05456256) evaluating LP-300 in combination with carboplatin and pemetrexed in patients with EGFR Exon 21 L858R-mutant non-small cell lung cancer (NSCLC) who have progressed following TKI-based therapy. The emerging dataset (data cutoff May 11, 2026) reveals a coherent pattern: the progression-free survival benefit of LP-300 deepens with treatment duration, and the signal is most pronounced in the L858R subgroup — a molecularly defined population with a poor prognosis and limited options following frontline TKI therapy. The Company has furnished the presentation and slides as an exhibit to a Current Report on Form 8-K filed today, and is using the updated data and slides for partnering and clinical discussions during ASCO (Free ASCO Whitepaper) 2026 in Chicago.

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"What we are seeing is an early signal that strengthens the longer the biomarker specific patients remain on therapy, and very importantly no notable changes in the exceptionally clean safety and tolerability profile for LP-300," said Panna Sharma, CEO & President of Lantern Pharma. "These patient observations and clinical benefit patterns provide the rationale behind the recently FDA-cleared protocol amendment extending LP-300 dosing from a maximum of six to eight cycles, and reinforces the Company’s focus on the highly undermet need for the L858R patient subgroup – which is about 40% of EGFR mutated patients globally."

A Deepening Signal: Benefit Concentrates with Treatment Duration

A key finding and early observation emerging from HARMONIC is the relationship between treatment duration and depth of benefit. Patients who received up to six cycles of LP-300 derived greater progression-free survival benefit than those treated for fewer cycles, and within the L858R subgroup this duration effect was most evident — a median PFS of 8.9 months in patients treated through up to six cycles, against 8.4 months in the overall L858R cohort (n=15).

The L858R subgroup also corresponded to a hazard ratio of 0.37 (95% CI 0.15–0.89) favoring L858R. The directional trend toward longer PFS with additional cycles provides the basis for extending treatment duration to eight cycles.

Depth and Durability of Response

Beyond the duration relationship, the data point to durable disease control in the L858R population. More than 70% of evaluable L858R patients experienced a reduction in target-lesion size — including a complete response and multiple partial responses among the deepest responders — and durable responses were sustained beyond two years in select patients. The L858R cohort showed a 77% clinical benefit rate, consistent with the depth and durability observed across the response data.

8.9 mo

Median PFS — L858R, up to 6 cycles

>70%

Evaluable L858R patients with tumor reduction

2+ yrs

Durable responses in select L858R patients

77%

Clinical benefit rate — L858R cohort

In a multivariable Cox proportional-hazards analysis, L858R remained significantly and independently associated with PFS benefit after adjustment for race and gender (hazard ratio 0.36; 95% CI 0.15–0.90; p=0.028), with the association persisting when adjusting for TP53 mutation status. These analyses are exploratory and based on a small cohort; they are intended to characterize the emerging signal and inform the enriched study design – which Lantern is pursuing going forward – rather than to establish efficacy.

A Consistently Clean Safety Profile Supports Extended Treatment

Critically, the deepening efficacy signal is accompanied by a tolerability profile that supports longer treatment durations. Across patients treated with LP-300 plus chemotherapy (N=31), LP-300 added no clinically meaningful toxicity beyond the carboplatin/pemetrexed backbone. On a cross-trial basis — provided for context only and not a head-to-head comparison — LP-300 plus chemotherapy compared favorably with the FDA-approved amivantamab-plus-chemotherapy regimen reported in the Phase 3 MARIPOSA-2 study (Passaro A, et al. Ann Oncol 2024), particularly on the administration-burden and dermatologic toxicities that most limit sustained treatment in heavily pre-treated patients:

Adverse Event (any grade unless noted)

LP-300 + Chemo (N=31)

Amivantamab + Chemo (N=130)¹

Treatment-related serious adverse event

3%

23%

TEAE leading to dose delay (any study drug)

19%

65%

TEAE leading to drug discontinuation

6%

18%

Infusion-related reaction (TRAE)

7%

58%

Rash (TRAE)

7%

43%

Paronychia (TRAE)

0%

36%

Stomatitis (TRAE)

0%

31%

¹ Cross-trial comparison; not a head-to-head study. Amivantamab + chemotherapy data from Passaro A, et al. Annals of Oncology 2024;35(1):77–90 (MARIPOSA-2). LP-300 + chemotherapy data are preliminary; HARMONIC data cutoff May 11, 2026.

Competitive Context: Comparable Efficacy, Differentiated Tolerability

Amivantamab plus chemotherapy is FDA-approved in the post-osimertinib setting and represents the current benchmark in this space, with a reported 9.7-month median PFS in L858R patients. LP-300’s emerging profile is positioned not as a claim of superior anti-tumor efficacy, but as a comparable efficacy range with a substantially more favorable safety, tolerability, and administration profile — highly relevant in a heavily pre-treated population where tolerability drives real-world outcomes such as quality of life, reduced costs and reduced clinical burden.

Regimen

ORR

mPFS

Key Tolerability Profile

LP-300 + Carboplatin + Pemetrexed (HARMONIC — L858R enriched)

43%*

8.4 mo* (6.2–NE)

8.9 mo**

Grade 1–2 predominant; no new added toxicity vs. chemo; 3% serious TRAEs

Amivantamab + Chemo (MARIPOSA-2) [FDA-approved, post-osimertinib] (L858R patients)

36%

9.7 mo (5.9–11.3)

23% serious TRAEs; 58% infusion reactions; 36% paronychia

Carboplatin + Pemetrexed alone (historical standard of care)

27–36%

4.2–5.5 mo

Standard chemotherapy toxicities

*Preliminary data. ORR derived from the initial safety lead-in (n=7); HARMONIC mPFS from the L858R-enriched cohort (n=31, data cutoff May 11, 2026). **Patients who received up to six cycles. All comparisons are cross-trial and not head-to-head. NE = not estimable.

Featured for Partnering and Clinical Discussions During ASCO (Free ASCO Whitepaper) 2026

The convergence of a duration-dependent efficacy signal with a clean, sustainable safety profile carries a clear strategic implication: patients can be treated longer, and longer treatment appears to deepen benefit. This relationship underpins the recently FDA-cleared amendment extending LP-300 dosing to eight cycles and the Company’s decision to concentrate enrollment on the L858R subgroup. Lantern Pharma has furnished the accompanying slides on Form 8-K and is using the updated dataset for partnering and clinical discussions during ASCO (Free ASCO Whitepaper) 2026 in Chicago, including potential global and regional licensing and co-development opportunities in never-smoker NSCLC. The Company expects to report additional data as the enriched L858R cohort matures.

LP-300 Shaped & Supported By Lantern’s AI Platform For Drug Development

Indication development and refinement for LP-300 were in part supported by early observations from prior trials and large scale differential gene expression and mutational analysis across NSCLC data sets. Panna Sharma commented, "Our LP-300 program reflects a data-driven, AI-powered approach to understanding how a previously overlooked molecule could meaningfully serve the needs of L858R NSCLC patients — a population that has consistently underperformed on existing therapies. The convergence of molecular modeling, high-resolution biology, and biomarker-driven patient selection is fundamentally changing what is possible for precision oncology drug developers, and we believe LP-300 is well positioned at that intersection."

About the HARMONIC Trial

HARMONIC (NCT05456256) is a Phase 2 clinical trial investigating LP-300 in combination with pemetrexed and carboplatin in never/non-smoker patients with advanced lung adenocarcinoma that has progressed following prior TKI therapy. The trial has enrolled in the United States, Taiwan, and Japan. Primary endpoints are progression-free survival and overall survival; secondary endpoints include objective response rate, duration of response, and clinical benefit rate.

About LP-300

LP-300 is a small-molecule investigational agent with a multimodal mechanism of action, including receptor tyrosine kinase modulation and redox regulation. It has been administered to more than 1,000 individuals across prior clinical studies. LP-300 is being developed using insights from Lantern’s proprietary RADR AI platform. LP-300 has not received marketing approval from the FDA or any other regulatory authority for any indication.

(Press release, Lantern Pharma, JUN 2, 2026, View Source [SID1234666376])