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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"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])

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])