On June 23, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported that it has received formal approval from Germany’s Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) to initiate its planned Phase 2/3 clinical trial of SIL204, the Company’s lead small interfering RNA (siRNA) product candidate, in patients with locally advanced pancreatic cancer (LAPC). The trial has been approved without conditions, with both Part I and Part II of the assessment determined to be justifiable, following the positive opinion of the Ethics Committee of the North Rhine Medical Association regarding the conduct of the trial in Germany.

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The decision was issued under Articles 5 and 8 of EU Regulation No. 536/2014 in conjunction with the German Medicines Act (AMG), with Germany serving as the Reporting Member State (rMS) leading the scientific assessment of the trial under the EU Clinical Trials Regulation. The approval follows the Company’s April 2026 submission of its Clinical Trial Application (CTA) through the EU Clinical Trials Information System (CTIS), which was informed by the positive written Scientific Advice from BfArM received in December 2025, the previously announced completion of two-species toxicology studies confirming no systemic organ toxicity, and the Company’s broader preclinical package. The decision also builds on the March 24, 2026 approval from the Israeli Ministry of Health, which authorized initiation of the same Phase 2/3 trial in Israel. With the assessment in Germany complete, Silexion is now positioned to potentially expand its Phase 2/3 program across additional EU member states under the harmonized CTIS framework.

"With this BfArM approval, Silexion has now secured clinical trial authorizations in the two leading regulatory jurisdictions where we sought to initiate the Phase 2/3 trial of SIL204," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Germany is widely regarded as one of the most rigorous regulatory environments globally, and an unconditional approval as Reporting Member State under the EU Clinical Trials Regulation is, for us, a strong external validation of the SIL204 preclinical and safety package and a meaningful endorsement of the trial design we developed in close engagement with the agency. With Israeli and German authorizations now in hand, our focus shifts entirely to clinical execution, and we expect to dose our first patient in the coming weeks at one of the activated sites in Israel or Germany."

With both regulatory authorizations now obtained, Silexion is finalizing site activation procedures at participating medical centers in Israel and Germany, including the contracting and budget arrangements customary for multi-site international trials of this scale. The Company expects first-patient dosing to occur in the coming weeks, with the initial dosing site to be determined by the timing of site activation across the participating centers. Site activation in Israel is led by Sheba Medical Center and Tel Aviv Sourasky Medical Center, both of which previously received local ethics approvals for the trial, with leading German oncology centers being brought into the program under the EU CTIS framework.

The Phase 2/3 trial is designed to evaluate SIL204 in combination with standard-of-care chemotherapy in patients with LAPC, using Silexion’s innovative dual-route administration strategy – combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate below 13%, and more than 80% of pancreatic cancer mortality driven by metastatic disease. KRAS mutations are present in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 30–35% of lung adenocarcinomas, representing one of the largest and most persistent unmet needs in oncology.

(Press release, Silexion Therapeutics, JUN 23, 2026, View Source [SID1234668925])

On June 23, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO100, the Company’s lead candidate, an intranasally administered formulation of purified perillyl alcohol designed for non-invasive nose-to-brain delivery. The authorization covers the Company’s NEO100-01, NEO100-02, and NEO100-03 protocols across Phase 1, Phase 1b, and Phase 2 studies in adults, together with pediatric studies authorized for Phase 1 and Phase 1b pending further protocol review. The authorized indication is progressive or recurrent Grade III or IV gliomas.

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The breadth of the UAE authorization, spanning three protocols and adult studies from Phase 1 through Phase 2 alongside a defined pediatric pathway, is intended to allow NeOnc to advance multiple stages of clinical development in parallel. The authorization follows the DOH’s recent IND clearance for the Company’s NEO212 program, announced in June 2026, and extends NeOnc’s clinical development footprint in the UAE across both of its lead platforms, the intranasal delivery platform represented by NEO100 and the drug-conjugation platform represented by NEO212.

In the United States, NEO100 has received FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, and its lead clinical study, the NEO100-01 Phase 2a trial in recurrent IDH1-mutant high-grade glioma, is fully enrolled.

The Company expects to report top-line data from the fully enrolled NEO100-01 Phase 2a trial by the end of July 2026, representing what NeOnc believes may be one of the most important clinical milestones in the Company’s history. Based on the strength of the data observed to date and ongoing interactions with regulators, NeOnc believes the upcoming results may support one or more important regulatory pathways, including potential Breakthrough Therapy designation, expansion of existing Fast Track benefits, and enhanced development opportunities under the program’s existing Orphan Drug designation. While no assurance can be given regarding regulatory outcomes, the Company believes the upcoming data represent a significant milestone in the continued development of NEO100.

"This authorization is significant because it comes at a pivotal moment for NeOnc and the NEO100 program," said Amir Heshmatpour, Chief Executive Officer, Executive Chairman and President of NeOnc. "NEO100 has already received FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, and we are now approaching what we believe could be one of the most important clinical milestones in our Company’s history. We anticipate reporting top-line Phase 2a data by the end of July and believe those results may position NEO100 for additional regulatory opportunities, including potential Breakthrough Therapy designation. If the data continue to reflect the encouraging trends observed to date, we believe NEO100 has the potential to meaningfully alter the treatment paradigm for patients suffering from recurrent high-grade gliomas. While regulatory decisions are ultimately made by the FDA, we are encouraged by the progress of the program and remain focused on bringing a non-invasive treatment option to patients facing devastating brain cancers. Our objective is not simply to advance another oncology drug candidate, but to establish a new paradigm for non-invasive delivery of therapeutics to the brain, potentially changing how CNS diseases are treated worldwide."

"NEO100 uses intranasal delivery to reach the brain directly, a practical route that circumvents the blood-brain barrier without surgery or systemic chemotherapy," said Thomas Chen, MD, Ph.D., Founder, Chief Medical Officer and Chief Scientific Officer of NeOnc. "Because it is non-invasive, this approach can enable studies in difficult groups, including children with high-grade gliomas that have few options today. An authorization spanning Phase 1 through Phase 2 with a pediatric pathway lets us pursue that work where it is needed most."

The upcoming Phase 2a readout represents the first controlled evaluation of NEO100 in recurrent IDH1-mutant high-grade glioma following encouraging earlier clinical observations. If the study meets its objectives, NeOnc believes the data could support discussions with regulators regarding accelerated development pathways and potentially serve as the foundation for future registrational planning.

High-grade gliomas, including WHO Grade III and IV disease, are among the most aggressive brain cancers, with limited treatment options after recurrence. The Company expects to work with healthcare institutions, investigators, and regulatory authorities in the UAE as clinical development activities advance.

The UAE authorization further positions NeOnc to rapidly expand clinical development activities internationally as the Company prepares for multiple anticipated regulatory and clinical milestones throughout the second half of 2026.

(Press release, Neonc, JUN 23, 2026, View Source [SID1234668924])

On June 23, 2026 Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported expanded availability of Precise MRD, broadening availability to patients undergoing treatment and surveillance for breast, colorectal and renal cancers. More than 6 million individuals are living with these cancers in the U.S., representing a significant expansion in access to Myriad’s ultrasensitive Precise MRD test1.

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Precise MRD is a next-generation, ultrasensitive, whole-genome sequencing-based assay that generates a personalized panel for each patient by tracking up to 1,000 variants. The test provides clinicians with a dynamic and quantitative molecular view of their patient’s disease status across the cancer care continuum, from neoadjuvant therapy through post-surgical assessment and long-term surveillance. Its ultrasensitive design enables robust detection of circulating tumor DNA (ctDNA) even in low-shedding tumors, delivering consistent performance across a range of disease settings2.

"Expanding Precise MRD into breast, colorectal and renal cancers marks a significant step forward in our broader precision oncology strategy," said Brian Donnelly, Chief Commercial Officer, Myriad Genetics. "In a single, easy-to-read report, Precise MRD delivers ultrasensitive ctDNA detection and longitudinal insights, along with the clinical interpretation support clinicians need to help guide treatment and surveillance decisions. As we continue to expand across tumor types and build clinical evidence, we believe Precise MRD will play an increasingly central role in managing cancer care."

MONITOR-Breast publication adds to growing evidence for Precise MRD
Myriad Genetics also announces the publication of results from the prospective, multi-center MONITOR-Breast study in Future Oncology, further supporting the clinical validity of Precise MRD in breast cancer. The study demonstrates that ultrasensitive ctDNA monitoring during neoadjuvant therapy provided real-time insight into treatment response and helped identify patients at increased risk for residual disease.

"MONITOR-Breast highlights the strength of a whole-genome, tumor-informed approach to MRD detection," said Dale Muzzey, Chief Scientific Officer, Myriad Genetics. "Precise MRD enables ultrasensitive ctDNA detection and longitudinal disease monitoring that captures dynamic treatment response. The ability to identify additional at-risk patients through frequent sampling, beyond a single timepoint assessment, demonstrates the importance of molecular monitoring in improving risk stratification and guiding clinical decision-making."

The study evaluated 154 patients with Stage I–III breast cancer across all molecular subtypes, analyzing 949 plasma samples collected longitudinally throughout treatment using Precise MRD to assess ctDNA status. Key findings include:

High baseline detection rates: ctDNA was detected in 93% of patients at baseline, including 20% at ultrasensitive levels below 100 parts per million (PPM).
Strong prediction of treatment response: Precise MRD predicted pathological complete response (pCR) with 100% specificity.
Post-treatment prognostic value: Patients who were ctDNA positive at the end of neoadjuvant therapy (NAT) were 47 times more likely to remain ctDNA positive after surgery.
Distinct response patterns through longitudinal testing:
78% of patients demonstrated sustained ctDNA clearance and were significantly more likely to achieve pCR.
22% showed persistent or intermittent positivity, identifying a population at elevated risk of worse outcomes. Longitudinal testing identified 44% more patients who were at risk for residual disease than testing at the post-NAT timepoint alone.
These findings add to the growing body of evidence supporting serial ctDNA monitoring throughout treatment to help clinicians personalize care decisions.

Supporting care across the cancer continuum
Precise MRD is designed for use across key points in patient cancer care, including neoadjuvant monitoring, post-surgical assessment and surveillance. It integrates into existing oncology workflows across academic and community settings and interested healthcare providers can learn more here.

About Precise MRD
The Precise MRD Test is an ultrasensitive assay that quantifies tumor levels as the patient traverses the care continuum. Built on whole-genome sequencing of tumor tissue, the test creates a unique panel of up to 1,000 patient-specific variants to measure ctDNA at ultrasensitive levels, while minimizing false positives. Precise MRD results can identify residual disease to provide prognostic information that can be used for risk stratification, track response to therapy and monitor for early signs of disease recurrence. Learn more at myriad.com/oncology/precise-mrd-test/.

(Press release, Myriad Genetics, JUN 23, 2026, View Source [SID1234668923])

On June 23, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS) and Zumutor Biologics Inc. ("Zumutor"), an immuno-oncology biotech company, reported a clinical collaboration and supply agreement to conduct a Phase 1 trial of ZM008, a novel NK checkpoint anti-LLT1 monoclonal antibody in combination with LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor (Trial ID: NCT06451497). The study will enroll patients with colorectal, head and neck, non-small cell lung cancer, clear cell renal cell carcinoma and urothelial cancers, among other solid tumors.

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"We are excited to partner with Zumutor Biologics on the development of LOQTORZI with ZM0008 as a novel combination treatment for cancer patients in this Phase 1 study," said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer at Coherus Oncology. "This collaboration is another example of our strategy to expand potential LOQTORZI indications beyond NPC and strengthen the clinical data package in the US through cost-efficient drug supply agreements, evaluating LOQTORZI with novel mechanisms in prioritized tumor types such as NSCLC, HNSCC, and others."

ZM008, discovered using Zumutor’s proprietary fully human monoclonal antibody library INABLR, has demonstrated a favorable safety profile, with no dose-limiting toxicities or anti-drug antibodies. In an ongoing monotherapy study, ZM008 has shown clinical benefit in metastatic patients previously treated with immune checkpoint inhibitors. Targeting complementary adaptive and innate immune pathways can unlock meaningful clinical benefit, particularly in hard-to-treat "cold tumors" that remain less responsive to current immunotherapies. "This Phase 1 study will evaluate ZM008 in combination with LOQTORZI and will generate key insights into response mechanisms, identify predictive biomarkers, and refine patient selection strategies to accelerate personalized therapies," said Maloy Ghosh, Ph.D., Chief Scientific Officer of Zumutor. The trial will evaluate safety, tolerability, and the recommended dose of ZM008, enrolling up to 45 patients across dose-escalation and expansion cohorts in the United States.

"The initiation of combination studies of ZM008 with toripalimab, from Coherus Oncology, represents a pivotal milestone for our lead program," said Kavitha Iyer Rodrigues, CEO of Zumutor Biologics Inc. "Building on encouraging early clinical data, this advancement strengthens our conviction in ZM008’s potential to deliver a differentiated and meaningful immunotherapy option for patients with difficult-to-treat cancers and underscores our commitment to accelerating its clinical development."

Under the terms of the clinical trial collaboration and supply agreement, Coherus Oncology will provide LOQTORZI to Zumutor, which will be the sponsor of the Phase 1 clinical combination trial. Zumutor and Coherus each retain all commercial rights to their respective compounds, as monotherapies or combination therapies.

(Press release, Coherus Oncology, JUN 23, 2026, View Source [SID1234668922])

On June 23, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Bladder Cancer to include tumor-informed multiplex PCR circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) testing in the treatment algorithm for patients with MIBC.

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The updated guidelines state that the Panel "recommends the consideration of ctDNA-MRD testing as a tool for risk stratification and to determine the use of adjuvant immunotherapy after cystectomy in patients who have not received previous immune checkpoint inhibitor treatment using an FDA-approved, personalized, tumor-informed, multiplex PCR-NGS assay for ctDNA."

For the first time, NCCN Guidelines recognize that personalized, tumor-informed ctDNA-MRD has emerged as a prognostic and predictive biomarker in MIBC – a significant step forward from previous guidance.

Signatera is based on personalized, tumor-informed, mPCR-NGS technology. This technology is patented and proprietary to Natera, and cited in numerous publications. In addition, Signatera was the MRD test used in the landmark IMvigor011 trial, which generated the Phase 3 evidence needed to move the field to this much stronger recommendation. That evidence is now reflected in a Category 1 recommendation for Signatera-guided adjuvant atezolizumab, initiated at MRD-positivity within 1 year post-cystectomy. Category 1 recommendations are NCCN’s highest designation.

"This guideline update marks an important turning point for patients with muscle-invasive bladder cancer," said Matthew D. Galsky, M.D., deputy director of the Mount Sinai Tisch Cancer Center, director of Genitourinary Medical Oncology, and co-director of the Center of Excellence for Bladder Cancer at the Mount Sinai Tisch Cancer Center. "For the first time, NCCN has incorporated ctDNA-MRD testing into clinical decision-making following cystectomy. These recommendations are supported by prospective phase 3 evidence showing that a ctDNA-guided approach, using Signatera, can help guide post-surgical treatment decisions."

"These recommendations reflect years of work to generate the clinical evidence establishing MRD as a clinically actionable and predictive tool," said Kevin Masukawa, Ph.D., vice president, life cycle management, oncology at Natera. "The IMvigor011 study is an important example of how Signatera-generated evidence can help change clinical practice, and we believe this guideline update is just the beginning of a broader shift toward MRD-guided cancer care."

In May 2026, the U.S. Food and Drug Administration approved Signatera CDx as a companion diagnostic to identify patients with MIBC who are ctDNA-MRD positive and may benefit from treatment with adjuvant immunotherapy.

(Press release, Natera, JUN 23, 2026, View Source [SID1234668921])