On June 24, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that Signatera has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

This approval supports the use of Signatera for patients with colorectal cancer (CRC) in the adjuvant setting and makes Signatera the first PMDA-approved MRD test in Japan. Natera expects to commercially launch Signatera for CRC in Japan by the end of 2026, subject to final pricing determination.

More than 150,000 people are diagnosed with CRC in Japan each year,1 making it one of the country’s most common cancers. This disease burden is comparable to that of the United States and highlights the need for more individualized tools to help Japanese clinicians inform adjuvant treatment decisions. Approval of Signatera fulfills this unmet need.

Commercialization of Signatera will be supported by an existing position statement from the Japan Society of Clinical Oncology (JSCO) and guidance from the Japanese Society of Medical Oncology (JSMO), which recommends the use of MRD testing in CRC.

"This approval marks an important milestone for Japanese patients with colorectal cancer," said Takayuki Yoshino, M.D., executive advisor to hospital director and director, department of global oncology, National Cancer Center Hospital East, chairman of JSCO, president of JSMO, and program director of the CIRCULATE-Japan Project. "Clinicians and medical societies in Japan deeply value the strength of the clinical evidence on Signatera, demonstrating its ability to inform treatment decisions."

Regulatory approval was supported by positive evidence from the GALAXY clinical trial, which demonstrated that patients who test MRD-positive after surgery derive significant benefit from adjuvant chemotherapy, while those who test MRD-negative derive no benefit from adjuvant chemotherapy. With analysis of 2,240 samples, this is one of the largest and most comprehensive prospective studies of MRD testing in resectable CRC and is part of the CIRCULATE-Japan platform involving thousands of CRC patients and >150 Japanese institutions.

"We are grateful to the investigators and patients who helped build the clinical evidence supporting this milestone," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "As we prepare for commercial launch in CRC, we remain committed to expanding global access to Signatera across additional cancer types, with muscle-invasive bladder cancer representing our next planned submission in Japan."

(Press release, Natera, JUN 24, 2026, View Source [SID1234668943])

On June 24, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that four oral and poster presentations highlighting data from its RAS(ON) pipeline will be featured at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress, taking place July 1–4, 2026 in Munich, Germany.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The program will include two oral presentations from Phase 1/2 trials evaluating zoldonrasib, an oral RAS(ON) G12D-selective covalent inhibitor, in combination regimens for patients with metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC). These presentations will report results from zoldonrasib plus chemotherapy in the first line setting, and zoldonrasib plus daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, in patients who had received one or more prior lines of therapy.

Additional presentations will include two Phase 3 trials-in-progress posters for RASolute 303, evaluating daraxonrasib as a monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard of care gemcitabine and nab-paclitaxel as a first line treatment for patients with metastatic PDAC, and RASolute 304, evaluating adjuvant daraxonrasib in patients with PDAC who have undergone resection and completed perioperative chemotherapy.

Details of Revolution Medicines’ presentations are listed below.

Revolution Medicines Oral Presentations:

Title: Safety and Efficacy of Zoldonrasib (RMC-9805) Plus Chemotherapy in Patients (pts) with 1L RAS G12D Metastatic Pancreatic Adenocarcinoma (mPDAC)
Abstract: #340O
Presenter: Brian Wolpin, M.D., Dana-Farber Cancer Institute
Session: Proffered Paper Session
Date/Time: July 2; 2:40 p.m. – 2:50 p.m. CEST

Title: Safety and Efficacy of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) in Patients with 2L+ KRAS G12D Metastatic Pancreatic Adenocarcinoma (mPDAC)
Abstract: #341O
Presenter: Nilofer Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Session: Proffered Paper Session
Date/Time: July 2; 2:50 p.m. – 3:00 p.m. CEST

Revolution Medicines Posters:

Title: RASolute 303: A Phase 3 Global, Multicenter, Open-Label, Randomized 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma
Abstract: #471TiP
Presenter: Thomas Seufferlein, M.D., Ph.D., University Hospital Ulm
Session: Upper Digestive – Biliary, ampullary and pancreatic cancer
Date/Time: July 3; 3:30 p.m. – 4:30 p.m. CEST

Title: RASolute 304 – A Phase 3 Multicenter, Open-label, Randomized Study of Adjuvant Daraxonrasib Versus Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Adenocarcinoma (PDAC)
Abstract: #472TiP
Presenter: Michel Ducreux, M.D., Ph.D., Institut Gustave Roussy
Session: Upper Digestive – Biliary, ampullary and pancreatic cancer
Date/Time: July 3; 3:30 p.m. – 4:30 p.m. CEST

(Press release, Revolution Medicines, JUN 24, 2026, View Source [SID1234668944])

On June 24, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma ("ICC") will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

"The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure," said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. "The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology."

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title: Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/​rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial
Lead Author: Jianming Xu, Chinese PLA General Hospital, Beijing, China
Session: Rapid oral session on innovation
Presentation Number: 343RO
Date & Time: Saturday, July 4, 2026, 9:00 am CEST
Location: Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, JUN 24, 2026, View Source [SID1234668945])

On June 23, 2026 Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, reported that the first patient has been dosed in a Phase Ib combination clinical trial evaluating VVD-214, an investigational oral inhibitor of Werner helicase (WRN). The study is evaluating VVD-214 in combination with bevacizumab in patients with microsatellite instability-high (MSI-high) or deficient mismatch repair (dMMR) colorectal cancer whose disease has progressed following prior lines of therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Colorectal cancer remains one of the most common and challenging cancers to treat worldwide, and a substantial proportion of cases are driven by underlying defects in DNA repair," said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. "VVD-214 reflects Vividion’s continued focus on uncovering and advancing therapies against critical cancer dependencies that have historically been difficult to target, including WRN, with the potential to deliver new precision medicines that address this urgent need."

VVD-214 is an investigational oral small-molecule inhibitor of WRN, a DNA repair enzyme that has emerged as a highly sought-after synthetic lethal target for cancers with microsatellite instability. Tumors that are MSI-high or dMMR rely on WRN to maintain DNA replication and repair despite their underlying genomic instability. By inhibiting WRN, VVD-214 is intended to cause lethal DNA damage in cancer cells while minimizing harm to normal cells, offering a potential precision medicine approach for patients with cancers such as colorectal, endometrial, ovarian and gastric tumors.

"Advancing precision oncology therapies for cancers driven by specific molecular vulnerabilities is a key focus of Bayer’s oncology strategy," said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer’s Pharmaceuticals Division. "Targeting WRN represents a promising new therapeutic approach for genetically distinct subsets of some of the most common cancers worldwide, and we are encouraged to see VVD-214 continue to advance through clinical development."

The global Phase Ib clinical trial (NCT06004245) is planned to enroll patients at clinical sites across the U.S., Australia, Belgium, Canada, China, Denmark, France, Malaysia, South Korea, Spain, and the U.K. Preliminary data from the Phase Ia study presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting showed that VVD-214 was well tolerated with early signals of activity.

(Press release, Vividion Therapeutics, JUN 23, 2026, View Source [SID1234668896])

On June 23, 2026 Orion Corporation (Orion Pharma) reported that its investigational drug ODM-212 has received Orphan Designation from the European Commission, based on the recommendation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), for the treatment of malignant mesothelioma, which is a rare and difficult to treat cancer. The US Food and Drug Administration (FDA) has previously granted Orphan Drug Designation to ODM-212 for the treatment of mesothelioma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor being tested in a Phase 2 clinical study (TEADES) for the treatment of malignant pleural mesothelioma (MPM), epithelioid hemangioendothelioma (EHE) and other solid tumors with dysfunction in Hippo pathway. The trial includes patients who have progressed after receiving standard treatments and have no further treatment options. This is a global trial conducted at leading oncology centers in the US and Europe. For more information on the TEADES Phase 2 clinical study, please visit ClinicalTrials.gov and reference identifier NCT06725758.

"The Orphan Designation for ODM-212 is an important milestone for Orion Pharma. It highlights the need for new treatments in mesothelioma and reinforces our commitment to developing innovative therapies for patients with rare cancers," said Praveen Aanur, MD, MPH, MBA, Chief Medical Officer, Oncology Therapy Area, Orion Pharma.

About Orphan Designation in the EU
The EMA grants Orphan Designation to medicines intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating rare diseases, defined as having a prevalence of no more than 5 in 10,000 in the EU. Additionally, for a medicine to be granted Orphan Designation there should be no satisfactory method of diagnosis, prevention or treatment of the condition concerned, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

With this designation for ODM-212, Orion Pharma, the sponsor, is now qualified for incentives including protocol assistance, fee reductions for certain regulatory activities, and eligibility for a 10-year period of market exclusivity following approval. Orphan Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumor growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

(Press release, Orion, JUN 23, 2026, View Source [SID1234668913])