On June 10, 2026 RadioMedix, Inc., a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and cancer therapy, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s GALLIUM GA 68 GOZETOTIDE INJECTION, also known as Ga 68 PSMA-11, a prostate-specific membrane antigen (PSMA)-targeted diagnostic radiopharmaceutical for positron emission tomography (PET) imaging in patients with prostate cancer. In connection with the approval, RadioMedix also completed an FDA inspection of its manufacturing site known as The SPICA Center located north of Houston, TX with no Form 483 observations.

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!

Ga-68 PSMA-11 is a radioactive diagnostic agent that targets PSMA, a protein commonly expressed in prostate cancer. The approval expands RadioMedix’s precision nuclear medicine portfolio and supports the Company’s continued work to advance diagnostic radiopharmaceuticals for patients and physicians.

"FDA approval of our Ga68 PSMA-11 Abbreviated New Drug Application (ANDA) represents an important milestone for RadioMedix and reinforces our commitment to expanding availability of cost effective and high-quality radiopharmaceuticals for patients," said Ebrahim S. Delpassand, M.D., Founder and Chief Executive Officer of RadioMedix. "We are also proud to have completed the FDA inspection with no Form 483 observations, which reflects the rigor of our quality systems, manufacturing capabilities, and teamwide commitment to regulatory excellence. As the radiopharmaceutical field continues to grow, quality, consistency, and regulatory readiness will be essential to ensuring these technologies can reliably reach patients."

The SPICA Center consist of a 27,500 sq. ft. radiopharmaceutical manufacturing facility, multiple clean rooms, fully equipped quality control suites, a strong quality assurance backbone, and 21 CFR 211 compliance supporting the development and production of targeted diagnostic and therapeutic radiopharmaceuticals for internal programs and external partners.

Connie Chang, Head of Quality at RadioMedix, added, "Successfully completing the FDA inspection with no Form 483 observations reflects more than a single milestone — it represents RadioMedix’s enduring commitment to a strong quality culture across the organization. This achievement is the result of sustained senior management support, cross-functional collaboration, and a company-wide dedication to quality, compliance, and continuous improvement. At RadioMedix, quality is not only a regulatory requirement, but a core value that guides our operations, strengthens our manufacturing and quality systems, and ultimately supports the reliable delivery of safe and high-quality radiopharmaceuticals to patients."

About Ga-68 PSMA-11 Injection
Ga-68 PSMA-11 Injection is a radioactive diagnostic agent for PET imaging of PSMA-positive lesions in patients with prostate cancer.

Important Safety Information
Please see safety information for GALLIUM GA 68 GOZETOTIDE INJECTION at View Source

(Press release, RadioMedix, JUN 10, 2026, View Source [SID1234666560])

On June 10, 2026 Sumitomo Pharma America, Inc. (SMPA) reported that it has enrolled the required number of participants in its pivotal Phase 2 monotherapy trial for enzomenib, an investigational, oral selective menin inhibitor for the treatment of relapsed/refractory acute leukemia with KMT2A rearrangement, to allow for interim analysis. Achieving this milestone will enable SMPA to obtain results of the interim analysis by the end of calendar year 2026. These results will be promptly disclosed, with detailed data to be presented at an upcoming medical congress. If the primary endpoint is met, SMPA would then proceed with preparation for regulatory submission with the aim of obtaining approval in the US and Japan during FY2027.

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!

"Acute leukemias, especially at the relapsed/refractory stage, are profoundly difficult to treat, and are associated with very poor outcomes," said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. "Achieving this enrollment milestone is an important step in our efforts to bring a new, differentiated therapeutic option to acute leukemia patients and their families. My sincere thanks to the patients who are taking part in this study to further our scientific understanding of leukemia treatment."

In addition to this study, SMPA continues to enroll patients in its pivotal Phase 2 monotherapy study of enzomenib in patients with relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation.

About Leukemia

Leukemia is a type of cancer that forms in blood-forming tissue, characterized by the uncontrolled growth of blood cells, usually white blood cells, in the bone marrow. Acute leukemia, a form of leukemia, requires immediate treatment as blood cells multiply rapidly leading to a sudden onset of symptoms.1 Approximately 30% of patients with AML have NPM1 mutations,2 and 5%-10% of patients with AML have KMT2A rearrangements.3

About Enzomenib (DSP-5336)

Enzomenib is an investigational, oral, small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth. Menin is a scaffold nuclear protein that plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.4,5 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutations.4,6 Enzomenib reduced the expression of the leukemia-associated genes HOXA9 and MEIS1 and increased the expression of the differentiation gene CD11b in human acute leukemia cell lines with KMT2A rearrangements and NPM1 mutation.7,8 The safety and efficacy of enzomenib is currently being clinically evaluated in a Phase 1/2 dose-escalation/dose-expansion study in patients with relapsed or refractory acute leukemia (NCT04988555) and the registrational Phase 2 Horizen-1 R/R mono AML/ALL (KMT2Ar + NPM1m) study. The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022. The FDA granted Fast Track Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in June 2024. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in September 2024.

(Press release, Sumitomo Dainippon Pharma, JUN 10, 2026, View Source [SID1234666545])

On June 10, 2026 MonTa Biosciences reported that the first patient has been dosed in Madrid at The START Center for Cancer Research FJD in our Phase 1b clinical study evaluating MBS8, our second-generation TLR7 agonist, in combination with checkpoint inhibitor therapy for patients with advanced cutaneous melanoma who have developed resistance to immunotherapy.

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!

For these patients, options for treatment are poor and we see this as an indication where we can really make a difference.
While checkpoint inhibitors have transformed outcomes in melanoma, many patients who initially respond eventually see their disease return. Once resistance develops, treatment options become limited and the path toward long-term disease control becomes far more difficult.

We have not taken the easiest path to make these decisions moving into cutaneous melanoma with secondary resistance to immunotherapy . With a new drug being tested in patients you are exploring new territory and the decisions you make are critical to the outcome. It is extremely important to understand how the drug works in patients, before deciding what patients you see benefit from the treatment. Based on the data generated to date, we believe this is a scientifically compelling setting in which to evaluate MBS8. Our hypothesis is that activating innate immunity may help restore anti-tumor immune responses and potentially restore sensitivity to checkpoint therapy.

(Press release, MonTa Biosciences, JUN 10, 2026, View Source [SID1234668755])

On June 10, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that the Taiwan’s Ministry of Health and Welfare (MOHW) has approved ropeginterferon alfa-2b-njft (BESREMi) for the treatment of adult patients with essential thrombocythemia (ET). BESREMi is the first new therapy approved for ET in nearly 30 years.

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 approval represents the first global regulatory approval of BESREMi in ET and marks an important milestone in the strategy to expand BESREMi across myeloproliferative neoplasms (MPNs). With the first global approval in ET now secured in Taiwan, BESREMi is well-positioned to address a significant global market opportunity, including in the United States, where the U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application (sBLA) for ET with a Prescription Drug User Fee Act (PDUFA) target action date of August 30, 2026.

ET is a chronic MPN characterized by excessive platelet production and increased risk of thrombosis, hemorrhage. Based on data from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET studies, PharmaEssentia believes BESREMi has the potential to address a broad ET patient population regardless of underlying disease subtype, supporting a significant global expansion opportunity for the BESREMi franchise.

"This first global approval of BESREMi in ET represents an important strategic milestone for PharmaEssentia and further strengthens the Company’s leadership position in myeloproliferative neoplasms," said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. "We believe ET represents a major long-term growth opportunity for BESREMi and has the potential to significantly expand the reach of the Company’s hematology franchise globally. This approval also advances our broader strategy to expand the global BESREMi franchise as we continue preparations for a potential U.S. approval and commercial launch in ET later this year."

Dr. Lin continued, "Data generated across the Phase 3 SURPASS-ET study and the Phase 2b EXCEED-ET trial demonstrated the potential of ropeginterferon alfa-2b to achieve durable hematologic and molecular responses in ET patients, supporting the potential for durable hematologic and molecular responses consistent with disease-modifying activity in ET. We believe the differentiated profile and dosing schedule of BESREMi position BESREMi as a differentiated treatment option for a broad range of ET patients."

The TFDA approval was supported by data from the global Phase 3 SURPASS-ET study, which evaluated ropeginterferon alfa-2b in high-risk ET patients resistant or intolerant to hydroxyurea. Specifically, in the global Phase 3 trial SURPASS-ET, BESREMi demonstrated a superior durable clinical response rate compared to anagrelide (42.9% vs. 6.0%; p=0.0001). Across clinical studies, BESREMi demonstrated clinically meaningful hematologic responses, molecular responses, and a manageable safety profile.

In addition to the ongoing FDA review of the ET sBLA, ropeginterferon alfa-2b has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for the treatment of ET, further supporting increasing adoption of interferon-based treatment approaches in ET and other MPNs.

PharmaEssentia is the inventor and owner of BESREMi (ropeginterferon alfa-2b-njft) and maintains intellectual property rights for the product across all indications.

(Press release, PharmaEssentia, JUN 10, 2026, View Source [SID1234666546])

On June 10, 2026 Predicta Biosciences, a company building ultra-sensitive molecular and immune diagnostic platforms, and CIMA LAB Diagnostics from the Clínica Universidad de Navarra, a leading European University Medical Center, reported a partnership to offer a combined service that integrates CIMA LAB’s flow cytometry capabilities with the GenoPredicta assay. The offering will be available to academic institutions and biopharma across Spain and the European Union.

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!

Led by Dr. Bruno Paiva, the CIMA LAB Diagnostics Flow Cytometry Unit has recognized expertise in the diagnosis and monitoring of hematologic malignancies. Flow cytometry is an essential technique for differential diagnosis, prognostic classification, and monitoring minimal residual disease (MRD) across multiple blood cancers.

"This partnership with CIMA LAB Diagnostics will accelerate and expand the availability of our GenoPredicta platform for EU partners," said Brian McKernan, CEO of Predicta Biosciences. "Dr. Paiva has been an outstanding collaborator, and we are excited about what this relationship with CIMA LAB Diagnostics will bring to the future of blood cancer diagnostics."

"We are honored and very excited to partner with Predicta Biosciences. The GenoPredicta assay is the optimal solution for a missing element in our quest for innovation and improved diagnosis and monitoring of patients with blood cancer. With this partnership, not only can we detect and quantify rare tumor clones, but also characterize their genome at the single-cell level. This is a novel and extremely powerful tool for precision medicine across different types of blood cancer," said Dr. Bruno Paiva.

Dr. Paiva will present an update on the GenoPredicta platform at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (June 11–14, Stockholm, Sweden, and virtual): PF787, "Whole Genome Sequencing of Multiple Myeloma Cells with a Novel Clinical Assay Uncovers Diversity of Genetic Alterations Underlying Immunotherapy Resistance."

(Press release, Predicta Biosciences, JUN 10, 2026, View Source [SID1234666547])