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Roche’s VENTANA MMR RxDx Panel companion diagnostic receives IVDR approval across multiple cancer types and therapies

On June 11, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported the European Union In Vitro Diagnostic Regulation (IVDR) approval of several label expansions for the VENTANA MMR RxDx Panel, an immunohistochemistry (IHC) companion diagnostic test that aids in identifying a cancer patient’s mismatch repair (MMR) status. MMR is a process that scans a person’s genetic code and fixes errors to prevent mutations that can lead to cancer. The test evaluates a panel of MMR proteins in tumours to provide this important treatment information to clinicians.

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"By providing a standardised testing option for mismatch repair status with our VENTANA MMR RxDx Panel, we are empowering clinicians to make more informed decisions and expanding access to important therapies for patients across multiple solid tumor types," said Laura Apitz, Head of Pathology Lab at Roche Diagnostics. "This milestone exemplifies our dedication to delivering high-medical-value solutions that help improve patient outcomes through precision medicine."

The VENTANA MMR RxDx Panel is now available in countries regulated by IVDR as a companion diagnostic for the following therapies and cancer types:

KEYTRUDA (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy: For the treatment of mismatch repair deficient (dMMR) tumors in certain adults with: metastatic colorectal cancer; advanced or recurrent endometrial carcinoma; unresectable or metastatic gastric, small intestine or biliary cancer.
IMFINZI (durvalumab), AstraZeneca’s anti-PD-L1 therapy: For adult patients with dMMR primary advanced or recurrent endometrial cancer.
IMFINZI + LYNPARZA (olaparib), AstraZeneca’s anti-PD-L1 therapy and PARP inhibitor: For adult patients with mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
JEMPERLI (dostarlimab-gxly), GSK’s anti-PD-1 therapy: for dMMR patients with endometrial cancer.1
About MMR
Cancer remains the second leading cause of death worldwide, resulting in nearly 10 million deaths annually.2, 3 Identifying specific biomarkers is critical to help identify patients who are eligible for certain therapies, as dMMR serves as a vital predictive biomarker for modern immunotherapies.

MMR is a naturally occurring mechanism that scans our DNA, correcting errors that cause disease. When MMR is deficient, cells mutate, which can lead to cancer. While MMR deficiency is most common in endometrial cancer, other high-prevalence dMMR tumour types include gastric, colorectal, small intestine and biliary tract cancers. Because dMMR tumours often have a high mutational burden they may respond well to immune checkpoint inhibitors (ICIs) such as PD-1 or PD-L1 inhibitors. For patients with endometrial cancer without MMR deficiency (pMMR), the addition of PARP inhibitors in maintenance to ICIs may further enhance the benefit of ICIs. PD-1 inhibitors may retain activity when combined with a tyrosine kinase inhibitor (TKI).

About the VENTANA MMR RxDx Panel
This IVDR approval for the VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market panel. The VENTANA MMR RxDx Panel is intended for the assessment of expression of MMR proteins in formalin-fixed, paraffin-embedded (FFPE) tumour tissue stained with OptiView DAB IHC Detection Kit and ancillary reagents in the panel for VENTANA anti-MLH1 (M1), VENTANA anti-MSH2 (G219-1129) and VENTANA anti-MSH6 (SP93), and OptiView DAB IHC Detection Kit with the OptiView Amplification Kit and ancillary reagents for VENTANA anti-PMS2 (A16-4) on a BenchMark ULTRA instrument.

MMR proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.4,5,6 PD-1 inhibitors can be effective in cancers with MMR deficiency.4,6 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins.

(Press release, Hoffmann-La Roche, JUN 11, 2026, View Source [SID1234666540])

First patient treated in Cutaneous Melanoma patient with secondary resistance

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.

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])

RadioMedix Announces Receiving FDA Approval of its Generic Ga-68 PSMA-11 Radiodiagnostic for Prostate Cancer

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.

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])

Lisata Therapeutics Announces Commencement of Tender Offer by Kuva Labs Inc.

On June 10, 2026 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported that Kuva Acquisition Corp. ("Purchaser"), a wholly owned subsidiary of Kuva Labs Inc. ("Kuva"), has commenced the previously announced tender offer to purchase all of the issued and outstanding shares of common stock of Lisata.

The tender offer is being made pursuant to the Agreement and Plan of Merger dated March 6, 2026, among Lisata, Purchaser and Kuva (as it may be amended from time to time, the "Merger Agreement").

Transaction Details

Under the terms of the Merger Agreement, Kuva will commence a tender offer to acquire all the issued and outstanding shares of Lisata common stock for:

$4.00 per share in cash, paid at the closing of the transaction (the "Closing Amount").
One non-tradeable contingent value right ("CVR"), representing a contractual right to receive two contingent cash payments up to an aggregate of $3.00 per CVR subject to achievement of specified milestones. The CVR entitles the holders of record to receive an additional cash payment of $1.25 per share, upon the achievement of, with respect to a Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (temozolomide) versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed Glioblastoma Multiforme (GBM) (Protocol Number: LSTA1-GBM-2A), (i) completion of enrollment of such trial, (ii) the enrollment of at least 90% of the target number of subjects of such trial or (iii) the termination of such trial by its sponsor for any reason (the "First Milestone") and an additional cash payment of $1.75 per share upon the achievement of with respect to any product candidate referred to as of the date of the merger agreement as certepetide (formerly LSTA1 or CEND-1), the filing or formal acceptance for review by any governmental authority of any New Drug Application for certepetide (formerly LSTA1 or CEND-1) (the "Second Milestone", and together with the First Milestone, the "Milestones"). Should any of the Milestones not be met, then no additional consideration will be payable to the holders of the CVRs in relation to the applicable Milestone.
The tender offer period will expire one minute after 11:59 p.m., New York City time on July 10, 2026, unless the offer is extended.

As described in the Schedule TO filed on June 10, 2026 by Kuva and its acquisition subsidiary, as of the commencement of the Offer, Parent and Purchaser do not have committed financing to fund the Offer Price. Parent and Purchaser intend to fund the Offer Price through a combination of debt and/or equity financings, borrowings under credit facilities that Parent will seek to obtain from lenders and/or private issuance of securities, none of which has been committed. If Parent obtains commitment letters for such financing, such commitments would be filed with the Securities and Exchange Commission and would be available in the manner described in the Offer to Purchase. There can be no assurance that such financing will be obtained.

Lisata has filed a Solicitation/Recommendation Statement with the U.S. Securities and Exchange Commission ("SEC") on Schedule 14D-9, which includes the unanimous recommendation of Lisata’s Board of Directors that Lisata stockholders tender their shares in the tender offer. The merger agreement does not include a financing condition. Following the successful tender of a majority of Lisata shares, Kuva will also acquire the untendered shares and convertible securities of Lisata through a second-step merger for the same consideration of $4.00 cash per share, plus the CVR. The closing of the transaction is expected to occur in the third quarter of 2026.

Following completion of the transaction, Lisata will become part of Kuva, a privately held company, and Lisata’s common stock will be delisted from the Nasdaq Capital Market. Lisata will apply to deregister its common stock and cease to be a reporting company under the United States Securities Exchange Act of 1934, as amended.

Free copies of all offering documents, including the Offer to Purchase and the solicitation/recommendation statement, are available to all stockholders of Lisata by accessing View Source or by contacting Investor Relations at 908-842-0084. In addition, the tender offer statement and the solicitation/recommendation statement (and all other documents filed with the SEC) will be available at no charge on the SEC’s website: www.sec.gov, upon filing with the SEC.

Before making any decision with respect to the tender offer, investors are urged to read the Offer to Purchase and related documents, as well as the Solicitation/Recommendation Statement, because they contain important information about the tender offer.

Advisors

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. is serving as legal counsel to Lisata and H.C. Wainwright & Co. acted as financial advisor to Lisata. Reed Smith LLP is acting as legal counsel to Kuva and Purchaser.

(Press release, Lisata Therapeutics, JUN 10, 2026, View Source [SID1234666559])

Parexel to Showcase Seven Research Posters and Debut New Hematology Playbook at the European Hematology Association Congress 2026

On June 10, 2026 Parexel, a leading global clinical development partner providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry, reported its experts will present seven research posters during the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, June 11–14 in Stockholm, Sweden. Parexel’s presence at EHA (Free EHA Whitepaper) 2026 will also mark the launch of At the Turning Point: Shaping the Future of Hematology, a thought leadership resource grounded in the company’s expertise and insights from 250 hematology programs across nearly 70 countries over the past five years.

Poster Presentations

Parexel researchers will present seven posters during EHA (Free EHA Whitepaper) 2026, including five in person and two available online. Poster abstracts are embargoed until June 11 at 8 a.m. CEST:

In-Person Presentations (all times are CEST):

"Comparative Real-World Overall Survival in Diffuse Large B-Cell Lymphoma: CAR T-Cell Therapies Versus Bispecific Antibodies"
First author: Vladimir Otasevic, M.D., Ph.D., Associate Medical Director
Date and time: Friday, June 12 from 6:45 p.m. – 7:45 p.m.
"ICANS After CAR-T Therapy: Persistent Cognitive but Not Psychiatric Risk — A Propensity Score-Matched Analysis"
First author: Heidi Cho, M.D., Vice President, Franchise Head and Global Therapeutic Area Head, Hematology
Date and time: Saturday, June 13 from 6:45 p.m. – 7:45 p.m.
"Impact of Autologous Stem Cell Transplantation Following Quadruplet Therapy (Dara-VRd) on Survival Outcomes in Multiple Myeloma: A Real-World Data Analysis"
First author: Lanzhu Yue, M.D., Ph.D., Medical Director, Therapeutic Area Head of Lymphoma and Non-Malignant Hematology
Date and time: Friday, June 12 from 6:45 p.m. – 7:45 p.m.
"Real-World Outcomes of Sickle Cell Disease Patients Transitioning From Pediatric to Adult Care: Impact on Acute Care Utilization"
First author: Heidi Cho, M.D., Vice President, Franchise Head and Global Therapeutic Area Head, Hematology
Date and time: Friday, June 12 from 6:45 p.m. – 7:45 p.m.
"Risk of Bleeding in Mantle Cell Lymphoma Patients Treated with Covalent Bruton Tyrosine Kinase Inhibitors and Contemporary Anticoagulant or Antiplatelet Agents: Real-World Data Insights"
First author: Vladimir Otasevic, M.D., Ph.D., Associate Medical Director
Date and time: Saturday, June 13 from 6:45 p.m. – 7:45 p.m.

Available Online:

"Infections Following Combined Therapy with a GPRC5DxCD3 Bispecific Antibody (Talquetamab) or BCMA Bispecific Antibodies (Elranatamab/Teclistamab) and Tocilizumab, in Multiple Myeloma Patients"
First author: Heidi Cho, M.D., Vice President, Franchise Head and Global Therapeutic Area Head, Hematology
"Regulatory Divergence in R/R AML: Contrasting FDA and EMA Approaches to Real-World Evidence and Trial Design"
First author: Sinan Sarac, M.D., Ph.D., Senior Vice President, Head of Oncology Europe, Regulatory Consulting

"Emerging therapies in hematology are advancing at an extraordinary pace, creating new opportunities to improve patient outcomes through longer remissions, more effective disease management and innovative treatment approaches," said Heidi Cho, M.D., Vice President, Franchise Head and Global Therapeutic Area Head, Hematology at Parexel, who will lead the company’s on-site activities at the meeting. "Our research presentations and new hematology playbook reflect the depth of experience Parexel has gained across hundreds of global hematology studies. Our experiences provide actionable insights to help sponsors navigate complexity, make critical development decisions with greater confidence and help bring transformative therapies to patients faster."

The European Hematology Association (EHA) (Free EHA Whitepaper) is the leading professional organization dedicated to the research, diagnosis and treatment of blood diseases, bringing together thousands of clinicians, scientists and industry professionals each year.

Launch of the Hematology Playbook

Authored by Parexel subject matter experts, At the Turning Point: Shaping the Future of Hematology addresses trial design innovation, patient-centric development strategies, navigation of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and National Medicinal Products Administration (NMPA) regulatory landscape, operationalization of complex hematology trials, and the integration of real-world evidence from the start of development. The resource is written for hematology drug developers, including biotech and pharmaceutical sponsors approaching first-in-human studies, preparing for Phase III studies, and managing multi-regional development.

Key Findings

Five-year relative survival rates for blood cancers have climbed significantly over the past three decades, rising from 48% to 68% for leukemia and 32% to 62% for myeloma. As a result, the pool of patients eligible for clinical trials has shifted, intensifying competition for enrollment across hematology studies.
Patient navigation deployment drove a 29% decrease in screen fail rate across a Parexel-supported hematology study, with 100% of sites opting into navigator support.
Gene therapies for sickle cell disease and hemophilia approved between 2023 and 2025 have fallen short of projected commercial uptake, a pattern the playbook traces to poorly defined patient profiles during protocol design.
China’s investigator-initiated trial pathway can be approximately two years faster and substantially less costly than other traditional IND routes, positioning the country as a strategic accelerator for first-in-human hematology studies.

For more information about Parexel’s presence at EHA (Free EHA Whitepaper) 2026 or to schedule a meeting with Parexel experts, please visit Parexel Events. To access Parexel’s hematology playbook, visit Parexel Insights.

(Press release, PAREXEL International, JUN 10, 2026, View Source [SID1234666558])