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Valerio Therapeutics Announces the Launch of InVimmune, a New Company Dedicated to Developing Differentiated in Vivo Cell Therapy Approaches

On May 4, 2026 Valerio Therapeutics (FR0010095596 – ALVIO), a biotechnology company specializing in the development of technology platforms dedicated to the targeted delivery of innovative therapies (the "Company"), reported the launch of InVimmune, a new company dedicated to developing differentiated in vivo cell therapy approaches with potential applications across oncology, fibrosis, autoimmune diseases and additional indications. InVimmune’s first indication is in oncology, addressing an area of high unmet medical need.

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"Through InVimmune, we are adding a new strategic pillar to Valerio and expanding the reach of our platform into in vivo cell therapy. Our differentiated approach has the potential to be applied across several therapeutic areas, including oncology, fibrosis and autoimmune diseases, with a first indication in oncology where unmet medical need remains high. We continue to strengthen our team and broaden the network of experts surrounding the Company to accelerate the development of our technologies and pipeline. We believe that the quality of our talent, combined with the exceptional scientific advisors supporting Valerio and InVimmune, provides a strong foundation to execute our strategy and deliver on our ambitions." said Julien Miara, Chief Executive Officer of the Company.

InVimmune has been established to extend the reach of Valerio’s technology platforms into in vivo cell therapy through a novel immune reprogramming approach. InVimmune will leverage Valerio’s proprietary single-domain antibody platform together with targeted-delivery capabilities to develop differentiated programs across multiple therapeutic areas, with an initial focus on oncology.
To support InVimmune’s first oncology program, Valerio has established a dedicated Oncology Scientific Advisory Board, chaired by Professor Eric Vivier. The Board also includes Frederick Ramsdell, PhD, 2025 Nobel Prize in Physiology or Medicine laureate and Chair of the Scientific Advisory Board at Sonoma Biotherapeutics; Alan Korman, PhD, Chief Scientific Officer and Board Member at BlueSphere Bio; Matteo Iannacone, MD, PhD, Director of the Division of Immunology, Transplantation and Infectious Diseases, Professor of Pathology, and Head of the Dynamics of Immune Responses laboratory at the San Raffaele Scientific Institute and University in Milan; and François Romagné, Former CSO of Innate pharma, Professor of Immunotechnology.

In parallel, Olivier Demaria, PhD, will serve as Chief Scientific Officer of both Valerio and InVimmune and will also sit on InVimmune’s Oncology Scientific Advisory Board, ensuring scientific continuity and close alignment across both organizations. Wael Jdey, PhD, will be promoted to Chief Technical Officer of Valerio.

Valerio Therapeutics will provide further updates on InVimmune’s development in due course.

Professor Eric Vivier, Chair of the Oncology Scientific Advisory Board, added:
"InVimmune is built around an innovative concept with the potential to open new therapeutic avenues across multiple disease areas. By combining targeted delivery with a differentiated immune reprogramming approach, the company aims to advance novel in vivo cell therapy programs. Its first indication in oncology addresses a setting of high unmet medical need and is supported by a strong scientific foundation."

(Press release, Valerio Therapeutics, MAY 4, 2026, View Source [SID1234665069])

Foundation Medicine to Launch FoundationOne®PGx, a Pharmacogenetic Offering, Through Expanded Partnership with Fulgent Genetics

On May 4, 2026 Foundation Medicine, Inc., a global, patient-focused precision medicine company, reported plans to launch FoundationOnePGx, a pharmacogenetic (PGx) offering to identify genetic differences that influence how medicines are metabolized and processed by the body. FoundationOne PGx will be offered in the United States through a partnership with Fulgent Genetics, Inc. (NASDAQ: FLGT) and will be available to order through the Foundation Medicine portal.

Based on their genetics, patients may metabolize medicines more slowly or more rapidly than expected, which can increase the risk of adverse drug reactions and impact treatment effectiveness. PGx testing helps inform how a patient will process certain medications. It may be ordered early in the disease course to help healthcare providers better understand the potential pharmacogenetic effects of therapies and reduce the risk of adverse drug reactions, or later, in advanced disease—particularly when patients are receiving combination regimens, including chemotherapies.

FoundationOne PGx’s current oncology-relevant panel includes genes associated with the metabolism of medicines that have strong clinical evidence and actionable guidelines, including: CYP2C19, CYP2C9, CYP2D6, DPYD, G6PD, NUDT15, TPMT, UGT1A1 and UGT1A4. Genetic variants in these genes can influence patient response to chemotherapies, targeted therapies and supportive care medications commonly used in oncology.

"FoundationOne PGx is an important addition to our portfolio, helping healthcare providers anticipate potential toxicity of medicines, reduced treatment effectiveness, and increased risk of adverse reactions," said Todd Druley, M.D., Ph.D., Chief Medical Officer at Foundation Medicine. "When combined with our high-quality comprehensive genomic profiling tests, this PGx offering powered by Fulgent can help healthcare providers build a more comprehensive understanding of each patient’s genomic profile to inform treatment decisions throughout their care."

"We are excited to expand our partnership with Foundation Medicine, and collectively launch this new service aimed at improving patient care in oncology," said Brandon Perthuis, Chief Commercial Officer at Fulgent. "This is perfect timing with the recent guideline updates and professional society positions signaling a clear shift toward proactive integration of PGx testing into routine oncology care. We look forward to working collaboratively to ensure patients have access to this important testing."

(Press release, Foundation Medicine, MAY 4, 2026, View Source [SID1234665068])

Assertio Announces Amended and Restated Merger Agreement with Garda Therapeutics

On May 4, 2026 Assertio Holdings, Inc. (Nasdaq: ASRT) ("Assertio" or the "Company") reported that, on May 1, 2026, Assertio and Garda Therapeutics ("Garda") entered into an Amended and Restated Agreement and Plan of Merger (the "Merger Agreement"), pursuant to which Garda has increased its offer to acquire all outstanding shares of Assertio to $21.80 per share in cash with no contingent value right.

The increased offer represents a 21.1% premium to Garda’s original offer on April 8, 2026, and a 63.1% premium to the Company’s unaffected stock price on March 20, 2026 – the day before a significant share price and trading volume movement.

The revised offer follows engagement with multiple parties during the Company’s "window-shop" period, including the receipt of a Superior Proposal, after which the Company negotiated in good faith with Garda as required by the terms of the merger agreement. The increased consideration and the revised Merger Agreement with Garda provides greater cash consideration to Assertio’s stockholders, and includes increased and fully-committed equity and debt financing commitments. After careful consideration, Assertio’s Board of Directors determined that Garda’s increased offer represents the most favorable outcome for Assertio’s stockholders.

Heather Mason, Chair of the Assertio Board of Directors, stated: "We are pleased with this outcome, which reflects the Board’s focus throughout this disciplined and comprehensive process on delivering the best possible result for Assertio’s stockholders. Garda’s decision to increase its offer underscores both the competitive dynamics of the process and the underlying value of Assertio. We would like to thank everyone involved for their dedication and execution throughout this process."

Transaction Overview

Under the terms of the amended agreement, Garda will acquire all outstanding shares of Assertio for $21.80 per share in cash. The Merger Agreement does not include a contingent value right. The transaction is expected to close in the second quarter of 2026 and remains subject to customary closing conditions, including the tender of a majority of Assertio’s outstanding shares.

Following the successful completion of the tender offer, Garda will acquire any remaining shares through a second-step merger at the same price of $21.80 per share in cash. Upon completion of the transaction, Assertio’s common stock will no longer be listed on Nasdaq.

Assertio will file a current report on Form 8-K with the U.S. Securities and Exchange Commission (the "SEC") containing a summary of terms and conditions of the Merger Agreement. The Company also expects to file a Schedule 14D-9 with the SEC in connection with the tender offer, which will include additional information regarding the transaction and the strategic review process.

On April 8, 2026, Assertio completed the previously announced sale of its non-Rolvedon assets to Cosette Pharmaceuticals, further streamlining the Company and supporting the transaction with Garda.

First Quarter Conference Call

In light of the announced transaction, Assertio will not host a conference call and webcast to discuss the Company’s financial and operating results for the first fiscal quarter of 2026. The call is not expected to be rescheduled. In addition, the Company is withdrawing its previously disclosed 2026 guidance in connection with the transaction. Assertio expects to file its Form 10-Q for the first quarter of 2026 on or before May 11, 2026.

Advisors

Moelis & Company LLC is serving as financial advisor, Gibson, Dunn & Crutcher LLP as legal counsel, and Longacre Square Partners as strategy and communications advisor to Assertio.

(Press release, Assertio Holdings, MAY 4, 2026, View Source [SID1234665067])

Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations

On May 4, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 CDx liquid biopsy test as a companion diagnostic for VEPPANU (vepdegestrant). VEPPANU, jointly developed by Arvinas, Inc. and Pfizer Inc., is approved for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

The approval of Guardant360 CDx enables a non-invasive, blood-based method to identify patients with ESR1 mutations who may be eligible for treatment with VEPPANU. ESR1 mutations are a known mechanism of resistance to endocrine therapy and are commonly observed in patients with advanced disease.

"This latest FDA approval using Guardant360 CDx reflects where cancer care is headed using blood-based testing to detect resistance earlier and guide smarter treatment decisions," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "By identifying ESR1 mutations with just a simple blood draw, we’re helping bring more precise, personalized options to patients when they need them most."

Vepdegestrant, discovered by Arvinas and co-developed with Pfizer, is a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. It is designed to selectively degrade the estrogen receptor, offering a targeted treatment option for patients whose cancers are driven by ESR1 mutations. The approval is supported by clinical data demonstrating the clinical utility of identifying ESR1 mutations to guide treatment selection in ER+/HER2- advanced breast cancer.

This latest FDA approval for Guardant360 CDx marks the third ESR1 companion diagnostic approval. It is the 26th companion diagnostic indication across multiple tumor types, building on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.

About Guardant360 CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer. For more information, visit Guardant360 CDx.

(Press release, Guardant Health, MAY 4, 2026, View Source;Advanced-Breast-Cancer-with-ESR1-Mutations [SID1234665066])

TriSalus Life Sciences Announces Launch of PREDICTT Clinical Trial Evaluating Pressure-Enabled Drug Delivery in Liver Tumors

On May 4, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported the initiation of patient enrollment for the PREDICTT clinical trial (NCT07444645), a prospective study designed to evaluate its novel Pressure-Enabled Drug Delivery (PEDD) approach in patients with primary or metastatic liver tumors.

The PREDICTT trial is an investigator-led single-arm, prospective, interventional study designed to evaluate how PEDD impacts tumor targeting and radiation dose distribution. Investigators at The University of Texas MD Anderson Cancer Center will assess the use of the TriNav Infusion System in conjunction with Y90 radioembolization therapy. Specifically, the trial will measure changes in CT-based tumor-to-normal liver ratios and assess how these changes correlate with tumor dose and treatment outcomes.

Advancing Precision Delivery in Liver-Directed Therapy

Y90 radioembolization is a widely used treatment for unresectable liver tumors. However, optimizing delivery to maximize tumor dose while minimizing exposure to healthy liver tissue remains a critical challenge. The PREDICTT study aims to address this by evaluating the TriNav Infusion System, a Pressure-Enabled Drug Delivery device designed to improve microsphere distribution within tumors.

Study Design and Objectives

The PREDICTT (Prospective Evaluation of Pressure-Enabled Delivery and Alterations in CT-Based Tumor-to-Normal Liver Ratio and Tumor Dose) trial is an investigator-led study evaluating the impact of pressure-enabled delivery using the TriNav Infusion System in patients undergoing Y90 radioembolization for liver tumors. The PREDICTT trial will enroll approximately 20 adult patients with unresectable primary or metastatic liver tumors who are eligible for Y90 radioembolization. The trial is led by principal investigator Peiman Habibollahi, M.D., associate professor of Interventional Radiology at UT MD Anderson.

Key objectives include:

Evaluate changes in CT-based tumor-to-normal liver enhancement ratios using the TriNav Infusion System
Correlate imaging-based measurements with tumor dose and microsphere distribution
Evaluate relationships between imaging metrics and post-treatment SPECT/CT findings
Assess safety of the TriNav Infusion System [with Y90] in liver directed therapy
Strengthening Clinical Collaboration

The launch of PREDICTT underscores the continued collaboration between TriSalus Life Sciences and UT MD Anderson.

"This study represents an important step toward optimizing locoregional therapies through advanced delivery technologies," said Richard Marshall, MD at Chief Medical Officer, TriSalus Life Sciences. "We are proud to collaborate with UT MD Anderson to generate clinical evidence that could redefine how Y90 therapies are delivered."

(Press release, TriSalus Life Sciences, MAY 4, 2026, View Source [SID1234665065])