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.

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 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])

On May 4, 2026 Iterion Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies for Wnt/β-catenin-driven cancers, reported that tegavivint, a first-in-class small-molecule inhibitor of TBL1, will be featured in three presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2 in Chicago.

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!

Headlining Iterion’s presence is a rapid oral abstract session presenting Phase 1/2 dose-finding data in advanced hepatocellular carcinoma (HCC), which is the third-leading cause of cancer death globally and an area where treatment options remain limited.

"Advanced HCC is a devastating cancer with limited treatment options, and for the approximately half of patients whose tumors harbor activating mutations in the Wnt/β-catenin pathway, there are currently no approved targeted therapies directed at this biology," said Rahul Aras, Ph.D., President and CEO of Iterion Therapeutics. "Tegavivint was specifically designed to address this urgent unmet need. By disrupting the TBL1–β-catenin transcriptional complex, it offers a highly differentiated mechanism that promotes nuclear β-catenin degradation and inhibits β-catenin driven oncogenic transcription. Selection of our dose-finding data for a rapid oral abstract session, alongside investigator-sponsored studies in NSCLC and pediatric osteosarcoma, reflects growing scientific interest in TBL1 as a druggable target across Wnt-driven cancers."

The ASCO (Free ASCO Whitepaper) presentations follow a series of recent milestones for Iterion, including dosing the first patients in clinical trials in metastatic colorectal cancer and relapsed/refractory pediatric osteosarcoma, as well as the presentation of new preclinical data earlier this year at AACR (Free AACR Whitepaper) supporting TBL1 as a druggable therapeutic target.

ASCO 2026 Presentation Details

Oral Presentation – Advanced Hepatocellular Carcinoma

Abstract #

4015

Title

Tegavivint, a downstream Wnt/β-catenin inhibitor: Dose-finding results from a phase 1/2 trial in advanced hepatocellular carcinoma (aHCC)

Session

Rapid Oral Abstract Session – Gastrointestinal Cancer (Gastroesophageal, Pancreatic, and Hepatobiliary)

Date/Time

June 1, 2026 | 1:15-2:45 PM CDT

Poster Presentation – Metastatic EGFR-Mutated NSCLC

Title

A phase Ib study of osimertinib and tegavivint as first-line therapy in patients with metastatic EGFR-mutated non-small cell lung cancer (NSCLC)

Session

Poster Session – Lung Cancer-Non-Small Cell Metastatic

Poster Board

438

Date/Time

May 31, 2026 | 9:00 AM-12:00 PM CDT

Poster Presentation – Relapsed or Refractory Osteosarcoma

Title

A phase 1b study of tegavivint, a TBL1 inhibitor, with gemcitabine in patients with relapsed or refractory osteosarcoma (TIGER)

Session

Poster Session – Sarcoma

Poster Board

376a

Date/Time

June 1, 2026 | 1:30-4:30 PM CDT

About Tegavivint
Tegavivint is a first-in-class small-molecule inhibitor of TBL1, a critical transcriptional regulator required for nuclear β-catenin stability and oncogenic gene expression. By disrupting the TBL1–β-catenin transcriptional complex, tegavivint promotes degradation of nuclear β-catenin, inhibits oncogenic transcriptional programs driven by Wnt signaling, and has demonstrated potent anti-tumor activity in preclinical models and clinical studies. Tegavivint is currently being evaluated in a Phase 1/2 clinical trial in advanced HCC and in investigator-sponsored studies in metastatic CRC, EGFR-mutated non-small cell lung cancer, and relapsed or refractory pediatric osteosarcoma.

(Press release, Iterion Therapeutics, MAY 4, 2026, View Source [SID1234665049])

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.

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!

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])

On May 4, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, reported new durability data in metastatic colorectal cancer ("mCRC"), demonstrating meaningful and sustained clinical benefit in patients with RAS-mutant, microsatellite-stable ("MSS") disease.

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!

Pelareorep-based combination therapy demonstrated a 19.5-month median duration of response in second-line ("2L") KRAS-mutant MSS mCRC patients in the REO 022 study, compared to historical benchmarks of approximately 4–6 months in this setting.1 Additional data from this study include an objective response rate of 33% for patients receiving pelareorep, bevacizumab, and FOLFIRI, tripling the 6-11% for the standard of care.2, 3

"We believe these data demonstrate a compelling durability signal for pelareorep in colorectal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics. "A 19.5-month median duration of response in second-line patients—representing a three- to four-fold improvement over historical expectations—highlights pelareorep’s potential to deliver sustained benefit in a population with few effective options. We believe these results support a path toward accelerated approval in second-line RAS-mutant MSS metastatic colorectal cancer, and we are actively engaging with the FDA to align on a regulatory strategy leveraging our ongoing randomized study."

Oncolytics is currently enrolling patients in its randomized Phase 2 study evaluating pelareorep in combination with FOLFIRI and bevacizumab in second-line RAS-mutant MSS mCRC (link to study on ClinicalTrials.gov). The Company is actively engaging with the U.S. Food and Drug Administration ("FDA") to discuss a potential accelerated approval pathway based on response durability and time-to-event endpoints from this study.

Colorectal cancer remains one of the largest oncology markets globally, with significant unmet need in later-line settings. RAS-mutant MSS mCRC represents a particularly difficult-to-treat population, where patients typically experience rapid disease progression and limited durability of response on standard therapies. The magnitude and consistency of durability and patient response observed with pelareorep-based combinations suggest the potential to meaningfully extend clinical benefit in this setting.

(Press release, Oncolytics Biotech, MAY 4, 2026, View Source [SID1234665050])

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.

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!

"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])