On March 26, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases, reported that it will host a virtual R&D Day Event on Tuesday, April 7, 2026 at 10:00 AM EDT.

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The virtual event will feature Richard DiPaolo, PhD (Saint Louis University) and Jonathan Kay, MD, FACP, MACR (UMass Chan Medical School, Worcester, Massachusetts), who will join company management to discuss CUE-401, the company’s lead asset designed to act mechanistically both as a regulator of proinflammatory mechanisms and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance in autoimmune and inflammatory diseases.

A live question and answer session will follow the formal presentations. In addition, a live and archived webcast of the event will be available in the News and Publications section of the Company’s website. The webcast will be archived for 30 days.

About Richard DiPaolo, PhD
Richard DiPaolo, PhD currently serves as Full Professor and Chair of the Department of Molecular Microbiology & Immunology at Saint Louis University. Dr. DiPaolo leads a successful and well-funded research program focused on inflammation and immune regulation in the contexts of autoimmunity, infection, and cancer. He completed his postdoctoral fellowship with Dr. Ethan Shevach in the Cellular Immunology Section of the NIAID/NIH, where he made significant contributions to the field of regulatory T cells (Tregs). Notably, Dr. DiPaolo was among the first to define the in vivo immunosuppressive functions of Tregs in autoimmune settings. He also played a pivotal role in early studies demonstrating the induction of FOXP3⁺ Tregs in vitro through activation of naïve T cells in the presence of TGF-β and IL-2, as well as their application in cell-based immunotherapies to suppress autoimmunity. Dr. DiPaolo earned his B.A. from the University of Chicago, where he spent four years in the laboratory of Dr. Jeffrey Bluestone studying T cell activation and costimulation. He went on to receive his Ph.D. from Washington University in St. Louis under the mentorship of Dr. Emil Unanue, making key discoveries related to antigen presentation and CD4⁺ T cell responses in the context of immunization and autoimmunity.

About Jonathan Kay, MD, FACP, MACR
Jonathan Kay, MD, FACP, MACR is Professor of Medicine and Population and Quantitative Health Sciences and holds the Timothy S. and Elaine L. Peterson Chair in Rheumatology at the UMass Chan Medical School in Worcester and is Executive Co-Director of the Medical Scientist Training Program (MSTP)-funded MD/PhD Program. His clinical appointment is as a Physician at UMass Memorial Medical Center, also in Worcester. He received his medical degree from the University of California School of Medicine in San Francisco, California. He then completed an internship and residency at the Hospital of the University of Pennsylvania in Philadelphia and fellowships in rheumatology and immunology at the Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts. Dr. Kay is a Fellow of the American College of Physicians. In 2018, he received the Distinguished Service Award from the American College of Rheumatology, and he was awarded honorary membership in EULAR. In 2023, he was awarded the distinction of Master by the American College of Rheumatology. He is an ad hoc reviewer for many journals. Dr. Kay’s clinical interests span the spectrum of rheumatic diseases, with special interest in rheumatoid arthritis, spondyloarthropathies, and other forms of inflammatory arthritis. He was a member of the group that developed the 2010 ACR/EULAR Diagnostic and Classification Criteria for Rheumatoid Arthritis. He chaired the Rheumatology Working Group and was a member of the Internal Medicine and Musculoskeletal Topic Advisory Groups for the World Health Organization in its Revision of the International Classification of Diseases (ICD)-11. Over the past three decades, his clinical research has focused on clinical aspects of inflammatory arthritis and on nephrogenic systemic fibrosis (formerly known as nephrogenic fibrosing dermopathy), β2-microglobulin amyloidosis, and other rheumatologic problems of patients with chronic kidney disease. Over the past 15 years, he also has been involved in the development of biosimilars to treat rheumatic diseases. Dr. Kay has been a principal investigator on over 70 clinical trials of novel therapies for rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, gout, and osteoarthritis. He lectures internationally and is the author of more than 220 publications and book chapters.

(Press release, Cue Biopharma, MAR 26, 2026, View Source [SID1234663963])

On March 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the Company has achieved a key milestone in its ongoing Phase III TIGeR‑PaC clinical trial by surpassing 100 randomized patients and remains on track for enrollment completion in the first half of 2026, with final data expected in 2027.

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"Reaching over 100 randomized patients marks an important milestone in our Phase III trial as we maintain strong momentum toward enrollment completion. We remain committed to completing the TIGeR-PaC trial and delivering final data in 2027," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "In parallel, select TIGeR-PaC cancer centers have begun using the TAMP therapy platform, enabled by the RenovoCath device, for targeted drug-delivery in the treatment of patients diagnosed with solid tumors."

RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) is being evaluated in the TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. TIGeR-PaC is evaluating IAG in locally advanced pancreatic cancer, and its potential to minimize a therapy’s toxicities versus systemic intravenous therapy.

The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred. RenovoRx anticipates completion of enrollment by the end of the first half of 2026, ensuring a minimum of 114 patients will be randomized.

The first and second pre-planned interim analyses were conducted per protocol specifications and triggered upon the 26th event (2023) and the 52nd event (2025), respectively. In both the first and second interim analyses, the independent data monitoring committee (DMC) for the trial recommended that RenovoRx continue with the trial, based on its review of the data.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, MAR 26, 2026, View Source [SID1234663962])

On March 26, 2026 LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, reported financial results for the year ended December 31, 2025, and provided recent pipeline and business updates.

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"2025 was a truly transformational year for LeonaBio. With our license for lasofoxifene, we added a late-stage drug candidate that has the potential to become the endocrine therapy of choice in the multi-billion-dollar second line metastatic breast cancer setting" stated Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. "Coupled with our successful $90 million fundraise with the potential for $146 million in additional capital available through warrant exercises, we enter 2026 with the financial resources needed to advance both our oncology and neurodegeneration programs with confidence."

"Our transition from Athira Pharma to LeonaBio reflects far more than a name change; it represents our evolution into a more focused, diversified, and opportunity-driven biopharmaceutical company. We now have two clinical-stage programs and an experienced team aligned around focused execution. As we look ahead to meaningful clinical milestones in 2026 — including the anticipated completion of enrollment of the Phase 3 ELAINE-3 clinical trial and initiation of patient dosing in our ATH-1105 ALS program — we are energized by what lies ahead. We are building a company that we believe has the potential to change the treatment landscape for patients who urgently need better options, and I couldn’t be more optimistic about the momentum we carry into 2026 and beyond," concluded Dr. Litton.

Clinical Development & Pipeline Programs

Lasofoxifene – A novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer.

In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene.

Lasofoxifene is being advanced in a Phase 3 clinical trial (NCT05696626) in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, a population with limited treatment options following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is statistically significant improvement in progression free survival (PFS) as determined by blinded, independent central review (BICR). The ongoing Phase 3 trial aims to establish a new standard of care for this genetically defined patient group.
LeonaBio is amending the ELAINE-3 trial protocol to increase the sample size from 500 participants to up to 600 participants. The primary goal of the amendment is to help ensure that the trial will have the appropriate number of disease progression events. The Company expects to complete enrollment of the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.
Lasofoxifene was previously evaluated in two Phase 2 studies in patients with ER+, HER2-negative locally advanced or metastatic breast cancer expressing an ESR1 mutation, ELAINE-1 and ELAINE-2
ELAINE-1, an open-label, randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene as a potential monotherapy. Although the trial was not powered, results included longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%) and a durable complete response lasting more than 2.5 years. The treatment was well-tolerated with patients reporting quality-of-life benefits.
ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56% and a clinical benefit rate of 65.5%. The combination was generally well-tolerated with most adverse events being low grade.
ATH-1105 – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. ATH-1105 is currently being developed for the potential treatment of ALS.

In August 2025, LeonaBio presented results from the first-in-human Phase 1 clinical trial (NCT 06432647) of ATH-1105 in healthy volunteers at the ALS Nexus 2025 conference.
Results from the Phase 1 trial demonstrated a favorable safety and tolerability profile as well as dose-proportional pharmacokinetics and CNS penetration.
Previously, the Company presented data from the Phase 1 clinical trial of ATH-1105 at the 4th Annual ALS Drug Development Summit. Key highlights from the presentation included:
ATH-1105 showed a favorable safety profile and was well tolerated in both single and multiple ascending dose studies in healthy volunteers
ATH-1105 showed dose proportional pharmacokinetics and central nervous system (CNS) penetration
ATH-1105 demonstrated consistent and robust beneficial effects in preclinical models of ALS
LeonaBio conducted the first-in-human Phase 1 double-blind, placebo-controlled clinical trial that enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of ATH-1105. The study was completed in November 2024 and evaluated the safety and tolerability of ATH-1105 and included measurements of pharmacokinetic outcomes.
ATH-1105’s potential is supported by a body of preclinical evidence demonstrating statistically significant improvements in nerve and motor function, biomarkers of inflammation and neurodegeneration, including neurofilament light chain and survival in various models of ALS.
LeonaBio is on track to dose ALS patients in a Phase 2 proof-of-concept clinical trial in the second half of 2026.
Corporate Updates

In February 2026, Mark F. Kubik was appointed as Chief Business Officer of LeonaBio, with responsibility for licensing, partnership strategy and corporate development initiatives.
In January 2026, LeonaBio changed its name from Athira Pharma to align with the Company’s transformative acquisition of rights to develop and commercialize lasofoxifene as a treatment for metastatic breast cancer and better reflect its commitment to continued leadership, resilience and innovation.
In December 2026, the Company acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene, a selective estrogen receptor modulator (SERM) for the potential treatment of metastatic breast cancer.
In conjunction with the Sermonix license agreement, LeonaBio announced a $90 million private placement financing of common stock and warrants, with the warrants providing, if exercised, up to an additional $146 million to support development through key clinical and regulatory milestones.
Financial Results

Cash Position. Cash, cash equivalents and investments were $88.3 million as of December 31, 2025, compared to $51.3 million as of December 31, 2024. Net cash used in operations was $45.7 million for the year ended December 31, 2025, compared to $97.2 million for the year ended December 31, 2024.
Research and Development (R&D) Expenses. R&D expenses were $85.6 million for the year ended December 31, 2025, compared to $70.7 million for the year ended December 31, 2024. The increase was driven primarily by acquired in-process research and development costs related to our license of lasofoxifene.
General and Administrative (G&A) Expenses. G&A expenses were $16.7 million for the year ended December 31, 2025, compared to $26.1 million for the year ended December 31, 2024. The decrease was driven primarily by a realization of cost efficiencies in 2025 as we pursued our strategic alternatives.
Net Loss. Net loss was $105.6 million, or $24.70 per share, for the year ended December 31, 2025, compared to a net loss of $96.9 million, or $25.19 per share, for the year ended December 31, 2024.

(Press release, LeonaBio, MAR 26, 2026, View Source [SID1234663961])

On March 26, 2026 Agilent Technologies Inc. (NYSE: A) reported that it has received U.S. Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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PD-L1 IHC 22C3 pharmDx, Code SK006, is the only FDA-approved companion diagnostic indicated to identify patients with esophageal or GEJ carcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) ≥ 1) who may be eligible for treatment with KEYTRUDA. This approval marks the eighth FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.

"With the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in esophageal or GEJ carcinoma, Agilent is proud to support clinicians in identifying patients eligible for treatment with KEYTRUDA," said Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division. "This milestone reinforces Agilent’s commitment to advancing precision medicine and underscores its leadership in delivering trusted companion diagnostics that help enable treatment with anti-PD-1 therapies."

In addition to esophageal or GEJ carcinoma, PD-L1 IHC 22C3 pharmDx, Code SK006, is also indicated to help physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), gastric or GEJ adenocarcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) who may benefit from treatment with KEYTRUDA.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1).

In 2025, esophageal cancer caused approximately 16,250 deaths in the United States, with a 5-year relative survival rate of 21.9 percent.3

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Agilent, MAR 26, 2026, View Source [SID1234663960])

On March 26, 2026 Novocure (NASDAQ: NVCR) reported positive results from the Phase 2 PANOVA-4 trial of Tumor Treating Fields (TTFields) therapy concomitant with atezolizumab (Tecentriq), gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC).

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PANOVA-4 met its pre-specified primary endpoint, achieving a statistically significant improvement in disease control rate (DCR) compared to the DCR reported in the Phase 3 MPACT study used as the historical control.1 The DCR in patients treated with TTFields therapy concomitantly with atezolizumab and gem/nab-pac (N=78) was 74.4% compared to a DCR of 48% in patients receiving gem/nab-pac alone (N=431) in the historical control (difference = 26.4%, 1-sided p-value < 0.001).

"The positive results from the PANOVA-4 trial further support the potential of Tumor Treating Fields to improve outcomes in pancreatic cancer," said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. "We are grateful to the patients, caregivers, and investigators whose dedication made this trial possible, and we look forward to evaluating the full results from PANOVA-4 as we advance Tumor Treating Fields therapy as a treatment for metastatic pancreatic cancer."

In the PANOVA-4 trial, DCR was defined as the proportion of patients who had either stable disease (SD) for at least 16 weeks or confirmed partial response (PR) or complete response (CR) according to the Response Evaluation Criteria in Solid Tumours (RECIST v1.1).

Secondary endpoints in PANOVA-4 include objective response rate (ORR) and overall survival (OS). The ORR in patients treated with TTFields therapy concomitantly with atezolizumab and gem/nab-pac was 34.6% (95% CI, 24.2% – 46.2%) and median OS was 9.7 months (95% CI, 7.9 – 12.7 months). Additional secondary endpoints were progression-free survival, one-year survival rate, progression-free survival at six months, duration of response, and rate of patients with treatment emergent adverse events.

Median TTFields therapy duration was 25.6 weeks and median systemic therapy treatment was six cycles for atezolizumab and gem/nab-pac. TTFields therapy was well-tolerated, and device related safety was consistent with prior clinical studies.

Novocure plans to present additional results from PANOVA-4 at a future scientific forum.

About Pancreatic Cancer

Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S. While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing. It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S. Pancreatic cancer has a five-year relative survival rate of just 13%.2

Physicians use different combinations of surgery, radiation, and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with metastatic disease, the standard of care is systemic chemotherapy supplemented by palliative radiotherapy, as needed, and clinical trial participation is encouraged.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and it demonstrated enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit novocure.com/ttfields.

(Press release, NovoCure, MAR 26, 2026, View Source [SID1234663959])