On March 27, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The filing will follow a standard review timeline.

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Taletrectinib (marketed as IBTROZI in the U.S. and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC. In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Following this filing to the EMA, additional filings are planned for the U.K., Canada and other regions included in Eisai’s licensed territories.

Across Europe, nearly 400,000 people are diagnosed with lung cancer each year, with NSCLC accounting for 80% of cases. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.

"The validation of the MAA is a significant moment for patients in Europe with ROS1+ NSCLC," said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. "With its efficacy and safety profile, we believe taletrectinib has the potential to become a standard of care therapy for the thousands of patients living with this aggressive disease in Europe. We look forward to working closely with the EMA during the review process with the goal of making this treatment available to appropriate patients who urgently need targeted options."

The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were published in the Journal of Clinical Oncology in April 2025, and Nuvation Bio anticipates near-term disclosure of updated data reflecting even longer patient follow-up, further building on the depth and durability of responses observed to date. Additionally, given the comprehensive nature of the taletrectinib clinical dataset and based on favorable feedback received at a pre-submission meeting with the CHMP Rapporteur and Co-Rapporteur, the accepted MAA will be considered to support full approval.

"Having seen the meaningful impact taletrectinib has already made for patients with ROS1+ NSCLC in the U.S., China and Japan, we are thrilled to partner with Eisai and have an accepted MAA for review in Europe," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "This accepted filing represents an important milestone in our global development strategy and brings us one step closer to delivering this highly selective, next-generation oral therapy to more patients who need it in Europe and around the world."

In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON.

* Eisai’s licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About Taletrectinib
Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

(Press release, Eisai, MAR 27, 2026, View Source [SID1234663939])

On March 26, 2026 Alphamab Oncology (stock code: 9966.HK) reported financial results for the full year ended December 31, 2025 and highlighted recent business progress.

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(Press release, Alphamab, MAR 26, 2026, View Source [SID1234669266])

On March 26, 2026 CStone Pharmaceauticals reported 2025 Annual Results.

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(Press release, CStone Pharmaceauticals, MAR 26, 2026, View Source [SID1234669263])

On March 26, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported it will host a business update conference call at 11:30 a.m. Eastern Time.

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The call will highlight new analysis from its Phase 2 SkinJect study, including an overall response rate (ORR) of 80% in the 200µg cohort at Day 57, and outline the Company’s planning toward an agentic AI–enabled clinical development platform.

The Company believes these results position the 200µg cohort as the leading dose regimen in the study, demonstrating the highest activity observed to date with continued improvement through Day 57.

Conference Call Details

Time: 11:30 a.m. ET
Pre-registration: View Source
Dial-in. (US/Canada): 833-890-6070
Dial-in. (International): 412-504-9736
Q&A Web Link: View Source
The Key Highlights to be presented at the conference call are:

Independent Clinical Perspective — Dr. Babar Rao (Principal Investigator)

The call will feature Dr. Babar Rao, an internationally acclaimed dermatology key opinion leader and Principal Investigator of the SKNJCT-003 study, who will provide an independent clinical interpretation of the dataset.

Dr. Rao is a board-certified dermatologist and dermatopathologist, and currently serves as:

Professor of Dermatology and Pathology, Rutgers Robert Wood Johnson Medical School
Clinical Associate Professor of Dermatology, Weill Cornell Medical College
He has authored over 200 peer-reviewed publications and has served as principal investigator in multiple dermatology clinical trials.

Dr. Rao is expected to highlight:

The clinical significance of 73% clearance at Day 57 in the 200µg cohort
A clear separation versus device-only active control, supporting incremental drug effect
The role of:
Microneedle-mediated tumor disruption
Local immune activation and wound-healing pathways
Importantly, Dr. Rao is expected to place these findings in the context of the broader basal cell carcinoma (BCC) treatment landscape:

BCC is the most common cancer worldwide, with millions of new cases diagnosed annually in the United States alone
Standard treatments such as Mohs surgery, while effective, are capacity constrained.
As a result, there is a significant treatment backlog, where patients may face delays or undergo procedures that may not be immediately necessary.

Dr. Rao is expected to emphasize:

The observed ~73% clinical clearance suggests that approximately three out of four treated lesions may achieve visual resolution, which in clinical practice could allow many patients to defer or avoid immediate surgical intervention.

If confirmed in future studies, this approach may:

Reduce procedural burden on healthcare systems
Improve patient access to care
Allow prioritization of surgical resources for higher-risk or refractory cases
He is also expected to reinforce that:

The dataset is clinically meaningful
Supports continued development and regulatory engagement
May be impactful in Gorlin Syndrome and other high-burden populations
Phase 2 Data Deep Dive — 200µg Cohort (Day 57)

Medicus will present expanded analysis of the 15-patient 200µg cohort, which demonstrated the highest activity in the study:

73% Clinical (visual) clearance
40% Histological complete response (CR)
80% Overall Response Rate (CR + partial response) with potential to exceed this level pending final Clinical Study Report (CSR)

Previously reported Topline results of the study, along with additional preliminary dataset representing partial response (PR) and over-all response rate (ORR) for each cohort, are tabulated which demonstrates that clearance rates increased between Day 29 and Day 57, consistent with continued biological activity over time.

Table 1. SKNJCT-003 Phase 2 topline Data by Treatment Arm

Treatment Arm (n) Day 29 post-treatment (n) Day 57 post-treatment
47 CC CR PR* ORR* 43 CC CR PR* ORR*
200 μg D-MNA 15 40% 27% 20% 47% 15 73% 40% 40% 80%
C-MNA 15 33% 20% 20% 40% 16 38% 38% 6% 44%
100 μg D-MNA 17 47% 24% 29% 53% 12 42% 33% 42% 75%

*Preliminary -pending final CSR (Clinical Study Report)
C-MNA: Microneedle device-only control arm, D-MNA: Doxorubicin-loaded microneedle array n:number of patients, CC: Clinical Clearance, CR: Histological Clearance, PR: Partial Response, ORR: Overall Response Rate

The Company will also highlight:

Continued improvement from Day 29 to Day 57, supporting a durable and evolving treatment effect
Evidence of biological activity across responders and partial responders
CEO Strategic and Clinical Positioning — Dr. Raza Bokhari

Dr. Raza Bokhari, Chairman and Chief Executive Officer, is expected to outline:

That the Phase 2 study was a proof-of-concept study "exploratory" study primarily designed to evaluate clinical (visual) clearance, with the objective of addressing a large unmet need and helping relieve the treatment backlog in basal cell carcinoma.
That refinement of histological clearance endpoints is expected to be a focus of registrational study design discussions at the planned End-of-Phase 2 (EOP2) meeting with the FDA
The Company’s view that the dataset is decision-grade and supports regulatory and business partnership engagement
He is also expected to discuss:

Optimization strategies focused on the 200µg dose
Treatment duration and repeat dosing strategies
And position the broader opportunity:

Addressing a large and underserved BCC patient population
Positioning SkinJect as a minimally invasive alternative to surgery
Expansion into Gorlin Syndrome and additional indications
Advancing Toward Agentic AI–Enabled Drug Development

The Company is expected to highlight its planning toward an Agentic AI–driven clinical development platform

Designed to:

Optimize clinical trial design and protocol simulation
Enable dynamic site selection and enrollment forecasting
Improve patient stratification and dose optimization
Increase capital efficiency and probability of success
Financial Position and Capital Strategy — Carolyn Bonner, CFO

Carolyn Bonner, President and Chief Financial Officer, is expected to provide an update on:

Approximately $31.9 million raised during 2025
$8.7 million in cash and cash equivalents at year-end 2025
Continued disciplined investment in clinical development
She is expected to emphasize alignment of capital strategy with key upcoming value inflection points, including:

Regulatory engagement
Clinical data maturation
Strategic partnering opportunities
Position Entering a Catalyst-Rich 2026

The Company believes it is entering a catalyst-rich period, including:

End-of-Phase 2 FDA meeting (SkinJect)
Potential registrational pathway alignment
Initiation of Phase 2b Teverelix study
Expansion into women’s health (endometriosis)
Advancement of AI-enabled development platform
Ongoing strategic partnering discussions

(Press release, Skinject, MAR 26, 2026, View Source [SID1234663964])

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])