Agendia to Present New Data Demonstrating the Expanded Clinical Utility of MammaPrint® and BluePrint® at the 2026 ESMO Breast Cancer Annual Congress

On April 30, 2026 Agendia, Inc., a leader in precision oncology for breast cancer, reported it will present new data at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress on Breast Cancer, taking place May 6-8 in Berlin, Germany. The company will present two posters featuring data from the prospective FLEX Study and an independent post hoc analysis of the landmark MINDACT trial that underscore the prognostic value of MammaPrint + BluePrint in early-stage breast cancer (EBC).

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Poster #65P | Thursday, May 7, 13:15 – 14:15 p.m. CEST | Presenter: Elena Shagisultanova

Prognostic Performance of MammaPrint in Patients with Small T1a, b, and c Node-Negative Early Breast Cancer

A retrospective analysis from the FLEX Study involving 4,349 patients highlights the biological heterogeneity within small, node-negative (T1a, b, and c) tumors – a group that typically has favorable outcomes.

MammaPrint (MP) identified a High Risk 2 (H2) subset, representing 10% of all patients and 5% of those with HR+HER2- disease who experienced significantly worse recurrence-free survival (RFS) compared to those with High-Risk 1 (H1) or Low/UltraLow Risk (LR/UL) tumors.
Among all patients, the 3-year RFS was 93% for MP H2 versus 98% for the LR/UL group, while in the HR+HER2- subgroup, MP H2 tumors had a 3-year RFS of 91% compared to 98% for the LR/UL group.
These findings highlight the prognostic value of MP in clinically small EBC, suggesting that a subset of T1N0 patients may benefit from escalated therapy or biology-informed treatment approaches.
"These findings highlight the prognostic value of MammaPrint in small, node-negative breast cancers," said William Audeh, MD, Chief Medical Officer of Agendia. "While this group of patients are generally regarded as having a favorable prognosis, our data reveal a distinct subset with high-risk biology who may benefit from escalated therapy and biology-informed treatment approaches that might have otherwise been overlooked based on tumor size alone."

Poster #71P | Thursday, May 7, 13:15 – 14:15 p.m. CEST | Presenter: Giacomo Biganzoli

Associations of body mass index with distant recurrence dynamics in the MINDACT trial

This exploratory analysis from the MINDACT trial, co-authored by Agendia co-founder and MammaPrint inventor Laura van ‘t Veer, PhD, analyzed the relationship between body mass index (BMI) and distant metastasis risk (DMR) dynamics in ER+/HER2- breast cancer.

Higher BMI was not linearly associated with worse outcomes in this cohort; patients with obesity showed a lower DMR (HR 0.36) compared to those with normal weight.
For patients with a BMI between 24–28, DMR dynamics showed a peak at 6 years, followed by a rapid decline.
The non-monotonic relationship between DMR and BMI warrants further investigation in large trials to optimize time-dependent management strategies.

(Press release, Agendia, APR 30, 2026, View Source [SID1234664990])

AC Immune First Quarter 2026 Financial and Corporate Updates

On April 30, 2026 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, reported financial and corporate updates for the quarter ended March 31, 2026.

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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "The progress in our collaborations with Takeda and Eli Lilly reflect great confidence in our anti-Abeta active immunotherapy and Tau aggregation inhibitor small molecules, respectively. These have the potential to change the way we target the proteinopathies that drive Alzheimer’s and other neurodegenerative diseases (NDDs). This is further exemplified by the presentation of the interim results for ACI-7104 at AD/PD 2026 showing that our active immunotherapy targeting a-synuclein (a-syn) has the potential to modify disease pathology in Parkinson’s disease (PD). We also advanced our NLRP3 inhibitor ACI-19764 into clinical development, further demonstrating the power of AC Immune’s technology to target the key pathways that contribute to neurodegeneration.

"We are now moving towards multiple value inflection points during 2026. These include Phase 2 data readouts on our active immunotherapies ACI-7104 and ACI-24, and initial results from the Phase 1 trial of ACI-19764 also anticipated this year."

Q1 2026 and Subsequent Highlights:

ACI-24 anti-Abeta active immunotherapy

· As announced separately today, AC Immune has initiated the final cohort, AD4, in the ongoing Phase 1b/2 ABATE trial of ACI-24 to treat Alzheimer’s Disease

· Treatment of the first patient in cohort AD4 triggers a $12 million milestone payment from Takeda

Morphomer-Tau small molecule program

· Amended agreement with Eli Lilly and Co. (Lilly) reflects growing excitement for targeting intracellular Tau and significant progress with our Morphomer small molecules

· The amendment continues the research and collaboration to cover development of new lead Tau Morphomer candidates and potential back-up compounds.

· Under this amendment, AC Immune receives a CHF10 million upfront payment (Q2 2026 event) and a subsequent milestone payment subject to Phase 1 dosing, in addition to milestones announced in a prior amendment. AC Immune is eligible for further development, regulatory and commercial milestones of over CHF1.7 billion, plus tiered percentage royalty payments in the low double digits, as previously disclosed.

· Investigational New Drug (IND)-enabling studies are expected to be initiated imminently.

ACI-7104, anti-a-syn active immunotherapy

· Presented updated interim results from Part 1 of the Phase 2 VacSYn clinical trial in early-stage Parkinson’s disease at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2026), including promising biomarker data.

· Interim results previously presented include changes in biomarkers and clinical measures all suggesting potential disease modification through treatment with ACI-7104

· Final results for the week 104 full data set from Part 1 of the VacSYn trial expected to be reported in H2 2026.

NLRP3 inhibitor, ACI-19764, small molecule program

· Dosed the first subjects in a Phase 1 clinical trial of ACI-19764, a brain-penetrant Morphomer small molecule targeting the NLRP3 inflammasome.

· Morphomer NLRP3 inhibitors have potential to intervene at the earliest stages of disease in neurodegenerative conditions, including AD, PD, amyotrophic lateral sclerosis (ALS) and frontotemporal dementia.

· Potential additional indications include inflammatory disorders, cardiovascular disease, metabolic disorders, skin inflammatory diseases, and certain rare diseases, among others.

ACI-35 (JNJ-2056) anti-pTau active immunotherapy

· AC Immune’s partner Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, is seeking a protocol amendment for the ReTain study to enable earlier insights into the biological activity of JNJ-2056 and its potential for clinical benefit. Submissions to all relevant health authorities are ongoing.

· The study remains active, with enrollment paused, and there is no change for enrolled participants at this time.

· The study is ongoing based on ~60 enrolled patients with a minimum of 12 months and up to 24 months of treatment and follow-up.

TDP-43 PET tracer

· Presented Phase 1 data including the first in vivo images of TDP-43 pathology in the human brain, detected using its first-in-class positron emission tomography (PET) tracer ACI-19626, at the International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD 2026).

· Initial Phase 1 data (PET scans) with ACI-19626 showed that tracer uptake was significantly higher in key regions of the brain in patients with frontotemporal dementia (FTD) and we are currently evaluating the tracer in ALS patients.

· Clinical data indicate a pharmacokinetic (PK) profile suitable for human brain imaging and potentially pharmacodynamic analysis of therapeutics targeting TDP-43 pathology.

AC Immune AD/PDTM 2026 symposium

· Hosted an industry symposium on achieving precision prevention in Parkinson’s disease, highlighting Phase 2 clinical data on our ACI-7104 active immunotherapy, our small molecule programs targeting intracellular alpha-synuclein, and innovative diagnostic approaches to identifying at-risk individuals.

Anticipated 2026 Milestones

Program Milestone Expected in
ACI-7104.056
anti-a-syn active immunotherapy Final data from Part 1 of the Phase 2 VacSYn trial in PD H2 2026
ACI-24.060
anti-Abeta active immunotherapy Interim results from ABATE Phase 2 trial after reaching 12-month treatment timepoint in the AD3 cohort H1 2026
ACI-19764
NLRP3 inhibitor Results from Phase 1 trial in healthy volunteers H2 2026
Morphomer-Tau aggregation inhibitors Initiation of IND-enabling studies H1 2026
Morphomer a-syn aggregation inhibitor Lead declaration H1 2026

Analysis of Financial Statements for the Quarter Ended March 31, 2026

· Cash Position: The Company had total cash resources of CHF 74.8 million (CHF 91.4 million as of December 31, 2025), composed of CHF 19.2 million in cash and cash equivalents and CHF 55.6 million in short-term financial assets. The Company’s cash resources are expected to provide sufficient capital to last into Q4 2027, excluding potential milestone payments.

· R&D expenditures: R&D expenses for the three months ended March 31, 2026, were CHF 11.8 million, compared with CHF 15.9 million for the comparable period in 2025. The decrease was partly due to lower personnel and operational spend of approximately CHF 1.7 million as a result of our pipeline focus initiatives announced in Q3 2025, as well as lower spend associated with our active immunotherapy programs, particularly in the upfront CMC costs prior to initiation of phase 2 studies.

· G&A expenditures: G&A expenses in the period were CHF 4.2 million in the period ended March 31, 2026, compared to CHF 4.4 million for same period in 2025.

· Financial result: The financial result was a loss of less than CHF 0.1 million for the period, compared with a gain of CHF 0.3 million for the comparable period. The change was primarily driven by a decrease in interest income earned on short-term financial assets, partially offset by lower foreign exchange losses.

· IFRS loss for the period: The Company had a net loss of CHF 14.8 million for the period ended March 31, 2026, compared to CHF 19.0 million for the same period in 2025.

(Press release, AC Immune, APR 30, 2026, View Source [SID1234664957])

OXC-101 for AML accepted to be presented at EHA

On April 30, 2026 Oxcia AB reported that the abstract "Interim results of the phase I/II study investigating karonudib in patients with refractory hematological malignancies paired with ex-vivo precision screen drug sensitivity screening" has been selected by the European Hematological Association (EHA) (Free EHA Whitepaper) Scientific Program Committee for a poster presentation during the EHA (Free EHA Whitepaper)2026 Congress. The congress takes place in Stockholm this year, June 11-14th. Stefan Deneberg, Principal Investigator of the clinical study and Austin Smith, Oxcia’s Chief Medical Officer, will present the interim results.

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The overall aim of the clinical study is to build on early encouraging signals of clinical activity and generate the data required to support a pivotal Phase II program in Acute Myeloid Leukemia. The on-going expansion group in the OXC-101 and idarubicin combination has expanded to Denmark and Serbia to facilitate timely recruitment.

OXC-101 (karonudib) has, as previously communicated, been granted ODD status by both the EMA and the FDA for Acute Myeloid Leukemia.

(Press release, Oxcia, APR 30, 2026, View Source;utm_medium=rss&utm_campaign=oxc-101-for-aml-accepted-to-be-presented-at-eha [SID1234664973])

Curocell’s RIMQARTO Inj. Wins Full Regulatory Approval, Poised to Enter CAR-T Market with 67% Complete Response Rate

On April 30, 2026 Curocell (KOSDAQ: 372320) reported that RIMQARTO Inj. (anbalcabtagene autoleucel), South Korea’s first domestically developed CAR T-cell therapy, has secured full regulatory approval from the Ministry of Food and Drug Safety (MFDS) on April 29. With this approval, RIMQARTO becomes the 42nd drug domestically developed under the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products for manufacture and sale. This represents the first commercialization of CAR T-cell therapy by a Korean company.

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The CAR T-cell therapy is a personalized autologous T-cell immunotherapy in which a patient’s immune cells are genetically modified to selectively target cancer cells. RIMQARTO has drawn attention as a next-generation CD19 CAR T-cell therapy powered by Curocell’s proprietary OVIS (Overcome Immune Suppression) technology. This technology is designed to regulate immunosuppressive signals in the tumor microenvironment, addressing "T-cell exhaustion," and enabling more sustained anticancer activity over the long term.

RIMQARTO is indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adults following two or more lines of systemic therapy.

In the pivotal Phase 2 trial supporting the approval, RIMQARTO achieved an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%. The therapy also showed its safety profile, with cytokine release syndrome (CRS), a key adverse event associated with CAR T-cell therapy, reported in 10% of patients, and immune effector cell-associated neurotoxicity syndrome (ICANS) reported in 5%.

Although RIMQARTO was initially submitted for conditional approval, the MFDS waived the requirement for Phase 3 trial data during the review process, taking into account its use as a third-line treatment for lymphoma and its classification as a novel CAR T-cell therapy. As with other global CAR T-cell therapies, the approval is subject to long-term follow-up studies and risk management plans to monitor the therapy’s safety and efficacy.

The approval reflects the combined impact of the MFDS’s expedited review framework and full-cycle support from government R&D programs. RIMQARTO was developed with support from the Ministry of Health and Welfare (MOHW) R&D program and the Korea Drug Development Fund. In addition, the MFDS’s "Bio-Challenger Program" for advanced biopharmaceuticals and RIMQARTO’s "Global Innovative Products on Fast Track" (GIFT) and fast-track processing designations enhanced both efficiency and speed throughout the development and approval review processes.

RIMQARTO was also selected for the MOHW’s "Concurrent Pilot Program for Approval-Evaluation-Negotiation," which is expected to shorten the timeline from its approval to national health insurance reimbursement listing.

Curocell CEO Kim Gun-soo said, "The latest approval is a milestone in Korea’s new drug development history. We would like to express our gratitude to everyone who has worked tirelessly to make this achievement possible. We have been researching because CAR T-cell technology was not available in Korea. We have now secured our first new drug approval. With the capabilities and experience accumulated so far, we are committed to advancing the global success of Korea’s CAR-T technology."

Building on RIMQARTO, Curocell plans to pursue indication expansion, global market entry, and the development of next-generation pipelines, while further demonstrating the scalability of its CAR-T platform by expanding into solid tumors and autoimmune diseases.

(Press release, Curocell, APR 30, 2026, View Source [SID1234664991])

Strong revenue growth and positive readouts from high-value NMEs reinforce confidence in 2030 ambition

On April 29, 2026 Astrazeneca reported strong revenue growth and positive readouts from high-value NMEs reinforce confidence in 2030 ambition.

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Pascal Soriot, CEO of AstraZeneca:
"We delivered strong growth in Q1 2026, with Total Revenue above $15 billion, demonstrating our consistent commercial execution. We are advancing through our catalyst‑rich period, with positive readouts for four high-value Phase III programmes since our last quarterly results, including first pivotal data for two key new molecular entities (NMEs)."

(Press release, AstraZeneca, APR 29, 2026, View Source [SID1234664869])