On May 26, 2026 Hologic, Inc. and its subsidiary, Biotheranostics, Inc., reported new data demonstrating how the Breast Cancer Index (BCI) Test results influence extended endocrine therapy decisions for patients with early-stage, hormone receptor-positive (HR+) breast cancer. According to the latest analysis, physician recommendations for extended endocrine therapy increased by more than 30% among patients identified by the BCI Test as likely to benefit, while recommendations decreased by nearly 40% for those identified as unlikely to benefit.

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The BCI Test is the established test for extended endocrine therapy decision-making, with exclusive guideline recognition from the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) for this purpose. Both classify the BCI Test as the only genomic assay shown to predict who is likely to benefit from extended endocrine therapy beyond five years.2,3

More information on these findings will be presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting on June 1. The data come from a new analysis of the ongoing BCI Registry Study, which evaluates how physicians incorporate prognostic and predictive BCI Test results into real-world treatment decisions.

"Understanding who is likely to benefit from extended endocrine therapy is critical to personalizing care," said Sami Diab, M.D., Medical Director, Oncology at Hologic. "Findings from the BCI Registry Study continue to highlight the real-world impact of the Breast Cancer Index Test in helping physicians make more informed treatment recommendations for their patients."

Detailed findings from the analysis include:

Overall:
The percentage of patients recommended for extended endocrine therapy decreased from 54.6% before BCI testing to 41.2% after BCI testing.
The percentage of patients not recommended for extended endocrine therapy increased from 44.9% before testing to 58% after testing.
Among patients identified by the BCI Test as likely to benefit from extended endocrine therapy (BCI H/I-High):
Physician recommendations for extended endocrine therapy increased from 60.4% before testing to 90.6% after testing.
Among patients identified as unlikely to benefit (BCI H/I-Low):
Recommendations decreased from 51.1% to 11.8%.
"Decisions about extended endocrine therapy are complex, requiring physicians to balance recurrence risk, potential side effects, and clinical and pathologic factors," said Tara B. Sanft, M.D., of Hartford Healthcare and lead author of the study. "Findings from the BCI Registry Study suggest that relying on those factors alone may not provide enough information for physicians and patients to make decisions with confidence. Genomic testing with the Breast Cancer Index Test provides additional insight into tumor biology, helping physicians refine extended endocrine therapy recommendations and better identify which patients are most likely to benefit."

Learn more on June 1, 2026, 1:30-4:30 p.m. CDT at ASCO (Free ASCO Whitepaper) 2026: Impact of the Breast Cancer Index on Extended Endocrine Therapy Recommendations in Patients from the BCI Registry Study1 (Abstract #527/Poster Board #12 — Breast Cancer — Local/Regional/Adjuvant)

About the Breast Cancer Index Test

The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment.

The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.2,3

The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com.

(Press release, Hologic, MAY 26, 2026, View Source [SID1234666072])

On May 26, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported a clinical trial collaboration and supply agreement with Bayer AG ("Bayer") to evaluate OP-3136, Olema’s investigational lysine acetyltransferase 6 (KAT6) inhibitor, in combination with NUBEQA (darolutamide), Bayer’s androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1b/2 study is designed to assess the safety, tolerability, and preliminary anti-tumor activity of OP-3136 in combination with darolutamide in approximately 36 patients with mCRPC.

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"We are very pleased to partner with Bayer to explore the combination of OP-3136 with darolutamide in metastatic castration-resistant prostate cancer, which is an aggressive disease characterized by poor clinical outcomes," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "This agreement represents the first clinical collaboration for OP-3136 and builds upon our ongoing Phase 1/2 study of this novel KAT6 inhibitor as a monotherapy in multiple solid tumor types and in combination with fulvestrant and palazestrant in ER+/HER2- metastatic breast cancer. We look forward to advancing OP-3136 in combination with darolutamide in the clinic as we work to bring better medicines to patients living with cancer."

Under the terms of the agreement, Bayer will supply darolutamide for use in the Phase 1b/2 study and Olema will lead the conduct of the study. All clinical data and inventions related to the combined use of OP-3136 and darolutamide will be jointly owned. Olema will maintain full global commercial and marketing rights to OP-3136.

As previously announced, Olema will present initial clinical data from the Phase 1 study of OP-3136 in a poster presentation on May 30, 2026 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.

(Press release, Olema Oncology, MAY 26, 2026, View Source [SID1234666057])

On May 26, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that 37 abstracts have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The event will take place May 29 – June 3, 2026 in Chicago, Illinois.

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"This year’s ASCO (Free ASCO Whitepaper) Annual Meeting marks a significant milestone for Tempus, as we are presenting our largest collection of accepted research to date, further underscoring the critical role that multimodal data and AI-driven insights play in advancing precision medicine across oncology," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "The breadth of our findings demonstrates the tangible impact of these tools in transforming complex real-world data into actionable evidence, helping more patients benefit from the next generation of innovative therapies."

Research highlights include:

Saturday, May 30, 2026
9:00am – 12:00pm CT

Impact of AI-augmented histopathology review on next-generation sequencing (NGS) success
Poster Board: 536; Abstract Number: 1618

AI-driven RNA-based homologous recombination deficiency algorithm to predict first-line platinum response in metastatic pancreatic cancer.
Poster Board: 193; Abstract Number: 4210

1:30 pm – 4:30 pm CT

ESR1 mutation longitudinal dynamics in RWD cohort of HR+/HER2- metastatic breast cancer patients treated with standard of care hormonal therapy
Poster Board: 199; Abstract Number: 3062

First-line lenvatinib versus dabrafenib plus trametinib (D+T) in BRAF-mutated differentiated thyroid cancer (DTC): Insights from real-world data.
Poster Board: 509; Abstract Number: 6052

Real-world characterization of SEZ6, a transmembrane protein expressed in various solid tumors
Poster Board: 219; Abstract Number: 3082

Sunday, May 31, 2026
9:00am – 12:00pm CT

Multi-center prospective study evaluating an AI-enabled clinical decision support tool to improve early-stage NSCLC biomarker testing
Poster Board: 518; Abstract Number: 8044

Monday, June 1, 2026
9:00 am – 12:00 pm CT

Whole genome sequencing to identify novel, clinically relevant findings missed by standard of care for patients with myelodysplastic syndrome
Poster Board: 363; Abstract Number: 6570

1:30 pm – 4:30 pm CT

GEMINI-BREAST: Evaluating minimal residual disease (MRD) through longitudinal circulating tumor DNA (ctDNA) profiling in breast malignancies
Poster Board: 130b; Abstract Number: TPS649

Explore the full scope of Tempus-authored research and discover how the company is advancing precision medicine at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting here.

(Press release, Tempus, MAY 26, 2026, View Source [SID1234666073])

On May 26, 2026 Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, reported that it has entered into an agreement with K2 HealthVentures LLC ("K2HV"), an alternative investment firm that provides flexible, long-term financing solutions in life sciences, to provide a credit facility of up to $150 million including an initial $50 million tranche. The proceeds from the initial tranche under the credit facility are expected to allow the Company to accelerate the ongoing investment in the commercial launch preparation activities for Descartes-08 in myasthenia gravis (MG) and myositis and to extend cash runway into 2028. The Company also announced progress across its pipeline, including updated timelines for all ongoing trials of Descartes-08, an autologous anti-B cell maturation antigen (BCMA) mRNA chimeric antigen receptor T-cell therapy (CAR-T).

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"We are very excited to partner with K2 HealthVentures for this financing, which we expect to provide us with access to the additional capital necessary to help support our continued growth. With this additional financing, we believe we are now fully funded beyond anticipated timelines for achievement of three near-term clinical catalysts, including topline data from our Phase 3 AURORA trial in MG in the first quarter of 2027, data from our Phase 2 TRITON trial in myositis and data from our Phase 1/2 HELIOS trial in JDM," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. "Descartes-08 remains the only CAR-T in autoimmune disease that we are aware of that is designed for outpatient administration without preconditioning chemotherapy, and our prior data demonstrate deep and durable responses after a single course of therapy. We look forward to advancing Descartes-08 toward registration and commercial launch in MG."

Cash Runway and Credit Facility

Under the Company’s credit facility with K2HV, the first $50 million term loan was funded upon signing of the agreement. The second $25 million term loan is expected to be available to be drawn between January 1, 2027 and December 1, 2027, subject to the Company’s achievement of specified clinical and financing milestones and the third $25 million term loan is expected to be available to be drawn between January 1, 2028 and June 1, 2028, subject to the Company’s achievement of specified approval and sales milestones. An additional $50 million tranche is available for draw at Cartesian’s option subject K2 HealthVentures’ discretion. Morgan Stanley served as sole structuring agent for the transaction.

The Company now anticipates current cash resources to support planned operations into 2028, including three clinical data readouts and accelerated investment in precommercial activities.

Multiple Clinical Catalysts Expected over the Next 12 Months

Phase 3 AURORA data in MG expected in 1Q27; biologics license application (BLA) filing planned for mid-2027
Phase 2 TRITON data in myositis expected in 1H27
Phase 1/2 HELIOS data in juvenile dermatomyositis (JDM) expected in 1H27
Phase 3 AURORA Trial in MG

The Company anticipates reporting topline data from the Phase 3 AURORA trial in the first quarter of 2027 with BLA filing planned for mid-2027.
The randomized, double-blind, placebo-controlled trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo (a two-point reduction in MG-ADL is considered clinically meaningful).
In January 2026, the Company published a peer-reviewed journal article in Nature Medicine outlining the efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with MG. After a single course of therapy, Descartes-08-treated participants were observed to sustain deep responses through long-term follow-up, with an average 4.8-point reduction in MG-ADL at Month 12. The deepest and most compelling sustained responses were observed in Descartes-08-treated participants who did not have prior exposure to biologic therapies, with an average 7.1-point reduction in MG-ADL and 57% of patients in this subgroup maintaining minimum symptom expression at Month 12. The safety profile of Descartes-08 was consistent with previously reported data and continues to support outpatient administration.
Phase 2 TRITON Trial in Myositis

Cartesian expects to evaluate clinical data from a subset of patients from the trial in the first half of 2027 to determine the path to a pivotal trial in these indications with significant unmet need.
The Phase 2 TRITON trial of Descartes-08 was initiated in April 2026, and enrollment continues to progress well. The randomized, double-blind, placebo-controlled trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is expected to assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis at Week 24.
Phase 1/2 HELIOS Trial in JDM

Clinical data from the Phase 1/2 HELIOS pediatric trial is expected in the first half of 2027.
The Phase 1/2 HELIOS trial of Descartes-08 in JDM was initiated in January 2026 and is designed to assess the safety, tolerability and efficacy of Descartes-08 in children, adolescents and young adults with childhood-onset autoimmune diseases, including JDM. The U.S. Food and Drug Administration (FDA) previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM.
Corporate Updates

Chief Medical Officer (CMO), Miloš Miljković, has informed the Company that he intends to step down from his role for personal reasons to return to practicing medicine. Dr. Miljković has helped support the development of both Descartes-08 and Cartesian through the Company’s transition from an early-stage research and development company to a late-stage clinical company.

Peter Traber, MD, Cartesian’s Head of R&D, who assisted in directing the Company’s clinical trials over the past year, is expected to continue supporting Cartesian through the full completion of the Company’s ongoing clinical trials and the preparation for BLA filing of Descartes-08 in MG in mid-2027. Dr. Traber brings more than three decades of leadership spanning academic medicine and biotechnology. He previously served as CMO of Selecta Biosciences, CEO of Galectin Therapeutics and CMO at GlaxoSmithKline. In previous academic roles, he served as the President of the Baylor College of Medicine and Chairman of Medicine and CEO of the University of Pennsylvania Health System.

About Descartes-08

Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous CAR-T product targeting BCMA in clinical development for generalized MG and myositis, specifically dermatomyositis and antisynthetase syndrome. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis.

(Press release, Cartesian Therapeutics, MAY 26, 2026, View Source [SID1234666058])

On May 26, 2026 Incyte (Nasdaq:INCY) reproted that it will present at the Goldman Sachs 47th Annual Global Healthcare Conference on Tuesday, June 9, 2026 at 8:40 a.m. EDT.

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

(Press release, Incyte, MAY 26, 2026, View Source [SID1234666075])