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Landmark OPTIMA Trial Delivers Practice-Changing Evidence that Veracyte’s Prosigna Test Identifies Patients with High-Risk Breast Cancer Who Can Safely Avoid Chemotherapy

On May 29, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported results from the independent OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis) trial, led by University College London (UCL). The results, which will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, conclude that the Prosigna Breast Risk of Recurrence (ROR) test safely guides adjuvant chemotherapy decisions in patients with early-stage, ER-positive HER2-negative breast cancer.

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"Behind every breast cancer treatment decision is a patient asking, ‘Do I really need chemotherapy?’" said Prof. Robert Stein, Lead Investigator, University College London. "OPTIMA answers this question with robust evidence. These study results can be practice-changing – we can now use the Prosigna test to predict which high-risk patients can safely avoid chemotherapy and its lasting side effects without compromising outcomes. That is a profound shift for patients and the clinicians who care for them."

The Phase III prospective, randomized controlled trial compared standard of care – chemotherapy followed by hormone therapy – to treatment guided by Prosigna test results: patients with high ROR scores (>60) received chemotherapy followed by hormone therapy while those with low ROR scores (≤60) received hormone therapy alone.

Key Trial Findings

The OPTIMA trial results demonstrate:

Chemotherapy can be safely avoided for many patients: The Prosigna test identified that 68% of patients with clinically high-risk node-positive breast cancer, who previously would have received chemotherapy, could safely forgo it entirely. These patients achieved 5-year cancer-free survival rates of 93.7% — statistically noninferior to the 94.9% achieved with chemotherapy — demonstrating that omitting treatment for these patients does not compromise outcomes or increase recurrence risk.
Robust results across broadest range of high-risk subgroups: Non-inferiority was confirmed in previously under-studied populations where treatment guidance has been most uncertain, demonstrating that tumor biology, vs clinical factors alone, can guide chemotherapy decisions for:
Premenopausal women treated with ovarian function suppression (HR 1.04; 90% CI 0.60–1.80)
Patients with extensive nodal involvement (4–9 positive nodes, or pN2 disease) (HR 1.19; 95% CI 0.62–2.29)
Highest level of prospective evidence: With 4,429 patients and 4.0-year median follow-up, OPTIMA provides Level 1A evidence, showing that the Prosigna test can accurately predict chemotherapy benefit and guide safe de-escalation across patient populations.
The Impact on Patients with Breast Cancer

Breast cancer remains the most commonly diagnosed cancer worldwide, affecting 1 in 8 women in the U.S.,1 with over 225,000 new HR+/HER2- breast cancer cases diagnosed annually.2 Treatment decisions play a critical role in preventing recurrence and improving long-term outcomes.

For many of these patients, chemotherapy decisions have historically been driven by clinical factors alone – age, tumor size, and lymph node status – and its potential for multiple, severe side effects. Up to 43% of breast cancer survivors experience persistent nerve damage years after chemotherapy, with studies showing a broader range of treatment-related side effects impacting the majority of patients during and after care.3

The Prosigna test is a genomic test that uniquely combines intrinsic subtypes and proliferation score with clinical pathological factors to calculate a patient’s Risk of Recurrence (ROR) score. In OPTIMA, an ROR score < 60 enabled clinicians to identify patients who could safely avoid chemotherapy. The results from the OPTIMA trial are in a position to transform how clinicians approach breast cancer treatment decisions using the Prosigna ROR score to confidently de-escalate therapy in a high percentage of high-risk patients.

"OPTIMA sets a new standard for how chemotherapy decisions are made in breast cancer," said Phillip Febbo, M.D., Chief Scientific and Medical Officer, Veracyte. "Prosigna now has the strongest prospective evidence of any genomic test to predict which patients with clinically high-risk hormone-receptor positive breast cancer can safely avoid chemotherapy. For patients, that means the option to choose a treatment with fewer unnecessary side effects, and for clinicians, the confidence to act on it."

ASCO Annual Meeting Presentation

The OPTIMA trial results are being presented this Saturday, May 30 at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting during the Breast Cancer—Local/Regional/Adjuvant Oral Abstract Session (1:15 PM CDT, Hall B1, Abstract 500). Prof. Robert C. Stein from University College London is presenting the findings, which will also be livestreamed via the ASCO (Free ASCO Whitepaper) conference platform.

About the OPTIMA Trial

OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis) is an international, multicenter randomized controlled trial led by University College London and funded by U.K. National Institute for Health and Care Research. The independent study enrolled 4,429 women and men aged ≥40 years with ER-positive HER2-negative early breast cancer and 0–9 involved axillary lymph nodes. Participants were randomly assigned to either the control arm for standard chemotherapy followed by hormone therapy or to the Prosigna test-directed arm of standard chemotherapy followed by hormone therapy for patients with Prosigna high ROR test results (>60), versus hormone therapy alone for patients with Prosigna low ROR test results (≤60). All premenopausal women were required to have ovarian function suppression.

(Press release, Veracyte, MAY 29, 2026, View Source [SID1234666204])

Tempest Therapeutics Announces Warrant Exercise for Approximately $2 Million in Gross Proceeds

On May 29, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) (the "Company"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported the entry a definitive agreement for the immediate exercise of certain outstanding warrants to purchase an aggregate of 1,172,414 shares of the Company’s common stock originally issued by the Company on November 26, 2025, having an original exercise price of $3.50 per share, at a reduced exercise price of $1.73 per share. The closing of the warrant exercise transaction is expected to occur on or about May 29, 2025, subject to satisfaction of customary closing conditions.

H.C. Wainwright is acting as the exclusive placement agent for the transaction.

As consideration for the exercise of such existing warrants for cash, the Company will issue new unregistered short-term warrants to purchase up to an aggregate of 2,344,828 shares of common stock at an exercise price of $1.73 per share. The new short-term warrants will be exercisable on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the new short-term warrants (the "Stockholder Approval") and will expire two years following the initial issuance date.

The aggregate gross proceeds from the exercise of the existing warrants are expected to be approximately $2 million, before deducting placement agent fees and other offering expenses payable by the Company. The additional potential gross proceeds from the new short-term warrants, if fully exercised on a cash basis, will be approximately $4 million. No assurance can be given that any of the new short-term warrants will be exercised. The Company expects to use the net proceeds from the transaction for working capital and general corporate purposes.

The resale of the shares of common stock issuable upon the exercise of the existing warrants has been registered pursuant to an effective registration statement on Form S-1 (File No. 333- 292026).

The offer and sale of the new short-term warrants and the shares of common stock issuable upon exercise of the new short-term warrants have not been registered under the Securities Act of 1933, as amended, or under applicable state securities laws. Accordingly, the new short-term warrants and the shares of common stock issuable upon the exercise of the new short-term warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Tempest Therapeutics, MAY 29, 2026, View Source [SID1234666203])

Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA

On May 29, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent matter upon receipt and will prioritize its review in recognition of the significant unmet need for patients in the advanced melanoma community. This constructive dialogue represents an important step forward for the thousands of patients living with advanced melanoma who have progressed on prior anti-PD-1 based therapy and have limited treatment options available to them.

"We are grateful to the FDA leadership for their willingness to engage in a collaborative dialogue towards finding a meaningful path forward for RP1," said Sushil Patel, Ph.D., Chief Executive Officer of Replimune. "We are encouraged by the agency’s commitment to supporting patients and U.S. innovation and look forward to working closely with the FDA to bring this important therapy to the advanced melanoma community as swiftly as possible."

The BLA is supported by data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen. Approximately 8,500 Americans with advanced melanoma die each year, and standard of care checkpoint inhibitor therapy fails approximately half of all patients who receive it, underscoring the urgent need for new treatment options.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate, based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R⁻) and GM-CSF. RP1 is designed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About Advanced Melanoma
Melanoma is the fifth most common cancer in the United States, with approximately 112,000 new cases estimated in 2026 and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Melanoma is considered advanced when the cancer has spread beyond the primary tumor. Standard of care therapy includes immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment, leaving a significant population in need of effective therapeutic alternatives.

(Press release, Replimune, MAY 29, 2026, View Source [SID1234666202])

Ratio Therapeutics and PharmaLogic Expand Manufacturing Collaboration to Support Clinical Development of [Ac-225]RTX-2358

On May 29, 2026 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment, reported an expanded manufacturing collaboration with PharmaLogic Holdings Corp. (PharmaLogic), a leading contract development and manufacturing organization (CDMO) specialized in radiopharmaceuticals, to support the continued clinical development and future commercialization readiness of Ratio’s lead therapeutic candidate, [Ac-225]RTX-2358.

Under the expanded agreement, PharmaLogic will increase manufacturing capacity for the clinical supply of Ratio’s fibroblast activation protein-alpha (FAP)-targeted therapeutic, [Ac-225]RTX-2358, by expanding manufacturing to PharmaLogic’s Idaho Falls therapeutics facility. The broadened collaboration will also include enhancements of production processes with the aim of providing larger scale multi-dose batch manufacturing. The partnership is designed to support ongoing and future clinical studies, including later-stage and potentially registrational trials evaluating [Ac-225]RTX-2358 in FAP-expressing tumors.

"This expanded collaboration with PharmaLogic represents an important step in advancing our manufacturing strategy as we continue to progress [Ac-225]RTX-2358 through clinical development," said Jack Hoppin, Chief Executive Officer of Ratio. "Reliable, redundant and scalable manufacturing infrastructure is critical to the successful development of radiopharmaceutical therapeutics, particularly Actinium-225-based therapies. PharmaLogic has been a strong and reliable partner in supporting our clinical programs, and this next phase of our collaboration is intended to support the progression of our clinical trials and achieve readiness for commercial supply."

"As a service provider to the radiopharmaceutical industry, PharmaLogic measures its success by the success of its partners," said Etienne Montagut, President and Chief Executive Officer of PharmaLogic. "The expansion of our collaboration with Ratio Therapeutics, including the addition of our Idaho Falls therapeutics facility and enhancements to enable larger multi-dose batch production will provide the capacity, redundancy, and scalability that the [Ac-225]-RTX-2358 program requires as it advances toward commercialization. Drawing on more than a decade of experience producing clinical and commercial radiopharmaceutical therapies, we are committed to supporting this program with the full depth of that capability. We thank the Ratio team for their continued trust and collaboration."

About [Ac-225]RTX-2358

[Ac-225]RTX-2358 is a FAP-targeted alpha particle emitting radiotherapeutic. [Ac-225]RTX-2358 is designed for high tumor uptake & long retention time: a trifunctional small molecule engineered for optimized plasma clearance, increased binding affinity, and prolonged tumor retention, radiolabeled with the potent alpha-emitting [Ac-225] radioactive payload. Ratio is currently evaluating [Ac-225]RTX-2358 to treat patients with relapsed or refractory soft tissue sarcomas in the ongoing Phase 1/2 ATLAS trial.

About the ATLAS Trial

Ratio is conducting the ATLAS, ‘Actinium Therapy for Late-stage Aggressive Sarcomas’, clinical study (clinicaltrials.gov: NCT07156565). ATLAS is an open-label, seamless, Phase 1/2 clinical trial to evaluate the safety, tolerability, dosimetry, biodistribution, pharmacokinetics (PK), and anti-tumor activity of [Ac-225]RTX-2358 to treat patients with relapsed or refractory soft tissue sarcoma.

The Phase 1 portion of the ATLAS trial uses a modified 3+3 with queue (IQ) dose escalation design with backfill. Cohorts of patients will assess increasing administered activity ‘dose’ levels and treatment schedules of [Ac-225]RTX-2358, to determine the maximum tolerated dose and establish a recommended dose and schedule for the Phase 2 Expansion. Backfill of Phase 1 cohorts will enable more patients to be treated and evaluated, to provide better characterization of safety and tolerability, as well as assessment of preliminary efficacy. The Phase 2 Expansion portion of the ATLAS study will evaluate the efficacy and safety of [Ac-225]RTX-2358 in up to 50 patients with soft tissue sarcoma.

(Press release, Ratio Therapeutics, MAY 29, 2026, View Source [SID1234666201])

One-carbon Therapeutics to Present Trial-in-Progress Poster on ODIN Phase 1/2 Study ofTH9619 at the 2026 ASCO Annual Meeting

On May 29, 2026 One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering first-in-class cancer therapies that exploit cancer’s oncogene addition, reported that a Trial-in-Progress poster on its ongoing ODIN Phase 1/2 clinical study (NCT07151040) of TH9619 will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 29th to June 2nd in Chicago, Illinois.

Presentation details: Abstract TPS3165 — "A Phase 1/2 First-in-Human Study of TH9619 in Patients with Advanced Refractory Solid Tumours (ODIN)" will be presented by Dr. Victor Moreno (START Madrid–FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain) during the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology poster session on Saturday, May 30th , 2026, from 1:30 to 4:30PM CDT (Board 297A).

TH9619 is a first-in-class potent small molecule MTHFD1/2 inhibitor that selectively kills cancer through folate trapping. In cancer cells, high MTHFD2 expression drives the release of formate from mitochondria into the cytosol, to generate 10-CHO-THF (formylfolate). Inhibition of MTHFD1 by TH9619 prevents further use of 10-CHO-THF for downstream thymidylate synthesis.  This creates a folate trap, depleting the folate (THF) necessary for thymidylate production, resulting in nucleotide shortage, DNA damage, and cancer cell death. Normal cells lack MTHFD2 expression, and the formate overflow needed to create this trap.

ODIN (NCT07151040; EudraCT No. 2024-519639-40-00) is a first-in-human, multicentre, open-label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of TH9619 as monotherapy in adult subjects with advanced colorectal cancer, non–small cell lung cancer, head and neck squamous cell carcinoma, gastric cancer, or gastroesophageal junction cancer who have exhausted standard-of-care options. The Phase 1a dose-escalation part is actively enrolling across leading academic and clinical research centres in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.

"We are pleased to share the rationale and design of the ODIN Phase 1/2 study with the global oncology community at ASCO (Free ASCO Whitepaper). This Trial-in-Progress poster presentation reflects the careful translation of years of preclinical research into a clinical programme aimed at a clear and pressing unmet need. Dose escalation is progressing as planned, and we look forward to generating the safety, pharmacokinetic and early activity data that will inform the path forward for TH9619 in subjects with advanced refractory solid tumours," said Eva Ehrnrooth, Chief Medical Officer of One-carbon Therapeutics and co-author of the presentation.

The poster will be made available on the One-carbon Therapeutics website (View Source) following its presentation at the meeting.

(Press release, One-carbon Therapeutics, MAY 29, 2026, View Sourceone-carbon-therapeutics-to-present-trial-in-progress-poster-on-odin-phase-1-2-study-ofth9619-at-the-2026-asco-annual-meeting/ [SID1234666200])