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])

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])

On April 30, 2026 Novocure (NASDAQ: NVCR) reported financial results for the first quarter that ended March 31, 2026. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"This was a very strong start to the year for Novocure and we are pleased with the progress made across our commercial and clinical programs," said Frank Leonard, CEO, Novocure. "We reached several key milestones in the first quarter and are eager to maintain this momentum as we approach numerous exciting catalysts later this year. Our focus remains on bringing Tumor Treating Fields therapy to patients diagnosed with some of the most aggressive forms of cancer, further exploring the use of our therapy to benefit patients in need, and achieving sustainable growth and profitability."

Financial updates for the quarter ended March 31, 2026:

Total net revenues for the quarter were $174.1 million, an increase of 12% compared to the same period in 2025. This increase was primarily driven by active patient growth in European markets.
The U.S., Germany, France and Japan contributed $96.0 million, $24.5 million, $22.9 million and $10.2 million, respectively, with other active markets contributing $15.7 million.
Net revenue from Germany benefitted from increased approval rates, including a one-time benefit of $2.5 million.
Net revenue from France benefitted from contract performance improvements, including a one-time benefit of $1 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.8 million.
Recognized revenue from Optune Lua in the quarter was $3.1 million.
Gross margin for the quarter was 78% compared to 75% in the prior year. The increase was primarily driven by lower array costs resulting from improved array utilization and lower supplier prices.
Research, development and clinical study expenses for the quarter were $58.3 million, an increase of 8% from the same period in 2025. This was primarily driven by increased costs associated with patient recruitment in the Phase 3 KEYNOTE D58 clinical trial.
Sales and marketing expenses for the quarter were $58.4 million, an increase of 5% compared to the same period in 2025. This was primarily driven by costs associated with the launch of Optune Pax in the U.S. and Optune Lua in Japan.
General and administrative expenses for the quarter were $85.9 million, an increase of 92% compared to the same period in 2025. This increase was primarily driven by a $43 million share-based compensation expense triggered by the U.S. FDA approval of Optune Pax. This non-cash expense is reported in accordance with U.S. GAAP, but the associated grant did not vest and shares were not distributed.
Net loss for the quarter was $71.1 million with loss per share of $0.62.
Adjusted EBITDA* for the quarter was $(0.3) million.
Cash, cash equivalents and short-term investments were $432.0 million as of March 31, 2026.
Operational updates for quarter ended March 31, 2026:

As of March 31, 2026, there were 4,791 total active patients on TTFields therapy globally.
Optune Gio
As of March 31, 2026, there were 4,543 active patients on Optune Gio, an increase of 9% from the same period in 2025.
The U.S., Germany, France and Japan contributed 2,250; 641; 503 and 535 Optune Gio active patients, respectively, with 614 active patients contributed by other active markets.
Optune Lua
As of March 31, 2026, there were 165 active patients on Optune Lua, an increase of 56% from the same period in 2025.
The U.S., Germany, France and Japan contributed 106; 47; 2 and 6 active patients, respectively, with 4 active patients contributed by other active markets.
Optune Pax
169 prescriptions for Optune Pax were received in the quarter.
As of March 31, 2026, there were 83 active patients on Optune Pax in the U.S.
Quarterly updates and achievements:

January 2026
Public health insurers in Czechia announced coverage for Optune Gio for the treatment of adult patients with newly diagnosed glioblastoma (GBM).
February 2026
The U.S. FDA approved Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel.
British Columbia (BC) Cancer announced coverage for Optune Gio for adult patients with newly diagnosed GBM.
March 2026
Japan’s Ministry of Health, Labour and Welfare approved reimbursement for Optune Lua through the country’s National Health Insurance coverage. Optune Lua is approved in Japan for concurrent use with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced/recurrent non-small cell lung cancer (NSCLC) who progressed on or after platinum-based chemotherapy.
Novocure announced the topline results from the Phase 2 PANOVA-4 clinical trial, evaluating TTFields therapy concomitant with atezolizumab (Tecentriq), gemcitabine and nab-paclitaxel as a first-line treatment for metastatic pancreatic cancer. PANOVA-4 met its primary endpoint, achieving a 74% disease control rate (DCR), a statistically significant improvement compared to a 48% DCR in patients treated with gemcitabine and nab-paclitaxel alone in the historical control.
2026 Financial Guidance:

Novocure’s updated guidance for the full year 2026, as of April 30, 2026, is summarized below:

Total net revenue: $690 million – $710 million (previous: $675 million – $705 million)
Adjusted EBITDA*: $(15) million – $0 million (previous: $(20) million – $0 million)
This guidance assumes full-year mid-single digit net revenue growth from Optune Gio, net revenue contribution from Optune Lua and Optune Pax, collectively, between $15 million and $25 million, a mid-70s percent gross margin, and foreign exchange rates as of March 31, 2026.

Anticipated clinical and regulatory milestones:

Topline data from the Phase 3 TRIDENT trial in newly diagnosed GBM (Q2 2026).
Decision by the U.S. FDA on the premarket approval application for use of TTFields therapy for the treatment of brain metastases from NSCLC (Q4 2026).
Complete enrollment in Phase 3 KEYNOTE D58 clinical trial in newly diagnosed GBM (Q4 2026).
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2026 financial results at 8:00 a.m. EDT today, Thursday, April 30, 2026. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, investor.novocure.com, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

(Press release, NovoCure, APR 30, 2026, View Source [SID1234664989])

On April 30, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a multi-year strategic collaboration with Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, to support the development and potential commercialization of Nuvalent’s oncology pipeline using the tissue and liquid offerings of the Guardant Infinity platform.

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The collaboration reflects the growing importance of precision diagnostics in oncology drug development, where biomarker-driven approaches are increasingly essential for identifying appropriate patient populations, improving trial efficiency, and supporting regulatory approvals.

As key components of the collaboration, Guardant Health and Nuvalent plan to:

Utilize Guardant’s portfolio of tissue and liquid biopsy tests to support certain Nuvalent global clinical studies;
Evaluate opportunities to develop Guardant tissue and/or liquid biopsy assays as companion diagnostics (CDx) to support potential regulatory approvals of Nuvalent’s current investigational candidates; and,
Collaborate on the global commercialization of Nuvalent’s product candidates, if approved, and Guardant companion diagnostics across major global key markets.

(Press release, Guardant Health, APR 30, 2026, View Source [SID1234664988])

On April 30, 2026 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Ticker symbol: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, reported its 2025 financial results, as approved by the Board of Directors on April 27, 2026.

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Philippe Genne, co-founder, President and Chief Executive Officer of OPM said: "2025 is a pivotal year for OPM, marked by the maturation of our clinical assets—particularly OPM-101 and OPM-201—and by a strong refocusing of our investments on our priority programs. OPM-101 continues its development in immuno-oncology with the approval to initiate the REVERT study, while OPM-201 confirms its strategic potential in Parkinson’s disease with the support of the Michael J. Fox Foundation. These advances reinforce the positioning of our programs as mature and attractive assets for industrial partners. In an environment where funding remains constrained, we are simultaneously maintaining rigorous management of our resources to secure our trajectory and maximize the value of our assets."

Karine LIGNEL, Deputy CEO and COO of Oncodesign Precision Medicine, adds: "In 2025, we strengthened our operational discipline and focused our efforts on the programs with the greatest potential to create value. The scientific progress made on OPM-101 and OPM-201 confirms the validity of our strategy, despite a funding environment that remains challenging for publicly traded biotechnology companies."

Oncodesign Precision Medicine – Income Statement

in M€

Audited data

2025

2024

Evolution

in %

in value

Revenues

0.26

0.21

+26%

0.26

Other revenues and operating income

1.55

1.43

+9%

1.55

Total revenues and operating income

1.81

1.64

+11%

0.18

Change in inventory

13.00

NS

13.00

Purchases consumed

(3.53

)

(6.51

)

-46%

2.98

Personnel costs

(2.59

)

(2.59

)

+0%

(0.00

)

Other operating expenses

(0.05

)

(0.01

)

+492%

(0.04

)

Taxes and duties

(0.06

)

(0.07

)

-21%

0.02

Net change in depreciation and amortization

(2.88

)

(0.26

)

+1013%

(2.62

)

Total operating expenses

3.89

(9.44

)

na

13.34

Operating result

5.71

(7.81

)

na

13.51

Financial expenses and income

(0.19

)

(0.15

)

+26%

0.04

Non-recurring expenses and income

Income tax

Net result

5.48

(7.21

)

na

12.69

Overview of Our Development Programs and Technologies in 2025

In 2025, OPM continued to advance its priority assets, particularly OPM-101 in oncology and OPM-201 for the treatment of Parkinson’s disease, accelerating the transition to advanced clinical phases.

OPM-101 confirmed a favorable safety and activity profile in Phase 1 and received approval to initiate the REVERT study (Phase 1b/2a) in immuno-oncology, in combination with pembrolizumab.

Meanwhile, OPM-201 has achieved key milestones with the consolidation of its data, the validation of its mechanism of action, and the signing of a strategic partnership with the Michael J. Fox Foundation, which materialized in early 2026 with significant funding (~$7 million) to prepare for its entry into clinical trials for Parkinson’s disease.

This momentum has been accompanied by a significant improvement in operational performance. Operating revenue rose to €1.81 million (+11%), consisting mainly of government grants and reversals of provisions.

A significant effort to control costs was made in 2025, particularly regarding consumable purchases (-46%), reflecting a refocus on priority programs and an optimization of subcontracting expenses. Personnel expenses remained stable, while other operating expenses remained limited.

Operating income amounted to €5.71 million, compared to a loss of €7.81 million in 2024. This change includes a one-time effect related to the recognition of a positive inventory change of €13 million, corresponding to the consolidation of OPM-201 active ingredient inventories.

Oncodesign Precision Medicine – R&D expenditure

in M€

Analytical data

2025

2024

Evolution

In %

in value

Partnerships

0.8

1.8

– 55%

– 1.0

Licensing

2.3

4.8

– 51%

– 2.5

Total R&D expenses

3.13

6.58

– 52%

– 3.45

R&D investments declined in 2025 due to refocusing on priority programs, notably OPM-101, and a reduction in external spending on partnership and non-strategic programs.

OPM received €0.53 million in Research Tax Credits in 2025, down from 2024, due to lower R&D spending and changes in applicable tax rules.

Cash position of €2.1 million as of December 31, 2025

OPM’s cash position stood at €2.11 million as of December 31, 2025, compared to €5.27 million at the start of the fiscal year, reflecting cash outflows related to the funding of R&D activities and strategic programs during the period.

At the same time, the Company has strengthened its financing and financial flexibility, notably through convertible bonds (ORA) and government programs, while implementing a cost optimization plan that generated €5.9 million in savings during fiscal year 2025.

OPM is also continuing discussions with industrial and financial partners to secure the next stages of development.

The Company has also secured a 12-month extension of its bank loan maturity to preserve its financial flexibility. The Company’s ability to continue as a going concern beyond December 31, 2026, remains contingent upon securing additional financing, implementing further cost reductions, or entering strategic partnerships, none of which had been finalized as of the balance sheet date.

Outlook for 2026

In 2026, OPM will continue preparations for the Phase 1b trial of OPM-201 with funding from the Michael J. Fox Foundation, while continuing to seek industrial or financial partners to secure the next clinical stages.

In addition, the Phase 1b/2a trial of OPM-101 is expected to begin before the end of 2026, with the study expected to conclude by the end of 2028. Similarly, a search for partners is underway for this compound.

Finally, the other programs will progress according to the opportunities presented by the funding OPM may receive throughout the year.

Availability of the 2025 Annual Financial Report

The 2025 Annual Financial Report will be available on the company’s website on April 30, 2026.

(Press release, Oncodesign Precision Medicine, APR 30, 2026, View Source [SID1234664987])