On February 5, 2026 Curium Group reported that together with PeptiDream Inc. and PDRadiopharma Inc., the first patient has been dosed in the companies’ registrational clinical trial of 177Lu-PSMA-I&T in Japan for patients with PSMA (*1)-positive metastatic castration-resistant prostate cancer (mCRPC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

177Lu-PSMA-I&T is a radiotherapeutic agent targeting PSMA conjugated to a chelator radiolabeled with Lutetium-177. The multicenter, open-label, single-arm registrational Phase 2 trial will evaluate efficacy and safety of 177Lu-PSMA-I&T. The trial will enroll patients who have been diagnosed with mCRPC and will be conducted as a registrational trial in Japan, utilizing the bridging data from Curium’s ongoing global clinical trials under the strategic collaboration between PDRadiopharma and Curium.

As announced on 15 October 2025, Curium Group, PeptiDream and PDRadiopharma initiated the clinical trial of 64Cu-PSMA-I&T which is being assessed as a diagnostic PET imaging agent with patients who have been newly diagnosed with prostate cancer (please refer to "PeptiDream, PDRadiopharma and Curium Group Enroll First Patient to Registrational Clinical Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan"). 64Cu-PSMA-I&T is also used in this trial to confirm PSMA positivity before the administration of 177Lu-PSMA-I&T.

Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to patients with prostate cancer in Japan."

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to initiate the development of 177Lu-PSMA-I&T in Japan. Introducing new treatment options is an important part of improving prostate cancer patient care. Together with 64Cu-PSMA-I&T, this program is expected to provide new options to visualize and treat prostate cancer more precisely, helping patients and their physicians make more informed decisions. In collaboration with Curium, PDRadiopharma is committed to bringing these radiopharmaceutical treatments to patients in Japan as safely and as quickly as possible."

About Prostate Cancer

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*2), with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

*1: PSMA – prostate-specific membrane antigen which is highly expressed on prostate cancer cells

*2: National Cancer Center Japan

Clinical trial progress

Phase 3 ECLIPSE trial – 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

Phase 3 trial SOLAR RECUR and SOLAR STAGE – 64Cu-PSMA-I&T trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

(Press release, PeptiDream, FEB 5, 2026, View Source [SID1234662465])

On February 5, 2026 Bristol Myers Squibb (NYSE: BMY) reported fourth quarter and full-year 2025 financial results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Visit the company’s Investor Relations website at View Source to view the detailed fourth quarter and full-year 2025 earnings press release and investor presentation.

The company will host a conference call and live audio webcast for analysts and investors at 8:00 a.m. ET today, February 5, 2026, which is accessible here. Company executives will review financial results with the investment community during the call.

A replay of the webcast will be available at View Source approximately three hours after the conference call concludes.

(Press release, Bristol-Myers Squibb, FEB 5, 2026, View Source [SID1234662504])

On February 5, 2026 Invivoscribe, a leader in precision medicine and measurable residual disease (MRD) testing, reported the addition of the LeukoStrat KMT2A + MRD Assay and Software to its industry-leading oncology portfolio. The assay leverages digital PCR (dPCR) to support both screening and precise longitudinal MRD monitoring for KMT2A rearrangements in acute myeloid leukemia (AML) subjects. This quantitative test is currently available for research use in clinical trials and as a stand-alone kit for purchase by our global customers, and will soon be available as a service in our regional LabPMM laboratories worldwide.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The assay is available to detect key AML-associated KMT2A rearrangements, which account for the vast majority of KMT2A fusion partners in AML1 and those most commonly targeted in menin-inhibitor clinical development programs. Later this year, the assay will be enhanced with four additional KMT2A rearrangements which are frequently found in acute lymphocytic leukemia (ALL), expanding its utility across leukemias.

The LeukoStrat KMT2A + MRD Assay accurately identifies and quantifies common KMT2A rearrangements that drive KMT2A-translocated acute leukemias, offering translational researchers and biopharmaceutical partners a critical tool to assess MRD and to evaluate therapeutic response. With unprecedented sensitivity down to 0.005% (5×10-5) and precise quantitation through normalization against a control gene, the assay enables far more rapid turnaround time and more sensitive detection of low-level KMT2A rearrangements that traditional cytogenetics and FISH methods miss. The LeukoStrat KMT2A + MRD Assay and Software streamline both initial screening and longitudinal MRD monitoring from a single workflow, facilitating efficient implementation both in research laboratories and as a service supporting clinical research.

"Invivoscribe is setting a new standard for how researchers and biopharmaceutical partners can identify, monitor and understand disease response," said Jeff Miller, CEO and CSO at Invivoscribe. "Our LeukoStrat KMT2A + MRD Assay provides partners with a powerful tool for exploratory and pivotal analyses in menin-inhibitor trials, offering precise insights into subject response throughout treatment. This assay builds on our international reputation as the ideal partner for pharmaceuticals looking to accelerate KMT2A trials using MRD as a surrogate endpoint and for companion diagnostic development as these therapies advance toward approval."

The assay integrates with LeukoStrat KMT2A + MRD Software for rapid, objective analysis, enabling labs and biopharmaceutical partners to unlock complex molecular insights. When paired with Invivoscribe’s globally standardized LabPMM network and regulatory expertise, it supports the full development pathway from early-phase trials through CDx validation and commercialization.

For a comprehensive approach to therapy development, biopharmaceutical partners can combine the LeukoStrat KMT2A + MRD Assay for treatment monitoring with Invivoscribe’s established myeloid portfolio of IVDR and research use only LeukoStrat CDx and MRD assays, including prognostic biomarkers such as FLT3 and NPM1.2,3,4,5 Invivoscribe’s proven track record in companion diagnostics (CDx) development and successful global regulatory submissions positions the company as a trusted strategic partner for menin-inhibitor programs progressing toward approval.

(Press release, Invivoscribe Technologies, FEB 5, 2026, View Source [SID1234662521])

On February 5, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Shanghai Henlius Biotech, Inc. (Headquarters: Shanghai, China, CEO: Jason Zhu, "Henlius") reported the conclusion of an exclusive commercialization and co-exclusive development and manufacturing license agreement for the anti-PD-1 antibody serplulimab (generic name, marketed as HANSIZHUANG in China and Hetronifly in the EU) in Japan.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Serplulimab, a novel anti-PD-1 monoclonal antibody developed by Henlius, is reported to possess a unique binding mode that differs from existing anti-PD-1 antibodies.[1] In China, it has been approved for indications such as squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), non-squamous non-small cell lung cancer (nsNSCLC), and esophageal squamous cell carcinoma (ESCC). In the EU, it has been approved for ES-SCLC. It is the world’s first anti-PD-1 antibody to be used as a first-line treatment for ES-SCLC.

In Japan, Henlius is currently conducting a Phase II bridging clinical trial for ES-SCLC, and plans to submit an application for fiscal year 2026 based on the results of this trial as well as the Phase III clinical trial data that supported approvals for this indication in China and Europe. Furthermore, a Phase III multi-national clinical trial for non-high-frequency microsatellite instability (non-MSI-High) metastatic colorectal cancer is underway, with development for new indications also planned.

In Japan, it is estimated that there are approximately 13,000 patients diagnosed with ES-SCLC and about 28,000 patients diagnosed with non-MSI-High metastatic colorectal cancer, both of which are considered to have high unmet medical needs.[2],[3],[4],[5]

Under the terms of this agreement, Eisai will obtain exclusive rights to commercialize serplulimab in Japan. In addition to ES-SCLC and non-MSI-High metastatic colorectal cancer, Henlius plans to also conduct a clinical trial for perioperative gastric cancer in Japan, and will assume the responsibilities of the Marketing Authorization Holder.

Eisai will pay Henlius a contractual upfront payment of USD 75 million (approximately JPY 11.6 billion*), in addition to regulatory milestone payments of up to USD 80.01 million (approximately JPY 12.4 billion), and sales milestone payments of up to USD 233.3 million (approximately JPY 36.2 billion). Furthermore, Eisai will pay double-digit royalties based on sales of the product. Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2026.

"We are pleased to collaborate with Eisai in Japan to advance the development of serplulimab in this important market," said Dr. Jason Zhu, CEO of Henlius. "Serplulimab has demonstrated its potential across multiple tumor types through global clinical development and regulatory approvals, and Japan represents a critical step in its international journey. By combining Henlius’ innovation capabilities with Eisai’s deep local expertise, we aim to support the efficient development of serplulimab and address unmet medical needs for patients in Japan."

"Serplulimab is an anti-PD-1 monoclonal antibody that has been developed with high priority for indications with significant unmet medical needs, including ES-SCLC, and has already obtained approval for multiple indications in China and the EU. We anticipate that it will also become a promising treatment option in Japan for ES-SCLC and non-MSI-high metastatic colorectal cancer, for which development is underway, as well as for other intractable cancers," said Toshihiko Yusa, Executive Officer and Head of Japan Business at Eisai. "Eisai will make every effort, in cooperation with Henlius, to deliver serplulimab to patients as soon as possible."

* Converted at an exchange rate of USD 1 = JPY 155

About Serplulimab
Serplulimab (generic name, marketed as HANSIZHUANG in China and Hetronifly in the EU) is an anti-PD-1 monoclonal antibody first developed by Shanghai Henlius Biotech, Inc. ("Henlius"), and launched in China in 2022. It has been approved by the National Medical Products Administration of China for indications including squamous non-small cell lung cancer, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma, and non-squamous non-small cell lung cancer, and is the world’s first anti-PD-1 antibody to be used as a first-line treatment for ES-SCLC. It has been approved for the treatment of ES-SCLC in over 40 markets, including the EU, Southeast Asia (Indonesia, Cambodia, Thailand, Singapore, Malaysia), and South America (Peru).

Henlius is actively promoting the broader use of serplulimab both as a standalone product and in combination with other innovative therapies, including those developed in-house and externally. Furthermore, the company is conducting numerous clinical trials worldwide on therapies for conditions where existing anti-PD-1 antibodies have not yet been used, focusing on indications such as lung cancer and gastrointestinal tumors.

(Press release, Eisai, FEB 5, 2026, View Source [SID1234662505])

On February 5, 2026 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the fourth quarter and fiscal year 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The Illumina team delivered a strong finish to 2025, marking a return to growth through disciplined execution against our strategy," said Jacob Thaysen, Chief Executive Officer of Illumina. "Momentum built in the second half of the year – especially in clinical markets, where adoption of NGS-based testing is expanding – reinforces our confidence as we enter 2026."

Fourth quarter results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q4 2025
Q4 2024
Q4 2025
Q4 2024
Revenue
$ 1,159 $ 1,104 $ 1,159 $ 1,104
Gross margin
65.5 % 65.9 % 67.0 % 67.4 %
Research and development (R&D) expense $ 239 $ 256 $ 238 $ 255
Selling, general and administrative (SG&A) expense $ 310 $ 279 $ 264 $ 271
Legal contingency and settlement $ 8 $ 18 $ — $ —
Operating profit
$ 202 $ 175 $ 275 $ 218
Operating margin 17.4 % 15.8 % 23.7 % 19.7 %
Tax provision $ 44 $ 70 $ 50 $ 47
Tax rate 11.6 % 37.9 % 19.5 % 23.7 %
Net income $ 334 $ 117 $ 208 $ 152
Diluted EPS $ 2.16 $ 0.73 $ 1.35 $ 0.95

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.

Capital expenditures for free cash flow purposes were $54 million for Q4 2025. Cash flow provided by operations was $321 million, compared to $364 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $267 million for the quarter, compared to $322 million in the prior year period. Depreciation and amortization expense was $67 million for Q4 2025. At the close of the quarter, the company held $1.63 billion in cash, cash equivalents and short-term investments.
Fiscal year results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
2025 2024 2025 2024
Revenue (b) $ 4,343 $ 4,332 $ 4,343 $ 4,332
Gross margin
66.1 % 67.1 % 68.2 % 68.6 %
R&D expense
$ 967 $ 988 $ 950 $ 982
SG&A expense
$ 1,086 $ 900 $ 1,009 $ 1,069
Goodwill and intangible impairment $ — $ 3 $ — $ —
Legal contingency and settlement $ 10 $ (456) $ — $ —
Operating profit
$ 807 $ 1,473 $ 1,004 $ 922
Operating margin 18.6 % 34.0 % 23.1 % 21.3 %
Tax provision $ 236 $ 229 $ 194 $ 204
Tax rate 21.7 % 20.4 % 20.5 % 23.6 %
Net income $ 850 $ 894 $ 756 $ 663
Diluted EPS $ 5.45 $ 5.61 $ 4.84 $ 4.16

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.
(b)Core Illumina revenue for 2024 included intercompany revenue of $15 million, which, prior to the spin-off of GRAIL in Q2 2024, was eliminated in consolidation.

Capital expenditures for free cash flow purposes were $148 million for fiscal year 2025. Cash flow provided by operations was $1.1 billion and free cash flow was $931 million. Depreciation and amortization was $270 million.

Key announcements since our last earnings release
•Completed the acquisition of SomaLogic, expanding Illumina’s multiomics portfolio and strengthening its position in scalable, NGS-enabled proteomics
•Introduced the Billion Cell Atlas, the first data product of the BioInsight business, to support AI-enabled drug discovery; AstraZeneca, Merck, and Eli Lilly are the first pharmaceutical partners
•Announced appointment of veteran genomics leader Eric Green, MD, PhD, as Chief Medical Officer to advance clinical genomics and expand access to precision medicine
•Achieved progress in China, where the Chinese Ministry of Commerce (MOFCOM) lifted the export ban on Illumina sequencers; the company remains on the Unreliable Entities List (UEL) in China, requiring approvals for instrument purchases

A full list of recent announcements can be found in the company’s News Center.

Financial outlook and guidance
The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

Conference call information
The conference call will begin at 1:30 pm Pacific Time (4:30 pm Eastern Time) on Thursday, February 5, 2026. Interested parties may access the live webcast via the Investor Info section of Illumina’s website or directly through the following link – View Source To ensure timely connection, please join at least ten minutes before the scheduled start of the call. A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

(Press release, Illumina, FEB 5, 2026, View Source [SID1234662506])