On January 29, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an update on its activities for the quarter ended 31 December 2025 (Q2 FY26).

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!

EFTI DEVELOPMENT PROGRAM IN ONCOLOGY

IMMUTEP AND DR. REDDY’S STRATEGIC COLLABORATION

Most significantly, in December, Immutep and Dr. Reddy’s announced that their respective wholly-owned subsidiaries, Immutep SAS and Dr. Reddy’s Laboratories SA, entered into a strategic collaboration and exclusive licensing agreement for the development and commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater China.

Efti is Immutep’s first-in-class novel immunotherapy that directly activates the immune system to fight cancer, which is under evaluation in a Phase III trial, TACTI-004 (KEYNOTE-F91).

As per the agreement, and after the quarter’s end, Immutep has received from Dr. Reddy’s the upfront payment of USD 20 million (~AUD 30.2 million). It is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million (~AUD 528.4 million), plus royalties on commercial sales in these markets.

Immutep holds the global manufacturing rights to the product across all markets and will supply the product to Dr. Reddy’s in the licensed markets. Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan.

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC

In December, Immutep reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC), one of the largest indications in oncology.

The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients’ survival.

As of mid-December, the registrational TACTI-004 trial had enrolled 289 patients (over 38% of the trial’s targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites exceeded 120 and 27 countries had received full regulatory approvals.

As announced in October 2025, TACTI-004 had enrolled the necessary number of patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Immutep anticipates reaching 50% of the patient enrolment target for TACTI-004 soon.

Additionally, with the completion of Project Optimus as discussed below, TACTI-004 has started to open sites in the United States.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC

In October, Immutep announced promising data from the investigator-initiated INSIGHT-003 trial, which is evaluating the same immunotherapy/chemotherapy combination used in TACTI-004 (KEYNOTE-F91), was detailed in a poster presented by Dr. med. Akin Atmaca, Head of the Thoracic Oncology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany at the ESMO (Free ESMO Whitepaper) Congress 2025.

In this multi-centre study, the novel combination of efti with KEYTRUDA and chemotherapy (carboplatin/pemetrexed) has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels.

Notably, the ORR and DCR reported in INSIGHT-003 outperforms historical controls irrespective of PD-L1 levels (e.g., TPS <1%, TPS 1-49%, and TPS >50%). This is particularly important for patients with low and no PD-L1 (TPS <50%), who represent over two-thirds of the 1L NSCLC patient population and for whom PD-(L)1 inhibitors typically perform suboptimally. In patients with TPS <50% (N=47), the combination with efti has achieved a strong and improved 61.7% ORR compared to historical control of 40.8%.1,2

Further to the strong efficacy data from INSIGHT-003, the combination with efti continues to have a favourable safety profile.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma

In October, Immutep announced that positive data from the EFTISARC-NEO Phase II investigator-initiated trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) was shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland at the ESMO (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany.

The EFTISARC-NEO trial met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis with a median 51.5% tumour hyalinization/fibrosis (p<0.001) in the evaluable patient population (N=38).3 This may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with improved survival in STS patients.4 Disease-free survival and overall survival data are immature at this stage and will be presented in the future.

In November, early translational data from the EFTISARC-NEO trial were detailed in an oral presentation by Paweł Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida. Results from the initial twenty patients who underwent surgery in the trial show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-γ.

The increase on treatment of immune response biomarkers like IFN-γ correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery.

Additionally, during the quarter, the EFTISARC NEO trial was awarded second place in the distinguished Golden Scalpel Award competition in Poland. This competition recognises the most innovative solutions in Polish medicine and is presented by independent experts to initiatives that set new standards in advancing healthcare. EFTISARC-NEO was the only oncology project to receive this accolade, underscoring its leadership and breakthrough potential in cancer treatment.

BREAST CANCER

AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer

Immutep continues to execute the AIPAC-003 trial, which has enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low patients resistant to endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or triple-negative breast cancer patients.

Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30 mg or 90 mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA.

In October, Immutep announced that positive feedback had been received from the US Food and Drug Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30 mg as the optimal biological dose for efti. The agreement with the FDA on efti’s optimal biological dosing carries strategic importance in the ongoing and future clinical development of efti, including the global TACTI-004 (KEYNOTE-F91) Phase III trial.

In December, Immutep announced that new data from the AIPAC-003 trial was presented by Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas.

The data presented shows that both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64).

New Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

Immutep continues to progress with a new investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients. The trial aims to assess pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC).

The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The GW University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget.

UROTHELIAL CANCER

INSIGHT-005

The investigator-initiated INSIGHT-005 Phase I study, conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) to evaluate the safety and efficacy of efti in combination with avelumab in up to 30 patients with metastatic urothelial cancer, was discontinued by IKF after the end of the quarter. This decision was made, as significant changes in the treatment landscape created challenges with patient recruitment. Only 3 patients were recruited in total.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial

In December, Immutep announced a positive update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases.

The single-ascending dose escalation portion of the trial successfully completed the 2.5 and 7 mg / kg dosing levels of IMP761 with continued positive safety and efficacy data. IMP761 was tolerated well with no treatment-related adverse reactions beyond mild intensity. Additionally, evidence of dose dependent immunosuppressive effects with IMP761 was observed with significant, long-lasting inhibition of the three T-cell-mediated intradermal reactions to a strong foreign antigen on day 2, 9 and 23.

Given the encouraging efficacy and safety to date, the trial will continue as planned and additional updates are anticipated in the first half of CY2026 including a planned presentation of data at a major medical conference.

INTELLECTUAL PROPERTY

During the quarter, Immutep was granted four patents.

The New Zealand Patent Office granted a new patent protecting Immutep’s intellectual property for a binding assay for determining MHC Class II binding activity of LAG-3 protein. The assay is used in the characterisation of efti in GMP-grade manufacturing.

Three new patents directed to IMP761 were also granted. Two were granted in Brazil and one in Japan.

CORPORATE & FINANCIAL SUMMARY

Annual General Meeting
Immutep successfully held its Annual General Meeting (AGM) during the quarter, with all resolutions put forward to shareholders strongly approved. The Company appreciates the continued support and engagement of its shareholders as it advances its strategic and operational objectives.

Cash Flow Summary

During the quarter, Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761.

The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 31 December 2025 of approximately A$99.1 million, which is in line with budget as at the beginning of FY2026, while progressing our clinical programs within announced timeframes. The total balance consists of 1) a cash and cash equivalent balance of A$72.7 million and 2) bank term deposits totaling A$26.4 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months. This amount is topped up by the upfront payment (~A$30.2 million) from Dr. Reddy’s received in January 2026, leading to a pro-forma balance of A$129.3 million at the time of preparing this report.

In Q2 FY26, cash receipts from customers were A$4k. The net cash used in G&A activities in the quarter was A$1.3 million, compared to A$578k in Q1 FY26. During the quarter, Immutep received EUR2.59 million (~ A$4.6 million) R&D tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR) to support the ongoing and planned global clinical development of efti and IMP761.

The cash used in R&D activities during the quarter was A$9.9 million, compared to A$15.8 million in Q1 FY26. The higher figure in the prior quarter was primarily due to the large prepaid clinical trial expenses and higher milestone‑based manufacturing payments made in Q1 FY26.

Payment for staff costs was A$2.6 million in the quarter, compared to A$3.4 million in Q1 FY26. Total net cash outflows used in operating activities in the quarter were A$9.4 million compared to A$19.0 million in Q1 FY26.

Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$474k.

Total cash outflow used in investing activities for the quarter was A$144k, which is mainly for the acquisition of office and lab equipment.

Furthermore, during the quarter, a long-term vendor* agreed to defer payment of ~A$30 million which would be payable by Immutep for future services related to Biologics License Application (BLA) readiness by up to 30 months. This provides strong external validation of Immutep’s development strategy and long-term value creation potential.

The current funds available to the Company at the time of this report provide an expected cash reach well into Q2 CY2027, not including receipt of any future potential milestone payments to be received.

(Press release, Immutep, JAN 29, 2026, View Source [SID1234662333])

On January 29, 2026 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) ("BioMarin") reported that it priced its previously announced offering of $850 million of 5.500% senior unsecured notes due 2034 (the "Notes"). The issue price of the Notes is 100.000%. The offering is expected to close on February 12, 2026, subject to the satisfaction of customary closing conditions.

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!

BioMarin also announced that, in connection with the pending acquisition (the "Acquisition") of Amicus Therapeutics, Inc. ("Amicus"), it completed the syndication of a new $2 billion senior secured term loan "B" facility (the "Term Loan B Facility"), which Term Loan B Facility is in addition to a $800 million senior secured term loan "A" facility (the "Term Loan A Facility" and, together with the Term Loan B Facility, the "Term Facilities"), and a $600 million senior secured revolving credit facility into which BioMarin expects to enter in connection with the Acquisition (the "New Revolving Facility" and, together with the Term Facilities, the "New Senior Secured Credit Facilities").

BioMarin intends to use the net proceeds from the offering of the Notes, together with borrowings under the Term Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition and related fees and expenses in connection with the Acquisition, the borrowings under the New Senior Secured Credit Facilities, and the issuance of the Notes. The company may also borrow up to $150 million under the New Revolving Facility to pay such fees and expenses.

Gross proceeds from the issuance of the Notes will be deposited into an escrow account at the closing of the Offering, pending consummation of the Acquisition. In the event that the Acquisition is not completed on or prior to December 19, 2026, or upon the occurrence of certain other events, BioMarin will be required to redeem all of the Notes at a redemption price equal to 100% of the initial issue price of the Notes plus accrued and unpaid interest from the date of issuance, or the most recent date to which interest has been paid or provided for, to but excluding the special mandatory redemption date.

The Notes will be jointly and severally guaranteed by certain of BioMarin’s subsidiaries that will guarantee the obligations under the New Senior Secured Credit Facilities, including, after the closing of the Acquisition, Amicus and certain of its subsidiaries that will guarantee the obligations under the New Senior Secured Credit Facilities.

The indenture governing the Notes is expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of BioMarin and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to a limited number of persons who are either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This press release is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. This press release contains information about the pending offering of the Notes, and there can be no assurance that the offering will be completed. The offering of the Notes may be made only by means of an offering memorandum.

(Press release, BioMarin, JAN 29, 2026, View Source [SID1234662350])

On January 29, 2026 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) ("Lexicon") reported the pricing of its previously announced underwritten public offering of 32,000,000 shares of its common stock, par value $0.001. The shares of common stock being offered pursuant to the public offering are being offered at a public offering price of $1.30 per share. All of the shares are being offered by Lexicon. The gross proceeds from the public offering are expected to be $41.6 million, before deducting underwriting discounts and commissions and other offering expenses. The public offering is expected to close on or about February 2, 2026, subject to the satisfaction of customary closing conditions. In addition, Lexicon has granted the underwriters a 30-day option to purchase up to an additional 4,800,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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!

In addition to the shares being sold in the underwritten public offering, Lexicon has agreed to sell, in a concurrent private placement for expected aggregate gross proceeds of approximately $41.1 million, (i) at a price of $1.30 per share of common stock, 22,400,000 shares of its common stock and (ii) at a price of $65.00 per share of series b convertible preferred stock (the "Series B Convertible Preferred Stock"), 184,366 shares of Series B Convertible Preferred Stock, which will be convertible into 9,218,290 shares of common stock, to an affiliate (the "Private Placement Purchaser") of Invus, L.P., Lexicon’s largest stockholder, pursuant to its preemptive right under Lexicon’s Sixth Amended and Restated Certificate of Incorporation. The Private Placement Purchaser will also have the option, pursuant to such preemptive right, to purchase up to an additional 94,855 shares of Series B Convertible Preferred Stock, which will be convertible into 4,742,744 shares of common stock, at a price of $65.00 per share of Series B Convertible Preferred Stock, to the extent the underwriters exercise their option to purchase additional shares of common stock. In addition to its purchases pursuant to its preemptive right, the Private Placement Purchaser has also agreed to purchase an additional 182,779 shares of Series B Convertible Preferred Stock, which will be convertible into 9,138,966 shares of common stock, at a price of $65.00 per share of Series B Convertible Preferred Stock, for expected additional aggregate gross proceeds of approximately $11.9 million.

The securities being offered to the Private Placement Purchaser will not be registered under the Securities Act of 1933, as amended (the "Securities Act"). Such issuances are also scheduled to close on or about February 2, 2026, subject to the closing of the public offering and the satisfaction of certain other customary closing conditions. The closing of the underwritten public offering is not conditioned on the closing of the concurrent private placement.

Lexicon currently intends to use the net proceeds that it will receive from the proposed offering and the concurrent private placement (i) to fund the continued research and development of its drug candidates and (ii) for working capital and other general corporate purposes.

Jefferies and Piper Sandler are acting as joint book-running managers for the public offering. H.C. Wainwright & Co. is acting as lead manager for the public offering.

A shelf registration statement on Form S-3 relating to the public offering was filed with the U.S. Securities and Exchange Commission ("SEC") on August 2, 2024 and declared effective by the SEC on August 15, 2024 (File No. 333-281208). The shares of common stock proposed to be issued in the concurrent private placement have not been registered under the Securities Act, or the securities laws of any state or other jurisdiction in the United States, and may not be offered, pledged, sold, delivered or otherwise transferred, directly or indirectly, in the United States except pursuant to registration under the Securities Act or an applicable exemption from the registration requirements of the Securities Act and, in each case, in compliance with other applicable securities laws. A preliminary prospectus supplement and accompanying prospectus relating to the public offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC and will also be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and accompanying prospectus may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; or Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, by telephone at (800) 747-3924, or via email at [email protected].

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale is not permitted.

(Press release, Lexicon Pharmaceuticals, JAN 29, 2026, View Source [SID1234662398])

On January 29, 2026 Oncoinvent, a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers, reported that the first patient has been enrolled at one of the newly activated sites in its Phase 2 study of Radspherin in patients with peritoneal carcinomatosis from ovarian cancer.

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 randomized part of the study has been actively recruiting patients at six sites since March 2025. Four additional sites have now been opened, and the first patient has been enrolled at one of these newly activated sites.

"The process of opening new clinical sites involves extensive regulatory reviews, contracting, and site-readiness work. We are therefore pleased to see both the successful activation of additional sites and the enrollment of the first patient at a newly onboarded site," said Kari Myren, Chief Medical Officer at Oncoinvent.

The Phase 2 trial (Clinicaltrial.gov: NCT06504147) is a randomized controlled trial assessing the efficacy and safety of Radspherin in patients with peritoneal metastases from ovarian cancer. The primary objective is to compare progression-free survival (PFS) between patients who receive Radspherin after complete surgical resection following pre-operative chemotherapy, and patients receiving pre-operative chemotherapy and surgery alone.

The study will recruit patients at a total of 11 sites across Norway (1), Spain (5), Belgium (1), the United Kingdom (2), the United States (1), and Italy (1). Positive Phase 1/2a data from the safety interim analysis demonstrated that Radspherin was well tolerated with no dose-limiting toxicity observed at the recommended dose of 7MBq.

(Press release, Oncoinvent, JAN 29, 2026, https://www.oncoinvent.com/press-release/four-additional-sites-open-for-recruitment-in-oncoinvents-phase-2-trial/ [SID1234662334])

On January 29, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its consolidated financial results for the fiscal year ended December 31, 2025, and forecasts for the fiscal year ending December 31, 2026.

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!

Chugai reported that revenue for the fiscal year ended December 31, 2025 totaled ¥1,257.9 billion (+ ¥87.3 billion, +7.5%, YoY).

Regarding revenue, domestic sales were ¥472.4 billion (+ ¥11.3 billion, +2.5%, YoY). In the oncology field, sales decreased by 0.5% YoY due to the decrease in Perjeta, which has the same active ingredient as Phesgo, due to Phesgo’s market penetration, and the impact of NHI drug price revisions and penetration of biosimilars on our mainstay product Avastin, despite steady growth of new products Phesgo and Lunsumio, and our mainstay product Polivy. In the specialty field, sales increased by 5.8% YoY, driven by steady performance of mainstay products Vabysmo, Enspryng, and Hemlibra, along with successful market penetration of the new product PiaSky. Overseas sales increased by 12.8%, driven by increases in Hemlibra and Actemra to Roche. Other revenue increased by 4.3%, despite the decrease in one-time income, mainly due to an increase in income related to Hemlibra.

Cost to sales ratio improved by 1.3 percentage points YoY to 32.6%, mainly due to foreign exchange effects and changes in the product mix. Research and development expenses increased to ¥180.1 billion (+1.8%, YoY) due to investments into drug discovery and early development, and increases associated with the progress of development projects, while selling, general and administrative expenses were ¥103.2 billion (+1.0%, YoY) mainly driven by miscellaneous expenses. Other operating income (expense) was ¥0.0 billion. As a result, core operating profit was ¥623.2 billion (+12.1%, YoY) with a core operating profit margin (to revenue) of 49.5%, and core net income increased for the nine consecutive years to ¥451.0 billion (+13.6%, YoY).

Chugai made steady progress in R&D activities for both in-house products and products in-licensed from Roche.

For in-house projects, NXT007, under development for hemophilia A, achieved Proof of Concept (PoC), an important milestone, with data from the high-dose cohort of the Phase I/II trial suggesting the potential to provide blood coagulation capacity equivalent to normal levels. For a Chugai-originated development, orforglipron, an oral GLP-1 receptor agonist out-licensed to Eli Lilly and Company, met the primary endpoints across all multiple Phase III clinical trials for obesity and type 2 diabetes. Based on favorable Phase III clinical trial results, Eli Lilly and Company submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the treatment of obesity. NEMLUVIO, being developed overseas by Galderma, received approval in Europe for moderate to severe atopic dermatitis and prurigo nodularis. AVMAPKI, out-licensed to Verastem Oncology, was approved by the FDA under the accelerated approval pathway based on response rate and duration of response for combination therapy with FAKZYNJA for KRAS-mutant recurrent low-grade serous ovarian cancer.*

*Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

For products in-licensed from Roche, the intravenous formulation of Lunsumio was launched in Japan as a treatment for relapsed or refractory follicular lymphoma, and additional approval was obtained for the subcutaneous formulation. In addition, Elevidys obtained regulatory approval in Japan as a regenerative medicine product for the treatment of duchenne muscular dystrophy under the conditional and time-limited approval pathway. Furthermore, Tecentriq and Vabysmo obtained approvals for expanded indications, and Lunsumio and Avastin have been filed for expanded indications.

For products in-licensed from third parties other than Roche, sparsentan, acquired through the wholly owned subsidiary of Renalys Pharma, Inc., showed positive topline results in a domestic Phase III trial for IgA nephropathy. Sparsentan is scheduled to be filed for regulatory approval in Japan in 2026.

In 2025, Chugai entered into a joint research and license agreement with Gero, which has target discovery technology for age-related diseases, and a license agreement with Rani Therapeutics, whose technology enables oral delivery of biologics and drugs. Chugai will continue to pursue the expansion of its drug discovery engine through open innovation.

In 2026, core revenue, core operating profit, and core net income are expected to be ¥1,345.0 billion (+ ¥87.1 billion, +6.9%, YoY), ¥670.0 billion (+ ¥46.8 billion, +7.5%, YoY), and ¥485.0 billion (+ ¥34.0 billion, +7.5%, YoY), resulting in an increase in both revenue and profit. Product sales are expected to increase in Japan and remain at similar levels to the previous year overseas, totaling ¥1,100.0 billion (+ ¥22.2 billion, +2.1%, YoY). Domestic sales are expected to be ¥498.0 billion (+ ¥25.6 billion, +5.4%, YoY) due to volume growth of new product Lunsumio and our mainstay products, despite a decrease in sales due to NHI drug price revisions and penetration of generics. Overseas sales are expected to be ¥602.0 billion (- ¥3.4 billion, -0.6%, YoY) due to growth in NEMLUVIO and Hemlibra, while a decrease in Actemra and others is expected. Other revenue is expected to be ¥245.0 billion (+ ¥64.9 billion, +36.0%, YoY). Royalty and profit-sharing income are forecasted to be ¥217.2 billion (+ ¥44.5 billion, +25.8%, YoY), due to an increase in income related to products out-licensed to third parties and Hemlibra. Other operating income is expected to be ¥27.8 billion (+ ¥20.3 billion, +270.7%, YoY), due to an increase in one-time income.

　

[2025 full year results]

Billion JPY 2025 2024 % change
Core results
　Revenue 1,257.9 1,170.6 +7.5%
　　Sales 1,077.8 997.9 +8.0%
　　Other revenue 180.1 172.7 +4.3%
　Operating profit 623.2 556.1 +12.1%
　Net income 451.0 397.1 +13.6%
IFRS results
　Revenue 1,257.9 1,170.6 +7.5%
　Operating profit 598.8 542.0 +10.5%
　Net income 434.0 387.3 +12.1%
[Sales breakdown]

Billion JPY 2025 2024 % change
Sales 1,077.8 997.9 +8.0%
　Domestic sales 472.4 461.1 -0.5%
　　Oncology 246.5 247.7 -0.5%
　　Specialty 225.8 213.4 +5.8%
　Overseas sales 605.4 536.8 +12.8%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025 2024 % change
　Tecentriq 62.8 65.4 -4.0%
　Polivy 37.2 34.1 +9.1%
　Phesgo 33.9 23.5 +44.3%
　Alecensa 33.5 31.0
+8.1%

　Avastin 26.1 33.8 -22.8%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2025 2024 % change
　Hemlibra 62.7 59.0 +6.3%
　Actemra 50.5 48.0 +5.2%
　Enspryng 29.2 24.7 +18.2%
　Vabysmo 26.2 21.5 +21.9%
　Evrysdi 16.2 15.9 +1.9%
[2026 full year forecast](Core-basis)

Billion JPY 2026 Forecast 2025 Actual % change
　Revenue 1,345.0 1,257.9 +6.9%
　Operating profit 670.0 623.2 +7.5%
　Net income 485.0 451.0 +7.5%
[Progress in R&D activities from Oct 25th, 2025 to Jan 29th, 2026]

2025 FY R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, JAN 29, 2026, View Source [SID1234662351])