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.

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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])

On January 29, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Group and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that Dong-Gun (DG) Kim has been appointed its Chief Executive Officer. He will concurrently retain his roles as CEO of HLB US and CEO of Immunomic Therapeutics, Inc., both affiliated companies within HLB Group.

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At Elevar, DG Kim replaces Dr. Bryan Kim, who will remain CEO of HLB Group’s Verismo Therapeutics, Inc. With Elevar having this week submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration for its top two developmental drugs, the transition allows Bryan Kim to now solely focus on his role with Verismo, which expects to reach several important milestones in the coming year.

On January 23, 2026, Elevar submitted an NDA for the combination of its drug candidate rivoceranib, a VEGFR-TKI, and Hengrui Pharma’s camrelizumab, an anti-PD-1 antibody, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC). HCC is the most common type of liver cancer. Elevar also submitted an NDA on January 27, 2026, for its investigational drug lirafugratinib as a second-line treatment option for cholangiocarcinoma (CCA) with fibroblast growth factor receptor (FGFR2) fusions or rearrangements. CCA is also known as bile duct cancer.

"Bryan Kim has done an exemplary job steering Elevar through the regulatory and developmental steps leading to NDAs for both the rivoceranib-camrelizumab combination in the liver cancer arena and lirafugratinib as a bile duct cancer therapy," said DG Kim, an Elevar board member since 2020. "With this critical phase completed, I look forward to executing on our commercialization strategy while simultaneously working to meet any requests from the FDA during its review of these important applications."

DG Kim previously served as CEO of HLB Co. Ltd. Prior to that, he spent more than 30 years as a specialist in mergers & acquisitions, corporate finance and investment management at leading corporations and professional firms (law, investment banking and private equity) both in the U.S. and Korea. He holds an A.B. in Physics from Harvard College and a J.D. from Harvard Law School.

(Press release, Elevar Therapeutics, JAN 29, 2026, View Source [SID1234662352])

On January 29, 2026 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) ("Lexicon") reported that it has commenced an underwritten public offering to offer and sell, subject to market and other conditions, shares of its common stock, par value $0.001. In addition, Lexicon intends to grant the underwriters a 30-day option to purchase additional shares of common stock. There can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Jefferies and Piper Sandler are acting as joint book-running managers for the proposed offering.

Concurrently with the closing of the underwritten public offering, Lexicon intends to sell shares of its common stock in a private placement to an affiliate of Invus, L.P., Lexicon’s largest stockholder, pursuant to its preemptive right under Lexicon’s Sixth Amended and Restated Certificate of Incorporation. Lexicon intends to grant the private placement purchaser an option to purchase, on a pro rata basis, additional shares of common stock to the extent the underwriters exercise their option to purchase additional common stock. Any shares of common stock offered pursuant to the concurrent private placement would not be registered under the Securities Act of 1933, as amended (the "Securities Act"). 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 (i) to fund the continued research and development of its drug candidates and (ii) for working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the proposed 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). A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary 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 [SID1234662353])

On January 29, 2026 Recordati reported that it has entered into a collaboration and license agreement with Moderna to develop and commercialize worldwide mRNA-3927, an investigational product for the treatment of propionic acidemia (PA). Under the terms of the agreement, Moderna will continue to lead the development of mRNA-3927, in collaboration with Recordati, and if approved, Recordati will lead global commercialization.

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mRNA-3927 is a post proof-of-concept, investigational product aimed to restore propionyl-CoA carboxylase (PCC) enzyme activity in patients with propionic acidemia. Propionic acidemia is a rare inherited metabolic disorder which is caused by defective mitochondrial enzymes (PCC) leading to abnormal toxic metabolite build up and organic acidemia. The disease often presents in early childhood with general symptoms of malaise but can progress with brain and cardiac damage and is associated with significant mortality. Current treatment options are symptomatic and may ultimately also include liver transplant. If approved, this could be the first disease-modifying treatment option on the market for this severe disease.

mRNA-3927 is a targeted disease modifying therapy in clinical development. Interim clinical data was recently published in the prestigious journal Nature showing early signs of clinical improvement. mRNA3927 is currently being evaluated in a potential registrational clinical study with the aim to reduce the risk of metabolic decompensation events in these patients. The target patient enrollment has been reached, with a potential data readout expected by the end of 2026.

Under the terms of the agreement, Recordati will pay Moderna an upfront payment of USD 50 million and up to an additional USD 110 million in near-term development and regulatory milestones. Moderna is also eligible to receive commercial and sales milestones, as well as tiered royalties on annual net sales. Recordati does not expect any significant impact on its EBITDA prior to a potential launch.

The transaction is subject to customary closing conditions, including U.S. antitrust clearance which is expected within 30 days from the relevant filing.

Rob Koremans, Chief Executive Officer, Recordati, commented, "Propionic acidemia is a serious rare disease with a significant unmet medical need due to the lack of disease modifying treatment options to date. We look forward to partnering with Moderna. Their experience in applying innovative mRNA technology, combined with our experience in rare metabolic disorders and strong established commercial infrastructure, positions us well to advance this potential therapy together to serve patients. We are encouraged by the clinical data and look forward to the pivotal readout expected by the end of 2026. This deal strengthens our development portfolio and builds on our heritage in the metabolic field."

Stéphane Bancel, Chief Executive Officer of Moderna, added, "We are proud to partner with Recordati in a joint mission to improve the lives of people living with propionic acidemia. Recordati brings deep rare disease commercial expertise and an established global commercial infrastructure in propionic acidemia that will help us accelerate the benefit of mRNA-3927 upon approval."

About propionic acidemia (PA)

Propionic acidemia is a rare, serious, inherited metabolic disorder with significant morbidity and mortality, affecting 1 in 100,000-150,000 individuals worldwide. PA is caused by pathogenic variants in the propionylcoenzyme A carboxylase (PCC) α or β subunits (PCCA and PCCB genes, respectively), leading to PCC deficiency and subsequent accumulation of toxic metabolites. PA is characterized by recurrent lifethreatening metabolic decompensation events (MDEs) and multisystemic complications. Currently, there are no effective therapies for PA that target the underlying root cause of the disease.

About mRNA-3927

mRNA-3927 is an investigational novel mRNA-based therapeutic agent that is composed of two mRNAs encoding for normal human PCCA and PCCB subunits. Intravenous (IV) administration of mRNA-3927 is intended to restore functional PCC enzymes in patients with PA.

Interim data from a first-in-human, phase 1/2, open-label, dose optimization study and extension study evaluating the safety and efficacy of mRNA-3927 indicate early signs of potential clinical benefit and demonstrate that mRNA-3927 has infrequent treatment-limiting side effects.

mRNA-3927 is currently being evaluated in a potential registrational clinical study with the aim to reduce the risk of metabolic decompensation events in these patients (NCT04159103).

(Press release, Recordati, JAN 29, 2026, View Source [SID1234662354])

On January 29, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported the first patient was dosed in its first-in-human clinical trial evaluating RMC-5127, a RAS(ON) G12V-selective inhibitor.

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The first-in-human trial, RMC-5127-001 [NCT07349537], is an open-label trial evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of RMC-5127 as both a monotherapy and in combination settings. The trial will enroll patients with RAS G12V–mutated solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and non–small cell lung cancer (NSCLC), who have progressed on or are intolerant to prior standard therapies, including targeted treatments.

"By bringing RMC-5127 to the clinic, we are building on our well-validated RAS(ON) inhibitor approach and extending it to RAS G12V, the second most common RAS mutation driving human cancers, where there are no approved targeted treatment options," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "As our fifth disclosed mutant-selective RAS(ON) inhibitor and fourth clinical-stage program, RMC-5127 broadens the RAS variant coverage of our growing portfolio and opens a suite of development opportunities aimed at improving outcomes for patients with RAS-driven cancers."

RMC-5127 is an innovative inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the oncogenic RAS(ON) form of the RAS G12V variant. RAS G12V is the second most common driver of RAS-addicted human cancers with approximately 48,000 patients diagnosed in the U.S.1 each year, predominantly among patients with PDAC, CRC, or NSCLC.

(Press release, Revolution Medicines, JAN 29, 2026, View Source [SID1234662355])