On January 29, 2026 Takeda (TOKYO:4502/NYSE:TAK) reported earnings results for the third quarter of fiscal year 2025 (nine months ended December 31, 2025). The gap between incremental Growth & Launch Products revenue and VYVANSE erosion is narrowing, and operational efficiencies drove year-on-year reductions in operating expenses, including R&D. The company raised its full-year forecasts based on cost discipline and FX tailwind, while its Revenue Management Guidance has been updated primarily due to the impact of VYVANSE generics.

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Takeda is positioned for long-term growth and has multiple late-stage programs with multibillion-dollar peak revenue potential. Following the positive readouts from Phase 3 studies in 2025, the company has submitted New Drug Applications (NDAs) for oveporexton and rusfertide and is on track to file an NDA for zasocitinib. Each of these programs, which Takeda expects to launch within the next 18 months, has the potential to redefine standards of care, transform patient lives and contribute to Takeda’s new growth trajectory.

Takeda chief financial officer, Milano Furuta, commented:
"While we manage the impact of VYVANSE generics, we are implementing disciplined cost management and improving operational efficiency and therefore expect to achieve the previously disclosed Management Guidance for Core Operating Profit.

"FY2025 remains a truly pivotal year for Takeda as we are in a phase of preparing for significant new product launches. Looking ahead, with multiple innovative launches and a robust late-stage pipeline, Takeda is positioned to bring life-transforming medicines that improve patient lives and deliver long-term shareholder value."

FINANCIAL HIGHLIGHTS for FY2025 Q3 YTD Ended December 31, 2025

(Billion yen, except percentages and per share amounts)

Item

FY2025 Q3 YTD

FY2024 Q3 YTD

vs. PRIOR YEAR

(Actual % change)

Revenue

3,411.2

3,528.2

-3.3%

Operating Profit

422.4

417.5

+1.2%

Net Profit

216.1

211.1

+2.4%

EPS (Yen)

137

134

+2.7%

Operating Cash Flow

966.9

835.0

+15.8%

Adjusted Free Cash Flow (Non-IFRS)

625.9

568.3

+10.1%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

Item

FY2025 Q3 YTD

FY2024 Q3 YTD

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change)

Revenue

3,411.2

3,528.2

-3.3%

-2.8%

Operating Profit

971.6

1,006.3

-3.4%

-3.4%

Margin

28.5%

28.5%

-0.0 pp

―

Net Profit

673.6

698.9

-3.6%

-3.4%

EPS (Yen)

428

443

-3.3%

-3.1%

FY2025 Outlook

Updating Full Year Management Guidance for Revenue and Forecasts

Takeda has updated its full year Management Guidance for Revenue primarily due to VYVANSE and raised full year forecasts to reflect cost discipline and FX tailwind.

FY2025 Management Guidance Core Change at CER (Non-IFRS)

Item

FY2025 PREVIOUS MANAGEMENT GUIDANCE
(October 2025)

FY2025 REVISED MANAGEMENT GUIDANCE
(January 2026)

Core Revenue

Broadly flat

Low-single-digit % decline

Core Operating Profit

Low-single-digit % decline

Low-single-digit % decline

Core EPS

Low-single-digit % decline

Low-single-digit % decline

FY2025 Reported and Core Forecasts

(Billion yen, except percentages and per share amounts)

Item

FY2025
PREVIOUS FORECAST

(October 2025)

FY2025

REVISED FORECAST

(January 2026)

Revenue

4,500.0

4,530.0

Core Revenue (Non-IFRS)

4,500.0

4,530.0

Operating Profit

400.0

410.0

Core Operating Profit (Non-IFRS)

1,130.0

1,150.0

Net Profit

153.0

154.0

EPS (Yen)

97

98

Core EPS (Yen) (Non-IFRS)

479

486

Adjusted Free Cash Flow (Non-IFRS)

600.0-700.0

650.0-750.0

Annual Dividend per Share (Yen)

200

200

Additional Information About Takeda’s FY2025 Q3 Results
For more details about Takeda’s FY2025 Q3 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2025 Q3 investor presentation (available at View Source).

(Press release, Takeda, JAN 29, 2026, View Source [SID1234662361])

On January 29, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported the submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri multi-cancer early detection (MCED) test. The FDA designated the test as a Breakthrough Device in 2018.

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"Cancer is now the leading killer of adults over 50 years old in the U.S., and most deadly cancers are often discovered too late, when they are difficult to treat and typically have worse outcomes," said Josh Ofman, MD, MSHS, President at GRAIL. "There is nothing acceptable about the status quo in cancer screening. Adding Galleri to standard-of-care single cancer screening tests has the potential to dramatically improve the performance of the nation’s current screening program and expand opportunities for earlier treatment and improved outcomes. Galleri has been rigorously studied in case-controlled and interventional studies. This FDA submission marks a critical step toward making Galleri available to more people and advancing early detection to provide a significant public health benefit."

The PMA submission is focused on the test performance and safety results from 25,490 consented participants in the US-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled trial of any MCED test in an intended use population. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval.

About the NHS-Galleri trial (NCT05611632)
The NHS-Galleri trial is the first and only prospective, randomized, controlled trial to assess the clinical utility and performance of a multi-cancer early detection test for population screening when added to standard care. The trial recruited more than 140,000 asymptomatic participants, aged 50 to 77, and was conducted in partnership with the NHS in England. Participants provided three blood samples over two years, about 12 months apart. The primary objective of the NHS-Galleri trial is to show a reduction in late-stage (III-IV) cancers in people who received the Galleri test compared with those who did not. This will be measured in three clinically important groups of cancers, focusing first in a pre-specified group of 12 cancer types that together represent approximately two-thirds of cancer deaths in England and the United States. Secondary objectives include reduction in stage IV cancer; performance of the Galleri test, including positive predictive value and false positive rate; cancer detection rate; safety; and healthcare resource utilization.

About the PATHFINDER 2 Study (NCT05155605)
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and performance of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes over several time points, including an assessment of participants’ anxiety and satisfaction with the MCED test.

(Press release, Grail, JAN 29, 2026, View Source [SID1234662360])

On January 29, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that the U.S. Food & Drug Administration (FDA) has accepted for filing Summit’s Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.

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The BLA was submitted based on the overall results of the Phase III HARMONi trial, which evaluated ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC who were previously treated with a 3rd generation EGFR TKI.

The FDA has noted that they intend to perform a complete review of the accepted and filed application in accordance with draft guidance, Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.1 This includes planned mid-cycle and wrap-up meetings, and, subject to major deficiencies not being identified during the FDA’s review, proposed labeling, prior to the PDUFA date.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 14 Phase III clinical studies that are either ongoing or have been completed studying ivonescimab, ten of which are being conducted in China by Akeso and four of which are Summit-sponsored global studies. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.

HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary tract cancer, colorectal cancer, breast cancer, pancreatic cancer, small cell lung cancer, and head and neck cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

(Press release, Summit Therapeutics, JAN 29, 2026, View Source;FDA-Acceptance-of-Biologics-License-Application-BLA-Seeking-Approval-for-Ivonescimab-in-Combination-with-Chemotherapy-in-Treatment-of-Patients-with-EGFRm-NSCLC-Post-TKI-Therapy/default.aspx [SID1234662359])

On January 29, 2026 Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, reported the closing of its previously announced registered direct offering pursuant to a securities purchase agreement with a new fundamental institutional investor for the purchase and sale of 17,045,454 shares of its common stock (or pre-funded warrants in lieu thereof) pursuant to a registered direct offering. The gross proceeds to the Company were approximately $75 million, before deducting placement agent fees and other offering expenses. All of the shares and pre-funded warrants in the offering are being offered by Altimmune. The pre-funded warrants have an exercise price of $0.001 per share, are exercisable immediately upon issuance and will not expire until fully exercised.

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"Pemvidutide, our balanced 1:1 glucagon/GLP-1 dual agonist, has the potential to be a differentiated therapy for patients with MASH as demonstrated by our recently-announced Phase 2b 48-week topline data and the Breakthrough Therapy Designation from the U.S. FDA. This investment is an important step in strengthening Altimmune’s balance sheet and increasing our operational and strategic flexibility as we move toward initiation of our Phase 3 trial" said Jerry Durso, President and Chief Executive Officer of Altimmune. "We continue to focus on delivering meaningful impact for patients and long-term value for our shareholders."

Altimmune intends to use the net proceeds towards its upcoming Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH) as well as for working capital and general corporate purposes.

Titan Partners, a division of American Capital Partners, acted as the sole placement agent for the offering.

The securities were offered by Altimmune pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC), which was declared effective by the SEC on December 5, 2025. A prospectus supplement relating to the shares of common stock (or pre-funded warrants in lieu thereof) has been filed by the Company with the SEC and is available on the SEC’s website located at www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, by contacting Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 49th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at [email protected].

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

(Press release, Altimmune, JAN 29, 2026, View Source [SID1234662358])

On January 29, 2026 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the fourth quarter and full year ended December 31, 2025.

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Fourth Quarter and Full Year 2025 Highlights

•Fourth quarter revenue grew 7% to $12.21 billion.
•Fourth quarter GAAP diluted earnings per share (EPS) grew 9% to $5.21.
•Fourth quarter adjusted EPS grew 8% to $6.57.

•Full year revenue grew 4% to $44.56 billion.
•Full year GAAP diluted earnings per share (EPS) grew 7% to $17.74.
•Full year adjusted EPS grew 5% to $22.87.

•Delivered another year of excellent operational performance and share gain reflecting our active management of the company, the strength of our proven growth strategy and the power of our PPI Business System.

•Advanced our proven growth strategy by launching a range of high-impact, innovative new products in 2025. Highlights include the Thermo Scientific Orbitrap Astral Zoom mass spectrometer, Thermo Scientific Krios 5 Cryo-TEM, Thermo Scientific Vulcan Automated Lab, and the bench-scale Thermo Scientific 5L DynaDrive Single-Use Bioreactor. During the fourth quarter we launched the Thermo Scientific Helios MX1 Plasma Focused Ion Beam Scanning Electron Microscope, a fully automated semiconductor analysis system designed to accelerate time-to-data for yield ramp and fab process control, and we received FDA approval for the Ion Torrent Oncomine Dx Target Test as a companion diagnostic for HYRNUO, Bayer’s targeted therapy for patients with HER2-mutated non-small cell lung cancer, as well as U.S. 510(k) clearance for the EXENT System, a first-of-its-kind automated platform to aid in the diagnosis of multiple myeloma.

•Strengthened our industry-leading commercial engine and deepened our trusted partner status with customers. We continued to scale adoption of our Accelerator Drug Development solution – our integrated CDMO and CRO offering, securing meaningful wins across our biopharma services businesses. We also entered into a technology alliance agreement with the Chan Zuckerberg Institute for Advanced Biological Imaging to advance new technologies enabling researchers to better visualize human cells. During the fourth quarter, we established a strategic collaboration with OpenAI to expand the use of artificial intelligence across our operations and our products and services to accelerate scientific breakthroughs, enhance drug development and drive greater productivity; and expanded our bioprocess design centers in Asia, including opening a new site in India, to further support pharma and biotech customers with process development and scale-up.

•Continued to successfully execute our capital deployment strategy, deploying approximately $16.5 billion in 2025. This included $13 billion committed to M&A. We completed the acquisition of our Filtration and Separation business from Solventum, an excellent complement to our bioproduction capabilities, and Sanofi’s Ridgefield, New Jersey, sterile fill-finish site, expanding our U.S. capacity for drug product manufacturing capacity. Then in the fourth quarter, we announced a definitive agreement to acquire Clario, a leading provider of endpoint data solutions for clinical trials, adding high-growth capabilities to enhance clinical insights for our pharma and biotech customers and further accelerate the digital transformation of clinical research. Additionally, during the year we returned $3.6 billion of capital to shareholders through stock buybacks and dividends.

"Thanks to our exceptional team, we delivered a strong finish to 2025, reflecting outstanding execution and the continued strength of our proven growth strategy," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Throughout the year we effectively navigated the external environment and leveraged our PPI Business System to enable excellent operational performance. It was also a very active year for capital deployment, as we advanced our strategy and added exciting new capabilities that further strengthen our long-term competitive position."

Casper added, "We enter 2026 from a position of strength. Our growth strategy is resonating with customers, positioning us for continued share gain, and our PPI Business System provides a strong foundation to continue our excellent operational performance. Together, this positions us well to deliver on our 2026 objectives as we create value for our stakeholders and build an even brighter future for our company."

Fourth Quarter 2025

Revenue for the fourth quarter of 2025 grew 7% to $12.21 billion, versus $11.40 billion in in the same quarter of 2024. Organic revenue growth was 3%.

GAAP Earnings Results

GAAP diluted EPS in the fourth quarter of 2025 was $5.21, 9% growth versus the fourth quarter of 2024. GAAP operating income for the fourth quarter of 2025 was $2.26 billion, 12% higher than the year-ago quarter. GAAP operating margin was 18.5%, compared with 17.7% in the fourth quarter of 2024.

Non-GAAP Earnings Results

Adjusted EPS for the fourth quarter of 2025 was $6.57, 8% growth versus the fourth quarter of 2024. Adjusted operating income for the fourth quarter of 2025 was $2.88 billion, 6% higher than the year-ago quarter. Adjusted operating margin was 23.6%, compared with 23.9% in the fourth quarter of 2024.

Full Year 2025

Revenue for the full year 2025 grew 4% to $44.56 billion, versus $42.88 billion in 2024. Organic revenue growth was 2%.

GAAP Earnings Results

GAAP diluted EPS for the full year was $17.74, 7% growth versus the full year 2024. GAAP operating income for the full year was $7.75 billion, 6% higher than 2024. GAAP operating margin was 17.4%, compared with 17.1% in 2024.

Non-GAAP Earnings Results

Adjusted EPS for the full year 2025 was $22.87, 5% growth versus the full year 2024. Adjusted operating income for the full year was $10.11 billion, 4% higher than 2024. Adjusted operating margin was 22.7%, compared with 22.6% in 2024.

Annual Guidance for 2026

The company will provide 2026 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Time.

(Press release, Thermo Fisher Scientific, JAN 29, 2026, View Source [SID1234662357])