On January 13, 2026 Decoy Therapeutics, Inc. (Nasdaq: DCOY) (Decoy, or the Company), a preclinical biopharmaceutical that is engineering the next generation of peptide conjugate therapeutics, announces that the development of a flexible, globally accessible manufacturing platform for peptide-conjugate antivirals is a key ‘funded development’ of Decoy’s Global Access Commitment Agreement (GACA) with the Gates Foundation.

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"We are excited to enter this new phase of our work funded by the Gates Foundation to support making countermeasures for emerging pathogens accessible to people in low- and middle-income countries," stated Decoy Chief Scientific Officer Barbara Hibner. "This new capability will establish a distributed network of manufacturing facilities with the ability to respond rapidly to viral outbreaks anywhere in the world. It will also support Decoy’s future commercial efforts by providing the ability to manufacture our antiviral inhibitors, and ultimately other classes like peptide drug conjugates for oncology indications, for global markets."

Decoy is creating an easily transferable manufacturing capability for peptide-conjugate antiviral fusion inhibitors designed on its IMP3ACT platform that can rapidly advance therapeutic products from laboratory to commercial scale. This manufacturing capability will be designed to enable cost-efficient, rapid and repeatable scale-up on standard commercial peptide-synthesis machinery, thus enabling a network of global manufacturing facilities that can be flexibly configured to meet demand.

"Our proprietary IMP3ACT platform allows for the rapid computational design and manufacturing of innovative peptide-conjugate therapeutics that have broad activity across entire viral families, or even across multiple viral families," said Peter Marschel, Decoy Chief Business Officer. "Our vision, ‘design-for-manufacturing’, allows us to minimize the marginal cost and regulatory effort to scale-up manufacturing for new therapeutics. We see this as a key element of an end-to-end platform that can design, develop and commercialize novel peptide-conjugate therapeutics with unprecedented speed."

Decoy is working with a leading contract manufacturing organization based in the U.S. and Europe to establish the manufacturing capability. The platform will be validated using Decoy’s intranasal pan-coronavirus fusion inhibitor funded from the same grant, which demonstrates the ‘design-for-manufacturing’ capability of Decoy’s proprietary IMP3ACT platform. The intranasal pan-coronavirus inhibitor is being developed as a conveniently administered, broad-acting, antiviral to prevent and mitigate infections from multiple coronaviruses in immune-compromised and high-risk populations.

The Company is focused on advancing its pipeline of peptide conjugate therapeutics engineered through its IMP3ACT platform that reduces the complexity of drug development and manufacturing. During the next 12 months, Decoy expects to advance its lead asset, a pan-coronavirus antiviral, to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), and to make progress on other programs including a novel broad-acting antiviral to treat flu, COVID-19 and respiratory syncytial virus (RSV), and a peptide drug conjugate targeting GI cancers.

About Decoy’s Peptide Conjugate Technology

Decoy’s drug design engine uses the power of computational tools and fast peptide synthesis technology pioneered in the laboratory of Brad Pentelute, Ph.D., Professor of Chemistry at MIT and Decoy co-founder, to rapidly engineer and synthesize novel antivirals that directly target highly conserved viral machinery. Its proprietary IMP3ACT peptide-conjugate drug design and manufacturing platform leverages machine learning (ML) and artificial intelligence (AI) tools. IMP3ACT allows for the rapid computational design and manufacturing of innovative peptide-conjugate therapeutics including rapid response to novel viral pathogens including H5N1 avian flu. Peptide conjugates are a new class of drug, perhaps best known for the popular diabetes and weight loss medications, that takes advantage of the strong activity and selectivity of peptides, and improves their targeting and durability by adding a lipid molecule. Decoy Therapeutics is expanding the use of this new drug class to indications including infectious diseases, cancer, and other therapeutic areas.

The IMP3ACT platform leverages peptide chemistry to design α-helical peptides using computational and ML tools. These peptides are transformed into multimeric conjugates by chemically linking a defined number of copies to lipids or other suitable membrane anchor moieties, enhancing their drug-like properties and dosing flexibility with extended pharmacokinetics. Decoy’s technology has produced peptide conjugates effective in vitro against multiple human coronaviruses, including all SARS-CoV-2 major variants of concern to date, and against RSV A, RSV B and hPIV3, and in vivo against the SARS-CoV-2 delta variant. By integrating machine learning algorithms in peptide design and synthesis, Decoy’s platform accelerates the creation of lead molecules for preclinical evaluation, simultaneously optimizing peptide conjugates for enhanced affinity, binding specificity, resistance to proteases, pharmacokinetic properties and manufacturability at early commercial scale.

On January 13, 2026 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported unaudited preliminary financial results for the fourth quarter and fiscal year 2025 ahead of its presentation at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 at 7:30 a.m. Pacific Time (10:30 a.m. Eastern Time). The webcast can be accessed through Illumina’s website at investor.illumina.com.

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Preliminary fourth quarter 2025 results:
•Revenue of approximately $1.155 billion, up 5% from Q4 2024 (up 4% on a constant currency basis)
•Ex-China revenue of approximately $1.100 billion, up 7% from Q4 2024 (and on a constant currency basis)
•GAAP diluted EPS of $2.14 to $2.17 and non-GAAP diluted EPS of $1.27 to $1.30

Preliminary fiscal year 2025 results:
•Revenue of approximately $4.34 billion, flat compared to 2024 (and on a constant currency basis)
•Ex-China revenue of approximately $4.10 billion, up 2% from 2024 (and on a constant currency basis)
•GAAP diluted EPS of $5.42 to $5.45 and non-GAAP diluted EPS of $4.76 to $4.79

As previously announced, the company expects to report its full fourth quarter and fiscal year 2025 results following the close of market on Thursday, February 5, 2026. The unaudited results in this press release are preliminary and subject to the completion of accounting and annual audit procedures and are therefore subject to adjustment.

Statement regarding use of non-GAAP financial measures
The company reports non-GAAP results for diluted earnings per share, net income, gross margin, operating expenses, including research and development expense, selling general and administrative expense, legal contingency and settlement, and goodwill and intangible impairment, operating income, operating margin, gross profit, other income (expense), tax provision, constant currency revenue and growth, and free cash flow (on a consolidated and, as applicable, segment basis) in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets among others that are listed in the reconciliations of GAAP and non-GAAP financial measures included in this press release, as well as the effects of currency translation. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Non-GAAP net income, diluted earnings per share and operating margin are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

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.

(Press release, Illumina, JAN 13, 2026, View Source [SID1234662012])

On January 13, 2026 Zonsen PepLib Biotech Inc. ("PepLib") reported that it has entered into a worldwide license agreement with Novartis for an undisclosed peptide-based asset in the field of radioligand therapies (RLTs). Under the agreement, Novartis has obtained an exclusive worldwide license and will be responsible for the development and commercialization activities for the asset.

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The asset has been developed internally by PepLib to date. Through this transaction, Novartis, an experienced global leader in RLTs, will advance the program to its next stage of development. The asset is expected to complement Novartis’ existing RLT portfolio and to leverage the company’s strong capabilities in the field to potentially bring a new targeted treatment option to patients worldwide.

"We are pleased to announce this new agreement with Novartis, a global leader in radioligand therapies," said Lei Chen, Chairman and Co-founder of PepLib. "We have advanced this peptide asset internally and believe that Novartis, with its deep expertise and proven track record in RLTs, is well-positioned to take the program forward and help translate our early work into a potential medicine for patients."

"Novartis is committed to expanding and strengthening our radioligand therapy portfolio to transform care for patients," said Shiva Malek, Global Head of Oncology, Biomedical Research, Novartis. "This asset complements our industry-leading efforts to advance promising next-generation RLTs and builds on our pipeline of innovative therapies for people living with cancer."

Under the terms of the agreement, PepLib will receive an upfront payment of USD 50 million, with the potential to receive additional development, regulatory, and sales milestone payments, and is also eligible for tiered royalties on future global net sales.

(Press release, Novartis, JAN 13, 2026, View Source [SID1234662028])

On January 13, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported positive results from its ANKTIVA (nogapendekin alfa inbakicept) clinical program in non-small cell lung cancer (NSCLC) based on two studies, QUILT-2.023 and QUILT-3.055. Across 151 patients spanning first-, second-, and later-line disease, ANKTIVA demonstrated statistically significant immune restoration and a consistent association between lymphocyte recovery and improved survival in checkpoint-experienced patients.

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Checkpoint inhibitors such as pembrolizumab (Keytruda) and nivolumab (Opdivo) have transformed the treatment landscape for lung cancer; however, clinical benefit is often transient, and effective treatment options remain limited once patients progress following standard-of-care chemo-radiation and checkpoint inhibition.

QUILT-2.023 and QUILT-3.055 were designed to test the hypothesis that disease recurrence after checkpoint therapy reflects immune exhaustion and lymphocyte depletion, and that restoration of immune competence through activation of natural killer cells and CD8* cytotoxic T cells with ANKTIVA, in combination with checkpoint inhibitors, could improve outcomes.

"Today, the default standard of care for these patients remains cytotoxic chemotherapy such as docetaxel, which is associated with substantial toxicity and limited survival benefit," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "Large, randomized trials have demonstrated median overall survival of approximately nine months with docetaxel. The results from these studies support a potential paradigm shift toward what we define as Immunotherapy 2.0, which is the coordinated activation of the innate immune system through natural killer cells and the adaptive immune system through T cells to restore immune competence and extend survival."

Detailed results from QUILT-2.023 and QUILT-3.055 are being prepared for peer-review publication and future scientific presentations and serve as foundational safety and efficacy data demonstrating meaningful clinical benefit in patients with NSCLC who have failed all standards of care including checkpoint inhibitors.

The combination of ANKTIVA plus checkpoint inhibitor therapy is protected by multiple issued patents, including U.S. Patent Nos. 9,925,247 and 11,071,774, with patent terms extending into 2032–2039.

About QUILT-2.023

QUILT-2.023 (NCT03520686) is a Phase 3, open-label, multicohort study evaluating ANKTIVA in combination with approved checkpoint inhibitor–based regimens as first-line treatment for patients with advanced or metastatic NSCLC. The study included three randomized cohorts and one exploratory cohort, each analyzed independently.

The primary randomized cohort enrolled patients with stage III or IV squamous or nonsquamous NSCLC with PD-L1 expression ≥1% and no prior systemic therapy for advanced disease. Patients were randomized 1:1 to CPI alone or CPI plus ANKTIVA. Stratification factors included CPI regimen, ECOG performance status, histology, and PD-L1 tumor proportion score. The primary endpoint was progression-free survival assessed by RECIST v1.1, with longitudinal absolute lymphocyte count prospectively incorporated as a key biological endpoint.

Enrollment was closed early following changes in the first-line NSCLC treatment landscape. All analyses were conducted according to the finalized protocol and statistical analysis plan.

About QUILT-3.055

QUILT-3.055 (NCT03228667) is a Phase 2b, multicohort, open-label study evaluating the addition of nogapendekin alfa inbakicept to continued PD-1/PD-L1 inhibitor therapy in patients with advanced solid tumors who progressed after prior checkpoint inhibition. The study enrolled heavily pretreated patients, including second- and later-line NSCLC.

Patients continued the same checkpoint inhibitor to which they had previously responded or stabilized, with ANKTIVA administered subcutaneously in repeated six-week cycles. The primary objective prospectively linked immune biology to clinical outcomes by evaluating overall survival in relation to absolute lymphocyte count response, defined as achieving or maintaining a mean on-treatment ALC ≥1,000 cells/µL. Secondary endpoints included objective response rate, progression-free survival, duration of therapy, and safety.

(Press release, ImmunityBio, JAN 13, 2026, View Source [SID1234662013])

On January 13, 2026 Bayer AG reported the strategic focus for its Pharmaceuticals Division in 2026 on the occasion of the 44th J.P. Morgan Healthcare Conference in San Francisco.

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Capitalizing on new launch momentum, the company will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio. High-value commercial products and an accelerating modality-rich pipeline across oncology, cardiology, neurology, and immunology have firmly cemented the Pharmaceuticals Division’s growth for the coming years. Five pivotal worldwide approvals in 2025 underscore a landmark year of strategic execution, validating the successful advancement of Bayer’s ambitious pharmaceutical growth strategy.

"We are now clearly seeing the success of our strategy. We have fundamentally accelerated Bayer Pharmaceutical’s growth runway with multiple high-impact launches across oncology, cardiology, and women’s health," said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. "Our strategic focus remains on delivering transformative medicines to patients faster, powered by our cutting-edge R&D expertise, dynamic operating model, partnership-driven innovation, AI-enabled development, and commitment to commercial excellence. Our Pharmaceuticals Division is poised for sustainable growth over the coming years."

Innovating to capture additional market opportunity in cardiovascular and cerebrovascular medicine

Bayer is advancing its global leadership in cardiovascular disease management through world-class science, strategic partnerships, and a high-value pipeline designed to deliver both patient and shareholder impact.

Asundexian, an investigational, once daily, oral Factor XIa inhibitor, has been investigated as a potential treatment for secondary stroke prevention. Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke.1,2 Despite available secondary stroke prevention options, the risk of secondary stroke remains high; one in five stroke survivors will have another stroke within five years.3 Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.2,4,5 Topline data from the Phase III OCEANIC-STROKE study showed it met its primary safety and efficacy endpoints. OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor and these results underscore the blockbuster potential of asundexian in secondary stroke prevention. Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke.

Additionally, Bayer is driving forward its global leadership in cardiovascular and renal disease, leveraging integrated capabilities and robust partnerships to unlock new value streams. The FDA and Japan’s Ministry of Health, Labour and Welfare (MHLW), among other regulatory authorities, have approved finerenone (marketed as Kerendia) for patients with heart failure with left ventricular ejection fraction (LVEF) of ≥40%, based on the positive results from the pivotal Phase III study FINEARTS-HF, further building on its established efficacy in chronic kidney disease (CKD) associated with type 2 diabetes. Applications in HF with LVEF ≥40% are under review in additional markets, including the EU and China. Ongoing, dedicated Phase III heart failure and chronic kidney disease programs (MOONRAKER and THUNDERBALL) continue to evaluate Kerendia’s potential across a broad spectrum of patients and clinical settings of Cardiovascular-Kidney-Metabolic (CKM) conditions. In November 2025, late-breaking, topline data from the Phase III study FINE-ONE presented at the American Society of Nephrology’s Kidney Week showed it met its primary safety and efficacy endpoints. For important risk and use information about KERENDIA, please see the full Prescribing Information.

The European Commission granted marketing authorization for Beyonttra (acoramidis), marketed by Bridge Bio in the U.S., to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Beyonttra slows the amyloidogenic process that results in ATTR-CM.

Beyond current successes, Bayer is actively shaping the future of cardiology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. This includes AB-1002, an investigational single-dose gene therapy in development for congestive heart failure (CHF) developed together with AskBio Inc., a wholly owned subsidiary of Bayer. AB-1002 is progressing well in Phase II. Its Phase I results were published in Nature Medicine and it has been granted Pioneering Regenerative Medical Product designation (SAKIGAKE) by Japan’s MHLW.

Additionally, Bayer has initiated the Phase II SIRIUS study of BAY-3018250, a first-in-class anti–alpha-2 antiplasmin (α2AP) antibody designed to enable targeted thrombolysis in deep vein thrombosis (DVT), and a Phase I clinical study of BAY-3670549, an investigational, highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, with the potential to help control the electrical activity of heart cells in patients with atrial fibrillation. Bayer’s commitment to cutting-edge science is further underscored by the company’s licensed dilated cardiomyopathy program with Dewpoint Therapeutics, which leverages condensate biology to develop genotype-guided therapies for dilated cardiomyopathy patients with specific genetic mutations. Concurrently, securing exclusive rights in Japan to aficamten from Cytokinetics—a cardiac myosin inhibitor in development for hypertrophic cardiomyopathy—strengthens Bayer’s precision cardiology footprint and expands its strategic market access.

Oncology growth engine: Leveraging blockbuster assets and precision pipeline for future leading position

Bayer’s oncology portfolio is delivering significant patient benefit and commercial success, with blockbuster Nubeqa (darolutamide) continuing its exceptional global uptake, progressing towards a market-leading position. With over 200,000 patients treated worldwide and a third approval in prostate cancer in both the U.S. and Europe, Nubeqa continues its strong growth trajectory. Total global sales are on the rise in all markets. Third approval in China is anticipated in 2026. Its comprehensive clinical development program is exploring Nubeqa’s potential in earlier prostate cancer settings, with two additional Phase III readouts expected in 2027 and 2028. Darolutamide, under the brand name Nubeqa is approved for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with ADT, with or without chemotherapy, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. For important risk and use information about Nubeqa, please see the full Prescribing Information.

Adding to this momentum in oncology, the FDA granted accelerated approval for Bayer’s Hyrnuo (sevabertinib) for adult patients with locally advanced or metastatic non-squamous HER2-mutant non-small cell lung cancer (NSCLC), who have received prior systemic therapy. Approval followed Breakthrough Therapy Designations from both the FDA and China’s CDE and was based on results from the SOHO-01 study. Bayer received Breakthrough Therapy Designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. The Breakthrough Therapy Designations are supported by preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 study. Sevabertinib addresses unmet needs for a patient population with limited treatment options. In addition to SOHO-01 the clinical program for sevabertinib includes ongoing trials evaluating its effectiveness as a first-line treatment for HER2-mutant NSCLC and in patients with metastatic solid tumors harboring HER2 activating mutations, excluding advanced NSCLC. For important risk and use information about Hyrnuo, please see the full Prescribing Information.

As pioneers in Targeted Radionuclide Therapy (TRT), Bayer was instrumental in helping establish Targeted Alpha Therapies (TATs) as a standard of care for patients with metastatic castration resistant prostate cancer (mCRPC) with bone metastases. The EORTC PEACE III study evaluating radium-223 dichloride (marketed as Xofigo) in combination with enzalutamide met its primary endpoint. An additional Phase III clinical study with radium-223 dichloride will be completed in 2026 and will guide decisions regarding future regulatory steps. Radium-223 dichloride is approved under the brand name Xofigo in over 50 countries for mCRPC patients with symptomatic bone metastases and no known visceral metastatic disease. For important risk and use information about Xofigo, please see the full Prescribing Information.

Bayer’s oncology pipeline is advancing precision-driven therapies, making pivotal progress by targeting challenging tumor types and previously undruggable mechanisms, proteins or pathways resistant to current therapies. This includes multiple investigational agents for KRAS-mutant cancers (an internal SOS1 inhibitor, and a partnership with Kumquat for a KRAS G12D inhibitor), next-generation TATs (225Ac-GPC3 for advanced hepatocellular carcinoma), and a PRMT5 inhibitor (from Suzhou Puhe BioPharma) for MTAP-deleted tumors, all of which have entered Phase I. Further strengthening its discovery engine, Bayer secured worldwide rights to the clinical-stage Werner helicase inhibitor (VVD 214) via Vividion, whose R&D capabilities were expanded through new facilities and the acquisition of Tavros Therapeutics. These strategic investments underscore Bayer’s commitment to driving groundbreaking innovation and securing long-term growth in oncology.

Menopause management: advancing care for women with diverse needs

Bayer achieved a big step forward in women’s health with the recent regulatory approvals of Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the only hormone-free therapy approved in the EU for both moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. These milestones follow consistent positive results across all four Phase III clinical studies (OASIS 1- 4). For important risk and use information about Lynkuet, please see the full Prescribing Information.

Developing a comprehensive cell and gene therapy (CGT) portfolio

Multiple regulatory priority designations granted by authorities in the U.S., Europe and Japan and across Bayer’s CGT portfolio reflect the potential of these programs to deliver transformative patient impact. Bemdaneprocel, an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease, developed with Bayer’s wholly owned subsidiary BlueRock Therapeutics, entered pivotal evaluation in a Phase III study. AskBio’s ametefgene parvec (AB-1005), an investigational gene therapy, is being assessed in a Phase II study in moderate stage Parkinson’s disease. The first participant has been randomized in Germany while recruitments in the U.S., UK and Poland are ongoing. In ophthalmology, BlueRock’s OpCT-001, an iPSC-derived photoreceptor cell therapy for primary photoreceptor diseases, received FDA Fast Track designation and is progressing in its Phase I/IIa study.

Radiology: Advancing innovation and expanding into Molecular Imaging

Bayer continues to advance innovation in medical imaging with gadoquatrane, its investigational low-dose magnetic resonance imagining (MRI) contrast designed to reduce the gadolinium dose by up to 60% compared to other macrocyclic MRI contrast agents. Building on positive Phase III results, Bayer has submitted marketing authorization applications in key markets worldwide, including the U.S., EU, Japan, and China. Complementing progress in its existing portfolio, Bayer announced the strategic acquisition of two investigational radiotracers – AT-01 (a Positron Emission Tomography or PET tracer in Phase III of clinical development) and AT-05 (a tracer for Single Photon Emission Computed Tomography, or SPECT, currently in Phase I) – for the diagnosis of cardiac amyloidosis. This step marks Bayer’s entry into diagnostic tracers and underscores its ambition to expand in molecular imaging, aiming to broaden diagnostic options and enhance patient outcomes.

(Press release, Bayer, JAN 13, 2026, View Source [SID1234662029])