On January 12, 2026 Kivu Bioscience, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, reported that the first patient has been dosed in its Phase 1 clinical trial of KIVU-107, a next-generation PTK7-targeting ADC for patients with advanced solid tumors.

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"Dosing the first patient with KIVU-107 marks an important milestone for Kivu and for patients with advanced solid tumors who urgently need better treatment options," said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. "Advancing KIVU-107 from preclinical development to first-in-human dosing in under 12 months underscores the efficiency of our platform and our commitment to developing a new generation of ADCs designed to expand the therapeutic window and deliver meaningful benefit to patients."

The first-in-human Phase 1 study (NCT07229313) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KIVU-107 in patients with advanced solid malignancies. KIVU-107 is built using GlycoConnect and HydraSpace site-specific conjugation technologies, enabling precise and stable drug-to-antibody ratios and optimized pharmacokinetics to improve the therapeutic window. KIVU-107 is designed to deliver potent, targeted cytotoxic activity in PTK7-expressing tumors while improving safety and tolerability compared to earlier-generation ADCs. The study has received regulatory approval in the United States and Australia.

(Press release, Kivu Bioscience, JAN 12, 2026, View Source [SID1234661997])

On January 12, 2026 Tempus, a leader in artificial intelligence and precision medicine, and NYU Langone Health, one of the nation’s premier academic medical centers, reported a multi-year strategic collaboration aimed at transforming cancer care through advanced molecular profiling and data-driven insights. The collaboration will support NYU Langone Health’s Center for Molecular Oncology at the Laura and Isaac Perlmutter Cancer Center, a comprehensive, pan-cancer initiative to more deeply understand disease biology over time.

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The research seeks to enhance genomic diagnostics to improve patient outcomes, inform future clinical practice, and accelerate the development and validation of novel assays and algorithmic diagnostics. As part of this work, the two organizations are launching a prospective observational study titled, "Serial Molecular Profiling and Monitoring of Human Cancer," in which patients enrolled in the study will be sequenced throughout their treatment journey in an effort to collect the longitudinal data critical to this research. The collaboration, which evolved independently from Tempus’ relationship as a trusted provider of NGS testing services, also includes a series of subsequent studies focused on assay validation, biomarker discovery, biological modeling, real-world data analysis, and the development of AI-powered predictive algorithms.

"Through the integration of advanced genomic technologies and data science, we are deepening our understanding of cancer’s complexity and pioneering transformative approaches for patient monitoring and treatment," said Ezra Cohen, MD, Chief Medical Officer, Oncology at Tempus. "Our research is focused on generating actionable insights through better understanding of cancer response, resistance, and trajectory that will not only refine and enhance current assays, but also drive the creation of innovative diagnostic tools and algorithms that can empower clinicians to deliver truly individualized care to their patients."

"This strategic collaboration will further our ability to analyze cutting-edge serial molecular profiling technology in the routine care of patients at the Perlmutter Cancer Center at NYU Langone Health," said Shridar Ganesan, MD, PhD, Director of the Center for Molecular Oncology at Perlmutter Cancer Center. "This approach will enable us to better understand the biology of individual cancers, inform our ability to implement and develop targeted therapies, and assess response and emerging resistance."

(Press release, Tempus, JAN 12, 2026, View Source [SID1234661996])

On January 12, 2026 Schrödinger, Inc. (Nasdaq: SDGR) reported an update on its progress across the business in 2025 and announced its strategic priorities for 2026. The company is continuing to focus on advancing its physics+AI computational platform and serving as a global leader in computational molecular discovery.

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"In 2025, we witnessed the continued impact of scaling ‘physics+AI’ to solve the challenges of data scarcity and to accelerate the discovery of differentiated molecules. We are entering 2026 with a clear mandate: to further strengthen our position as the essential design engine for the industry," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "Our priorities for 2026 are focused on scaling our impact, maintaining scientific leadership, expanding the reach of our platform, advancing our collaborative portfolio of drug discovery programs, and securing development partners for our clinical programs. We are entering 2026 with strong momentum, highlighted by new strategic agreements with Lilly and Manas AI."

Last week, Schrödinger announced that the Lilly TuneLab platform will be integrated into LiveDesign, Schrödinger’s widely used enterprise informatics solution. This allows users to combine Lilly’s federated learning models with Schrödinger’s physics-based simulations, solving the data scarcity problem that often hinders AI-driven discovery.

Today Manas AI announced that it entered into a strategic agreement with Schrödinger that grants Manas AI access to Schrödinger’s computational platform at an ultra-large scale and integrates Schrödinger’s physics-based modeling solutions with Manas AI’s algorithms to improve predictive accuracy and speed.

2025 Achievements

Today Schrödinger highlighted several 2025 achievements, including the following:

Computational Platform

Advanced its predictive toxicology initiative and made the beta version available to customers, which encompasses approximately 50 representative kinases in addition to multiple key anti-targets.
Launched a new AI-powered conversational interface in Schrödinger’s graphical interface, Maestro, providing context-aware help and enabling natural language commands for manipulation of the 3D workspace.
Published 20 peer-reviewed articles in life sciences and materials science journals, including research describing computational approaches to achieve kinome-wide selectivity in drug discovery campaigns, using the discovery of selective Wee1 kinase inhibitors as a case study, and research describing the development of an advanced Machine Learning Force Field (MPNICE) for liquid and materials properties.
Collaborative Portfolio and Co-Founded Companies

Expanded its research collaboration with Ajax Therapeutics, a company co-founded by Schrödinger. The expansion added a new Janus kinase (JAK) target to the collaboration. Also in 2025, Ajax reported positive preclinical data for AJ1-11095, a first-in-class Type II JAK2 inhibitor and that was granted FDA orphan drug designation for the treatment of myelofibrosis.
Expanded its research agreements with both Lilly and Otsuka Pharmaceutical Co., Ltd., adding additional undisclosed targets to the existing collaborations.
Takeda announced positive topline results for the two pivotal Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib, a next-generation, highly selective oral TYK2 inhibitor, in adults with moderate-to-severe plaque psoriasis. Takeda acquired zasocitinib in 2023 from Nimbus, a company co-founded by Schrödinger. Zascocitinib was co-invented by Schrödinger and Nimbus by applying Schrödinger’s platform at scale and is one of the most advanced molecules in clinical development discovered using a predict-first paradigm.
Structure Therapeutics, a company co-founded by Schrödinger, announced the initiation of a first-in-human Phase 1 clinical study of ACCG-2671, an oral small molecule amylin receptor agonist for the treatment of obesity.
Copernic Catalysts announced the creation of a new, more efficient, ammonia synthesis catalyst. This new chemistry reduces energy consumption used in ammonia production by up to 47%, representing substantial cost savings and environmental benefits for industrial producers.
Proprietary Therapeutics Portfolio

Presented encouraging initial Phase 1 clinical data for SGR-1505, the company’s MALT1 inhibitor in patients with relapsed/refractory B-cell malignancies, at three medical conferences. SGR-1505 has been observed to have a favorable safety profile and demonstrated clinical activity, with responses observed in multiple histologies, including in patients with chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM). Additionally, SGR-1505 received Fast Track Designation from the FDA for the treatment of adult patients with WM that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor, as well as Orphan Drug Designation for the treatment of WM.
Advanced the Phase 1 study of SGR-3515, the company’s Wee1/Myt1 co-inhibitor, in patients with advanced solid tumors.
Progressed its portfolio of proprietary preclinical programs, including presenting data for SGR-5573, the company’s potent, selective, brain-penetrant inhibitor of osimertinib-resistant EGFR variants, presenting data for SGR-4174, the company’s SOS1 inhibitor, and selecting SGR-6016, a brain-penetrant NLRP3 inhibitor development candidate.
Advanced its portfolio of discovery-stage programs, including programs with first-in-class and best-in-class potential in the areas of inflammation and immunology, neurology and oncology.
2026 Strategic Priorities

Today, Schrödinger outlined the following priorities to drive growth and innovation:

Platform Scaling and Evolution

Drive increased customer adoption of its computational technology and enterprise informatics platform
Complete beta testing for the Predictive Toxicology solution
Expand its offering into new customer segments, including biologics, formulation, and synthetic chemistry
Therapeutics Portfolio Execution

Complete the Phase 1 data packages for SGR-1505 and SGR-3515
Present initial data from the Phase 1 study of SGR-3515 in patients with advanced solid tumors in the first half of 2026
Explore strategic partnerships for the SGR-1505 and SGR-3515 programs to advance the development of these programs
Advance collaborative and proprietary discovery programs

(Press release, Schrodinger, JAN 12, 2026, View Source [SID1234661995])

On January 12, 2026 OSR Holdings, Inc. (NASDAQ: OSRH) reported that its Swiss biotechnology subsidiary, Vaximm AG, has received a binding term sheet from BCM Europe AG confirming BCM Europe’s interest in entering a global exclusive licensing transaction for VXM01, Vaximm’s lead immunotherapy candidate.

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Under the terms of the binding term sheet, BCM Europe intends to establish and manage a dedicated investment vehicle, anchored by a strategic investor, tentatively named BCM Decentralized Science Investors I, LP (the "Fund"), which would act as the Licensee under the contemplated definitive license agreement. The proposed transaction structure includes:

the grant of global exclusive rights to develop and commercialize VXM01 to the Fund;
an upfront payment of $30 million, an increase from the previously discussed non-binding proposal, structured as 50% cash and 50% digital assets;
aggregate milestone payments of up to $815 million, with the milestone structure weighted primarily toward clinical and development achievements, rather than operational milestones; and
a royalty pass-through structure, pursuant to which the Fund would pass through royalty revenues received from a future sublicensee or commercial partner (the "Ultimate Licensee") to Vaximm, subject to a reconciliation mechanism reflecting the difference, if any, between milestone payments received from the Ultimate Licensee and the aggregate milestone payments paid by the Fund to Vaximm.
Vaximm’s Board of Directors will conduct a comprehensive review of the binding term sheet and has determined to engage an independent third-party valuation firm with recognized expertise in life-science and biotechnology licensing transactions to provide a fairness opinion. The fairness opinion will evaluate whether the proposed transaction is fair and reasonable to Vaximm and OSR Holdings’ shareholders from a financial point of view, based on the fair market value of VXM01.

"VXM01 has demonstrated encouraging clinical and safety data across multiple indications. The receipt of this binding term sheet reflects the growing recognition of VXM01’s potential value as a differentiated immunotherapy asset and underscores BCM Europe’s genuine intent and capability to close the deal," said Andreas Niethammer, CEO of Vaximm AG. "If completed, this proposed licensing framework would provide a strong foundation to advance VXM01 into later-stage development while preserving long-term upside for Vaximm."

The parties currently target, on a best-efforts basis, to negotiate and execute a definitive global exclusive license agreement by the end of May 2026, subject to customary conditions, including the completion of Vaximm’s board review, receipt of an independent third-party fairness opinion, final documentation, and required approvals.

"This binding term sheet represents a meaningful progression from earlier discussions and reflects third-party confidence in the value of VXM01," said Tim Smith, Head of Investor Relations at OSR Holdings. "While we remain mindful that a definitive agreement has not yet been executed, we believe the proposed structure, together with an independent valuation review, demonstrates a disciplined approach to unlocking long-term value for OSR Holdings’ shareholders."

(Press release, Vaximm, JAN 12, 2026, View Source [SID1234661994])

On January 12, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress and outlined key anticipated milestones towards its first potential U.S. commercial launch under its "OnTarget 2026" operating plan.

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As part of this plan, Nuvalent anticipates the following 2026 milestones:

Commercial launch in the U.S. of zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI), pending U.S. Food and Drug Administration (FDA) review;
Submit data to FDA for potential indication expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026;
Submit a New Drug Application (NDA) for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC in the first half of 2026;
Progress the ongoing ALKAZAR Phase 3 randomized, controlled trial of neladalkib for TKI-naïve patients with ALK-positive NSCLC;
Progress the ongoing HEROEX-1 Phase 1a/1b trial of NVL-330 for patients with advanced HER2-altered NSCLC; and,
Disclose a new development candidate by year-end 2026.
"Over the past two years, the Nuvalent team has seamlessly executed against our OnTarget 2026 operating plan towards our goal of a first potential FDA approval, ending 2025 with the recent FDA acceptance of our NDA for zidesamtinib in TKI pre-treated ROS1-positive NSCLC and commercial preparedness activities well underway," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "If zidesamtinib is approved, a first commercial launch in 2026 would be a transformative moment for Nuvalent and the first step towards realizing our mission of becoming a sustainable company capable of not only discovering and developing, but delivering new medicines for patients with cancer."

"With cash runway anticipated into 2029, our strong financial position enables us to focus on the execution of a first U.S. launch while also supporting the continued advancement and expansion of both our commercial and development portfolios," said Alexandra Balcom, Chief Financial Officer at Nuvalent. "We have completed a pre-NDA meeting with the FDA for our ALK program and plan to move forward with an NDA submission of the data for TKI pre-treated patients with ALK-positive NSCLC from our ALKOVE-1 study of neladalkib in the first half of this year. In the second half of the year, we anticipate submitting data to support a potential indication expansion for zidesamtinib in ROS1-positive NSCLC, and growing our discovery portfolio with a new development candidate. Together, we believe the achievement of these anticipated 2026 milestones would position Nuvalent for continued, long-term growth driven by delivering meaningful impact for patients with NSCLC and beyond."

2025 Year-End Cash and Guidance

Nuvalent ended 2025 with approximately $1.4 billion in cash, cash equivalents and marketable securities (unaudited), which, based on its current operating plans, is expected to fund its operations into 2029. This amount is a preliminary, unaudited estimate only as of today, could change following completion of year-end closing procedures, and does not present all information necessary for an understanding of the company’s financial position as of December 31, 2025.

Presentation at 44th Annual J.P. Morgan Healthcare Conference

Dr. Porter will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 9:00 a.m. PT. A live webcast will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC.

About Neladalkib
Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About NVL-330
NVL-330 is an investigational, brain-penetrant, HER2-selective tyrosine kinase inhibitor designed to address the combined medical need of treating HER2-mutant tumors, including those with HER2 exon 20 insertion mutations, avoiding treatment related adverse events due to off-target inhibition of wild-type EGFR, and treating brain metastases.

(Press release, Nuvalent, JAN 12, 2026, View Source [SID1234661993])