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])

On January 12, 2026 Swiss Rockets AG and Alloy Therapeutics, Inc. reported the signing of a Master Research Agreement (MRA) establishing a multi-target collaboration to discover and develop next-generation radioligand therapeutics (RLTs) for oncology. The collaboration will be executed through Swiss Rockets’ radiotherapeutics subsidiary, Torpedo Pharmaceuticals AG.

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Radioligand therapeutics are an emerging modality that can deliver radiation directly to tumor cells via highly selective targeting agents. Under the MRA, Alloy will provide access to its proprietary antibody discovery and engineering platforms, while Swiss Rockets and Torpedo will apply their radioisotope and radiopharmaceutical development expertise – including the use of Terbium-161 – to advance prioritized targets toward clinical development.

Collaboration highlights:

Multi-target oncology collaboration spanning discovery, engineering, and radiopharmaceutical development.
Access to Alloy’s enabling technologies for antibody discovery and optimization to generate high-quality targeting agents.
Torpedo-led radiochemistry, isotope integration, and translational development to advance RLT candidates toward the clinic.
"This agreement reflects Swiss Rockets’ strategy to unite cutting-edge discovery technologies with our translational and radiotherapeutic expertise. Together with Alloy, we aim to accelerate the emergence of next-generation cancer therapies through scientific and entrepreneurial collaboration. It exemplifies how strategic partnership and scientific innovation can speed the development of transformative oncology medicines," said Dr. Vladimir Cmiljanovic, Chief Executive Officer of Swiss Rockets AG and Torpedo Pharmaceuticals AG.

"Radioligand therapeutics represent an exciting frontier in oncology, and this partnership reflects Alloy’s broader mission to democratize access to enabling technologies and work with founders advancing breakthrough science," said Errik Anderson, Chief Executive Officer and Founder of Alloy Therapeutics. "We’re excited to collaborate with Swiss Rockets and Torpedo to help build a robust radioligand therapeutics capability that combines our discovery platforms with their radiotherapeutic infrastructure to deliver meaningful innovation for patients."

The parties intend to apply this framework to generate novel RLT candidates for high-value oncology targets and to accelerate translation from discovery into development-ready programs.

(Press release, Alloy Therapeutics, JAN 12, 2026, View Source [SID1234661914])

On January 12, 2026 Aclaris therapeutics presented its corporate presentation.

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(Presentation, Aclaris Therapeutics, JAN 12, 2026, View Source [SID1234661933])

On January 12, 2026 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported its 2026 priorities across its five growth pillars focused on advancing product commercialization, regulatory milestones and automation system innovations to support its goal for $2 billion of combined annual pillar sales in 2028.

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Following strong operational execution in 2025, QIAGEN enters 2026 with plans for new product launches and submissions among its pillars designed to expand addressable markets, increase its installed base of automation systems and strengthen recurring consumables and software revenues across the continuum from life sciences to diagnostics customers.

The five pillars – Sample technologies, QIAstat-Dx syndromic testing, QIAcuity digital PCR, QIAGEN Digital Insights (QDI) bioinformatics and QuantiFERON for latent tuberculosis testing – represent areas where QIAGEN has established leadership and scaling differentiated platforms with growth potential.

"We delivered on key targets in 2025 and enter 2026 with strong momentum," said Thierry Bernard, CEO of QIAGEN. "Our investments we are making in automation, menu expansion and AI, together with targeted and differentiated acquisitions, are designed to accelerate growth, advancing in high-value areas of life sciences and diagnostics and sharpening our competitive edge as we move toward achieving our 2028 ambitions."

Sample technologies: Adding Parse single-cell analysis and launching new systems

In December 2025, QIAGEN completed the acquisition of Parse Biosciences, expanding its Sample technologies portfolio into single-cell analysis. Parse’s instrument-free Evercode chemistry is used by more than 3,000 customers and supports large-scale single-cell studies, strengthening QIAGEN’s exposure to a fast-growing research segment.

Parse is expected to contribute approximately $40 million in sales in 2026, with opportunities to scale through QIAGEN’s global commercial infrastructure. Recent launches such as Evercode Whole Blood Fixation, a new kit that enables immediate fixation of whole blood directly at the point of collection, are set to extend Parse’s reach into translational and clinical research workflows.

QIAGEN is also advancing the launches of three new sample preparation systems in 2026 to address demand for automation and throughput in applications, in particular liquid biopsy, minimal residual disease testing and microbiome research. These new systems, which will be exhibited at the SLAS Show in February 2026, are designed to expand the installed base of instruments and drive consumables pull-through over time:

QIAsymphony Connect: Controlled placements began in late 2025, with IVDR commercialization targeted for mid-2026. This new generation of QIAsymphony enables faster processing, improved connectivity and workflow standardization, especially with up to 50% higher throughput for certain liquid biopsy applications.
QIAsprint Connect: First purchase orders were received in 2025 ahead of launch in February 2026 of this new system that marks QIAGEN’s entry into high-throughput sample processing. It enables preparation of up to 192 samples per run while reducing plastic consumption.
QIAmini: On track for launch in Fall 2026, this compact system offers walkaway automation for lower-throughput labs seeking affordable, user-friendly solutions.
QIAstat-Dx: Expanding test menu and building installed base

QIAGEN submitted in December 2025 its first blood culture identification (BCID) panels for regulatory clearance in the U.S. and CE-IVDR registration, extending the QIAstat-Dx menu into bloodstream infections and sepsis-related applications.

At year-end 2025, cumulative QIAstat-Dx placements exceeded 5,200 instruments worldwide, providing a solid foundation for future growth. The BCID submissions build on six U.S.-cleared panels and three CE-IVDR panels already commercialized internationally. In the U.S., gastrointestinal panels have also been submitted for use on QIAstat-Dx Rise, the higher-throughput platform designed for larger laboratories with capacity of up to 160 tests per day.

The development pipeline includes panels for complicated urinary tract infections (cUTI) and pneumonia, as well as additional panels for companion diagnostics developed with pharmaceutical partners.

QIAcuity digital PCR: Scaling pharma adoption and improving workflow automation

QIAGEN plans to expand its QIAcuity digital PCR portfolio in 2026 with the launch of thousands of new gene expression assays, further strengthening adoption in pharmaceutical and biopharma applications.

To support higher-throughput and standardized workflows, QIAGEN and Hamilton have co-developed an automated nanoplate handling solution on the Microlab STAR platform, enabling walkaway automation from pipetting through plate sealing prior to QIAcuity loading. This integration supports reproducibility across sites, an important requirement for regulated and GMP-compliant environments.

QIAcuity adoption continues to grow across academia, biopharma and clinical research, with over 3,200 cumulative placements at the end of 2025. New assay offerings, including lentivirus detection and host-cell DNA sizing kits planned for 2026, are designed to expand use in Cell and Gene Therapy manufacturing and quality control.

QDI: Advancing AI-enabled bioinformatics and expanding single-cell applications

QIAGEN Digital Insights (QDI) plans for multiple new product advancements in 2026 as part of its roadmap to introduce at least 14 AI-enabled software solutions by 2028.

Key priorities for 2026 include the rollout of new AI capabilities for pharmaceutical R&D, multilingual automation for clinical reporting and agentic AI decision support for novel target identification. These AI offerings aim to better identify insights from high-quality curated genomics knowledge and accelerate precision in clinical decision-making in areas such as oncology and hereditary disease diagnostics.

QDI is also gaining momentum from the integration and expansion of the Franklin platform, which was acquired with Genoox in 2025. Franklin now combines trusted content from QIAGEN’s clinical interpretation portfolio with intuitive AI-supported workflows to guide genetic analysis and reporting across hereditary and oncology applications.

QDI is also planning to integrate single-cell datasets generated through Parse Biosciences, enabling development of predictive modeling and target discovery tools for pharmaceutical partners in areas including oncology, neurology and immunology.

QuantiFERON: Accelerating workflow automation and AI-related investments

QIAGEN is developing a fifth generation of its QuantiFERON test, with updates planned during 2026 as part of its commitment to leadership in tuberculosis diagnostics. The new version will build on the proven performance of earlier generations while introducing improvements to support laboratories facing increasing testing demands.

In parallel, a new generation of chemistry for partner Diasorin’s LIAISON QuantiFERON-TB Gold Plus II assay is planned for U.S. launch in early 2026, following its introduction in Europe in 2025. The updated assay enables laboratories to test up to 75% more patients per hour and deliver results 25% faster than the previous version on the automated LIAISON platforms. QIAGEN is continuously working on workflow solutions to help customers handle increasing testing demands.

Latent TB infection affects an estimated one in four people globally, with up to 10% at risk of progressing to active disease if left untreated. To support assessment of progression risk, QIAGEN is investigating the use of AI to facilitate clinical decision making to guide preventive treatment and improve patient care. About 60% of the global latent TB testing market still relies on the 120-year-old skin test, offering significant opportunities for ongoing conversion to modern blood-based diagnostics like QuantiFERON.

(Press release, Qiagen, JAN 12, 2026, View Source [SID1234661967])

On January 12, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported updated clinical data from GOBLET Cohort 4 in patients with third-line metastatic squamous cell anal carcinoma ("SCAC"), a setting with no U.S. Food and Drug Administration ("FDA")-approved treatment options. Previous analysis from this cohort has focused on second-line or later SCAC patients.

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Updated GOBLET Cohort 4 Third-Line Anal Cancer Data

As of the current data cut, four of 14 evaluable third-line patients receiving pelareorep and atezolizumab achieved objective responses, resulting in an objective response rate ("ORR") of approximately 29%. These responses included two complete responses and two partial responses. The median duration of response ("DOR") is approximately 17 months (67 weeks), indicating both depth and durability of clinical benefit in a heavily pretreated population.

Patients enrolled in this cohort had progressed following multiple prior systemic therapies and represent a highly refractory disease population. In historical third-line SCAC studies, objective response rates are typically approximately 10% or less, with limited durability.1, 2 There are currently no FDA-approved therapies for patients with third-line anal cancer.

The observed response rate and emerging durability in GOBLET Cohort 4 compare favorably with historical outcomes and highlight the potential clinical relevance of pelareorep plus atezolizumab in this setting of significant unmet medical need.

"As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients’ lives who have no options."

In the second-line setting, pelareorep and atezolizumab achieved a 30% ORR, more than doubling the 13.8% ORR that was approved by the FDA for the current standard of care therapy. Additionally, the median duration of response is 15.5 months for pelareorep and atezolizumab compared to 9.5 months (link to the PR).

Planned Registration Strategy and Accelerated Approval Pathway

If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies. After initial encouraging feedback from KOLS and the FDA, Oncolytics is planning to have a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan.

(Press release, Oncolytics Biotech, JAN 12, 2026, https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-announces-updated-clinical-data-from-goblet-cohort-4-demonstrating-activity-of-pelareorep-plus-atezolizumab-in-third-line-anal-cancer/ [SID1234662101])