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])

On January 12, 2026 10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, reported a collaboration with Dana-Farber Cancer Institute to analyze tumor samples from patients with major solid cancer types to uncover biological features associated with treatment response, resistance and disease progression. The company also announced plans to establish a CLIA-certified laboratory. Together, these efforts mark the beginning of a multi-year research initiative to incorporate single cell and spatial tumor analysis into potential diagnostic workflows to support cancer patient care.

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The study with Dana-Farber intends to examine samples from hundreds of patients to evaluate therapeutic targets and relevant tumor microenvironment features for the most promising emerging therapies in oncology, including antibody-drug conjugates (ADCs), radioligand therapies (RLTs), bispecific antibodies, immune checkpoint inhibitors and other precision approaches. These treatments are reshaping the standard of care, yet patients can experience dramatically different outcomes. By understanding why patients respond differently to the same treatments, this research initiative may eventually help clinicians optimize therapy accordingly and move beyond current assays to capture the cellular ecosystems, immune activity and spatial context that influence how tumors respond to treatment.

Using 10x’s Chromium Flex single cell assay and Xenium spatial platform, the investigators will generate molecularly detailed maps of tumors that integrate both cellular composition and spatial architecture. By pairing these profiles with known clinical outcomes, the collaboration aims to reveal the biological features that distinguish patients who benefit from treatment from those who do not. Additionally, 10x and Dana-Farber will collaborate in defining actionable biomarkers for future clinical reporting, exploring how spatial and single cell insights, such as target expression patterns, immune contexture or indicators of therapeutic sensitivity, could be summarized in a format designed to support oncologists as they navigate increasingly complex treatment decisions.

"Collaborations like this are important for advancing precision oncology," said Himisha Beltran, MD, Director of Translational Research in Medical Oncology at Dana-Farber. "Integrating high-resolution tumor profiling with clinical outcomes allows us to study treatment response and resistance across solid tumors, generating insights that can inform future clinical applications."

In parallel with this scientific collaboration, 10x’s planned CLIA laboratory build-out will provide the regulated infrastructure needed for assay implementation, analytical validation and clinical sample processing, and also create the critical infrastructure necessary to deploy innovative diagnostic services for future clinical use.

"Through partnerships announced in 2025, we’ve already seen how single cell and spatial profiling can impact translational research, and we believe this is only the beginning," said Serge Saxonov, Co-founder and CEO of 10x Genomics. "Our goal is to accelerate the arrival of a world where deep, multidimensional biology directly informs patient care. That means continuing to empower our customers in their research, while also engaging in clinical collaborations like the one with Dana-Farber that help us advance how these insights translate into improved outcomes for patients. Establishing a CLIA lab is a natural next step for 10x and will strengthen the support we provide to investigators in academia and biopharma as they design, validate and bring forward the next generation of precision medicines."

This collaboration marks the beginning of a multi-year research effort through which 10x will collaborate with leading institutions to generate the scientific evidence needed to develop the clinical potential of single cell and spatial technologies. Additional studies and collaborations are planned, each contributing to the foundational work required to develop potential clinical tests in the future.

(Press release, 10x Genomics, JAN 12, 2026, View Source [SID1234661983])

On January 12, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that new additional and promising patient survival and biomarker data from treatment with elraglusib for metastatic pancreatic cancer were featured in oral and poster presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) on January 9, 2026. The presentations highlighted new, expanded data from the Company’s Phase 2 clinical program (Actuate 1801-Part 3B) evaluating elraglusib in combination with gemcitabine/nab-paclitaxel (GnP), a first-line chemotherapy regimen for metastatic pancreatic cancer, providing additional evidence that suggests that elraglusib combined with GnP is associated with improved survival when compared with GnP alone.

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"Pancreatic cancer continues to have a high unmet medical need, particularly at the metastatic stage," said Dr. Devalingam Mahalingam, MD, PhD. "The results from this Phase 2 study suggest that adding elraglusib to standard gemcitabine and nab-paclitaxel chemotherapy may improve survival outcomes while maintaining a manageable safety profile. The scope of this trial, which enrolled 286 patients across 60 sites in six countries, underscores the robustness of the dataset. We are grateful to the patients and their families whose participation made this research possible."

"Metastatic pancreatic cancer remains one of the most difficult cancers to treat, with few effective first-line options," said Dan Schmitt, Chief Executive Officer of Actuate Therapeutics. "In this randomized Phase 2 study, the addition of elraglusib to gemcitabine and nab-paclitaxel resulted in a meaningful improvement in overall survival compared with chemotherapy alone. As of November 2025, seventeen patients are still alive in the elraglusib/GnP arm, and three of them have remarkably passed the 24-month mark on first-line treatment, while no patients remain on GnP treatment alone. Current patient survival for metastatic pancreatic cancer is less than 12 months, so our findings are especially encouraging. We look forward to building from this data and continuing to advance elraglusib for patients with this devastating disease."

Key Findings:

Efficacy: The primary efficacy endpoints were met in this study:

· The median overall survival (OS) showed significant benefit in the elraglusib/GnP vs GnP alone arms (mOS 10.1 months vs. 7.2 months, p=0.02, HR=0.62)
· 12-month survival rate doubled to 44.4% (elraglusib/GnP) vs 22.3% (GnP)
· 24-month survival rate increased fivefold to 12.9% in the elraglusib/GnP arm compared to 2.6% in the GnP arm, emphasizing the potential for long-term clinical benefit.

Safety: The safety and tolerability profile of elraglusib was consistent with previously reported data at the 9.3 mg/kg dose, and no new safety signals were identified:

· Serious TEAE were similar between the elraglusib/GnP (56.1%) and the GnP alone arm (56.4%),
· TEAE resulting in death were similar between treatment arms: elraglusib/GnP (12.3%) and GnP alone (16.7%)
· Grade-3 or higher TEAE leading to stoppage of any study drug: elraglusib/GnP (16.8%) and GnP alone (21.8%)

Genomic biomarkers: Several mutations commonly associated with pancreatic cancer were identified as potential predictive biomarkers of overall survival in the elraglusib/GnP arm, but not in the GnP-alone arm. Actionable mutations like KRAS or ARID1A could suggest novel drug combinations for future clinical studies.

Immunological biomarkers: The percentage of CD8+ and Granzyme B+ cells, as well as NK cells, was increased in tumors obtained from elraglusib/GnP-treated patients but not in GnP-treated patients, suggesting that combination therapy may potentiate improved anti-tumor immune response.

Oral Presentation

Title: Results from the randomized Phase 2 study (1801 Part 3B) of elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).
Abstract: 653
Session: Rapid Oral Abstract Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time: January 9, 2026, 4:15 PM-5:00 PM (PST)
First Author: Devalingam Mahalingam, MD, PhD, Gastrointestinal Oncologist and Professor of Medicine at Northwestern University Feinberg School of Medicine

Poster Presentation

Title: Mutational analysis and identification of potential biomarkers in patients with metastatic pancreatic cancer treated with the combination of the GSK-3 inhibitor elraglusib and gemcitabine/nab-paclitaxel in the 1801 Part 3β Phase 2 study.
Abstract: 761
Poster Bd: L5
Session: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time: January 9, 2026, 11:30 AM-1:00 PM; 5:00 PM-6:00 PM (PST)
First Author: Andrey Ugolkov, MD, PhD, Senior Director, Clinical Science at Actuate Therapeutics

About Actuate-1801 Part 3B Study

The Actuate-1801 Part 3B study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib/GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint for this study is median overall survival, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints are DCR, ORR, PFS, and AE.

(Press release, Actuate Therapeutics, JAN 12, 2026, View Source [SID1234661934])