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])

On January 12, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) — one of the highest-risk and most treatment-resistant NMIBC populations — and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies.

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In its written response to Relmada’s Type B pre-IND submission, the FDA indicated that a single-arm, open-label clinical trial in this high-grade, BCG-unresponsive with CIS population is an appropriate registrational approach for NDV-01. This feedback provides a clear and efficient development path toward a potential NDA submission for NDV-01 as a bladder-sparing therapeutic option in a patient population with significant unmet need.

The FDA also provided separate, supportive written feedback on the Company’s planned single registrational study in intermediate-risk NMIBC in the adjuvant setting, which is expected to follow an open-label, randomized-to-observation design.

Relmada continues to anticipate initiating both registrational trials in the first half of 2026.

"We are very pleased with the FDA’s alignment on the registrational design for NDV-01 in high-grade BCG-unresponsive NMIBC," said Raj S. Pruthi, MD, Chief Medical Officer – Oncology at Relmada Therapeutics. "A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives. This study represents the fastest path to approval for NDV-01."

Dr. Pruthi continued, "We are also encouraged by the FDA’s feedback on our intermediate-risk registration plans, where we believe NDV-01 could potentially provide meaningful clinical benefit to patients where no approved treatments currently exist."

About the Planned High-Grade Registrational Study

The planned pivotal Phase 3 study in 2nd-line, refractory, high-grade BCG-unresponsive NMIBC with carcinoma in situ (CIS) will be an open-label, single-arm trial evaluating:

Primary endpoint: Complete response (CR) rate at any time
Key secondary endpoint: Duration of response (DOR)
Assessments: Cystoscopy, cytology, and biopsy per protocol

The design reflects FDA’s written guidance on the study population, endpoint selection, and evaluation methodology and is consistent with prior FDA precedents for single-arm registrational trials in NMIBC.

About the Planned Intermediate-Risk Registrational Study

The planned pivotal Phase 3 study in intermediate-risk NMIBC in the adjuvant setting will be an open label randomized-to-observation study:

Primary endpoint: Disease Free Survival (DFS)
Key secondary endpoint: Duration of response (DOR)
Assessments: Cystoscopy, cytology, and biopsy per protocol

The design reflects FDA’s written guidance on the study population, endpoint selection, and evaluation methodology.

About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over ten days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is a ready to use, convenient to administer in-office in less than five minutes, and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

On January 12, 2026 Pierre Fabre Pharmaceuticals, Inc. reported a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) stating that the Agency is unable to approve the tabelecleucel Biologics License Application (BLA) in its present form.

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We are surprised and deeply disappointed by the FDA’s decision, particularly given the urgent and life-threatening unmet medical need faced by patients with Epstein-Barr virus–positive post-transplant lymphoproliferative disease (EBV+ PTLD) after failure of standard-of-care therapy. These patients have no FDA-approved treatment options and a life expectancy often measured in weeks to months.

The BLA was resubmitted following clear alignment with the FDA on the acceptability of the resubmission criteria and fulfillment of the conditions outlined in the January 15, 2025, CRL, which identified a single GMP-related deficiency and raised no concerns regarding safety, efficacy, or trial design. Upon acceptance of the resubmission in July 2025, the FDA granted tabelecleucel accelerated approval status.

In the new CRL, despite acknowledging that the GMP issue had been resolved and raising no safety concerns, the FDA stated that it no longer considers the previously accepted single-arm ALLELE study to be adequate to support accelerated approval and requested a new study. This represents a significant and unexpected change in position, and one that is contrary to extensive dialogue with the Agency over more than five years.

We are concerned that this decision may have far-reaching consequences for the development of rare disease treatments, effectively creating barriers for generating clinical evidence within a unique patient population with ultra-rare conditions thereby significantly delaying—or preventing altogether— patient access to urgently needed therapies.

We firmly believe that tabelecleucel represents an important treatment advance for patients with EBV+ PTLD and that the totality of data supports its efficacy and safety. We intend to engage with the FDA to urgently pursue a path forward, in collaboration with Atara Biotherapeutics (Nasdaq: ATRA) and our clinical and patient partners, to enable timely accelerated approval of tabelecleucel. We continue to be committed to making tabelecleucel available to patients through our Expanded Access Program.

Approval and real-world use of tabelecleucel over several years in multiple countries outside the United States further support its clinical value. We remain fully committed to securing approval of this critical treatment option for U.S. patients and the physicians who care for them.

(Press release, Pierre Fabre, JAN 12, 2026, View Source [SID1234661984])

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])