On January 12, 2026 NMS Group (NMS), a global leader in oncological innovation, reported that the China’s National Medical Products Administration (NMPA) has granted approval to the Investigational New Drug (IND) application for its first-in-class, orally bioavailable PARP7-selective inhibitor, atamparib, enabling its clinical studies in patients with advanced solid tumors.

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The phase Ib/II clinical trial expected to start in the first quarter of 2026 is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib in patients with advanced solid tumors, with a focus on a promising new therapeutic sub-setting. The goal is to validate the molecule’s differentiated mechanism of action and its favorable safety and tolerability with more than 200 patients treated so far, both in late-line patients and in future combination with standard-of-care in earlier treatment settings.

"The IND approval in China represents a key strategic milestone for the development of atamparib," said Hugues Dolgos, CEO of NMS Srl. "Recent data generated across preclinical and clinical programs, along with the newly published mechanism of action, have enabled us to reposition this asset into a promising sizeable indication where we believe it can deliver meaningful clinical benefit."

"Conducting the study in China is expected to support atamparib global clinical development by enabling timely access to a clinically relevant patient population and facilitating the potential availability of new treatment options for patients in China and worldwide," said Dadong Li, CEO of NMS Shanghai. "This milestone marks an important step in advancing the development of atamparib and exploring its potential to expand treatment options for patients."

In parallel, NMS is advancing a dual inhibitor program currently in preclinical development, targeting PARP7 and another undisclosed target, which is expected to complement the clinical development strategy of atamparib and underscores the company’s commitment to building a differentiated portfolio of innovative therapeutic candidates.

(Press release, Nerviano Medical Sciences, JAN 12, 2026, View Source [SID1234661961])

On January 12, 2026 Moderna, Inc. (NASDAQ:MRNA) reported business updates and progress across its pipeline of mRNA medicines. Moderna enters 2026 with a focus on growing sales, launching new infectious disease products and delivering pivotal readouts across oncology, rare disease and infectious disease portfolios.

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"In 2025, we strengthened our commercial execution, successfully launched our third product, and continued to advance our mRNA pipeline. At the same time, we reduced our annual operating expenses by approximately $2 billion, significantly exceeding the financial cost reduction commitments we set at the start of the year," said Stéphane Bancel, Chief Executive Officer of Moderna. "We remain focused on our strategy to build a large seasonal vaccine franchise for at-risk populations, creating a strong cash engine to fund our next phase of innovation in oncology and rare disease. We expect this approach to support up to 10 percent revenue growth in 2026, as we further reduce costs, expand our commercial portfolio with approvals of additional seasonal vaccines, and anticipate multiple clinical data catalysts driven by our late-stage oncology pipeline."

The Company’s presentation will take place on Monday, January 12, 2026, at 4:30 p.m. PT/7:30 p.m. ET at the 44th Annual J.P. Morgan Healthcare Conference. A live webcast of both the presentation and the question-and-answer session will be available.

Summary of Financial Updates

2025 financial updates: Moderna expects 2025 revenue of approximately $1.9 billion (unaudited), $100 million above the midpoint of the $1.6 – $2.0 billion range communicated on the Company’s 3Q25 Earnings Call. The Company is also improving2025 expected GAAP operating expenses by $200 million to a range of $5.0 – $5.2 billion (unaudited). Cash, cash equivalents and investments at year-end 2025 were approximately $8.1 billion (unaudited), which includes a $0.6 billion draw down from our recently announced $1.5 billion term loan facility. Full financial details will be reported in connection with the Company’s Earnings Call on February 13, 2026.

2026 financial framework: Moderna reiterates its target of up to 10% revenue growth in 2026. The Company expects GAAP operating expenses of approximately $4.9 billion in 2026. Moderna expects to further reduce GAAP operating expenses to $4.2 – $4.6 billion in 2027, on the path to targeted cash breakeven in 2028.

Summary of Late-Stage Pipeline and Approved Product Milestones

Seasonal vaccines:

COVID vaccines: Moderna’s new COVID vaccine, mNEXSPIKE, is currently approved in the U.S., Canada and Australia. Moderna is expecting potential approvals of mNEXSPIKE in Europe, Japan and Taiwan in 2026.

RSV vaccine: Moderna’s RSV vaccine, mRESVIA, is in an ongoing Phase 3 heterologous revaccination study with data expected in 2026.

Seasonal flu vaccine: The Company has completed submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe and expects potential approvals to begin in 2026.

Seasonal flu/COVID vaccine: The Company’s mRNA-1083 filing is under review with the European Medicines Agency (EMA). Moderna submitted for approval to Health Canada in 2025. The Company is awaiting further guidance from the U.S. FDA on refiling.

Norovirus vaccine: Moderna’s ongoing Phase 3 study of mRNA-1403 is enrolling a second Northern Hemisphere season (2025-2026) for additional case accruals, which will inform the timing of the Phase 3 readout. The Company expects an interim analysis in 2026.

Oncology therapeutics:

Intismeran autogene: The Company is advancing mRNA-4157 in collaboration with Merck, with eight total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. In adjuvant melanoma, Moderna expects the five-year Phase 2b data in early 2026, and the Phase 3 data potentially in 2026.

mRNA-4359: Moderna’s Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: The Company’s PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects a potential data readout in 2026.

Methylmalonic acidemia (MMA) therapeutic: Moderna’s mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, with a registrational study expected to begin in 2026.

Corporate Updates:

Moderna announced it closed a five-year term loan facility for up to $1.5 billion of capital from Ares Management Credit Funds.

Moderna announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $54.3 million to support a pivotal Phase 3 clinical trial to help advance Moderna’s investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, to licensure.

Key 2026 Investor and Analyst Event Dates

Fourth Quarter and Fiscal Year 2025 Earnings Call: February 13, 2026

Analyst Day: November 12, 2026

Event Information

Moderna’s presentation will take place on Monday, January 12, 2026, at 4:30 p.m. PT/7:30 p.m. ET at the 44th Annual J.P. Morgan Healthcare Conference. A live webcast of both the presentation and the question-and-answer session will be available under "Events and Presentations" in the investor section of Moderna’s website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

(Press release, Moderna Therapeutics, JAN 12, 2026, View Source [SID1234661977])

On January 12, 2026 Bio‑Sourcing and Zerion Pharma A/S reported that their joint project to develop an oral formulation of Trastuzumab, the pioneer monoclonal antibody used to treat breast cancer, has been awarded funding under EUREKA Eurostars. This is Bio‑Sourcing’s second Eurostars success and, together with Zerion’s breakthrough Dispersome technology, it will support the development of an oral formulation of an anti‑HER2 antibody for the treatment of HER2‑positive breast cancer.

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The program brings together Bio‑Sourcing’s disruptive BioMilk platform—which leverages natural milk components to protect and transport biologics through the gastrointestinal tract and has already been used to produce TrastuzOral —and Zerion’s solid oral‑dosage capabilities using its protein‑based Dispersome technology. Over 36 months, the consortium will optimize an orally deliverable trastuzumab biobetter produced in goat’s milk and progress it through preclinical validation, with the ambition to prepare for entry into Phase I clinical studies around 2030. The total project budget is €1.3 million, with Bio‑Sourcing as lead and Zerion as partner.

An effective oral therapy for HER2 breast cancer has the potential to move care beyond infusion centers, improving patient convenience and adherence while reducing pressure on healthcare resources. The differentiated oral route offers a compelling value proposition in a mature trastuzumab market and creates a platform opportunity to expand oral delivery to other biologics. With the global trastuzumab market estimated at $4.1 billion by 2030, an orally delivered formulation offers clear differentiation and the potential to both capture a significant share of this demand as well as increase overall market size.

Bertrand Mérot, CEO of Bio‑Sourcing: "We are delighted and very proud of Eurostars’ confirmation of the relevance of our unique strategy for oral administration of monoclonal antibodies. I am confident that our partnership with Zerion will further accelerate the development and commercialization of this disruptive formulation for breast cancer. Bio-Sourcing is thus continuing its strategy of developing oral administration of monoclonal antibodies, which has already led to the production of OralimuMab and TrastuzOral in a synergistic partnership with Zerion to further enhance this paradigm shift. The development of this breakthrough in the systemic oral administration of monoclonal antibodies will not only greatly improve patient comfort but also increase access to these innovative treatments, thereby significantly expanding the biopharmaceutical markets."

Ole Wiborg, CEO of Zerion Pharma A/S: "We are excited and very pleased to obtain this Eurostar grant together with Bio-Sourcing. I believe that our joint project holds a significant promise for improving the treatment of breast cancer patients and will further open up a plethora of additional opportunities for switching injectables to orally administered drugs. This blue stamping from EUREKA is also another recognition of our Dispersome technology and our excellent team of scientists that has relentlessly transformed great academic science into a commercially successful technology. I am grateful for that."

Eurostars forms part of the Horizon Europe framework and supports innovative SMEs and project partners—including universities and research organizations—through funding for international collaborative R&D and innovation projects. It is managed by EUREKA, an intergovernmental network covering 37 countries.

(Press release, Zerion, JAN 12, 2026, View Source [SID1234662004])

On January 12, 2026 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported its strategic priorities and anticipated 2026 milestones.

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"Entering 2026, CRISPR Therapeutics is well positioned, with CASGEVY gaining momentum, and multiple programs with encouraging data advancing rapidly through clinical trials across a diverse set of therapeutic areas," said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. "Across the portfolio, clinical data demonstrated the transformative potential of CTX310 for patients suffering from severe cardiovascular disease, as well as zugo-cel in oncology and autoimmune diseases. We also added a siRNA pillar through our partnership with Sirius and are advancing our lead siRNA asset, CTX611 targeting Factor XI through the clinic. Beyond these clinical stage programs, we have multiple additional assets in preclinical development that leverage our best-in-class advanced editing platform. Together, our broad portfolio, strong balance sheet and effective operating model reinforce our confidence as we move into the next phase."

Anticipated Key Milestones in 2026
CRISPR Therapeutics anticipates several key milestones across its portfolio:

Continued global commercialization and adoption of CASGEVY, with ongoing quarterly updates.
Global regulatory submissions for CASGEVY in patients ages 5 – 11 are expected to be initiated by Vertex in the first half of 2026.
Updates from CTX310 are expected in the second half of 2026.
Updates from the Lp(a) program are expected in 2026.
Top-line Phase 2 clinical data from CTX611 in patients undergoing total knee arthroplasty (TKA) are expected in the second half of 2026.
Updates across autoimmune disease and immuno-oncology for zugocabtagene geleucel (zugo-cel; formerly CTX112) are expected in the second half of 2026.
The Company expects to initiate a clinical trial for CTX460 in alpha-1 antitrypsin deficiency (AATD) in mid-2026.
The Company expects to initiate a clinical trial for CTX340 in refractory hypertension in the first half of 2026.

Portfolio Highlights and Outlook

Hemoglobinopathies and CASGEVY (exagamglogene autotemcel [exa-cel])

CASGEVY now approved in the U.S., the United Kingdom, the EU, the Kingdom of Saudi Arabia, the Kingdom of Bahrain, Qatar, Canada, Switzerland, the United Arab Emirates, and Kuwait for patients 12 years and older with sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT).
CASGEVY exceeded $100M in revenue in 2025, reflecting more than 60 patients receiving CASGEVY infusions.
Achieved a nearly three-fold increase in patient initiations and first cell collections in 2025 compared to 2024.
Regulatory submissions for CASGEVY in patients aged 5-11 years with SCD and TDT are expected in the first half of 2026.
CASGEVY awarded a Commissioner’s National Priority Voucher for pediatric submissions in SCD and TDT, enabling accelerated regulatory review once submissions are complete.
Continued development of next-generation conditioning approaches with the potential to expand addressable patient populations for SCD and TDT with CASGEVY.
Continued development of a lipid nanoparticle (LNP) based in vivo approach for editing hematopoietic stem cells (HSCs), with the potential to address a broader patient population in SCD and TDT.

In Vivo Liver Editing

CRISPR Therapeutics continues to advance a diversified portfolio of in vivo gene editing programs leveraging its proprietary LNP delivery platform.

In 2025, CRISPR Therapeutics presented data for CTX310, demonstrating deep and durable reductions of triglycerides (TG) and low-density lipoprotein (LDL) following a single-course intravenous infusion, with a well-tolerated safety profile. Based on the positive Phase 1 results, the Company has advanced CTX310, targeting angiopoietin-related protein 3 (ANGPTL3), into Phase 1b clinical trials, prioritizing development in severe hypertriglyceridemia (sHTG) and refractory hypercholesterolemia. The Company expects to provide an update in the second half of 2026.
CTX320, targeting LPA, has demonstrated reductions of up to 73% in the dose escalation phase of the clinical trial. In parallel, the Company is advancing a next-generation LPA program, CTX321, incorporating an updated guide RNA that demonstrates approximately two-fold greater potency in preclinical testing, while utilizing the same LNP delivery system. CTX321 is currently in IND/CTA-enabling studies, with an Lp(a) program update expected in 2026.
In addition to its clinical-stage programs, CRISPR Therapeutics continues to advance several preclinical in vivo gene editing candidates, including:
CTX460, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD), is the first investigational candidate to emerge from the Company’s SyNTase editing platform. The Company expects to initiate a clinical trial for CTX460 in mid-2026.
CTX340, targeting angiotensinogen (AGT) for refractory hypertension, is currently in IND/CTA-enabling studies. The Company expects to initiate a clinical trial for CTX340 in the first half of 2026.

siRNA-based Programs
CRISPR Therapeutics’ small interfering RNA (siRNA)-based portfolio includes clinical-stage programs in cardiovascular and thromboembolic diseases, developed in collaboration with Sirius Therapeutics.

CTX611 (SRSD107), a long-acting siRNA targeting Factor XI (FXI), is in an ongoing Phase 2 clinical trial in patients undergoing total knee arthroplasty (TKA). The Company expects to provide an update in the second half of 2026.

CRISPR Therapeutics will lead global Phase 3 development of CTX611, excluding Greater China. The program targets a range of thromboembolic and clotting-related indications and represents a multi-billion-dollar market opportunity, including arterial fibrillation (AF), venous thromboembolism (VTE), ischemic stroke, cancer-associated thrombosis (CAT), chronic kidney disease (CKD), peripheral vascular disease (PVD), chronic coronary artery disease (CAD).

Autoimmune Disease and Immuno-Oncology
Zugocabtagene geleucel (zugo-cel; formerly CTX112) continues to advance in both autoimmune disease and hematologic malignancies.

In autoimmune disease, Phase 1 clinical trials are ongoing across multiple indications, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and inflammatory myositis and a second Phase 1 trial in immune thrombocytopenia purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The first patient with SLE, refractory to 9 prior therapies with a baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 8, has maintained drug-free DORIS clinical remission through month 9 following CAR-T therapy. The second SLE patient with a baseline SLEDAI-2K score of 8, has sustained B cell depletion with SLEDAI-2K score of 0 through month 2 following CAR-T therapy. The Company expects to provide updates in the second half of 2026.

The Phase 1/2 clinical trial of zugo-cel in B-cell malignancies is ongoing. The Company expects to provide updates in the second half of 2026. CRISPR Therapeutics has also established a collaboration and clinical supply agreement with Lilly to evaluate zugo-cel together with pirtobrutinib in aggressive B-cell lymphomas, further expanding the program’s development in oncology.

Regenerative Medicine
CRISPR Therapeutics continues to advance its regenerative medicine portfolio, including its efforts in diabetes. Clinical data generated from CTX211 were promising, demonstrating detectable C-peptide levels 12 months after implantation. These data have informed the Company’s approach to hypoimmune cell engineering, supporting a transition to a next-generation candidate, CTX213. CTX213 has demonstrated compelling preclinical efficacy and is progressing towards the clinic. The Company expects to provide additional updates as development progresses.

About CASGEVY (exagamglogene autotemcel [exa-cel])

CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved for eligible SCD and TDT patients 12 years and older by multiple regulatory bodies around the world.

About the CRISPR Therapeutics – Vertex Collaboration for CASGEVY

CRISPR Therapeutics and Vertex established a strategic research collaboration in 2015 to discover and develop therapies using CRISPR/Cas9 technology to address the underlying genetic causes of human disease. CASGEVY is the first approved therapy to emerge from this collaboration. Under an amended collaboration agreement, Vertex leads global development, manufacturing, and commercialization of CASGEVY and shares program costs and profits worldwide 60/40 with CRISPR Therapeutics. Vertex is the manufacturer and exclusive license holder of CASGEVY.

About In Vivo Programs

CRISPR Therapeutics has established a proprietary lipid nanoparticle (LNP) delivery platform to enable gene editing in the liver using both CRISPR/Cas9 and its novel, proprietary SyNTase editing technologies. The Company’s in vivo portfolio includes its lead investigational programs, CTX310 (directed towards angiopoietin-related protein 3 (ANGPTL3)) and CTX320 (directed towards LPA, the gene encoding apolipoprotein(a) (apo(a)), a major component of lipoprotein(a) [Lp(a)]). Both are validated therapeutic targets for cardiovascular disease. CTX310 and CTX320 are being developed for patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, mixed dyslipidemias, or severe hypertriglyceridemia, and in patients with elevated lipoprotein(a), respectively. In addition, the Company’s research and preclinical development candidates include: CTX460, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD), CTX340, targeting AGT for the treatment of refractory hypertension and CTX321, targeting LPA for the treatment of patients with elevated lipoprotein(a).

About CTX611 (SRSD107)

CTX611 is a novel double-stranded siRNA, designed to target the human coagulation FXI messenger RNA and inhibit FXI protein expression. Through modulation of the intrinsic coagulation pathway, CTX611 is intended to provide anticoagulant and antithrombotic effects. Supported by clinical experience to date, CTX611 is being developed as a long-acting FXI inhibitor with the potential to support infrequent, including semi-annual, subcutaneous administration.

About Zugocabtagene Geleucel (zugo-cel; formerly CTX112)

Zugocabtagene geleucel (zugo-cel) is a wholly-owned, allogeneic chimeric antigen receptor (CAR) T cell therapy product candidate targeting Cluster of Differentiation 19 (CD19), in development for both autoimmune and immuno-oncology indications. Zugo-cel is an off-the-shelf allogeneic CAR-T that utilizes CRISPR Cas9 for targeted gene knockout and CAR insertion for immune evasion and enhanced T effector cell potency. Zugo-cel is given following a standard lymphodepletion regimen without the need for HLA matching. Zugo-cel is being investigated in ongoing clinical trials in adult patients with systemic lupus erythematosus, systemic sclerosis, and inflammatory myositis and in adult patients with relapsed or refractory B-cell malignancies.

(Press release, CRISPR Therapeutics, JAN 12, 2026, View Source [SID1234661944])

On January 12, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune diseases, reported the Company’s achievements in 2025 and outlined key objectives and anticipated milestones for 2026, which will be the subject of Nurix’s corporate update at the 44th Annual J.P. Morgan Healthcare Conference today at 4:30 p.m. PT, in San Francisco.

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"2025 was a defining year for Nurix, having advanced our potentially best-in-class BTK degrader, bexobrutideg, into pivotal development for patients with relapsed or refractory CLL," said Arthur T. Sands, president and chief executive officer of Nurix. "As we enter 2026, we are focused on executing the DAYBreak CLL-201 study and initiating the confirmatory Phase 3 trial, DAYBreak CLL-306. We are also excited to advance our pipeline of wholly owned and partnered programs in inflammation and autoimmune diseases, including our new tablet formulation of bexobrutideg, our IRAK4 degrader program partnered with Gilead, and our STAT6 degrader program partnered with Sanofi. With our pivotal DAYBreak program underway, a strong balance sheet, and multiple catalysts across oncology and immunology, we believe Nurix is exceptionally well positioned to make 2026 a transformative year for the Company and the field of targeted protein degradation."

2025 Select Accomplishments and Business Highlights

Potential Best-in-Class BTK degrader, Bexobrutideg, in CLL

Presented new and updated clinical and preclinical data supporting a potential best-in-class BTK degrader profile. New and updated clinical data were presented in December 2025 at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH2025) that provide a maturing clinical picture of bexobrutideg’s efficacy, durability, and tolerability. Highlights included an 83% objective response rate, including two complete responses (4.3%) in CLL patients with a median of four prior lines of treatment. Responses were durable and deepened over time with a median progression-free survival estimated at 22.1 months, which is highly competitive with currently approved agents in a similar line of therapy. Bexobrutideg was well tolerated with no dose-limiting toxicities across all doses tested. New preclinical data were presented in October 2025 that support bexobrutideg’s potential best-in-class BTK degrader profile, demonstrating superior degradation potency, broad coverage of clinically relevant BTK mutations, and exquisite selectivity. These findings strengthen the Company’s conviction that bexobrutideg may prove to be a clinically superior medicine for the treatment of patients with CLL and other B-cell driven diseases.

Successfully addressed FDA’s Project Optimus with the selection of the 600 mg once daily dose for pivotal development in r/r CLL. The selection of the 600 mg dose was supported by data from a randomized cohort within the Phase 1b study comparing 200 mg and 600 mg in accordance with Project Optimus and reflects alignment with global regulators, including the U.S. Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency. The results, subsequently reported at ASH (Free ASH Whitepaper)2025, demonstrated a trend toward a higher objective response rate and longer progression-free survival with the 600 mg dose without an increase in adverse events. The clearance by regulators of the 600 mg dose allows Nurix to optimize bexobrutideg’s therapeutic effect, providing patients the opportunity to regain control of CLL that has progressed or has failed to respond to other therapies.

Initiated pivotal clinical development in patients with relapsed or refractory CLL. In October 2025, Nurix initiated enrollment in the DAYBreak CLL-201 pivotal Phase 2 study (NCT07221500). This single-arm, global study is evaluating bexobrutideg at 600 mg once daily in patients with relapsed or refractory CLL whose disease progressed following treatment with a BTK inhibitor and a BCL2 inhibitor. The trial is designed to support accelerated approval of bexobrutideg in triple-exposed CLL/SLL patients. Nurix plans to initiate a randomized confirmatory Phase 3 trial in 2026 to support full approval of bexobrutideg.

First-in-class CBL-B Inhibitor NX-1607

Presented positive Phase 1a clinical data demonstrating immune activation and clinical activity. New Phase 1a clinical data for NX-1607 were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October and the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November, demonstrating dose-dependent pharmacologic activity and signals of clinical activity across a diverse set of 82 patients with eleven different tumor types. Clinical activity was observed through reductions in tumor-specific biomarkers such as prostate-specific antigen (PSA) in prostate cancer and carcinoembryonic antigen (CEA) in colorectal cancer. Notably, there was a confirmed partial response in a patient with micro-satellite stable colorectal cancer (MSS CRC), a tumor type typically unresponsive to immune checkpoint therapy. As anticipated, treatment with NX-1607 led to increased peripheral T cell activation and proliferation, indicating active T-cell receptor engagement and immune responsiveness, suggesting its potential as an active immune-oncology agent with a unique mechanism distinct from PD-1/PD-L1 therapies.

Advancing Pipeline in Inflammation and Autoimmune Diseases

Introduced new tablet formulation of bexobrutideg into Phase 1 testing to support an IND for inflammation and autoimmune indications. In 2025, Nurix initiated a Phase 1 single ascending and multiple ascending dose (SAD/MAD) study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), and safety of a new tablet formulation of bexobrutideg. This study is intended to support an IND filing and enable expansion into inflammatory and autoimmune indications beginning in 2026.

Partner Gilead initiated Phase 1 testing of IRAK-4 degrader. In April 2025, Nurix announced that the FDA cleared the Investigational New Drug (IND) application for GS-6791 (previously NX-0479), a novel, potentially best-in-class oral degrader of IRAK4 being developed in collaboration with Gilead Sciences. GS-6791 is designed to selectively degrade IRAK4, a key signaling protein that drives inflammation in autoimmune and inflammatory diseases. Gilead subsequently initiated an ongoing Phase 1 trial in healthy volunteers, the results of which will inform Nurix’s option for a 50/50 co-development and U.S. profit share.

Partner Sanofi advanced STAT6 degrader program into IND enabling studies: In June 2025, Nurix announced that Sanofi exercised its option to extend its license for Nurix’s STAT6 program, including the development candidate NX-3911. NX-3911 is an oral, highly selective degrader of STAT6, a key transcription factor within the IL-4/IL-13 signaling pathways that drive inflammation in allergic and type 2 inflammatory conditions, which currently is in IND enabling studies. Sanofi is responsible for all development activities, and Nurix retains an option for a 50/50 U.S. profit share and co-promotion after initial clinical proof of concept.

Corporate and Leadership

Strengthened financial position to support execution of bexobrutideg pivotal program and expansion into inflammation and autoimmune disease. In October 2025, Nurix closed an underwritten registered offering of 24,485,799 shares of its common stock, providing gross proceeds to Nurix of $250.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Nurix. In addition, Nurix earned $47.0 million in non-dilutive capital through its strategic collaborations with Gilead, Sanofi and Pfizer. Nurix is well capitalized with pro forma cash/investments of $663.8 million1.

Strengthened leadership with appointments of chief commercial officer and new board members with deep experience in drug development and commercialization. In 2025, Nurix announced the hiring of John Northcott as chief commercial officer, bringing extensive U.S. and global commercial leadership experience, including both pre-launch planning and on-market commercialization in hematology, oncology and a wide range of other therapeutic areas. In addition Nurix also appointed two board members: Roy Baynes, MB.Bch., M.Med., Ph.D., who has extensive experience in the development of innovative, blockbuster medicines during a distinguished career in hematology and oncology, and Roger Dansey, M.D., senior leader in drug development and operations with over 25 years of executive experience in pharmaceutical and biotech companies across both U.S. and international markets.

2026 Outlook: Executing the Next Phase of Growth

Execute pivotal development pathway in CLL:
Enrollment of pivotal Phase 2 trial – DAYBreak CLL-201
Initiation of a confirmatory Phase 3 study in patients with r/r CLL in the 2L+ setting comparing bexobrutideg monotherapy to pirtobrutinib – DAYBreak CLL-306
Initiation of a Phase 1b/2 clinical study in patients with CLL in combination with other therapeutic agents including venetoclax (BCL-2 inhibitor)
Advance Degrader Programs in I&I:
Bexobrutideg – data from new tablet formulation SAD/MAD study supporting IND in I&I
GS-6791 IRAK4 degrader – potential Phase 1 results2
NX-3911 STAT6 degrader – potential IND filing by Sanofi2
Report Ongoing Clinical Data Updates:
Bexobrutideg Phase 1a/b CLL cohorts
Bexobrutideg Phase 1a/b NHL cohorts
Zelebrudomide Phase 1a cohorts
Progress Research and Development Pipeline:
Leverage DEL-AITM platform to fuel wholly owned and partnered drug discovery programs
Earn additional research milestones and potential licensing fees from its collaborations with Gilead, Sanofi, and Pfizer.

1Represents cash balance as of August 31, 2025, plus the net proceeds from the October 2025 registered direct offering

2Statements include Nurix estimate for partnered programs using industry standard timelines based on current stage of development (not official guidance of partners).

About Bexobrutideg (NX-5948)
Bexobrutideg is an investigational, orally bioavailable, brain penetrant, highly selective small molecule degrader of BTK currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia. Bexobrutideg also continues to be studied in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B cell malignancies.

About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

(Press release, Nurix Therapeutics, JAN 12, 2026, View Source [SID1234661962])