Shorla Oncology® Announces U.S. FDA Approval of Larger Vial Size for Nelarabine Intravenous Administration for the Treatment of T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma

On January 28, 2026 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, reported that the U.S. Food and Drug Administration has approved the company’s oncology drug, Nelarabine Injection, in a larger vial size, 375mg/75mL, for adult and pediatric patients with T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL). Nelarabine Injection carries a Boxed Warning. Please see Important Safety Information below and full Prescribing Information, including a Boxed Warning.

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This larger vial size is the second FDA approval of Nelarabine Injection from Shorla, both using the same formulation. The first approval, for a 250mg/50mL vial, was introduced to help address ongoing product shortages in the U.S. market. Depending on the dose, the new 375mg/75mL vial offers greater dosing flexibility for pediatric patients and provides higher-dosing options for adults. Its larger volume can allow for more precise dosing based on individual treatment needs.

"We are delighted to offer this new larger vial size of Nelarabine Injection to better serve adult and pediatric patients with T-cell leukemia and lymphoma," said Sharon Cunningham, CEO and Co-Founder of Shorla Oncology. "Both adult and pediatric patients have differing dose needs, which can make treatment preparation complex. With this FDA approval, we hope to support healthcare providers in delivering care more efficiently, reducing waste, and improving precision in managing these types of aggressive blood cancers."

T-cell acute lymphoblastic leukemia is an aggressive blood cancer in which too many T-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. T-ALL affects both pediatric and adult populations, yet treatment needs differ due to variation in body surface (BSA). The median age of diagnosis for pediatric T-ALL is nine years, with an average BSA of 1.07 m², which requires a 696 mg dose. The new 375mg vial’s flexibility could enable precise dosing with fewer vials. Additionally, adult patients have an average BSA of 1.7 m² and typically demand a higher nelarabine dose of approximately 2,550 mg.

"Launching Nelarabine Injection, as our first product in the U.S., was a major milestone. Expanding that footprint with a 375mg vial of Nelarabine Injection reflects our ongoing commitment to solving real-world challenges for patients with T-cell leukemia by prioritizing improvements in healthcare delivery, pharmacy workflow, and waste reduction," said Orlaith Ryan, CTO and Co-Founder of Shorla Oncology. "This additional vial size strengthens our ability to support both clinicians and patients living with T-ALL and T-LBL, where flexibility and accuracy in dosing is important."

(Press release, Shorla Oncology, JAN 28, 2026, View Source [SID1234662330])

Physiomics Awarded New Contract by Numab Therapeutic

On January 28, 2026 Physiomics plc (AIM: PYC), a leading mathematical modelling, data science and biostatistics company supporting the development of new therapeutics and personalised medicine solutions, reported a new contract with its valued and long-standing client, Numab Therapeutics AG ("Numab Therapeutics").

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This project reflects the continued application of Physiomics’ modelling expertise across Numab Therapeutics’ pipeline to accelerate the development of innovative therapies, building further on the already well-established relationship.

Numab Therapeutics is a biopharmaceutical company focused on the discovery and development of next-generation multispecific antibody-based therapeutics for inflammation and oncology. Under this new contract, Physiomics will develop a pharmacokinetic-pharmacodynamic (PK/PD) model to inform the Target Candidate Profile of a key asset in Numab Therapeutics’ Immunology and Inflammation pipeline. The modelling work is intended to support data-driven decision-making at an early stage of development and is expected to commence imminently, with completion anticipated within Q2 2026.

Dr Peter Sargent, CEO of Physiomics, commented:

"We are delighted to continue our collaboration with Numab Therapeutics and to have the opportunity to contribute further insights across its promising pipeline. In particular, this work allows us to support earlier research and development decisions through quantitative, data-driven approaches, helping to shape candidate profiles at a critical stage and thus streamlining drug development journeys."

(Press release, Physiomics, JAN 28, 2026, View Source [SID1234662329])

PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI

On January 28, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that results of a National Cancer Institute ("NCI")-led study of the Company’s investigational Interleukin-12 (IL-12) tumor targeted immunocytokine, PDS01ADC, were presented at the American Association of Cancer Research ("AACR") special conference on prostate cancer research, held in Boston, MA on January 20-22, 2026.

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The study, titled Docetaxel and the Tumor-Targeting Interleukin-12 ("IL-12") PDS01ADC in Patients with Metastatic Castration-Resistant Prostate Cancer ("mCRPC"), was presented by Melissa Abel, MD., Assistant Research Physician, Genitourinary Malignancies Branch, Center for Cancer Research, at the NCI, part of the National Institutes of Health ("NIH"). The clinical study is being done to evaluate the ability of PDS01ADC to enhance responses to docetaxel in advanced prostate cancer, based on the potential synergy of PDS01ADC with the necrosis inducing chemotherapeutic agent. The study was performed in advanced cancer patients, the majority of whom had failed 2nd line treatment with androgen deprivation therapy and an androgen pathway inhibitor (ARPI), and therefore had few remaining treatment options (3rd line). Results showed median progression-free survival ("PFS") of 9.6 months (range: 4.3–32.2 months) for the combination therapy in mCRPC patients. Additionally, a promising median PSA decline of 40% was observed, with 6 of 16 patients achieving greater than 50% decline. Patients interested in enrolling in this study may contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or visit the web site: View Source and/or email [email protected].

"These findings reinforce the potential of our tumor-targeting IL-12 immunocytokine to enhance the efficacy of existing therapies across multiple solid tumor types," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We are encouraged by the progression-free survival and PSA declines observed in this difficult-to-treat population and remain focused on advancing PDS01ADC as a key component of our immuno-oncology pipeline."

PDS01ADC is a fused IL-12 antibody drug conjugate designed using an antibody that binds to necrotic DNA found within tumors. This enables targeted delivery of IL-12 into the tumor microenvironment, suppressing the tumor’s ability to evade the immune response while promoting T cell and Natural Killer (NK) cell infiltration and activation within the tumor.

(Press release, PDS Biotechnology, JAN 28, 2026, View Source [SID1234662328])

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides a Corporate Update

On January 28, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported financial results for the fiscal quarter ended November 30, 2025, and highlighted significant progress across its clinical programs and strategic collaborations.

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"The fourth quarter marked a pivotal inflection point for Nurix as we initiated the DAYBreak registrational program for bexobrutideg and strengthened our balance sheet to support execution across our pipeline," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "With regulatory alignment on Phase 2 dose, compelling Phase 1 clinical data in CLL, and the continued advancement of our autoimmune and immuno-oncology programs, we believe we are well positioned to deliver the benefits of degrader-based medicines to significant populations of patients in need of new therapies."

Recent Business Highlights

Bexobrutideg (NX-5948): Compelling Clinical Activity and Durability Presented at ASH (Free ASH Whitepaper) 2025

At the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Nurix presented updated and maturing clinical data from the ongoing Phase 1a/1b NX-5948-301 study of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), demonstrating durable and deepening responses in a heavily pretreated population. In the Phase 1a cohort, bexobrutideg achieved an objective response rate (ORR) of 83.0%, including two complete responses, with a median progression-free survival (PFS) of 22.1 months and a median duration of response of 20.1 months across all doses tested. Emerging data from the randomized Phase 1b cohort comparing 200 mg and 600 mg once-daily dosing showed higher response rates and a favorable trend toward longer PFS at the 600 mg dose, supporting its selection as the recommended Phase 2 dose in alignment with FDA’s Project Optimus. Bexobrutideg was well tolerated, with a consistent safety profile across dose levels and no dose-limiting toxicities, no systemic fungal infections, and no Grade 4 infections observed. Collectively, these data reinforce the differentiated efficacy, durability, and tolerability profile of bexobrutideg and provide a strong foundation for the ongoing DAYBreak pivotal clinical program in relapsed or refractory CLL.

Bexobrutideg (NX-5948): Transitioned to Pivotal-Stage Development in CLL

During the fourth quarter of 2025, Nurix initiated the DAYBreak pivotal Phase 2 single-arm study evaluating bexobrutideg at 600 mg once daily in patients with relapsed or refractory CLL (r/r CLL) who have progressed following treatment with a covalent BTK inhibitor (cBTKi), a BCL-2 inhibitor (BCL-2i), and a non-covalent BTK inhibitor (ncBTKi). Dose selection was supported by comparative analysis conducted under Project Optimus and achieved alignment with global regulatory authorities.

Bexobrutideg: Encouraging Activity in Waldenström Macroglobulinemia Presented at ASH (Free ASH Whitepaper) 2025

At the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Nurix presented new Phase 1 clinical data demonstrating encouraging efficacy and favorable tolerability of bexobrutideg in patients with relapsed or refractory Waldenström macroglobulinemia (WM). In this heavily pre-treated population, bexobrutideg achieved an objective response rate of 75.0%, including three very good partial responses, with responses observed across patients regardless of their baseline mutations in MYD88 and CXCR4. With a median follow-up of 8.1 months, median duration of response and progression-free survival were not reached, underscoring the durability of clinical benefit. Bexobrutideg was well tolerated in patients with WM, consistent with the overall study population and previous disclosures. Collectively, these results support continued development of bexobrutideg in WM and further reinforce its potential as a differentiated therapeutic option across BTK-driven B-cell malignancies.

October Bexobrutideg Update

During the quarter, Nurix continued to strengthen the clinical and scientific differentiation of bexobrutideg through ongoing clinical execution and new mechanistic insights. In an October 2025 investor update, management highlighted how bexobrutideg is designed to overcome key limitations of existing BTK inhibitors by catalytically degrading the BTK protein, thereby eliminating both its kinase and scaffolding functions and enabling deeper, more durable pathway suppression at low free-plasma concentrations. The data presented profiled bexobrutideg’s best-in-class in vitro potency, exceptional proteomic selectivity, and broad activity across clinically relevant BTK resistance mutations that limit the effectiveness of both covalent and non-covalent BTK inhibitors.

IRAK4 Degrader Program (GS-6791 / NX-0479, partnered with Gilead)

In September, Nurix and its collaboration partner Gilead presented preclinical data at the 2025 European Academy of Dermatology and Venereology Congress demonstrating that GS-6791, a novel oral IRAK4 degrader, achieved potent and sustained degradation of IRAK4, resulting in robust inhibition of IL-1 and IL-36 signaling pathways. The data also showed suppression of pro-inflammatory cytokine production and meaningful efficacy in a mouse model of dermatitis, supporting the differentiated potential of IRAK4 degradation compared with kinase inhibition alone. GS-6791 is currently being evaluated in an ongoing first-in-human Phase 1 study in healthy volunteers, which includes pharmacodynamic biomarker assessments in the skin, and these results support continued advancement toward autoimmune and inflammatory disease indications.

NX-1607 (CBL-B Inhibitor): Continued Clinical and Translational Validation

At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November, Nurix presented new translational data from its ongoing Phase 1 study of NX-1607 demonstrating dose-dependent target engagement, peripheral immune activation, and enhanced T-cell proliferation, with greater immune activation observed in patients achieving stable disease compared with those with progressive disease. These findings provide mechanistic evidence linking systemic immune activation to tumor microenvironment remodeling. In addition, clinical data presented at the 2025 European Society for Medical Oncology Congress showed evidence of single-agent anti-tumor activity across multiple solid tumor types, including durable stable disease and a confirmed partial response in heavily pretreated patients. Collectively, these data support continued dose expansion and combination strategies for NX-1607 as a potential next-generation immune checkpoint therapy.

Corporate and Financial Strengthening

In October 2025, Nurix completed a $250.0 million underwritten registered offering of the Company’s common stock, with participation from leading healthcare-focused institutional investors. The proceeds from the offering significantly strengthened the Company’s balance sheet and enabled accelerated execution of pivotal clinical programs, including the registrational development of bexobrutideg, as well as continued investment in pipeline expansion and autoimmune disease opportunities.

In November 2025, Nurix appointed accomplished biopharmaceutical leader Roger Dansey, M.D., to its Board of Directors, adding deep expertise in oncology research, clinical development, and commercialization as the Company advances toward late-stage development and potential registration.

Upcoming Program Highlights*

DAYBreak CLL-201
Nurix will continue enrollment and execution of the DAYBreak pivotal Phase 2 single-arm study (NCT07221500) of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia, which is designed to support a potential Accelerated Approval submission. The DAYBreak study is enrolling patients whose disease has progressed following treatment with a cBTKi, a BCL-2i, and an ncBTKi inhibitor, representing a population with significant unmet medical need.
DAYBreak CLL-306
Nurix plans to initiate a global randomized confirmatory Phase 3 trial in the first half of 2026, following continued engagement with regulatory authorities, to support full approval. The Phase 3 study is expected to compare bexobrutideg monotherapy to pirtobrutinib in patients with relapsed or refractory CLL whose disease has progressed after prior BTK inhibitor therapy. Together, these studies are intended to form a comprehensive registrational program designed to establish the clinical benefit, safety, and durability of bexobrutideg and support its advancement toward regulatory approval.
NX-5948-301
Nurix also continues enrollment in the NX-5948-301 Phase 1a/1b clinical trial of bexobrutideg in patients with relapsed or refractory B cell malignancies. To support future development of bexobrutideg in autoimmune and inflammatory diseases, Nurix is enrolling a Phase 1b cohort for patients with CLL and autoimmune hemolytic anemia and is conducting the necessary Phase 1 healthy volunteer studies to support a potential autoimmune IND in 2026. More information on the ongoing Phase 1a/1b trial of bexobrutideg is available at www.clinicaltrials.gov.
Zelebrudomide
Zelebrudomide is an orally bioavailable degrader of BTK and the cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) designed for the treatment of relapsed or refractory B-cell malignancies. Nurix is conducting a Phase 1a/1b clinical trial, including a Phase 1b expansion cohort focused on patients with diffuse large B-cell lymphoma and mantle cell lymphoma. Nurix is enrolling a dose escalation study within the current Phase 1a/1b trial using the chirally controlled drug product. Additional information on the zelebrudomide clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
NX-1607
NX-1607 is an investigational 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 and lymphomas. 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).
Continued pipeline advancement of strategic collaborations with Gilead, Sanofi and Pfizer: Nurix and Sanofi continue to advance the STAT6 degrader, NX-3911, in IND-enabling studies and future updates are anticipated. Nurix expects to continue to achieve substantial research collaboration milestones throughout the terms of its collaborations with Gilead, Sanofi, and Pfizer.

Nurix expects to provide additional preclinical, clinical, and program updates throughout 2026 to multiple key audiences, including the European Hematology Association (EHA) (Free EHA Whitepaper), the European Society for Medical Oncology, the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper).

*Expected timing of events throughout this press release is based on calendar year quarters.

Fiscal Fourth Quarter 2025 Financial Results

Revenue for the three and twelve months ended November 30, 2025, was $13.6 million and $84.0 million, respectively, compared with $13.3 million and $54.5 million for the three and twelve months ended November 30, 2024, respectively. The increase for the twelve-month period was primarily due to $30 million of license revenue from the achievement of two Sanofi license extensions. During the year ended November 30, 2025, Nurix achieved research milestones under its collaborations with Sanofi and Pfizer totaling $7.0 million and $5.0 million, respectively. In addition, Nurix also achieved a clinical milestone under its collaboration with Gilead of $5 million for the twelve-month period. The increase was partially offset by a decrease in revenue from the collaborations with Sanofi and Gilead as the initial research term for certain drug targets ended.

Research and development expenses for the three and twelve months ended November 30, 2025, were $83.0 million and $316.9 million, respectively, compared with $67.2 million and $221.6 million for the three and twelve months ended November 30,2024, respectively. For the twelve-month period, the increase was primarily related to compensation and related personnel costs, clinical costs and contract manufacturing costs as Nurix continued to accelerate the enrollment of patients in the ongoing trial of bexobrutideg and prepare for the initiation of pivotal trials.

General and administrative expenses for the three and twelve months ended November 30, 2025, were $13.6 million and $52.7 million, respectively, compared with $10.7 million and $45.9 million for the three and twelve months ended November 30, 2024, respectively. The increase for the twelve-month period was primarily due to an increase in compensation and related personnel costs.

Net loss for the three and twelve months ended November 30, 2025, was $78.2 million or ($0.82) per share and $264.5 million or ($3.05) per share, respectively, compared with $58.5 million or ($0.75) per share and $193.6 million or ($2.88) per share, for the three and twelve months ended November 30, 2024, respectively.

Cash, cash equivalents and marketable securities was $592.9 million as of November 30, 2025, compared to $609.6 million as of November 30, 2024.

(Press release, Nurix Therapeutics, JAN 28, 2026, View Source [SID1234662327])

Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201

On January 28, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), the global leader in relapsed/refractory AL Amyloidosis, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

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Per FDA, Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

The FDA Breakthrough Therapy designation is based on Phase 2 NXC-201 interim clinical results from the NEXICART-2 clinical trial, presented December 7, 2025 in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, FL.

"We are grateful to FDA for recognizing NXC-201 as the only granted FDA Breakthrough Designation for a therapy in active development in relapsed/refractory AL Amyloidosis, where no approved therapies exist for patients today," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We are looking forward to completing enrollment of NEXICART-2 with the goal of delivering this promising therapy to patients upon planned BLA submission this year."

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is expected to enroll 40 patients.

About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.

The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

(Press release, Immix Biopharma, JAN 28, 2026, View Source [SID1234662326])