On December 1, 2025 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported the commercial launch of LYMPHIR (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (r/r) Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

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"LYMPHIR is an important new treatment option for the CTCL community, and its launch marks the beginning of a new chapter for Citius Oncology. With a median time to response of 1.4 months in the Phase 3 trial, we believe LYMPHIR may offer rapid skin relief, among other benefits, to patients suffering from severe and debilitating itching common with the disease," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "This is our first marketed product and the culmination of years of development work and commercial preparation. LYMPHIR addresses a clear clinical need in a disease with limited treatment options. Ultimately, we expect LYMPHIR to be a meaningful addition to the treatment paradigm for CTCL and a value-driving catalyst for Citius Oncology shareholders. We estimate that LYMPHIR is entering a growing U.S. market valued at over $400 million, with further upside opportunities through international market access and potential expanded indications in the future. Our focus now is on execution to ensure that LYMPHIR reaches the patients who need it," added Mazur.

The FDA approval of LYMPHIR was based on data from Pivotal Study 302 (NCT01871727), which evaluated the efficacy and safety of LYMPHIR in patients with Stage I–III CTCL who had received at least one prior systemic treatment. The study demonstrated an Objective Response Rate (ORR) of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden. Moreover, LYMPHIR demonstrated meaningful activity on severe pruritus (itchiness), a significant quality of life issue for CTCL patients. Median time to response was 1.4 months. Importantly, LYMPHIR was not associated with cumulative toxicity.

"LYMPHIR is an important new tool in the fight against CTCL. It is the only FDA-approved systemic therapy for CTCL in more than seven years," said Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma. "LYMPHIR’s direct tumoricidal activity and transient T-regulatory cell depletion offer a powerful new approach to disease control without cumulative toxicity. As such, LYMPHIR’s clinical profile makes it a compelling treatment option for physicians and patients facing the burden of relapsed or refractory CTCL."

Commercial Access and Distribution

LYMPHIR is now available in the U.S. through specialty distributors nationwide. Healthcare providers can access treatment resources and prescribing information via the dedicated portal: www.lymphirhcp.com. The product has been assigned a permanent J-code (J9161), effective April 1, 2025, to facilitate reimbursement and streamline claims processing.

The launch is supported by medical education and payer access programs, alongside a field engagement strategy. LYMPHIR has also been included in the National Comprehensive Cancer Network (NCCN) Guidelines for CTCL with a Category 2A recommendation.

Outside the U.S., Citius Oncology holds exclusive rights to develop and commercialize LYMPHIR in all global markets except India, Japan, and certain parts of Asia. The company recently announced a distribution agreement with Integris Pharma S.A. to initiate named-patient access programs in Greece, Cyprus, and other Southern European and Balkan countries. This partnership marks the first pillar in Citius Oncology’s international strategy and supports efforts to provide patients worldwide with access to LYMPHIR.

Patient and Provider Resources

To support informed treatment decisions and facilitate access to care, Citius Oncology has developed clinical, administrative and educational resources for healthcare providers, available at www.lymphirhcp.com. The site includes prescribing information, reimbursement support materials, and product ordering guidance. Additionally, the site features information about Citius Advantage, a dedicated patient assistance program that includes reimbursement and benefits support, prior authorization assistance, and coordination with specialty pharmacies for eligible patients to help reduce out-of-pocket costs and improve access to treatment.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA in August 2024.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

(Press release, Citius Pharmaceuticals, DEC 1, 2025, View Source [SID1234661017])

On December 1, 2025 Flatiron Health reported its presence at the San Antonio Breast Cancer Symposium (SABCS) happening from December 9-12, 2025, in San Antonio, Texas. Flatiron’s real-world data and research capabilities are featured across multiple acceptances, including three spotlight presentations and four poster presentations that leverage the breadth of Flatiron’s breast cancer solutions."Breast cancer is the most common cancer in women worldwide, and every patient’s journey raises critical questions—about treatment effectiveness, biomarker-driven approaches, clinical outcomes, and real-world access," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "At Flatiron, we’ve built a comprehensive, integrated ecosystem of breast cancer solutions that serve every stage of the oncology development life cycle and our research at SABCS demonstrates that when you have the right data infrastructure, analytics, and clinical expertise working together, you can answer virtually any question about breast cancer care and outcomes."

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Research highlights include:

A Spotlight poster presentation leveraging the Flatiron Health–Caris Life Sciences Clinical-Molecular Database, the largest and most robust multimodal dataset of its kind, to identify key genetic alterations and expression changes linked to CDK4/6i treatment resistance.
A Spotlight poster presentation utilizing large language models to explore the real-world use of GLP-1 medications among breast cancer patients and their potential impact on treatment outcomes.
Multiple posters using Flatiron’s Panoramic breast cancer dataset to answer critical research questions on treatment patterns and the effectiveness of novel treatments in improving overall survival and progression-free survival in large, representative patient cohorts.
Learn more about our presence on Flatiron.com and follow Flatiron Health on X and LinkedIn for more updates from #SABCS25.

Abstracts and Poster Presentations
Personalized acquired CDK4/6i resistance: Associations with baseline characteristics like obesity in real-world (RW) clinical-multiomics data
Spotlight Poster Presentation
Kristin M. Zimmerman Savill, Lilia Bouzit, Noelle Liao, Cheryl Cho-Phan, Simon Papillon-Cavanagh
Author Affiliations: Caris Life Sciences, Flatiron Health
Presentation Number: PD3-02
Poster Spotlight 3: Emerging Paradigms of CDK Inhibitor and Antibody Drug Conjugate Resistance in Metastatic Breast Cancer
Presentation Date/Time: Wednesday, December 10, 2025, 7:33 AM – 7:36 AM
Location: 302 ABC

Racial/ethnic inequities in access to novel therapies and outcomes in triple negative breast cancer
Spotlight Poster Presentation
Olive M. Mbah, Gene G. Ho, Catherine Keane, Aaron Dolor, Cleo Ryals
Presentation Number: PD1-06
Poster Spotlight 1: Addressing breast cancer disparities and treatment related toxicities
Presentation Date/Time: Wednesday, December 10, 2025, 7:45 AM – 7:48 AM
Location: Hemisfair 3

Real-world glucagon-like peptide-1 use and association with clinical characteristics, social determinants, and circulating tumor DNA positivity in patients with breast cancer
Spotlight Poster Presentation
Cleo A. Ryals, Auriane Blarre, Blythe Adamson, Daniel Bower, Gene G. Ho, Olive Mbah, Selina Radlein, Erin Fidyk, Fatima Cody Stanford, Aaron B. Cohen
Author Affiliations: Massachusetts General Hospital, Flatiron Health
Presentation Number: PD8-08
Poster Spotlight 8: Beyond the Scale- Obesity and GLP-1 Therapies in Breast Cancer
Presentation Date/Time: Thursday, December 11, 2025, 8:03 AM – 8:06 AM
Location: 221 ABC

Real-world progression-free survival 2 (rwPFS2) and tumor response with CDK4/6is + aromatase inhibitor (AI) in patients (pts) with HR+/HER2– metastatic breast cancer (MBC)
Hope M. Rugo, Adam Brufsky, Rachel M. Layman, Xianchen Liu, Benjamin Li, Lynn McRoy, Aaron B. Cohen, Melissa Estevez, Paul Cottu, Marc Thill, Giuseppe Curigliano
Author Affiliations: City of Hope Comprehensive Cancer Center, UPMC Hillman Cancer Center, The University of Texas MD Anderson Cancer Center, Pfizer, Université Paris Cité, Agaplesion Markus Krankenhaus, University of Milano, European Institute of Oncology, Flatiron Health
Presentation Number: PS1-11-10
Poster Session 1: Wednesday, December 10, 2025, 12:30 PM–2:00 PM

Real-world treatment patterns and clinical outcomes in patients with emerging estrogen receptor 1 (ESR1)-mutated ER+ metastatic breast cancer in the U.S., 2018-2024
Jane Meisel, Tim Pham, Clara Chen, Ayush Kris, James Roose
Author Affiliations: Emory Winship Cancer Institute, AstraZeneca, Flatiron Health
Presentation Number: PS2-02-04
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

Real-world treatment patterns in 1954 US patients with HER2-negative early breast cancer and germline BRCA mutations (2021–2025)
Sagar Sardesai, Meng Ru, Xinran Ma, Catherine Keane, Jingru Wang, Miguel Miranda, Xiaoqing Xu, Claudine Isaacs
Author Affiliations: The Ohio State University Comprehensive Cancer Center, Lombardi Comprehensive Cancer Center, AstraZeneca, Flatiron Health
Presentation Number: PS2-02-03
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

Real-world overall survival with palbociclib plus an aromatase inhibitor (AI) in patients with HR+/HER2− metastatic breast cancer (MBC) who are overweight/obese
Adam Brufsky, Neil M. Iyengar, Xianchen Liu, Benjamin Li, Doris Makari, Lynn McRoy, Aaron B. Cohen, Melissa Estevez, Vandana G. Abramson, Rachel M. Layman, Giuseppe Curigliano
Author Affiliations: UPMC Hillman Cancer Center, Emory University School of Medicine, Pfizer, Vanderbilt University Medical Center, The University of Texas MD Anderson Cancer Center, University of Milano, European Institute of Oncology, Flatiron Health
Presentation Number: PS2-04-12
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

(Press release, Flatiron Health, DEC 1, 2025, View Source [SID1234661033])

On December 1, 2025 GSK plc (LSE/NYSE: GSK) reported it will present new data from its haematology portfolio at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (6 – 9 December), reinforcing its potential to redefine outcomes for patients with difficult-to-treat blood cancers.

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New results from the DREAMM programme for belantamab mafodotin further support its potential to extend remission in relapsed or refractory multiple myeloma, with development in newly diagnosed patients underway

Key presentations include:

Updated results from DREAMM-8 (median 35.8 months of follow-up) explore depth of response and sustained benefit for patients with relapsed or refractory multiple myeloma (Abstract #2264)
DREAMM-7 post hoc analysis explores patient characteristics and outcomes associated with duration and depth of response in responders with progression-free survival (PFS) greater than three years (Abstract #2262)
Combined DREAMM-7 and DREAMM-8 subgroup analysis evaluates PFS and minimal residual disease negativity rates following treatment with belantamab mafodotin versus standard of care therapies in patients with functional high-risk relapsed or refractory multiple myeloma, a population with typically poor outcomes (Abstract #5820)
Analyses from DREAMM-9 in transplant-ineligible newly diagnosed multiple myeloma patients assess the potential for higher initial dose intensity to optimise response, followed by dosing schedule extensions to minimise the potential for eye-related side effects (Abstract #5840)
New analyses for momelotinib build on positive MOMENTUM and SIMPLIFY trial results, assessing spleen and anaemia endpoints alongside overall survival, and early results from a first combination trial will be presented

Additional analyses from MOMENTUM and SIMPLIFY-1 highlight the ability of momelotinib to improve haemoglobin levels and achieve a dual response — both transfusion independence and spleen volume reduction — and the association of these outcomes with survival outcomes in myelofibrosis patients with or without prior JAK inhibitor therapy. (Abstract #2023)

Preliminary efficacy and safety results will be shared from the ODYSSEY trial — the first combination trial for momelotinib evaluating it in combination with luspatercept. The trial explores whether momelotinib’s unique dual mechanism, targeting both anaemia and splenomegaly, can serve as a foundational backbone in future combination therapies to deliver deeper, more durable responses. (Abstract #3803).

Additional presentations include:

Post hoc analysis from the MOMENTUM trial assesses the association between increased momelotinib exposure and greater anaemia-related benefits in patients previously treated with JAK inhibitors (Abstract #5580)
Analyses show momelotinib survival results in intermediate- and high-risk patients as defined by the RR6 model following switch from ruxolitinib, a standard of care, at or before 6 months (Abstract #5579)
Full list of GSK’s presentations at ASH (Free ASH Whitepaper):
Belantamab mafodotin
Abstract name Presenter Presentation details
Deep responses and durable outcomes in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone from long-term follow-up of the phase 3 DREAMM-8 study S. Trudel Poster, Abstract #2264
Long-term responders from the phase 3 DREAMM-7 study of belantamab mafodotin plus bortezomib and dexamethasone vs daratumumab plus bortezomib and dexamethasone in relapsed/refractory multiple myeloma V. Hungria Poster, Abstract #2262
Functional high-risk relapsed/refractory multiple myeloma (RRMM) outcomes with belantamab mafodotin (belamaf): DREAMM-7 and DREAMM-8 subgroup analysis M. Mateos Poster, Abstract #5820
Health-related quality of life with belantamab mafodotin in patients with relapsed or refractory multiple myeloma (RRMM): An exploratory analysis of overall quality of life in DREAMM-7 S. Lonial Poster, Abstract #4029
Belantamab mafodotin (Belamaf) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for patients (pts) with transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM): A focus on treatment efficacy and management/resolution of ocular events in the Phase 1 DREAMM-9 study S. Usmani Poster, Abstract #5840
Patients with relapsed/refractory multiple myeloma who achieved sustained minimal residual disease negativity in the DREAMM-7 trial M. Mateos Poster, Abstract #2265
Impact of belantamab mafodotin–containing regimens on renal function in patients with relapsed/refractory multiple myeloma (RRMM) and mild/moderate renal impairment in the DREAMM-7 and DREAMM-8 trials M. Lacerda Poster, Abstract #2260
Belantamab mafodotin (belamaf) ocular events are manageable and reversible with dose modifications guided by standard assessments S. Lonial Poster, Abstract #4055
An exploratory analysis of health-related quality of life measures with belantamab mafodotin in combination with pomalidomide and dexamethasone (BPd) in patients with relapsed or refractory multiple myeloma (RRMM) enrolled in DREAMM-8 P. Richardson Poster, Abstract #2284
Patient-reported outcomes from DREAMM-7 and DREAMM-8 using the EQ-5D-3L, patient global impression of severity, and patient global impression of change S. Trudel Poster, Abstract #5823
Integrated modeling analyses for belantamab mafodotin in combination with standard of care in patients with relapsed/refractory multiple myeloma (RRMM) From DREAMM-6, DREAMM-7, and DREAMM-8 F. Carreño Poster, Abstract #4043
Years of life lost to multiple myeloma remains high: A targeted literature review A. Bates Poster, Abstract #2804
Life-years and quality-adjusted life-years with belantamab mafodotin, bortezomib, and dexamethasone vs alternative regimens in patients with relapsed/refractory multiple myeloma who received ≥1 prior line of therapy A. Suvannasankha Poster, Abstract #4041
Chimeric antigen receptor T cells in real-world care of multiple myeloma: Patient characteristics and healthcare resource utilization N. Boytsov Poster, Abstract #2787
Bispecific antibodies in real-world care of multiple myeloma: Patient characteristics and healthcare resource utilization N. Boytsov Poster, Abstract #2790
Characteristics of patients with relapsed/refractory multiple myeloma (RRMM) in Europe and the US L. Kalilani ePublication
Indirect treatment comparison of belantamab mafodotin + pomalidomide + dexamethasone Versus comparator regimens in lenalidomide-exposed relapsed/refractory multiple myeloma: A network meta-analysis J. Richter ePublication
Administration- and adverse event-related costs among patients with multiple myeloma treated with B-cell maturation antigen (BCMA)-targeted agents N. Boytsov ePublication
Momelotinib
Abstract name Presenter Presentation details
Dual transfusion independence and spleen volume reduction is associated with overall survival in patients with myelofibrosis treated with momelotinib: Post hoc analyses of SIMPLIFY-1 and MOMENTUM B. Psaila Poster, Abstract #2023
Association between momelotinib exposure and hemoglobin improvement in patients with myelofibrosis and anemia: An exposure-response and time-to-event analysis V. Gupta Poster, Abstract #5580
Preliminary experience from the ODYSSEY trial: Efficacy and safety of momelotinib in combination with luspatercept in patients with transfusion-dependent myelofibrosis P. Bose Poster, Abstract #3803
Survival outcomes in ruxolitinib-treated patients with myelofibrosis following crossover to momelotinib: Application of the response to ruxolitinib at 6 months (RR6) prognostic model to SIMPLIFY-1 R. Rampal Poster, Abstract #5579
Impact of hemoglobin improvement with momelotinib on survival in patients with myelofibrosis and anemia: Post hoc analyses of the SIMPLIFY-1 and MOMENTUM trials P. Vachhani Poster, Abstract #5581
Transfusion independence with momelotinib regardless of baseline erythropoietin levels in the Phase 3 SIMPLIFY-1 trial S. Oh Poster, Abstract #2025
Survival and clinical outcomes in patients with myelofibrosis and new or worsening anemia treated with ruxolitinib: A systematic review and meta-analysis A. Kuykendall Poster, Abstract #2031
Impact of new or worsening anemia and thrombocytopenia on clinical outcomes in JAK inhibitor–naive myelofibrosis patients treated with ruxolitinib V. Gupta Poster, Abstract #3809
Unveiling prognostic subtypes in myelofibrosis through routine blood counts: a population-based analysis of the cytopenic and proliferative phenotypes in andalusia, spain R. Garcia Delgardo ePublication
Discovery of drug combinations with momelotinib to improve myelofibrosis outcomes S. O’Brien ePublication
Momelotinib’s unique polypharmacology supports indication expansion beyond myelofibrosis S. O’Brien ePublication
Full list of Alliance, investigator-initiated studies and supported collaborative studies:
Abstract name Presenter Presentation details
Belantamab mafodotin
Target antigen density impacts clinical response in multiple myeloma patients undergoing treatment with elotuzumab and belantamab mafodotin N. Neparidze ePublication
Can a patient questionnaire (VRAT) reduce the need for ocular examinations with less frequent belantamab mafodotin combined with bortezomib and dexamethasone? The UKMRA PROMMISE D trial R. Popat Poster, Abstract #4065
Belantamab mafodotin, nirogacestat, and pomalidomide in patients with relapsed/refractory multiple myeloma M. Hultcrantz Poster, Abstract #4060
Hematologist-led ocular safety management using the vra tool with belantamab mafodotin plus lenalidomide/dexamethasone in transplant ineligible NDMM: updated results from the RP2D cohort E. Terpos Poster, Abstract #4038
Phase II trial of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone in multiple myeloma following BCMA CAR T-cell therapy B. Derman Poster, Abstract #5832
Momelotinib
Preliminary data from the Phase I/II study of nuvisertib, an oral investigational selective PIM1 inhibitor, in combination with momelotinib showed clinical responses in patients with relapsed/refractory myelofibrosis J. Mascarenhas Oral, Abstract #482
About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.1,2 There are approximately 180,000 new cases of multiple myeloma diagnosed globally each year.3 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.4 Many patients with multiple myeloma, including approximately 70% in the US, are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.5,6,7

About myelofibrosis
Myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells because of dysregulated JAK-signal transducer and activator of transcription protein signalling. The clinical hallmarks of myelofibrosis are splenomegaly (enlarged spleen), severely low blood counts, including anaemia and thrombocytopenia, and debilitating constitutional symptoms, such as fatigue, night sweats and bone pain, attributable to ineffective haematopoiesis and excessive production of proinflammatory cytokines.8,9

About belantamab mafodotin
Belantamab mafodotin is a monoclonal ADC (antibody-drug conjugate) comprising a humanised BCMA (B-cell maturation antigen) conjugated to the cytotoxic agent monomethyl auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

In October 2025, the US FDA approved10 belantamab mafodotin under the brand name Blenrep in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Belantamab mafodotin in combination with bortezomib and dexamethasone and belantamab mafodotin in combination with pomalidomide and dexamethasone are approved in 2L+ relapsed or refractory multiple myeloma in the European Union11, UK12, Japan13, Canada, Switzerland and Brazil.

Applications are currently under review in other markets globally, including China14 where the application is based on the results of DREAMM-7 and has been granted Breakthrough Therapy Designation and Priority Review.

Indication
In the US, Blenrep is indicated in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Please see accompanying US Prescribing Information.

About momelotinib
Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1).15,16,17,18 Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.15,16,17 Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin levels, potentially contributing to anaemia-related benefit.15,16,17,18

In September 2023, the US Food and Drug Administration approved19 momelotinib under the brand name Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia), in adults with anaemia.

In January 2024, the European Commission granted marketing authorisation20 for momelotinib for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. Momelotinib was also approved21 by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to treat the symptoms experienced by adult myelofibrosis patients who have moderate or severe anaemia.

In June 2024, the Japan Ministry of Health, Labour and Welfare (MHLW) approved22 momelotinib for the treatment of myelofibrosis. Momelotinib is currently approved in 21 countries and applications are under review in other markets globally.

Important information for momelotinib in the EU
Indication
Momelotinib is indicated for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Refer to the Omjjara EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.

(Press release, GlaxoSmithKline, DEC 1, 2025, View Source [SID1234661018])

On December 1, 2025 Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels.

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"FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable," shared Arnon Chait, PhD, company president and CEO. "We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide."

FDA approval of the IsoPSA test was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than 1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.

"As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing," added Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago. "IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence."

"FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer," said Dr. Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc.* "I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade."

The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.

Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).

(Press release, Cleveland Diagnostics, DEC 1, 2025, View Source;-Cleveland-Diagnostics-Novel-Blood-Based-Prostate-Cancer-Test [SID1234661034])

On December 1, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate at the Piper Sandler 37th Annual Healthcare Conference in a fireside chat on Thursday, December 4, 2025 at 10:30 a.m. ET in New York, NY.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay following the event.

(Press release, Karyopharm, DEC 1, 2025, View Source [SID1234661019])