ALK2 inhibitors(Activin receptor type-1 inhibitors), JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors)

Therapeutic Areas

Hemic and Lymphatic DiseasesOther DiseasesNeoplasms+ [1]

Active Indication

Post-essential thrombocythemia myelofibrosisPost-polycythemia vera myelofibrosisPrimary Myelofibrosis+ [12]

Inactive Indication

EGFR-mutated non-small Cell Lung CancerKRAS mutant Non-small Cell Lung Cancermetastatic non-small cell lung cancer+ [5]

Originator Organization

Gilead Sciences, Inc.

Active Organization

GSK PlcGlaxoSmithKline Australia Pty Ltd.GlaxoSmithKline Trading Services Ltd.

+ [2]

Inactive Organization

Sierra Oncology, Inc.

License Organization

YM BioSciences, Inc.

Sierra Oncology, Inc.

AstraZeneca PLC

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (15 Sep 2023),

Myelofibrosis

RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia)

Structure/Sequence

Molecular FormulaC23H26Cl2N6O3

InChIKeyRQKCPSIFARJBOR-UHFFFAOYSA-N

CAS Registry1841094-17-4

Clinical Trials associated with Momelotinib Dihydrochloride

NCT07734077

/ Not yet recruitingPhase 1/2IIT

Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis

This is a Phase Ib/II 2 study investigating the safety and efficacy of revumenib in two cohorts of participants with myelofibrosis. COHORT-1 will investigate the safety of revumenib as monotherapy in participants with myelofibrosis previously treated with a JAK inhibitor. Following confirmation of safety in COHORT-1, the study will proceed with enrollment in COHORT-2, which will evaluate the efficacy and safety of revumenib in combination with a JAK inhibitor.

Start Date01 Dec 2026

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+2]

ISRCTN98283910

/ Not yet recruitingPhase 2IIT

Study to assess the safety and efficacy of bomedemstat (IMG-7289) in combination with momelotinib in patients with myelofibrosis

Start Date01 Nov 2026

Sponsor / Collaborator

United Lincolnshire Hospitals NHS Trust

CTIS2026-526821-16-00

/ Not yet recruitingPhase 1/2IIT

Melanoma-TBK1-inhibitor enhanced Immuno Therapy with Checkpoint Inhibitors: a Phase IB/II Trial in Unresectable Stage III or Stage IV Cutaneous Melanoma

Start Date01 Sep 2026

Sponsor / Collaborator

Karolinska University Hospital

100 Clinical Results associated with Momelotinib Dihydrochloride

100 Translational Medicine associated with Momelotinib Dihydrochloride

100 Patents (Medical) associated with Momelotinib Dihydrochloride

392

Literatures (Medical) associated with Momelotinib Dihydrochloride

01 Jun 2026·RESEARCH IN VETERINARY SCIENCE

Dynamics of blood glucose changes and hormonal sensitivity under anesthesia with medetomidine–midazolam–butorphanol anesthesia in rats

Article

Author: Horii, Yuuki ; Shiina, Takahiko ; Naitou, Kiyotada

Recent trends in laboratory animal research have shifted the anesthetic choice as a result of concerns about safety, animal welfare, and regulatory issues. Consequently, rodent studies have widely adopted the combination of medetomidine, midazolam, and butorphanol (MMB). Although studies have reported that MMB anesthesia elevates blood glucose levels, the time-dependent changes in blood glucose and the responsiveness to hormones involved in glucose regulation have not been sufficiently investigated. This study aimed to clarify the temporal profile of blood glucose levels under MMB anesthesia and evaluate the responsiveness to adrenaline and insulin, representative hormones that influence glucose levels. Beginning 10 min after administration, MMB anesthesia induced a marked increase in blood glucose levels, and the elevation persisted up to 60 min. In contrast, pentobarbital anesthesia produced only a transient and mild increase, with no changes observed in the saline group. Blood glucose levels increased under awake and pentobarbital-anesthetized conditions in response to adrenaline, but exhibited no change under MMB anesthesia. In streptozotocin-induced hyperglycemic rats, the glucose-lowering effect of insulin was observed to a similar extent under awake, pentobarbital-anesthetized, and MMB-anesthetized conditions. The present results show that MMB anesthesia has a marked effect on blood glucose levels and alters the response to adrenaline. Therefore, in experiments that measure physiological or biochemical parameters under anesthesia, it is necessary to carefully consider the potential influence of MMB anesthesia on experimental outcomes and critically evaluate the appropriateness of its use.

24 May 2026·EXPERT OPINION ON PHARMACOTHERAPY

Targeted treatment of anemia in myelofibrosis and the impact of JAK inhibitors

Review

Author: Al Noumani, Iman ; Harrison, Claire

INTRODUCTION:

Anemia is a hallmark feature of Myelofibrosis (MF), frequently present at diagnosis and almost universal with disease evolution. It is a major contributor to symptom burden, transfusion dependence, healthcare utilization, and adverse prognosis, and is incorporated into contemporary risk stratification models.

AREAS COVERED:

This review highlights current definitions of MF-associated anemia, including trial and prognostic thresholds, and outlines its incidence, clinical impact, and multifactorial pathophysiology. Therapeutic approaches reviewed include supportive options, differential anemia profiles of JAK inhibitors and emerging targeted strategies like TGF-β ligand traps, hepcidin-pathway modulation, novel agents and combination approaches.

EXPERT OPINION:

Anemia in MF is a core feature, not just a complication. The shift is from supportive to mechanism-guided therapy targeting iron restriction, erythroid maturation, inflammation, and newer JAK inhibitors with anemia benefits as well as mutation targeted therapy. Unmet needs include standardized endpoints, biologically stratified trials, and validation of hemoglobin and transfusion responses as markers. Strategies like momelotinib plus luspatercept, earlier intervention, and new molecular therapies could turn treatment from palliation to durable control and disease modification.

15 May 2026·CANCER

Clinical benefit and predictors of response to momelotinib after ruxolitinib failure: A cooperative real‐world study

Article

Author: Dedola, Alessandra ; Calistri, Elisabetta ; Crugnola, Monica ; Montefusco, Vittorio ; Rossi, Marco ; Guerzoni, Selene ; Martino, Bruno ; Mulas, Olga ; Votto, Amedeo ; Santoro, Marco ; Pugliese, Novella ; Duminuco, Andrea ; Breccia, Massimo ; Palumbo, Giuseppe A. ; Itri, Federico ; Elli, Elena M. ; Galimberti, Sara ; Caocci, Giovanni ; Beggiato, Eloise ; Gallo, Susanna ; Salvatore, Flavia ; Morsia, Erika ; Heidel, Florian H. ; Abruzzese, Elisabetta ; Isidori, Alessandro ; Lanza, Francesco ; Biagi, Annalisa ; Tiribelli, Mario ; Palandri, Francesca ; Di Perna, Maria ; Iurlo, Alessandra ; Kuykendall, Andrew T. ; Lucchesi, Alessandro ; Marchetti, Monia ; Sartor, Chiara ; Pane, Fabrizio ; Branzanti, Filippo ; Fava, Carmen ; Crisà, Elena ; Dizdari, Arbana ; Gianesello, Ilaria ; Benevolo, Giulia

Abstract:

Background:

Momelotinib, a JAK1 / JAK2 / ACVR1 inhibitor, is approved for treating myelofibrosis with splenomegaly, symptoms, and moderate‐to‐severe anemia. Evidence on its real‐world effectiveness after ruxolitinib failure is limited.

Methods:

This study retrospectively analyzed 221 patients who received momelotinib after ruxolitinib failure by assessing spleen, symptom, and anemia responses, safety, and survival. Logistic regression analyses identified the responses’ predictors.

Results:

Before momelotinib initiation, all patients had received ruxolitinib for a median of 31.5 months and discontinued as a result of resistance (29.9%), intolerance (48.0%), or both (22.1%). At baseline, all patients started at full dose; 97.3% presented with cytopenia, 34.8% presented with large splenomegaly, and 43.9% were highly symptomatic. Most patients (74.7%) switched from ruxolitinib stop to momelotinib within 2 months without tapering, whereas 18.1% waited over a year. After a median exposure of 8.2 months, adverse events occurred in 35.7% of patients, which prompted dose reductions or permanent discontinuation in 12.7% and 19.9% of cases, respectively. At 6 months, 30.0% achieved ≥50% spleen length reduction (SR50), with higher responses in those with prior SR50 to ruxolitinib and shorter transition intervals. Symptom and anemia responses occurred in 39.2% and 63.4% of cases, respectively. After a median follow‐up of 10.3 months, 11 patients (5.0%) progressed to blast phase, and 37 patients (16.7%) died. Two‐year overall and progression‐free survival (including death and blast phase transformation) were 60.9% and 59.0%, respectively.

Conclusions:

Momelotinib demonstrated meaningful clinical benefit and acceptable safety in cytopenic patients pretreated with ruxolitinib, which supports its role after ruxolitinib failure.

113

News (Medical) associated with Momelotinib Dihydrochloride

15 Jun 2026

·www.biospace.com

Sumitomo Pharma America Announces Encouraging Clinical and Translational Data at EHA 2026, Highlighting Investigational Combination Therapy in Relapsed/Refractory Myelofibrosis and New Research Findings in Menin Inhibition in Leukemia

– Preliminary clinical data on nuvisertib and momelotinib combination highlight encouraging clinical responses with 60% of evaluable patients achieving responses in spleen size, symptoms, and anemia at 24 weeks – – In addition to its primary activity as a PIM1 inhibitor, in vitro and biochemical data demonstrated that nuvisertib also binds to and inhibits ACVR1 – – New translational research in leukemia and menin inhibition has identified distinct MEN1 mutational signatures associated with acquired resistance to the menin inhibitor (MI) enzomenib – MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Sumitomo Pharma America, Inc. (SMPA) today announced the presentation of new clinical and translational research at the European Hematology Association (EHA) 2026 Congress, held from June 11-14, 2026, in Stockholm, Sweden. Among the data is the first-ever disclosure of preliminary clinical data for the investigational PIM1 inhibitor nuvisertib in combination with momelotinib (MMB) for patients with myelofibrosis (MF), and new translational research into the mechanistic basis for hemoglobin improvement observed in patients with MF in an ongoing Phase 1/2 study with nuvisertib. Alongside these findings, SMPA is also sharing new data gathered around acquired resistance patterns observed with enzomenib in acute leukemia. “We are excited to present the preliminary data for our investigational combination of nuvisertib and momelotinib at EHA 2026, while also sharing learnings from our ongoing translational research of nuvisertib and enzomenib,” said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. “We appreciate this opportunity to share the latest data for these two programs with the oncology community, and these results reinforce our commitment to developing multi-faceted therapeutic approaches that address the most persistent challenges in treating hematologic malignancies.” Promising clinical response with nuvisertib and momelotinib in myelofibrosis James McCloskey, M.D., Interim Chief of the Division of Leukemia, John Theurer Cancer Center, Hackensack, USA, presented preliminary clinical data from the ongoing global Phase 1/2 study ( NCT04176198 ). As of December 6, 2025, a total of 26 patients with relapsed/refractory (R/R) MF and anemia were enrolled across four dose levels of nuvisertib (240, 360, 480, and 720 mg twice daily under fed condition) in combination with the approved dose of momelotinib in MF (200 mg once daily). This study population was particularly challenging to treat as every patient had previously received at least one approved Janus Kinase (JAK) inhibitor and 41% of patients carried high molecular risk (HMR) mutations. Despite these complexities, the combination appeared well tolerated with no dose-limiting toxicities (DLTs) observed. The most common treatment-related adverse events occurring in ≥20% patients were diarrhea, nausea, and thrombocytopenia. The most frequent treatment-related Grade 3 adverse event was thrombocytopenia without bleeding, which occurred in three patients. Of note, mean hemoglobin and platelet count levels remained stable throughout the 24-week treatment period. Among the efficacy evaluable patients who completed at least 12 weeks of treatment (n=15), the combination of nuvisertib and momelotinib demonstrated evidence of clinical activity. Spleen volume reduction of at least 25% (SVR25) was achieved by 73% of patients at Week 12 and reached 100% at Week 24 (n=5). Similarly, 53% of patients achieved a total symptom score reduction of at least 50% percent (TSS50) at Week 12 that further improved to 60% of patients at Week 24 (n=5). Anemia response by IWG ELN2024 criteria was observed in 50% of patients at any time. Most significantly, 60% of patients achieved a triple response at the Week 24 mark, meeting concurrent criteria for symptom reduction, spleen volume reduction, and anemia improvement. The development of nuvisertib and momelotinib combination therapy was driven by the need to address the pathways that drive MF progression more comprehensively. While standard treatments focus on inhibiting the JAK signaling pathway, research has shown that PIM1 expression is often upregulated in MF and can be driven by JAK-independent compensatory pathways, such as Nuclear Factor kappa-light-chain-enhancer of activated B cells (NF-kB) and Ets Related Gene (ERG). These secondary pathways can allow the disease to survive and progress even during JAK inhibitor therapy. By combining nuvisertib with the JAK/Activin A Receptor Type 1 (ACVR1) inhibitor momelotinib, researchers aim to shut down these escape routes, potentially leading to deeper and more durable clinical responses for patients. New Nuvisertib translational research presented in MF Joseph M Scandura, M.D., Ph.D., Division of Hematology and Medical Oncology, Weill/Cornell Leukemia Program, New York, USA, presented translational research further elucidating the proposed mechanism of action of nuvisertib. In addition to its primary activity as a PIM1 inhibitor, in vitro and biochemical data demonstrated that nuvisertib also binds to and inhibits ACVR1, resulting in reduced hepcidin mRNA expression, a central regulator of iron homeostasis. Consistent with these findings, preliminary clinical data from a Phase 1/2 study of nuvisertib monotherapy showed reduced hepcidin levels in patients with R/R MF, providing a potential mechanistic explanation for the hemoglobin stability and improvement observed in patients with MF treated with nuvisertib. “Preliminary clinical data suggests that the combination of nuvisertib and momelotinib may provide a more comprehensive suppression of the disease pathways driving myelofibrosis,” said Raajit Rampal, M.D. Ph.D., Director of the Myeloproliferative Neoplasms Program at the Memorial Sloan Kettering Cancer Centre, New York, USA. “The promising symptom, spleen and anemia responses, coupled with the new nonclinical data on potential dual PIM1 and ACVR1 inhibitory activity by nuvisertib, suggest that this combination therapy may potentially offer meaningful clinical benefits for patients with myelofibrosis.” Translational research in leukemia and menin inhibition identifies E368K mutation as key resistance signature at relapse Also, during the conference, translational research in leukemia and menin inhibition was shared by Jevon Cutler, PhD, Assistant Professor of Cell, Developmental and Cancer Biology at the Oregon Health Sciences University School of Medicine, that identified distinct MEN1 mutational signatures associated with acquired resistance to the menin inhibitor (MI) enzomenib in patients with acute leukemia. Serial molecular profiling revealed that the E368K mutation was the predominant resistance signature identified at relapse, appearing in 53% of patients who relapsed after an initial response. Preclinical work predicted the E368K mutation to be the primary resistance mutation and that this mutation may not affect the other menin inhibitors; these findings support the further exploration of rational, sequential MI therapy to improve clinical outcomes for patients with acute leukemia. Presentation Details Abstract title Lead Author Investigational PIM1 Inhibitor Nuvisertib in Combination with Momelotinib Showed Promising Clinical Activity in Patients with Myelofibrosis and Anemia: Data from an Ongoing Global Phase 1/2 Study James McCloskey, MD Preclinical Evidence of Targeting ACVR1/Hepcidin by Nuvisertib, an Oral Investigational PIM1 Kinase Inhibitor, Suggests Potential Mechanistic Basis for Hemoglobin Benefit in Myelofibrosis Joseph M Scandura, MD, PhD Distinct MEN1 Mutational Signatures Are Associated with Acquired Resistance During MENIN-KMT2A Inhibition in a Phase 1 Enzomenib Trial Jevon Cutler, PhD About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.) focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn . The Sumitomo corporate symbol mark is a registered trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. ©2026 Sumitomo Pharma America, Inc. All rights reserved. Contacts For further information: SMPA CONTACT: Dave Murdoch, Sumitomo Pharma America, Inc., david.murdoch@us.sumitomo-pharma.com , +1 (774) 405-5570

Clinical ResultPhase 1

01 Jun 2026

·www.gsk.com

GSK delivers strong Q2 core results performance and continued momentum. Plans announced to accelerate R&D and late-stage pipeline portfolio. Expect 20+ phase III trial starts in 2026

Strong Specialty Medicines and Vaccines performance drives sales and core operating profit growth Total Q2 sales £8.4 billion +5% AER; +5% CER Specialty Medicines sales £3.8 billion (+14%); Respiratory, Immunology & Inflammation £1.1 billion (+19%); Oncology £0.6 billion (+17%); HIV sales £2.1 billion (+10%) Vaccines sales £2.3 billion (+8%); Shingrix £0.9 billion (+3%); Meningitis vaccines £0.5 billion (+21%); and Arexvy £0.2 billion (+>100%) General Medicines sales £2.3 billion (-9%); Trelegy £0.8 billion (-7%) Total operating profit -75% and Total EPS -69% driven by higher impairments, primarily related to camlipixant of £1.3 billion, and higher CCL charges, partly offset by Core operating profit growth and higher divestment income Core operating profit +7% and Core EPS +9% reflecting higher sales and favourable product and regional mix, partly offset by increased investment in R&D and new asset launches and lower royalty income Cash generated from operations of £2.9 billion with free cash flow of £2.0 billion Pipeline progress: Two late-stage medicines for non-small cell lung cancer acquired: Jideytro (FDA approval) & neladalkib (PDUFAH2 2026) Positive phase III Hansoh China data for Ris-Rez in lung cancer – first positive phase III overall survival datareported for a B7-H3 targeted ADC in any tumour type Positive data (AZUR-1) supports regulatory reviews for use of Jemperli in treatment of advanced rectal cancer Momelotinib (Ojjaara) granted Orphan Drug Designations in US and EU for VEXAS syndrome Pivotal data demonstrates unprecedented functional cure rates for bepirovirsen (chronic hepatitis B) Arexvy expanded approval in Japan for adults aged 18-59 at increased risk of RSV Decision not to progress further development of camlipixant in RCC following CALM-1/2 phase III results R&D acceleration: 62 assets in clinical development with opportunities for significant growth 7 asset accelerations - across 18 indications - identified in: Oncology, Respiratory, Hepatology & Vaccines Now expect 20+ phase III trial starts in 2026 (previously 10) New flagship R&D Centre to be established in Cambridge Biomedical Campus, UK 3-year programme to fund investment in late-stage portfolio and to improve operating margin with £1.9 billion annual savings targeted by 2029 for costs of £2.4 billion (£2.1 billion cash costs) Growth outlooks: 2026 guidance reaffirmed with expected growth in: turnover 3% to 5%; Core OP 7% to 9%; Core EPS 7% to 9% On track for 2031 sales outlook of more than £40 billion; Accelerating growth from 2031 onwards Operating margin stable to improving through dolutegravir loss of exclusivity period of 2028-2030 Shareholder returns: Q2 2026 dividend of 17p declared; 70p expected for full year 2026 Completed £2 billion share buyback programme as announced at FY 2024 Luke Miels, Chief Executive Officer, GSK: “GSK has delivered another quarter of strong core results performance, with our key growth drivers performing well. We remain focused on operational delivery, execution, and accelerating R&D. To that end, we have identified late-stage pipeline accelerations - across 18 indications – for 7 key assets in Oncology, Respiratory, Hepatology and Vaccines. Based on clinical data, and their opportunities to improve upon current standards-of-care, we see strong reasons for all these assets to bring meaningful benefits and protection to patients. We have also decided to establish a new flagship R&D Centre on the UK’s Cambridge Biomedical Campus – an investment that will further integrate GSK into one of the world’s leading ecosystems for life-sciences. To fund investment in the late-stage portfolio and R&D, we are starting a 3-year cost savings programme to simplify the organisation and to reallocate capital and resources. Savings will primarily be reinvested, with some used to improve margins and profitability in the dolutegravir patent expiry period (2028-2030). We believe these plans, together with continued disciplined capital allocation, will drive strong operational performance and shareholder returns over the next five years, delivering our 2031 sales outlook and accelerated long-term growth.” Assumptions and cautionary statement regarding forward-looking statements The Group’s management believes that the assumptions outlined above are reasonable, and that the guidance, outlooks, and expectations described in this report are achievable based on those assumptions. However, given the forward-looking nature of these guidance, outlooks, and expectations, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macro-economic activity, the impact of outbreaks, epidemics or pandemics, changes in legislation, regulation, government actions and policies, including the impact of any potential tariffs or other restrictive trade policies on the Group's products, or intellectual property protection, product development and approvals, actions by our competitors, and other risks inherent to the industries in which we operate. This document contains statements that are, or may be deemed to be, “forward-looking statements”. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as 'aim', 'ambition', ‘anticipate’, 'believe', 'could', ‘estimate’, ‘expect’, ‘goal’, ‘intend’, 'may', ‘outlook’, ‘plan’, ‘project’, ‘seek’, ‘should’, ‘target’, 'will' and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, dividend payments and financial results. Other than in accordance with its legal or regulatory obligations (including under the Market Abuse Regulation, the UK Listing Rules and the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and readers are cautioned not to place undue reliance on the forward-looking statements. All guidance, outlooks and expectations should be read together with the guidance and outlooks, assumptions and cautionary statements in this Q2 2026 earnings release and in the Group's 2025 Annual Report on Form 20-F. Forward-looking statements are subject to assumptions, inherent risks and uncertainties, many of which relate to factors that are beyond the Group’s control or precise estimate. The Group cautions investors that a number of important factors, including those in this document, could cause actual results to differ materially from those expressed or implied in any forward-looking statement. Such factors include, but are not limited to, those discussed under ‘Risk Factors’ in the Group’s Annual Report on Form 20-F for 2025 and as described on pages 48 and 49 in this Q2 2026 earnings release. Any forward-looking statements made by or on behalf of the Group speak only as of the date they are made and are based upon the knowledge and information available to the Directors on the date of this report. Inside information This announcement contains inside information. The person responsible for arranging the release of this announcement on behalf of GSK is Victoria Whyte, Company Secretary. You might also like

Phase 3VaccineFinancial StatementOrphan DrugClinical Result

18 May 2026

·www.biospace.com

CytomX Therapeutics Appoints Mamata Gokhale, Ph.D., RAC, as Senior Vice President of Regulatory Affairs

SOUTH SAN FRANCISCO, Calif., May 18, 2026 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced the appointment of Mamata Gokhale, Ph.D., RAC, as Senior Vice President of Regulatory Affairs. In this role, Dr. Gokhale will lead CytomX’s global regulatory strategy and oversee regulatory engagement to support the continued advancement of the Company’s PROBODY ® pipeline through clinical development and toward potential commercialization. “Mamata brings deep global regulatory expertise and a proven track record of advancing oncology assets through late-stage development, global approvals and commercialization,” said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. “She joins CytomX at an important juncture as we prepare for regulatory interactions across our pipeline, notably with our lead program Varseta-M. Mamata’s experience leading regulatory strategy will be instrumental as we advance our PROBODY therapeutics towards cancer patients in need.” “I am excited to join CytomX at this important time for the company, with lead program Varseta-M potentially advancing into a registrational study in late line CRC by the first half of 2027,” said Dr. Gokhale. “I look forward to working with the CytomX team and with regulators to advance Varseta-M towards potential approval and commercialization for patients in need.” Dr. Gokhale joins CytomX with more than 25 years of experience leading global regulatory strategy from early-stage clinical development through commercialization from both an industry and agency lens. Most recently, she was VP of Global Regulatory Affairs at Perspective Therapeutics, where she led the regulatory strategy for multiple oncology programs, secured expedited designations and played a key role in shaping regulatory approaches for the development and optimization of targeted therapies. Prior to joining Perspective, Dr. Gokhale served as VP of Global Regulatory Affairs at Sierra Oncology, a late-stage oncology company acquired by GSK, where she led the regulatory strategy resulting in successful U.S. and European approvals of OJJAARA (momelotinib). Previously, she held senior regulatory and clinical development leadership roles at Actinium Pharmaceuticals and Amgen, contributing to multiple oncology approvals and served as a Principal Consultant at Parexel and Voisin Consulting Life Sciences, advising a diverse portfolio of biotechnology companies on regulatory strategy. She began her career at the U.S. Food and Drug Administration as a Clinical Pharmacologist and Reviewer. Dr. Gokhale received her Ph.D. in Biochemistry from the University of Bombay, India and completed her postdoctoral training at the Johns Hopkins School of Medicine & Public Health. She received her M.S. in Biochemistry and B.S. in Microbiology, both from the University of Poona, India. About CytomX Therapeutics, Inc. CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked PROBODY ® therapeutics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), cytokines and T-cell engagers. CytomX’s clinical-stage pipeline includes varsetatug masetecan (Varseta-M; CX-2051) and CX-801. Varseta-M is a masked, conditionally activated ADC armed with a topoisomerase-1 inhibitor payload and directed toward epithelial cell adhesion molecule (EpCAM). EpCAM is a highly expressed tumor antigen that has previously been undruggable due to expression on normal tissues. Varseta-M is designed to open a therapeutic window for this high potential target and is initially being developed for the treatment of metastatic colorectal cancer. Varseta-M was discovered in collaboration with ImmunoGen, now part of AbbVie. CX-801 is a masked interferon alpha-2b PROBODY ® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CX-801 is initially being developed for the treatment of metastatic melanoma. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit and follow us on LinkedIn and X (formerly Twitter). CytomX Therapeutics Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond CytomX’s control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements and projected cash runway. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including varsetatug masetecan (Varseta-M) and CX-801, the potential benefits or applications of CytomX’s PROBODY ® therapeutic platform, CytomX's planned interactions with the U.S. Food and Drug Administration and the ability to align on a potential registrational study design and regulatory pathway for Varseta-M, CytomX’s or its collaborative partners’ ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of Varseta-M and CX-801 and the timing of initial and ongoing data availability for CytomX’s clinical trials, including Varseta-M and CX-801, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel PROBODY ® therapeutic technology; uncertainties around the Company’s ability to raise sufficient funds to carry out its planned research and development; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial Varseta-M clinical trial results, may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of Varseta-M and CX-801; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in the United States and foreign countries, including China and the European Union; and the risk that we may incur higher costs than expected for research and development. Additional applicable risks and uncertainties include those relating to CytomX’s preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on May 7, 2026. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc. All other trademarks are the properties of their respective owners. Company Contact: Chris Ogden SVP, Chief Financial Officer cogden@cytomx.com Investor Contact: Precision AQ Stephanie Ascher stephanie.ascher@precisionaq.com Media Contact: Precision AQ Colleen Ketchum colleen.ketchum@precisionaq.com

Executive Change

100 Deals associated with Momelotinib Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10358 D10889	Momelotinib Dihydrochloride	-	DB11763

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Post-essential thrombocythemia myelofibrosis	Canada	GSK Plc	12 Nov 2024
Post-polycythemia vera myelofibrosis	Canada	GSK Plc	12 Nov 2024
Primary Myelofibrosis	Canada	GSK Plc	12 Nov 2024
Anemia	United Kingdom	GSK Plc	30 Jan 2024
Anemia, Myelophthisic	European Union	GlaxoSmithKline Trading Services Ltd.	25 Jan 2024
Anemia, Myelophthisic	Iceland	GlaxoSmithKline Trading Services Ltd.	25 Jan 2024
Anemia, Myelophthisic	Liechtenstein	GlaxoSmithKline Trading Services Ltd.	25 Jan 2024
Anemia, Myelophthisic	Norway	GlaxoSmithKline Trading Services Ltd.	25 Jan 2024
Splenomegaly	European Union	GlaxoSmithKline Trading Services Ltd.	25 Jan 2024
Splenomegaly	Iceland	GlaxoSmithKline Trading Services Ltd.	25 Jan 2024
Splenomegaly	Liechtenstein	GlaxoSmithKline Trading Services Ltd.	25 Jan 2024
Splenomegaly	Norway	GlaxoSmithKline Trading Services Ltd.	25 Jan 2024
Myelofibrosis	United States	GlaxoSmithKline LLC	15 Sep 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
VEXAS syndrome	Phase 3	-	GSK Plc	05 Aug 2026
Thrombocytopenia	Phase 3	United States	Sierra Oncology, Inc.	19 Jun 2014
Thrombocytopenia	Phase 3	Canada	Sierra Oncology, Inc.	19 Jun 2014
Thrombocytopenia	Phase 3	France	Sierra Oncology, Inc.	19 Jun 2014
Thrombocytopenia	Phase 3	Germany	Sierra Oncology, Inc.	19 Jun 2014
Thrombocytopenia	Phase 3	Israel	Sierra Oncology, Inc.	19 Jun 2014
Thrombocytopenia	Phase 3	Italy	Sierra Oncology, Inc.	19 Jun 2014
Thrombocytopenia	Phase 3	Spain	Sierra Oncology, Inc.	19 Jun 2014
Thrombocytopenia	Phase 3	United Kingdom	Sierra Oncology, Inc.	19 Jun 2014
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	United States	Sierra Oncology, Inc.	02 Jun 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2026	Not Applicable	VEXAS syndrome	6	Momelotinib	pyzpszgmsl(ovtitmtufg) = ijkdfeingr eohqhzjozj (vmibiiiazc, 8 - 27.6) View more	Positive	12 May 2026
EHA2026	Phase 1/2	Acute Myeloid Leukemia with FLT3/ITD Mutation FLT3-MUTATED	13	Gilteritinib + Momelotinib	ynyqirgyvi(zlqgtcqwwy) = not observed at any dose level thxfgyheeo (fwhjwmjbux ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Myelofibrosis	23	Momelotinib	zucnyfmmzn(wtvltsxqvv) = ijmlasmqvs rcgortevzg (lmruodsgpd ) View more	Positive	12 May 2026
NCT01969838 (SIMPLIFY-1, EHA2026)	Phase 3	-	345	Momelotinib (SIMPLIFY-1(int-1-risk))	fpilsfnahx(gqdzyjaudb) = qyasasufcj dtmcnxarob (xhkdlnprox ) View more	Positive	12 May 2026
NCT01969838 (SIMPLIFY-1, EHA2026)	Phase 3	-	345	Momelotinib (SIMPLIFY-1(int-2-/high-risk))	fpilsfnahx(gqdzyjaudb) = vemukbirqh dtmcnxarob (xhkdlnprox ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Myelofibrosis	29	Momelotinib	xralscbbbl(nfafqmgesb) = xwefivshhg hmiosoyvoi (tvluekveys ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Myelofibrosis	29	Momelotinib (JAKi-naive)	xralscbbbl(nfafqmgesb) = nevfknuvmr hmiosoyvoi (tvluekveys ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Myelofibrosis	10	Momelotinib	fcjrdpunmv(yhkujtjweu) = mlmynojfii pfykehxiri (hvnneotuup ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Primary Myelofibrosis	31	Momelotinib	cydrioghws(drdotscpeh) = kudximvbhg ihtuvucmfc (oggvftisab ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Anemia \| Myelofibrosis	77	Momelotinib (JAKi naive)	uoiuzonsoc(rgnjkheqee) = rlajtwyyaf mgwcgnnshc (gkrptpodew, 1.1 - 2.1) View more	Positive	12 May 2026
EHA2026	Not Applicable	Anemia \| Myelofibrosis	77	Momelotinib (JAKi experienced)	uoiuzonsoc(rgnjkheqee) = xzufdunrqy mgwcgnnshc (gkrptpodew, 0.6 - 2.1) View more	Positive	12 May 2026
NCT01969838 (SIMPLIFY-1, ASH2025)	Phase 3	Myelofibrosis	212	Momelotinib	msxtrqostw(dazhwxsmdv) = ctrpqvagwf goovndjdsd (jyrklzbxqk )	Positive	06 Dec 2025
NCT01969838 (SIMPLIFY-1, ASH2025)	Phase 3	Myelofibrosis	212	Momelotinib	msxtrqostw(dazhwxsmdv) = amhaxfekpi goovndjdsd (jyrklzbxqk ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Myelofibrosis	60	Momelotinib	ecsxylfkfz(qhprwxjbvv) = elrakmzkgp atvqgsqhxt (fpznwzphfg ) View more	Positive	06 Dec 2025

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis