On November 4, 2025 NEOK Bio, Inc., a biotechnology company focused on the development of novel antibody drug conjugates (ADCs) for improving outcomes for cancer patients, reported that it has emerged from stealth mode with $75 million in Series A financing. The company’s principal investor is ABL Bio, Inc., a leading Korean biotech company and a proven leader in antibody engineering. The funding will be used to advance two bispecific ADC programs into the clinic. The company aims to be a leading bispecific ADC company in the U.S.

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Leveraging ABL’s innovative ADC platform technology, NEOK is building a pipeline of bispecific ADCs by pursuing validated targets, while balancing high expression, selectivity, and target-related safety signals. NEOK utilizes a proprietary, linker-payload technology (SYNtecan E) that enables ADC generation with strong linker stability and superior biophysical properties. The company aims to overcome the efficacy and safety limitations of conventional ADCs through its bispecific approach which targets unique pairs of cancer targets.

"ADCs are a proven modality in treating select cancers, but historically have had limitations related to stability, selectivity, and therapeutic window. We believe our dual-targeting strategy has the potential to overcome drug resistance, target a wider range of tumors, increase internalization rates and cell killing, and improve the safety profile of ADCs by increasing selectivity and reducing off-tumor toxicity," said Mayank Gandhi, Chief Executive Officer of NEOK Bio. "The financing is a critical step in our journey to a clinical-stage company and enables the execution of a robust and efficient clinical development plan for our bispecific ADCs."

"Our investment in the formation of NEOK Bio underscores our commitment to deliver transformative therapeutic innovation to the dynamic and growing ADC landscape," said ABL Bio CEO Dr. Sang Hoon Lee. "We are excited to support an outstanding and experienced NEOK team as they aim to fulfill the significant untapped potential of bispecific ADCs to improve the lives of people with cancer."

The financing will support the initiation of clinical studies for NEOK’s two lead ADC candidates, which target proteins that are broadly expressed in multiple tumor types with significant unmet needs. They include NEOK001 (previously ABL206), a bispecific ADC targeting ROR1 and B7-H3, and NEOK002 (previously ABL209), a bispecific ADC targeting EGFR and MUC1 proteins. Both assets have the potential to demonstrate enhanced efficacy and safety over monovalent ADCs in large patient populations across thoracic, gastrointestinal, and gynecological cancers.

NEOK plans to file an Investigational New Drug (IND) application for both programs by early 2026 and initiate Phase 1 clinical trials in mid-2026 in the U.S. First data readouts from both programs are expected in 2027.

(Press release, Neok Bio, NOV 4, 2025, View Source [SID1234659407])

On November 3, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported recent business highlights and financial results for the third quarter ended September 30, 2025.

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"Cogent had a very productive and busy third quarter and we now find ourselves weeks away from reporting top-line results from our Phase 3 PEAK trial of bezuclastinib plus sunitinib in Gastrointestinal Stromal Tumor (GIST) patients and our registration-directed APEX trial in Advanced Systemic Mastocytosis (AdvSM) patients. In addition, we are pleased to announce we will have three bezuclastinib presentations at ASH (Free ASH Whitepaper) 2025, including two oral presentations focused on the results from the SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "On top of this progress, we recently presented updated preclinical data from our research pipeline that demonstrated potential best-in-class attributes of our pan-KRAS inhibitor and plan to describe for the first time at ASH (Free ASH Whitepaper) 2025 our highly potent, highly selective JAK2 V617F mutant-selective inhibitor. Both of these programs are on track for IND in 2026. Our continued financial discipline and business execution position us well as we head into pivotal data readouts and prepare for our first NDA filing for NonAdvSM later this year."

Recent Business Highlights

•Announced alignment with the U.S. Food and Drug Administration (FDA) on the SUMMIT New Drug Application (NDA) submission plan for broad NonAdvSM patient population following a productive pre-NDA meeting, as well as the receipt of Breakthrough Therapy Designation for bezuclastinib in NonAdvSM patients previously treated with avapritinib and in patients with Smoldering Systemic Mastocytosis; populations with no currently approved standard of care.

•Reported positive top-line results from SUMMIT evaluating bezuclastinib in patients with NonAdvSM, achieving statistical significance across all primary and key secondary endpoints.

•Announced multiple presentations have been accepted at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) being held December 6-9, 2025, in Orlando, FL, including two SUMMIT oral presentations and a poster presentation on Cogent’s novel JAK2 V617F mutant-selective inhibitor, the company’s newest discovery stage program. Details of the ASH (Free ASH Whitepaper) presentations can be found in a separate release issued today.

•Recently received clearance from the FDA on Cogent’s Investigational New Drug (IND) submission for CGT4255, a novel, selective, potent, CNS-penetrant ErbB2 inhibitor. A Phase 1 dose escalation trial is on track to initiate in November.

•In July, successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at $9.00 per share, including the full exercise of the underwriters’ option to purchase an additional 3,333,333 shares. This offering generated net proceeds of $215.8 million. Cogent also recently raised $39 million through targeted share sales via the Company’s at-the-market facility (ATM).

Anticipated Upcoming Milestones

•Announce top-line results from PEAK in November 2025. PEAK is a global, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant GIST.

•Announce top-line results from APEX in December 2025. APEX is a registration-directed, global, open-label trial in patients with AdvSM.

•Submit Cogent’s first NDA for bezuclastinib by the end of 2025.

Third Quarter 2025 Financial Results

Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $390.9 million, as compared to $345.5 million as of June 30, 2025. The company believes that its cash, cash equivalents and marketable securities, together with the $39.0 million gross proceeds from shares sold through the ATM since last quarterly filing, will be sufficient to fund its operating expenses and capital expenditure requirements into 2027, including through potential FDA approval of bezuclastinib for NonAdvSM and early commercial launch activities.

R&D Expenses: Research and development expenses were $69.0 million for the third quarter of 2025 as compared to $63.6 million for the third quarter of 2024. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $5.4 million for the third quarter of 2025 compared to $4.8 million for the third quarter of 2024.

G&A Expenses: General and administrative expenses were $14.4 million for the third quarter of 2025 as compared to $11.8 million for the third quarter of 2024. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $5.2 million for the third quarter of 2025 compared to $5.6 million for the third quarter of 2024.

Net Loss: Net loss was $80.9 million for the third quarter of 2025 as compared to a net loss of $70.6 million for the same period of 2024.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on October 22, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grant of "inducement" equity awards to five new employees under the company’s 2020 Inducement Plan with a grant date of November 3, 2025. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, nonqualified options to purchase 89,500 shares of Cogent common stock. Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a four-year vesting schedule with 25% vesting on the one-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date.

(Press release, Cogent Biosciences, NOV 3, 2025, View Source [SID1234659248])

On November 3, 2025 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that results from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, will be featured in two oral presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting, on December 8, 2025 in Orlando, FL.

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KOMET-007 is an ongoing Phase 1a/b dose-escalation/expansion study of ziftomenib in combination with standard-of-care chemotherapies in adults with NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The combination data presented at ASH (Free ASH Whitepaper) will include data in both newly diagnosed adults with NPM1-m AML and updated data in adults with relapsed or refractory NPM1-m or KMT2A-r AML treated with ziftomenib in combination with the non-intensive chemotherapy regimen of venetoclax and azacitidine (ven/aza).

The two ziftomenib abstracts are based on an earlier data cutoff of June 2025, in line with ASH (Free ASH Whitepaper) submission timelines. The oral presentations at ASH (Free ASH Whitepaper) will include more mature data, including additional response-evaluable patients, longer follow-up and expanded safety summaries.

"At ASH (Free ASH Whitepaper) 2025, we look forward to sharing data evaluating ziftomenib with venetoclax / azacitidine in both the newly diagnosed and relapsed/refractory AML settings," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These trials are part of a comprehensive and focused clinical development plan designed to understand how menin inhibition can benefit the greatest number of patients in need. We expect to continue generating data from the combination of ziftomenib with commonly used treatment backbones across multiple trials, including the KOMET-017 Phase 3 trial. The emerging profile from this effort gives us confidence that ziftomenib as monotherapy and in combination represents a meaningful step forward for patients if these findings are confirmed."

ASH Presentations:

Ziftomenib in Combination with Venetoclax and Azacitidine in Relapsed / Refractory NPM1-m or KMT2A-r Acute Myeloid Leukemia: Updated Phase 1a/b safety and clinical activity results from KOMET-007
Session 616. Menin inhibitors and FLT3 inhibitors in AML
Monday, December 8, 2025; 10:45-11:00 AM ET
Chapin Theater (320)
Oral #764

Ziftomenib in Combination with Venetoclax and Azacitidine in Newly Diagnosed NPM1-m Acute Myeloid Leukemia: Phase 1b Results from KOMET-007
Session 616. Menin inhibitors and FLT3 inhibitors in AML
Monday, December 8, 2025; 11:15-11:30 AM ET
Chapin Theater (320)
Oral #766

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.

(Press release, Kura Oncology, NOV 3, 2025, View Source [SID1234659264])

On November 3, 2025 Star Therapeutics, a clinical stage biotechnology company discovering and developing best-in-class antibodies for bleeding disorders and other diseases, reported that the company will present an oral presentation on interim data from its Phase 1/2 multidose study of VGA039 for von Willebrand disease (VWD), along with additional posters on the program, at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 6-9, 2025, in Orlando, Fla. VGA039 is a first-in-class monoclonal antibody therapy with a novel mechanism of action that targets Protein S, thereby restoring balance to the blood clotting process.

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Presentation details include:

Oral Presentation

Title: Subcutaneous, Every-Four-Week Maintenance Dosing of a Novel Protein S Antibody is Well-Tolerated and Substantially Reduces Bleeding Rates: Results from a Phase 1/2 Multidose Study of VGA039 in Patients with Von Willebrand Disease
Publication Number: 308
Oral Session: 323. Disorders of Coagulation, Bleeding, or Fibrinolysis, Excluding Congenital Hemophilias: Clinical and Epidemiological: Novel Insights into Diagnostics and Therapeutics of Bleeding in Inherited, Acquired Coagulopathies and BDUC
Presentation Date and Time: Saturday, December 6, 2025, 4:15 – 4:30 p.m. ET
Presenter: Allison Wheeler, M.D., MSCI
Poster Presentations

Title: The First Characterization of Disease Burden and Healthcare Resource Utilization for the Recent Definition of Severe Von Willebrand Disease Using a Large United States Real-World Dataset
Publication Number: 2611
Poster Session: 901. Health Services and Quality Improvement: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster I
Session Date and Time: Saturday, December 6, 2025, 5:30 – 7:30 p.m. ET
Presenter: Angela Weyand, M.D.
Title: VGA039 as a Protein S-Targeted Hemostatic Promoting Monoclonal Antibody, Promotes in-vitro Thrombin Generation in Plasma Samples from Subjects Across a Broad Range of Bleeding Disorders, Including Von Willebrand Disease, Hemophilia A, Hemophilia B and Hemophilia C
Publication Number: 1277
Poster Session: 321. Coagulation and Fibrinolysis: Basic and Translational: Poster I
Session Date and Time: Saturday, December 6, 2025, 5:30 – 7:30 p.m. ET
Presenter: Alina He, B.S.
Title: A Protein S-Targeting Monoclonal Antibody, VGA039, Improves Both Primary and Secondary Hemostatic Activity of Von Willebrand Disease Patient Blood in an ex vivo Vascularized Hemostasis-on-a-Chip
Publication Number: 3051
Poster Session: 321. Coagulation and Fibrinolysis: Basic and Translational: Poster II
Session Date and Time: Sunday, December 7, 2025, 6:00 – 8:00 p.m. ET
Presenter: Yumiko Sakurai, M.S.
About VGA039
VGA039 is a monoclonal antibody therapy with a novel mechanism of action that targets Protein S, thereby restoring balance to the blood clotting process. VGA039 has potential to be a universal hemostatic therapy that can treat numerous bleeding disorders, starting with VWD. As a subcutaneously self-administered antibody therapy with a convenient once monthly dosing regimen, VGA039 has the potential to dramatically reduce treatment burden for patients. VGA039 has received Fast Track and orphan drug designations from the United States Food and Drug Administration (FDA).

Interim positive data from a Phase 1 single ascending dose study of VGA039 in patients with VWD were previously reported at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2024. A Phase 1/2 multidose study is ongoing (NCT05776069), with an interim readout planned for presentation at the 2025 ASH (Free ASH Whitepaper) Annual Meeting. VGA039 has advanced into a Phase 3 study (NCT07115004), a global single arm cross-over study designed to investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD. For additional information on our VIVID trials of VGA039, including how to enroll, please visit the website here.

About von Willebrand disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by absent or defective von Willebrand factor (VWF). VWD patients may experience excessive bleeding with variability in severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. More than 130,000 people in the U.S. are diagnosed with VWD.

(Press release, Star Therapeutics, NOV 3, 2025, View Source [SID1234659280])

On November 3, 2025 Sumitomo Pharma America, Inc. (SMPA) reported three oral presentations and one poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition taking place in Orlando, Florida, from December 6-9, 2025. The presentations will include new clinical data supporting enzomenib, an investigational, oral small molecule menin inhibitor being researched as a monotherapy and in combination with venetoclax and azacitidine (VEN/AZA) for relapsed or refractory acute leukemia, and nuvisertib, an oral investigational highly selective small molecule PIM1 kinase inhibitor being evaluated as a monotherapy and in combination with momelotinib (MMB) for the treatment of relapsed or refractory myelofibrosis (MF).

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Updated clinical data from the ongoing Phase 1/2 study of enzomenib continue to show promising clinical activity across a wide range of potentially therapeutic doses in patients with relapsed or refractory acute leukemia with KMT2A-rearranged (KMT2Ar), NPM1-mutated (NPM1m), and other HOXA9/MEIS1-driven leukemia subtypes. Enzomenib is designed to target the menin and mixed-lineage leukemia (MLL) protein interaction, a key interaction for acute leukemia and cell growth in a variety of cancers. In this dose-escalation study of enzomenib monotherapy, enzomenib was escalated from 40 mg twice a day (BID) to 400 mg BID with no dose-limiting toxicities (DLTs) in 116 patients with sustained complete remission (CR) and complete remission with partial hematologic recovery (CRh) seen at doses of 200, 300 and 400 mg BID. Given the wide therapeutic window of enzomenib, these findings suggest that dosing may be tailored to the specific biology of different leukemia subtypes for potential optimal therapeutic effect.

Additionally, preliminary findings from a Phase 1 study of enzomenib in combination with VEN/AZA in patients with relapsed or refractory AML with KMT2Ar or NPM1m subtypes show enzomenib with VEN/AZA to be well-tolerated to up to 300 mg BID with no DLTs and no evidence of significant drug-drug interaction between enzomenib and VEN. Promising early clinical activity, particularly in patients without prior VEN or menin exposure, was also observed.

New clinical data from the Phase 1/2 study evaluating the safety and efficacy of nuvisertib in combination with MMB demonstrate early clinical activity and show that the treatment combination was well-tolerated supporting further development in patients with MF. Lastly, findings from the ongoing Phase 1/2 study of nuvisertib continue to support that nuvisertib monotherapy was well-tolerated with no DLTs and notable modulation of cytokine profiles demonstrating a strong correlation with clinical responses.

"Patients living with relapsed/refractory AML or MF desperately need effective therapies to overcome the poor prognoses typically associated with these cancers. The clinical data are highly compelling, especially for patients with particularly challenging forms of acute leukemia including those with KMT2A-rearranged and NPM1-mutated subtypes," said Jatin Shah, M.D., Chief Medical Officer, Oncology, SMPA. "Based on this progress, we look forward to sharing more comprehensive data further supporting the development of enzomenib and nuvisertib at the upcoming meeting in December and remain committed to advancing both of these programs."

Abstract Title

Detail

Lead Author

Nuvisertib, an oral investigational selective PIM1 kinase inhibitor, showed clinical responses strongly correlating with cytokine modulation in patients with relapsed/refractory myelofibrosis in the ongoing global phase I/II study

Poster Presentation

Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I

Saturday, December 6.

5:30 – 7:30 p.m. EST

Presentation Time and Location: 5:30 p.m. EST

West Halls B3-B4 (Orange County Convention Center)

Lindsay A.M. Rein, M.D.

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

Oral Podium Presentation

Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Between a Rock and a Ropeg – Innovative Therapies for MPNs

Sunday, December 7.

9:30 – 11 a.m. EST

Presentation Time and Location: 9:45 a.m. EST

W414AB (Orange County Convention Center)

John Mascarenhas, M.D.

Monotherapy Update from Phase 1 Portion in Phase1/2 trial of the Menin-MLL Inhibitor Enzomenib (DSP-5336) in Patients with Relapsed or Refractory Acute Leukemia

Oral Podium Presentation

Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Menin inhibitors and FLT3 inhibitors in AML

Monday, December 8.

10:30 a.m. – noon EST

Presentation Time and Location: 10:30 a.m. EST

Chapin Theater (320) (Orange County Convention Center)

Naval G. Daver, M.D.

Preliminary data from the ongoing Phase 1 study of the menin-MLL inhibitor enzomenib

(DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory Acute

Myeloid Leukemia

Oral Podium Presentation

Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Menin inhibitors and FLT3 inhibitors in AML

Monday, December 8.

10:30 a.m. – noon EST

Presentation Time and Location: 11 a.m. EST

Chapin Theater (320) (Orange County Convention Center)

Justin M. Watts, M.D.

About Enzomenib
Enzomenib is an investigational, oral, small molecule inhibitor of the menin and mixed-lineage leukemia (MLL) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth. Menin is a scaffold nuclear protein which plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.1,2 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A (MLL) rearrangements or NPM1 mutations.1,3 Enzomenib reduced the expression of the leukemia-associated genes HOXA9 and MEIS1, and increased the expression of the differentiation gene CD11b in human acute leukemia cell lines with MLL rearrangements and NPM1 mutation.4,5 The safety and efficacy of enzomenib is currently being clinically evaluated in a Phase 1/2 dose escalation/dose expansion study in patients with relapsed or refractory acute leukemia (NCT04988555). The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022. The FDA granted Fast Track Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with MLLr or NPM1m in June 2024. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with MLLr or NPM1m in September 2024.

About Nuvisertib (TP-3654)
Nuvisertib (TP-3654) is an oral investigational selective inhibitor of PIM1 kinase, which has shown potential antitumor and antifibrotic activity through multiple pathways, including induction of apoptosis in preclinical models.6,7 Nuvisertib was observed to inhibit proliferation and increase apoptosis in murine and human hematopoietic cells expressing the clinically relevant JAK2 V617F mutation.7 Nuvisertib alone and in combination with ruxolitinib showed white blood cell and neutrophil count normalization, and also reduced spleen size and bone marrow fibrosis in JAK2 V617F and MPLW515L murine models of myelofibrosis.6 The safety and efficacy of nuvisertib is currently being clinically evaluated in a Phase 1/2 study in patients with intermediate and high-risk myelofibrosis (NCT04176198). The FDA granted Orphan Drug Designation to nuvisertib for the indication of myelofibrosis in May 2022. The Japan Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation to nuvisertib for the treatment of myelofibrosis in November 2024. The FDA granted Fast Track Designation to nuvisertib for the indication of myelofibrosis in June 2025, and the European Medicines Agency granted Orphan Drug Designation to nuvisertib for the treatment of myelofibrosis in July 2025.

(Press release, Sumitomo Pharmaceuticals, NOV 3, 2025, View Source [SID1234659298])