On November 4, 2026 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with Ryvu Therapeutics (WSE: RVU), reported that the first clinical data from the ongoing Phase II JASPIS-01 study (NCT06534437) of dapolsertib (MEN1703, SEL24) in patients with r/r aggressive B-NHL will be presented in a poster session at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, held December 12-15, 2026, in New Orleans, Louisiana, and virtually.

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Dapolsertib is a first-in-class oral dual PIM/FLT3 kinase inhibitor that has demonstrated preclinical antitumor activity and synergy with anti-CD20-directed therapies. The abstract reports the first clinical results from Group 2 of the JASPIS-01 study, which evaluates dapolsertib monotherapy (125 mg orally once daily on days 1-14 of 21-day cycles) in adults with r/r aggressive B-NHL who have exhausted available standard treatment options following at least two prior systemic therapies. Clinical activity was observed in heavily pretreated patients. The safety profile was manageable and allowed dosing of dapolsertib at the intended dose level.

"Patients with aggressive B-cell lymphoma whose disease progresses after CAR-T cell therapy and bispecific antibodies have limited treatment options and face very poor outcomes," said Elcin Barker Ergun, CEO of the Menarini Group. "The encouraging initial findings in heavily pretreated patients support the continued clinical development of dapolsertib, a first-in-class oral dual PIM/FLT3 inhibitor, as a potential option for this grim disease, and we look forward to further results from the ongoing study."

"We are very pleased that the first clinical data from JASPIS-01 will be presented at ASH (Free ASH Whitepaper), a leading hematology meeting. The activity seen in the JASPIS-01 study are particularly encouraging, given the highly aggressive biology of the disease in this population," said Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics. "As dapolsertib inventors and Menarini’s operational partner for the study, we remain committed to advancing dapolsertib for patients with aggressive B-cell lymphoma, who urgently need new treatment options."

Details on the poster presentation are as follows:
Poster Title: Preliminary clinical activity and safety of dapolsertib (MEN1703), a first-in-class dual PIM/FLT3 inhibitor, in heavily pretreated relapsed/refractory aggressive B-cell non-Hodgkin lymphoma: Initial results from the Phase II JASPIS-01 trial
Publication Number: 3662
Session: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II
Session date and time: Sunday, December 13, 2026, 6:00-8:00 PM CST (1:00-3:00 AM CET on December 14)
Location: Ernest N. Morial Convention Center, Hall F, New Orleans, Louisiana

The abstract is available on the ASH (Free ASH Whitepaper) website: View Source

About JASPIS-01
JASPIS-01 (NCT06534437) is an ongoing multicenter, open-label Phase II study evaluating dapolsertib as monotherapy and in combination with glofitamab in adults with r/r aggressive B-NHL, including diffuse large B-cell lymphoma (DLBCL), after at least two prior systemic therapies. Group 1 evaluates dapolsertib in combination with glofitamab in patients naïve to CD3×CD20 bispecific antibodies. Group 2 evaluates dapolsertib as monotherapy in patients who have exhausted available standard treatment options. The primary endpoint is overall response rate (ORR) per the Lugano Classification; secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety.

About dapolsertib
Dapolsertib (MEN1703, SEL24) is a first-in-class, oral, selective small-molecule dual inhibitor of PIM and FLT3 kinases, discovered by Ryvu. Global development and commercial rights to dapolsertib are licensed to the Menarini Group. Since September 2023, Ryvu has been Menarini’s operational partner for Phase II study execution, with Menarini funding all research and development costs. Dapolsertib is an investigational agent and has not been approved by any regulatory authority.

(Press release, Menarini, NOV 4, 2026, View Source [SID1234674220])

On November 4, 2026 ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported upcoming presentations describing the IND-enabling activities and therapeutic potential for IMGS-203, the company’s novel Stimulator of Interferon Genes (STING) Agonist, for the treatment of recurrent glioblastoma (GBM). These data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting taking place from November 4-8, 2026, at the Phoenix Convention Center in Phoenix, AZ.

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Poster Presentation Details:

Presentation Title:

IND-enabling nonclinical development of IMGS-203, a novel STING agonist, supports first-in-human translation in glioblastoma

Abstract No.:

839

Presenter:

Akash Boda, PhD, ImmunoGenesis

Presentation Date:

Friday, November 6, 2026

Presentation Time:

12:15 – 1:45 PM MT

Location:

PCC-North Building – Lower Level Exhibition Halls 4-5-6

Oral Presentation Details:

Presentation Title:

IND-enabling nonclinical development of IMGS-203, a novel STING agonist, supports first-in-human translation in glioblastoma

Abstract No.:

839

Presenter:

Akash Boda, PhD, ImmunoGenesis

Presentation Date:

Saturday, November 7, 2026

Presentation Time:

12:53 – 1:01 PM MT

Session:

204b: Rapid Oral – Clinical 2

Location:

PCC-West Building – 300 Level – 301BC

About IMGS-203
IMGS-203 is a novel STING agonist being developed by ImmunoGenesis as a cancer immunotherapy designed to stimulate antitumor immune responses. ImmunoGenesis plans to initially advance IMGS-203 into clinical development for recurrent glioblastoma (GBM), an aggressive and difficult-to-treat brain cancer with limited therapeutic options and significant unmet medical need.

(Press release, ImmunoGenesis, NOV 4, 2026, View Source [SID1234674219])

On November 4, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported financial results for the third quarter ended September 30, 2026, and provided a business update.

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"Just over one year after launch, IBTROZI was established as the market leader in advanced ROS1+ NSCLC, for both new patient starts and active patients across all lines of therapy combined, based on IQVIA claims data," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Our rapid rise to market leadership reflects growing provider confidence in IBTROZI’s durability of more than four years in TKI-naïve patients and a generally favorable safety profile that helps patients stay on therapy. With our recent sNDA approval, the label now reflects IBTROZI’s 49.7-month median duration of response in TRUST-I, giving physicians clear data to guide treatment decisions and supporting its use early in a patient’s care."

Dr. Hung continued, "The FDA’s recent Fast Track Designation for safusidenib underscores both the significant unmet need in IDH1-mutant glioma and the potential of this investigational medicine to address it. We are moving quickly to advance our comprehensive development program, with two Phase 2 and two pivotal Phase 3 studies spanning multiple IDH1-mutant glioma subpopulations, designed to reach a broad spectrum of patients with this disease."

Third Quarter 2026 and Recent Highlights:

IBTROZI (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC

In the third quarter of 2026, Nuvation Bio reported $27.5 million in net product revenue for IBTROZI, an 18% quarter-over-quarter growth that reflects the continued adoption and durability of treatment.
New patient starts in Q3 remained consistent with the prior quarter at approximately 160 patients, despite an approximately 15% quarter-over-quarter decline in new patient starts across the overall ROS1-positive non-small cell lung cancer (ROS1+ NSCLC) tyrosine kinase inhibitor (TKI) market, based on IQVIA claims data. Of these starts, 65% were TKI-naïve, demonstrating that IBTROZI is becoming standard of care in the first-line treatment setting. The remaining starts, in TKI-pretreated patients, show that physicians also continue to prescribe IBTROZI in later lines.
In September 2026, Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for IBTROZI, four months ahead of the January 4, 2027, target action date. The updated label reflects a median duration of response (mDOR) of 49.7 months in TKI-naïve patients, based on a median patient follow-up of 51 months from the pivotal TRUST-I study. No changes were made to the safety sections of the label.
In September 2026, Nuvation Bio announced new subgroup analyses from the pivotal TRUST-I and TRUST-II studies, presented at the IASLC 2026 World Conference on Lung Cancer (WCLC), showing consistent efficacy across key patient subgroups.
In October 2026, Nuvation Bio presented updated TRUST-II efficacy and safety data for IBTROZI in patients previously treated with entrectinib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain.
Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma

In August 2026, Nuvation Bio announced that the FDA granted Fast Track Designation to safusidenib for the treatment of IDH1-mutant glioma. The designation was supported by favorable data from the safusidenib clinical program, including updated long-term results from the Phase 2 J201 study, and provides for more frequent interactions with the FDA throughout development.
In July 2026, Nuvation Bio announced updated long-term data and new clinical studies for safusidenib:
Updated Phase 2 J201 data in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma showed a centrally assessed ORR of 51.9% at a median follow-up of 38.8 months. Median progression-free survival (PFS) was not reached; the 36-month PFS rate was 79.1%. No new safety signals were identified.
Initiation of a pivotal Phase 3 study (G307) in patients with grade 2 IDH1-mutant glioma outside the U.S.
Initiation of a Phase 2 study (G209) in patients with IDH1-mutant glioma that has progressed after prior treatment with vorasidenib in the U.S.
In October 2026, Nuvation Bio announced expansion of the pivotal Phase 3 SIGMA study of investigational safusidenib to include study sites in the United Kingdom, France, Sweden, Germany, Italy and Spain. These additional countries extend SIGMA’s global footprint beyond the U.S., Australia, China, Canada and Japan, where the study is currently enrolling or will soon begin enrolling.
In November 2026, Nuvation Bio announced four posters to be presented at the 2026 Society for Neuro-Oncology Annual Meeting taking place November 12–15, 2026, in Philadelphia, PA, including additional updated data from the Phase 2 J201 study beyond the topline results shared in July 2026.
Drug-drug conjugate (DDC) platform: Solid tumors

Nuvation Bio continues to explore new preclinical candidates for this novel modality and aims to provide further updates by year-end 2026.
Corporate Update:

In July 2026, Nuvation Bio announced the full exercise of the greenshoe option in its offering of 0.75% Convertible Senior Notes due 2032. The underwriters purchased an additional $37.5 million aggregate principal amount of notes, bringing the aggregate principal amount sold in the offering to $287.5 million, with net proceeds of approximately $279.1 million after deducting underwriting discounts and commissions and offering expenses.
Third Quarter 2026 Financial Results
As of September 30, 2026, Nuvation Bio had cash, cash equivalents, and marketable securities of $663.4 million, which includes an additional $36.5 million in net proceeds secured in July 2026 from exercise of the convertible senior notes overallotment option.

Product Revenue, Net
To date, Nuvation Bio’s product revenue comes exclusively from U.S. sales of IBTROZI, which Nuvation Bio began distributing to its U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $27.5 million for the three months ended September 30, 2026.

Collaboration and License Agreements Revenue
For the three months ended September 30, 2026, collaboration and license agreements revenue was $17.5 million, compared to $5.4 million for the three months ended September 30, 2025. The increase is due to a $7.6 million increase in product supply revenue, a $5.0 million sales milestone received from Innovent, and a $2.4 million increase in royalty revenue, offset by a $2.9 million decrease in research and development service revenue under the collaboration agreements with Innovent and Nippon Kayaku.

Taletrectinib was included in China’s National Reimbursement Drug List effective January 1, 2026. Royalty revenue for the quarter from collaboration agreements for China and Japan was $2.7 million.

Research and Development Expenses
For the three months ended September 30, 2026, research and development expenses were $32.7 million, compared to $28.8 million for the three months ended September 30, 2025. The increase was primarily due to a $3.3 million increase in third-party costs related to clinical trial expense and a $0.5 million increase in personnel costs driven by the increase in headcount and stock-based compensation.

Selling, General and Administrative Expenses
For the three months ended September 30, 2026, selling, general and administrative expenses were $42.6 million, compared to $37.4 million for the three months ended September 30, 2025. The increase was due to a $2.5 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, a $1.8 million increase in sales and marketing expenses and a $1.6 million increase in miscellaneous expense, offset by a $0.7 million decrease in legal fees.

Net Loss
For the three months ended September 30, 2026, Nuvation Bio reported a net loss of $41.9 million, or $(0.12) per share on a basic and diluted basis. The net loss for the comparable period in 2025 was $55.8 million, or $(0.16) per share on a basic and diluted basis.

Conference Call and Webcast
Nuvation Bio will host a conference call and webcast today, November 4, 2026, at 4:30 p.m. ET to discuss its financial results for the third quarter of 2026 and provide business updates.

Investors and the general public are invited to listen to the live webcast and may register on the Investor Relations section of the Nuvation Bio website. To access the live conference call, participants can dial +1 833-461-5787 (U.S. toll-free) and enter access code 480 013 916. An archived recording will be available on Nuvation Bio’s website for 90 days following the event.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. In June 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.
Please see accompanying full Prescribing Information.

About IDH1-mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high-grade tumors.

About Safusidenib
Safusidenib is an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. In Phase 1 and Phase 2 clinical studies, safusidenib demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile. These early findings support further investigation of safusidenib in the currently enrolling Phase 3 SIGMA study, as well as in the Phase 3 G307 study in regions where vorasidenib is not yet approved or accessible and the Phase 2 G209 study in patients whose cancer has progressed on vorasidenib.

In August 2026, the FDA granted Fast Track Designation to safusidenib for the treatment of IDH1-mutant glioma.

About the SIGMA (G203) Study
SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients.

A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients.

(Press release, Nuvation Bio, NOV 4, 2026, View Source [SID1234674218])

On November 4, 2026 Akeso, Inc. (HKEX: 9926.HK) reported that ivonescimab in combination with chemotherapy for the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC) has been granted Priority Review by China’s National Medical Products Administration (NMPA). The Priority Review designation is expected to accelerate the subsequent regulatory review process for this indication in China.

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In the randomized, double-blind, multicenter Phase III registrational study HARMONi-GI1 (AK112-309), ivonescimab plus chemotherapy demonstrated superior survival benefit for patients versus durvalumab plus chemotherapy, the current global standard for the first-line treatment of BTC. In a prespecified interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), HARMONi-GI1 met its primary endpoint of overall survival (OS), with the ivonescimab plus chemotherapy arm demonstrating statistically significant and clinically meaningful improvement over the control arm. The trial also met all key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR).

The HARMONi-GI1 results were presented as a Late-Breaking Abstract in an oral presentation at the ESMO (Free ESMO Whitepaper) Presidential Symposium in October 2026. HARMONi-GI1 is the first Phase III trial in BTC to show statistically significant overall survival benefit against the established PD-L1 inhibitor plus chemotherapy standard of care.

On October 21, 2026, Summit announced a clinical trial collaboration with ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate the safety and efficacy of ivonescimab with chemotherapy compared to pembrolizumab or durvalumab plus chemotherapy in a registration-enabling Phase II/III study (EA2251), in the first-line treatment of patients with advanced BTC.

About Ivonescimab

Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody independently developed by Akeso. It is the world’s first approved bispecific antibody that combines immuno-oncology and anti-angiogenesis mechanisms in a single molecule, helping to define a new generation of bispecific immuno-oncology therapies. Ivonescimab is also the first therapy to demonstrate positive results in a Phase III head-to-head study against pembrolizumab.

Building on its strong clinical profile in the IO2.0 landscape, Akeso is advancing a comprehensive global development program for ivonescimab across multiple tumor types and treatment settings. As a cornerstone of the Company’s IO2.0 + ADC2.0 strategy, ivonescimab aims to help reshape standards of care in major cancers worldwide.

More than 17 Phase III studies of ivonescimab are underway globally, including seven international multi-regional registrational Phase III trials and seven head-to-head studies versus PD-1/PD-L1 therapies. These programs encompass eight registrational or Phase III studies in lung cancer, as well as trials in first-line MSS/pMMR colorectal cancer, first-line PD-L1-positive head and neck squamous cell carcinoma (in combination with ligufalimab versus pembrolizumab), first-line biliary tract cancer (versus pembrolizumab/ durvalumab-based regimen), first-line triple-negative breast cancer, first-line pancreatic cancer, and first-line urothelial carcinoma (versus pembrolizumab plus a Nectin-4 ADC).

Akeso has out-licensed the exclusive rights to develop and commercialize ivonescimab in the United States and Canada, South America, Europe, the Middle East, Africa, and Japan to Summit Therapeutics under an agreement with a total potential value of up to US$5 billion.

(Press release, Akeso Biopharma, NOV 4, 2026, View Source [SID1234674217])

On November 4, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported the acceptance of multiple Revuforj (revumenib) and Niktimvo (axatilimab-csfr) abstracts for presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place in New Orleans, Louisiana, from December 12-15, 2026. A total of nineteen abstracts were accepted, including seven revumenib abstracts accepted for oral presentation.

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"The breadth of data accepted for presentation at ASH (Free ASH Whitepaper) highlights our scientific leadership in menin and CSF-1R inhibition and deep commitment to advancing the standard of care for menin-dependent acute leukemias and chronic GVHD," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "Across fourteen revumenib abstracts, including seven oral presentations, we will highlight the growing body of clinical trial and real-world data showing compelling revumenib activity spanning the acute leukemia treatment continuum and multiple genetic subtypes."

Dr. Botwood continued, "We particularly look forward to the presentation of updated frontline data from the BEAT AML, SAVE, and 708 trials showing high rates of remission, MRD negativity, and encouraging survival among patients treated with revumenib in combination with standard of care therapies. These results bolster our confidence that the ongoing pivotal frontline trials of revumenib-based combinations could transform outcomes for newly diagnosed NPM1m or KMT2Ar AML."

The Company will host an in-person investor event, along with a live webcast, at the ASH (Free ASH Whitepaper) Annual Meeting on Monday, December 14, 2026, from 7:00–8:30 a.m. CT / 8:00–9:30 a.m. ET to discuss key data presented at the meeting. The live webcast will be available on the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

Key abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2026:

Revumenib:

BEAT AML (oral presentation): Updated results from a Phase 1b trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed patients with NPM1-mutated (NPM1m) or KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML)
SAVE (oral presentation): Updated results from the newly diagnosed cohort in a Phase 1/2 trial of the all-oral combination of revumenib, venetoclax, and decitabine/cedazuridine in patients with NPM1m, KMT2Ar, or NUP98-rearranged (NUP98r) AML
SNDX-5613-0708 (poster presentation): Updated results from a Phase 1 trial of revumenib in combination with intensive chemotherapy in newly diagnosed patients with NPM1m, KMT2Ar, or NUP98r AML
Pre- and post-transplant data (oral presentation): Characterization of disease response and outcomes among relapsed or refractory (R/R) KMT2Ar, NPM1m, and NUP98r patients in the pivotal Phase 1/2 trial of revumenib who proceeded to a stem cell transplant after receiving revumenib
Post-transplant maintenance data (oral presentation): First results from a Phase 1 multicenter trial evaluating revumenib as maintenance following stem cell transplantation in patients with KMT2Ar or NPM1m acute leukemia
INTERCEPT (oral presentation): Updated results from a Phase 1 trial evaluating revumenib as pre-emptive therapy for measurable residual disease (MRD) or early relapse among patients with NPM1m or KMT2Ar AML
Real-world evidence (two poster presentations): Real-world outcomes from multiple centers using revumenib as monotherapy or in combination therapy for patients with KMT2Ar, NPM1m, or NUP98r acute leukemias
Axatilimab:

AGAVE-201 (poster presentation): Updated long-term efficacy, safety, and duration of therapy observed in the pivotal Phase 2 trial of axatilimab in recurrent or refractory chronic graft-versus-host disease (GVHD)
The accepted abstracts listed below will be available on the ASH (Free ASH Whitepaper) conference website. Copies of the oral and poster presentations will be made available through the ‘Pipeline — Publications & Meetings Presentations’ section of the Syndax website after the relevant embargoes lift.

Full list of abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2026 (all times in CT):

Revumenib

Abstract Titles Presentation Details
Frontline combinations
Azacitidine, venetoclax, and revumenib in newly diagnosed NPM1-mutated (NPM1m) or KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML): final analysis of Beat AML phase 1b study Oral Presentation
Publication Number: 662
Sunday, December 13th
Session Time: 4:30–6:00 PM
Update on the phase II study of the all-oral combination of revumenib (SNDX-5613) with decitabine/cedazuridine (ASTX727) and venetoclax (SAVE) in newly diagnosed AML Oral Presentation
Publication Number: 904
Monday, December 14th
Session Time: 2:45–4:15 PM
Revumenib + intensive chemotherapy for newly diagnosed acute myeloid leukemia harboring genetic alterations in NPM1, KMT2A, or NUP98: updated phase 1/2 and pharmacokinetic results from SNDX-5613-0708 Poster Presentation
Publication Number: 3406
Sunday, December 13th
Session Time: 6:00–8:00 PM
Pre- and post-transplant data
Revumenib monotherapy enables patients with relapsed/refractory acute leukemia to proceed to hematopoietic stem cell transplant Oral Presentation
Publication Number: 905
Monday, December 14th
Session Time: 2:45–4:15 PM
A multicenter phase 1 trial of revumenib as post-transplant maintenance after allogeneic stem cell transplant in patients with KMT2A-rearranged or NPM1-mutated acute leukemia Oral Presentation
Publication Number: 715
Sunday, December 13th
Session Time: 4:30–6:00 PM
MRD relapse
Revumenib as pre-emptive therapy for measurable residual disease in NPM1 mutated or KMT2A rearranged AML: the ALLG AMLM26 INTERCEPT platform trial Oral Presentation
Publication Number: 388
Saturday, December 12th
Session Time: 4:00–5:30 PM
Real-world evidence
Revumenib in real-world practice for relapsed/refractory acute leukemia: second interim findings from the multicenter ROAR study Poster Presentation
Publication Number: 3403
Sunday, December 13th
Session Time: 6:00–8:00 PM
Real-world outcomes with revumenib across diverse molecular subtypes and treatment settings in acute myeloid leukemia: a single-center experience Poster Presentation
Publication Number: 3424
Sunday, December 13th
Session Time: 6:00–8:00 PM
Relapsed/refractory
Clinical activity of revumenib in relapsed/refractory therapy-related KMT2A-rearranged acute myeloid leukemia Poster Presentation
Publication Number: 1669
Saturday, December 12th
Session Time: 5:30–7:30 PM
Impact of revumenib on transfusion dependence in patients with relapsed/refractory NPM1-mutated acute myeloid leukemia Poster Presentation
Publication Number: 5170
Monday, December 14th
Session Time: 6:00–8:00 PM
Clinical pharmacology
Exposure-response analysis and quantitative systems pharmacology modeling for recommended phase 3 dose selection of revumenib in newly diagnosed AML Poster Presentation
Publication Number: 3408
Sunday, December 13th
Session Time: 6:00–8:00 PM
Pipeline programs & preclinical data
Phase Ib/II study of revumenib as monotherapy or in combination with JAK inhibitors in patients with myelofibrosis Poster Presentation
Publication Number: 5557
Monday, December 14th
Session Time: 6:00–8:00 PM
Differential drug responses to menin inhibitors in KMT2A-rearranged ALL and AML Oral Presentation
Publication Number: 47
Saturday, December 12th
Session Time: 9:30–11:00 AM
Beyond MEN1: mutations in KMT2A and LEDGF drive cross-resistance to menin inhibitors in preclinical models Oral Presentation
Publication Number: 760
Monday, December 14th
Session Time: 10:30 AM–12:00 PM

Axatilimab

Abstract Titles Presentation Details
Long-term efficacy and safety of axatilimab among patients with chronic graft-versus-host disease in AGAVE-201 Poster Presentation
Publication Number: 5995
Monday, December 14th
Session Time: 6:00–8:00 PM
Axatilimab demonstrated clinical benefit without baseline corticosteroid use in patients with chronic graft-versus-host-disease: a subgroup analysis of the AGAVE-201 study Poster Presentation
Publication Number: 2478
Saturday, December 12th
Session Time: 5:30–7:30 PM
Immune reprogramming with axatilimab: CSF-1R–dependent myeloid modulation and reduced CD4⁺ T-cell activation in chronic graft-versus-host disease Poster Presentation
Publication Number: 6012
Monday, December 14th
Session Time: 6:00–8:00 PM
Molecular signatures associated with clinical improvement in patients with chronic graft-versus-host disease receiving axatilimab: a correlation analysis from AGAVE-201 Poster Presentation
Publication Number: 4252
Sunday, December 13th
Session Time: 6:00–8:00 PM
Assessments of bone mineral density in patients with chronic graft-versus-host disease treated with axatilimab in AGAVE-201 Online publication only

About Revuforj (revumenib)

Revuforj (revumenib) is the first and only menin inhibitor that is FDA approved for the treatment of adult and pediatric patients one year and older with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options or R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test.

Multiple trials of revumenib are underway across the acute leukemia treatment continuum, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

About Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway.

Revuforj (revumenib)

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES

Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

QTc prolongation and Torsades de Pointes have occurred in patients receiving Revuforj. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate Revuforj in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension.

In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.

QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes.

Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation. QTc prolongation occurred in 21% of the 34 patients less than 17 years old, 35% of the 146 patients 17 years to less than 65 years old, and 46% of the 61 patients 65 years or older. One patient had a fatal outcome of cardiac arrest, and one patient had non-sustained Torsades de Pointes.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and throughout treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.

Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower-dose level after the QTcF interval returns to ≤480 msec
Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia
Embryo-Fetal Toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 9 (4%) patients who received Revuforj, including 4 with sudden death, 2 with differentiation syndrome, 2 with hemorrhage, and 1 with cardiac arrest.

Serious adverse reactions were reported in 184 (76%) patients. The most frequent serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).

The most common adverse reactions (≥20%) including laboratory abnormalities, were phosphate increased (51%), hemorrhage (48%), nausea (48%), infection without identified pathogen (46%), aspartate aminotransferase increased (44%), alanine aminotransferase increased (40%), creatinine increased (38%), musculoskeletal pain (37%), febrile neutropenia (37%), electrocardiogram QT prolonged (36%), potassium decreased (34%), parathyroid hormone intact increased (34%), alkaline phosphatase increased (33%), diarrhea (29%), bacterial infection (27%), triglycerides increased (27%), phosphate decreased (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).

DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

Strong CYP3A4 inhibitors: reduce Revuforj dose
Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj
QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec
SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.

Pregnancy and testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: no overall differences were observed in the effectiveness of Revuforj between patients who were 65 years and older, and younger patients. Compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.

To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including BOXED WARNINGS.

Niktimvo (axatilimab-csfr)

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Niktimvo (axatilimab-csfr) can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who received Niktimvo in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in 1.3%.

Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to Niktimvo. Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue Niktimvo based on severity of the reaction.

Embryo-Fetal Toxicity
Based on its mechanism of action, Niktimvo may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose.

ADVERSE REACTIONS
Serious adverse reactions occurred in 44% of patients who received Niktimvo (N=79). Serious adverse reactions in >2 patients included infection (pathogen unspecified) (14%), viral infection (14%) and respiratory failure (5.1%). Permanent discontinuation of Niktimvo due to an adverse reaction occurred in 10% of patients and dose reduction due to adverse reaction occurred in 8% of patients. Dose interruptions due to an adverse reaction occurred in 44% of patients. The adverse reactions leading to dose interruption in >2 patients were viral infection, infection (pathogen unspecified), bacterial infection, musculoskeletal pain, and pyrexia.

The most common (≥15%) adverse reactions, including laboratory abnormalities, were increased aspartate aminotransferase (AST), infection (pathogen unspecified), increased alanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

Clinically relevant adverse reactions in <10% of patients who received Niktimvo included:

Eye disorders: periorbital edema
Skin and subcutaneous skin disorders: pruritus
Vascular disorders: hypertension
Immunogenicity: Anti-Drug Antibody–Associated Adverse Reactions
Across treatment arms in patients with cGVHD who received Niktimvo in clinical trials, among the patients who developed anti-drug antibodies (ADAs), hypersensitivity reactions occurred in 26% (13/50) of patients with neutralizing antibodies (NAb) and in 4% (2/45) of those without NAb.

USE IN SPECIFIC POPULATIONS
Lactation
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of Niktimvo.

Females and Males of Reproductive Potential
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating Niktimvo.

Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose of Niktimvo.

DOSAGE AND ADMINISTRATION
Dosage Modifications for Adverse Reactions
Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of Niktimvo therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved. See Table 1 in the Prescribing Information for more recommendations.

Please see the full Prescribing Information for Niktimvo.

(Press release, Syndax, NOV 4, 2026, View Source [SID1234674216])