Nuvation Bio to Present New Subgroup Analyses of Pivotal Data for IBTROZI® (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at WCLC and ESMO Annual Congresses

On August 4, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that new analyses of long-term Phase 2 TRUST-I and TRUST-II data will be presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) taking place September 12–15, 2026, in Seoul, South Korea, and at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) October 23–27, 2026, in Madrid, Spain. These findings from the pivotal Phase 2 studies will feature the efficacy and safety of IBTROZI (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) across key patient subgroups.

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"Every patient has a unique treatment journey, and physicians need confidence that a therapy can deliver consistent, long-term benefit across a broad range of patients," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "At WCLC and ESMO (Free ESMO Whitepaper), we look forward to presenting subgroup analyses of our pivotal data, including for patients previously treated with earlier-generation ROS1 inhibitors, that will further underscore the durable clinical benefits of IBTROZI demonstrated in our long-term data and reinforce its potential as a standard of care across all lines of advanced ROS1-positive NSCLC."

Presentations Overview:

WCLC

Title: Taletrectinib Across Key Subgroups in Patients With ROS1+ Non-Small Cell Lung Cancer: Results From TRUST-I and TRUST-II

Presenter: Hidetoshi Hayashi, Kindai University Faculty of Medicine, Osaka, Japan

Date: Tuesday, September 15, 2026

Session Time: 9:30-11:00 a.m. KST

ESMO

Title: Updated Efficacy and Safety of Taletrectinib in Patients with Advanced ROS1+ Non-Small Cell Lung Cancer (NSCLC) After Prior Entrectinib Exposure: Results from the Global TRUST-II Study

Presenter: Maurice Pérol, Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France

Date: Monday, October 26, 2026

Session Time: 12:00-12:45 p.m. CEST

The materials will be made available in the Publications section of Nuvation Bio’s website after the presentations. To meet representatives from Nuvation Bio, visit Booth #115 at WCLC and Booth #1080 at ESMO (Free ESMO Whitepaper).

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. On June 11, 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.

U.S. 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.

(Press release, Nuvation Bio, AUG 4, 2026, View Source [SID1234669673])

Tyra Biosciences Reports Second Quarter 2026 Financial Results and Recent Highlights

On August 4, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the second quarter ended June 30, 2026, and highlighted recent corporate progress.

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"September marks an important milestone for TYRA as we prepare to share initial clinical data from SURF302 evaluating oral dabogratinib in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). Patients with IR NMIBC often endure a lifelong cycle of recurrent disease, repeated surgical procedures, catheterization, and ongoing surveillance, highlighting the need for more convenient and effective treatment options. We believe dabogratinib has the potential to redefine the treatment paradigm as the first targeted oral therapy for FGFR3-driven IR NMIBC, addressing the underlying biology of the disease while offering the convenience of an oral therapy," said Todd Harris, PhD, President and Chief Executive Officer of TYRA.

Dr. Harris continued, "Beyond SURF302, we continue to advance our broader pipeline, including progressing BEACH301 to a fifth dose level in achondroplasia, and strengthening our skeletal dysplasia leadership with the addition of Jonathan Day, whose work was instrumental in the development of vosoritide. Across our portfolio, we remain focused on realizing the full potential of oral dabogratinib for patients with FGFR3-driven conditions and diseases."

"Over the past decade, I’ve had the privilege of helping advance therapies that have transformed the treatment landscape for children with achondroplasia. I believe there is still meaningful opportunity to further improve outcomes, and TYRA’s highly selective approach to FGFR3 inhibition offers a compelling opportunity to do just that," commented Dr. Day, TYRA’s newly appointed Executive Vice President, Clinical Development. "I’m excited to join the team and help advance dabogratinib as we work to develop a differentiated oral therapy for children with achondroplasia and their families."

Second Quarter and Recent Corporate Highlights

Dabogratinib 3×3 Strategy

In the second quarter of 2026, TYRA continued to advance its "dabogratinib 3×3" strategy: developing the first orally available, FGFR3-selective inhibitor in 3 future potentially pivotal clinical studies to support regulatory submissions with the aim to commercialize in 3 potential blockbuster indications: LG-UTUC, IR NMIBC and ACH.

Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses (60 mg and 80 mg) in participants with low-grade upper tract urothelial carcinoma (LG-UTUC), a rare cancer where approximately 85% of tumors are driven by FGFR3. Initial results from this study are expected in 2027.
Phase 2 IR NMIBC Study – SURF302. SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses (50 mg and 60 mg) in participants with FGFR3-altered low-grade IR NMIBC. The Company will host a conference call and webcast in September 2026 to report initial results from the SURF302 study, including safety results from more than 40 patients and efficacy from more than 20 patients in the aggregate at both QD dose levels.
Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with achondroplasia (ACH). The study has enrolled the safety sentinel cohort and successfully cleared four dose levels, with no notable safety events reported to date. Given the favorable safety profile seen to date across dose levels 1 through 4 in BEACH301, the Data Safety Monitoring Committee authorized the opening of a fifth dose level to evaluate 0.625 mg/kg in the safety sentinel cohort. Initial results from the safety sentinel cohort, including 6-month annualized height velocity and safety data for dose levels 1-5, which will include an aggregate of approximately 25 children, are expected to be reported at the end of Q1 2027.
Corporate

Appointed Jonathan Day as EVP, Clinical Development for Skeletal Dysplasia Conditions. In June 2026, TYRA appointed Jonathan Day, MBBS, PhD, FFPM, FESC, as Executive Vice President, Clinical Development, where he will lead the Company’s development program and clinical strategy for oral dabogratinib in skeletal dysplasia conditions. Dr. Day is a physician-scientist and pharmaceutical executive with extensive experience leading late-stage clinical development programs in rare diseases. At BioMarin Pharmaceutical, he served as Head of R&D for the Skeletal Conditions Business Unit (previously Group Vice President, Late-Stage Clinical Development), where he led the global clinical development strategy for the company’s skeletal dysplasia portfolio, including vosoritide (Voxzogo) for achondroplasia. Before joining BioMarin, Dr. Day was Vice President and Global Medical Lead for Acute Cardiovascular Care at The Medicines Company, and earlier served as Medical Director for the UK & Ireland at AstraZeneca. Prior to industry, he trained in cardiothoracic surgery and completed a PhD at Imperial College London focused on thrombin inhibition and cardiovascular medicine. He is also a Fellow of the European Society of Cardiology and the Faculty of Pharmaceutical Medicine.
Amended ATM Sales Agreement. In August 2026, TYRA entered into an amended sales agreement with TD Securities (USA) LLC, under which TYRA may sell up to the amount registered on an effective registration statement under which the offering is made, subject to other limitations. Pursuant to the amended sales agreement, as of the date hereof, TYRA may sell an additional $250.0 million of shares of its common stock from time to time in "at-the-market" offerings.
SNÅP Platform and Pipeline

TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.
Second Quarter Financial Results

Cash, Cash Equivalents and Marketable Securities. As of June 30, 2026, TYRA had cash, cash equivalents and marketable securities of $353.9 million. The Company’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans into the second half of 2028.
Research and Development (R&D) Expenses. R&D expenses for the three months ended June 30, 2026 were $39.2 million compared to $24.3 million for the same period in 2025. The increase was primarily associated with development activities for oral dabogratinib, supporting the ongoing SURF303, SURF302 and BEACH301 clinical trials, partially offset by a decrease in development activities for other programs. There were also increases in personnel expenses, driven by headcount growth to support expanding clinical and development activities, and expenses for facilities and other costs.
General and Administrative (G&A) Expenses. G&A expenses for the three months ended June 30, 2026 were $9.8 million compared to $7.1 million for the same period in 2025. The increase was primarily driven by higher compensation and other personnel costs, driven by headcount growth.
Net Loss. Second quarter net loss was $45.6 million compared to $28.1 million for the same period in 2025.
Upcoming Anticipated Clinical Milestones:

SURF303: initial results – 2027
SURF302: initial results from both dose cohorts – September 2026
BEACH301: initial results from dose levels 1-5 of safety sentinel cohort – end of Q1 2027
About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3-selective inhibitor to enter clinical development, and it has been studied in more than 200 individuals to date across multiple clinical and healthy volunteer studies.

Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

Please visit the Patients page of our website for more information on our clinical trials.

(Press release, Tyra Biosciences, AUG 4, 2026, View Source [SID1234669672])

Faeth Therapeutics Reports Second Quarter 2026 Financial Results and Operational Updates

On August 4, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing PIKTOR, an investigational all-oral, multi-node inhibitor of the PI3K/AKT/mTOR pathway, reported financial results for the quarter ended June 30, 2026, and highlighted recent corporate accomplishments and 2026 milestones.

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"Our combination with Sensei Biotherapeutics marked an important milestone in the history of Faeth Therapeutics," said Anand Parikh, Chief Executive Officer. "With the concurrent $200 million PIPE financing, we now have the capital to interrogate the multi-nodal hypothesis in multiple cancers. We look forward to reading out topline data from our Phase 2 PIK-201 trial in endometrial cancer, which is expected by year-end."

Mr. Parikh continued, "We are also excited to have expanded development of PIKTOR into its second indication with the first patient dosed in our PIK-101 trial in HR+ breast cancer in April. We look forward to reporting initial safety and efficacy data from PIK-101 in 2027."

Recent Corporate Updates:

In April, the Company dosed the first patient in its Phase 1b/2 Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer
In June, stockholders approved the conversion of the Series B preferred stock issued in the February 2026 acquisition of Faeth Therapeutics and concurrent private placement into common stock
In June, the Company changed its name to Faeth Therapeutics, Inc. and began trading under the ticker symbol "FTH"
In June, Anand Parikh, Faeth co-founder, was appointed Chairman, President and Chief Executive Officer, and Brian Stephenson, Ph.D., CFA was appointed Chief Financial Officer. Additionally, the board was strengthened with the addition of former FDA Commissioner Stephen M. Hahn, M.D., and Saira Ramasastry.
Second Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $186.4 million as of June 30, 2026, as compared to $21.2 million as of December 31, 2025.
Research and Development Expenses (R&D): R&D expenses for the quarter ended June 30, 2026 were $9.2 million, compared to $2.5 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily driven by clinical trial and manufacturing (CMC) costs supporting the development of PIKTOR, together with higher personnel costs, partially offset by lower clinical trial costs for SNS-101.
General and Administrative Expenses (G&A): G&A expenses for the quarter ended June 30, 2026, were $9.2 million, compared to $2.7 million during the quarter ended June 30, 2025. The increase in G&A expense was primarily attributable to increased personnel costs and increased professional fees related to financing and reporting activities.
Net Loss: Net loss was $16.0 million, or $2.84 per basic and diluted share, for the quarter ended June 30, 2026, compared with a net loss of $4.9 million, or $3.91 per basic and diluted share, for the quarter ended June 30, 2025.

Weighted-average common shares outstanding, basic and diluted, were 5,643,222 for the quarter ended June 30, 2026, compared with 1,260,867 for the quarter ended June 30, 2025.

Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)

For the Three Months
Ended June 30,

2026

2025

Operating expenses:
Research and development
$

9,180

$

2,533

General and administrative

9,205

2,673

Total operating expenses

18,385

5,206

Loss from operations

(18,385

)

(5,206

)

Total other income

2,378

270

Net loss

(16,007

)

(4,936

)

Net loss per share, basic and diluted
$

(2.84

)

$

(3.91

)

Weighted-average common shares outstanding, basic and diluted

5,643,222

1,260,867

Selected Condensed Balance Sheet Data
(Unaudited, in thousands)

June 30,
2026 December 31,
2025
Cash and cash equivalents
$

26,903

$

8,668

Marketable securities

159,538

12,516

Total assets

189,306

22,902

Total liabilities

9,581

4,310

Series B redeemable convertible preferred stock

6,767

Total stockholders’ equity

172,958

18,592

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. According to published literature, this pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated in the second half of 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.

(Press release, Faeth Therapeutics, AUG 4, 2026, View Source [SID1234669671])

Syndax Reports Second Quarter 2026 Financial Results and Provides Business Update

On August 4, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported its financial results for the second quarter ended June 30, 2026, and provided a business update.

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"We delivered another quarter of strong commercial results, with both our medicines now annualizing at well over $200 million each and positioned for further growth," said Michael A. Metzger, Chief Executive Officer. "Notably, we achieved $55 million in Revuforj net revenue and the sixth consecutive quarter of double-digit net revenue and prescription growth, highlighting our leadership in menin inhibition, robust demand in both NPM1 and KMT2A, and an increasing average treatment duration. Niktimvo net revenue grew to $60 million this quarter, underscoring the benefits of its unique mechanism of action in cGVHD and the substantial commercial opportunity."

Mr. Metzger continued, "We’ve made excellent progress advancing our growing pipeline targeting multiple blockbuster opportunities, including two recently announced assets with first- and best-in-class potential in EGFR-mutated NSCLC and myelofibrosis. We are positioned to be first to frontline AML with Revuforj, driven by strong global site initiation and patient enrollment in our pivotal trials. We also have multiple near-term catalysts with Niktimvo Phase 2 data in IPF and frontline cGVHD expected in the fourth quarter, plus additional practice-informing and potentially guideline-enabling Revuforj data in acute leukemia."

Recent Business Highlights and Anticipated Milestones

Revuforj (revumenib)


Achieved $54.7 million in Revuforj net revenue in the second quarter of 2026, a 91% increase over the second quarter of 2025 and a 12% increase over the first quarter of 2026. Total prescriptions were approximately 1,500 in the second quarter of 2026, an approximate 121% increase over the second quarter of 2025 and a 15% increase over the first quarter of 2026. The net revenue and prescription growth reflects an increasing average treatment duration, primarily driven by a growing pool of patients receiving Revuforj for an extended period in the post-transplant setting.

Advanced the Company’s scientific leadership in menin inhibition with the presentation of 16 revumenib abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings in June 2026. The data presented span multiple acute leukemia subtypes and settings, including frontline and post-transplant maintenance.

Published data from the Phase 1/2 SAVE trial of an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in relapsed/refractory (R/R) NPM1-mutated (NPM1m), KMT2A-rearranged (KMT2Ar), and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML) in the Journal of Clinical Oncology in June 2026. The results showed deep and durable remissions in a heavily pretreated patient population. The ORR was 88% (37/42), CRc was 71% (30/42), and CR/CRh was 60% (25/42). 80% of evaluable CRc responders were measurable residual disease (MRD) negative. 45% (19/42) of patients proceeded to a transplant and 63% (12/19) resumed revumenib post-transplant.

Published preclinical revumenib data showing that menin is a novel dependency in proliferative megakaryocytes, major drivers of myelofibrosis (MF), in Cancer Cell in July 2026. These data provide the basis for the Company’s plans to develop SNDX-62122, an internally developed, next-generation menin inhibitor, for MF.

The Company expects to have a major presence at upcoming medical meetings in the second half of 2026 with the presentation of new/updated revumenib data including:

Real-world evidence from multiple centers

Post-transplant maintenance data


Frontline data from the BEAT AML trial of revumenib in combination with venetoclax/azacitidine in NPM1m and KMT2Ar AML

Frontline data from the Phase 1/2 SAVE trial of an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in NPM1m, KMT2Ar, or NUP98r AML

Frontline data from the Phase 1 trial of revumenib in combination with intensive chemotherapy in NPM1m, KMT2Ar, or NUP98r AML

Multiple clinical trials evaluating revumenib across the acute leukemia treatment continuum are ongoing, such as:

EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed NPM1m (primary efficacy analysis population) and KMT2Ar AML patients who are unfit for intensive chemotherapy. The trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.

REVEAL-ND: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed NPM1m AML patients.

SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with newly diagnosed and R/R AML or mixed-lineage acute leukemia harboring either NPM1m, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center.

Intensive chemotherapy: Two ongoing Phase 1 trials evaluating the combination of revumenib with intensive chemotherapy (7+3) in newly diagnosed NPM1m or KMT2Ar acute leukemia patients.

BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with NPM1m or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial.

Post-transplant maintenance: A Phase 1 trial evaluating the safety and preliminary efficacy of revumenib as post-transplant maintenance in patients with KMT2Ar or NPM1m acute leukemia. The trial is being conducted by investigators from the City of Hope Medical Center.

Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate MRD in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading U.S. cancer research centers.

INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial.

The Company expects the RAVEN trial to initiate in the second half of 2026. RAVEN is a Phase 2 collaborative trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed KMT2Ar patients who would be considered eligible, or fit, for intensive chemotherapy.

The Company expects the MenTain Phase 2 trial to initiate around the end of 2026. MenTain will be the first randomized, placebo-controlled trial specifically focused on evaluating revumenib as post-transplant maintenance.

The Company expects to publish safety and efficacy data from R/R NUP98r acute leukemia patients treated with revumenib in the fourth quarter of 2026.
Niktimvo (axatilimab-csfr)


Achieved $60.3 million in Niktimvo net revenue in the second quarter of 2026, a 67% increase over the second quarter of 2025 and a 9% increase over the first quarter of 2026. Syndax and Incyte are co-commercializing Niktimvo. Syndax records 50% of the Niktimvo net commercial profit, defined as net product revenue minus the cost of sales and commercial expenses. Syndax’s share of the Niktimvo product contribution, reported as collaboration revenue, was $18.1 million in the second quarter of 2026.

Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic graft-versus-host disease (cGVHD) patients are ongoing, including:
o
A Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥ 12 years of age with newly diagnosed cGVHD. Topline data are anticipated in the fourth quarter of 2026.o
A pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed cGVHD. Topline data are anticipated in early 2028.

The Company anticipates topline data from MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis in the fourth quarter of 2026.
Pipeline Assets

SNDX-4321


In July 2026, the Company announced the expansion of its pipeline with SNDX-4321, a mutant-selective, CNS-penetrant, allosteric EGFR inhibitor. SNDX-4321 is in development for non-small cell lung cancer (NSCLC) patient populations with significant unmet needs, such as those with L858R mutations, CNS metastases, atypical activating mutations, or acquired resistance to current therapies. In contrast to ATP-site directed third and fourth generation EGFR inhibitors, SNDX-4321 is a novel allosteric inhibitor which binds at a pocket adjacent to the ATP site that is only accessible in the presence of L858R and certain other EGFR mutations.

The Company expects to submit an investigational new drug (IND) application for SNDX-4321 by the end of 2026 and to initiate a Phase 1 trial in EGFRm NSCLC in 2027.
SNDX-62122


In July 2026, the Company announced the selection of SNDX-62122, a next-generation menin inhibitor, for development in MF. SNDX-62122 is the first candidate from a library of internally developed, wholly owned next-generation menin inhibitors that the Company intends to advance into new areas.

The Company expects to submit an IND and initiate a Phase 1 trial of SNDX-62122 in MF in 2027. The development of SNDX-62122 will be informed by a Phase 1/2 proof-of-principle trial of revumenib in MF that is expected to initiate in the fourth quarter of 2026 with initial clinical data expected in the second half of 2027.
Second Quarter 2026 Financial Results

As of June 30, 2026, Syndax had cash, cash equivalents, and short- and long-term investments of $575.1 million and 89.4 million common shares and prefunded warrants outstanding.

Total revenue for the second quarter of 2026 was $72.8 million, which consisted of $54.7 million in Revuforj net revenue and $18.1 million in Niktimvo collaboration revenue. The Niktimvo collaboration revenue is derived from the $60.3 million in Niktimvo net revenue that was previously reported by the Company’s partner Incyte for the second quarter 2026. Syndax records 50% of the Niktimvo net commercial profit, defined as net revenue (recorded by Incyte) minus the cost of sales and commercial expenses.

Second quarter 2026 research and development expenses increased to $68.0 million from $62.2 million for the comparable prior year period. The year-over-year change was primarily the result of increased expenses associated with frontline trials evaluating revumenib in combination with standard-of-care agents in the treatment of AML.

Second quarter 2026 selling, general and administrative expenses decreased to $41.5 million from $43.8 million for the comparable prior year period. The year-over-year change was primarily the result of decreased commercial expenses due to launch costs incurred in the second quarter of 2025 for Revuforj and Niktimvo that were not incurred in the same period in 2026.

For the six months ended June 30, 2026, Syndax reported a net loss attributable to common stockholders of $49.4 million, or $0.55 per share, compared to a net loss attributable to common stockholders of $71.8 million, or $0.83 per share, for the comparable prior year period.

Financial Guidance

For the full year of 2026, the Company continues to expect total research and development plus selling, general and administrative expenses to be approximately $400 million, excluding the impact of $50 million in estimated non-cash stock compensation expense.

Syndax expects that its cash, cash equivalents and short-term investments, combined with its anticipated product revenue, collaboration revenue and interest income, will enable the Company to reach profitability.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, August 4, 2026.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: Syndax2Q26
Domestic Dial-in Number: 800-590-8290
International Dial-in Number: 240-690-8800
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

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 ongoing or planned across the treatment landscape, 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, including a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774). Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

(Press release, Syndax, AUG 4, 2026, View Source [SID1234669668])

Rigel Reports Second Quarter 2026 Financial Results

On August 4, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the second quarter ended June 30, 2026, including sales of TAVALISSE (fostamatinib disodium hexahydrate), GAVRETO (pralsetinib) and REZLIDHIA (olutasidenib), and recent business progress, including the in-license of VEPPANU (vepdegestrant), a PRoteolysis TArgeting Chimera (PROTAC).

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"Rigel delivered a strong second quarter, highlighted by record net product sales, continued profitability and the in-license of VEPPANU, the first and only FDA-approved PROTAC for patients with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. We expect VEPPANU to be commercially available later this month, further expanding our commercial business in hematology and oncology," said Raul Rodriguez, Rigel’s president and CEO. "We are also advancing the development of R289 in our ongoing Phase 1b study in patients with R/R lower-risk MDS, and remain on track to complete enrollment in the dose expansion phase of the study, select a recommended Phase 2 dose in the second half of 2026 and share preliminary data by year end."

Second Quarter 2026 Business Update

Corporate

Rigel entered into an exclusive, global licensing agreement with Arvinas, Inc. (Arvinas) and Pfizer Inc. (Pfizer) to develop, manufacture and commercialize VEPPANU (vepdegestrant). VEPPANU is the first and only PROTAC approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer (mBC), as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. The agreement became effective on June 11, 2026, and Rigel paid the upfront payment of $70.0 million to Arvinas and Pfizer in the second quarter. Upon close of the transaction, Rigel immediately initiated launch activities and expects VEPPANU to be commercially available in the United States for the treatment of second line-plus (2L+) ER+/HER2-, ESR1-mutated mBC in mid-August 2026.
In July, Rigel announced the appointment of Alison L. Hannah, M.D. to the role of Executive Vice President and Chief Medical Officer. Dr. Hannah has decades of oncology drug development experience and served on Rigel’s Board of Directors since 2021. She resigned from Rigel’s Board of Directors in connection with her appointment.
Commercial

Second quarter net product sales were $67.0 million, an increase of 14% from the same period of 2025.
Rigel’s partner Knight Therapeutics Inc. (Knight) received regulatory approval from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) in May for TAVALISSE for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Also in May, Knight commercially launched TAVALISSE in Mexico.
Rigel’s partner Kissei Pharmaceutical Co., Ltd. (Kissei) submitted a new drug application for manufacturing and marketing approval in Japan for olutasidenib in May. In connection with the submission, Rigel received a $4.0 million regulatory milestone payment from Kissei during the second quarter.
Clinical Development

Rigel continues to advance its Phase 1b clinical study of R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS), with enrollment in the dose expansion phase ongoing and on track to be completed in the second half of 2026. The company expects to select the recommended Phase 2 dose in the second half of 2026 and share preliminary dose expansion data by year end.
The 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress featured an oral presentation and several poster presentations for pralsetinib and olutasidenib. The final data from the Phase 3 AcceleRET-Lung clinical trial of pralsetinib as first-line treatment of rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) were presented in an oral session at ASCO (Free ASCO Whitepaper). In addition, ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) featured poster presentations that included additional data for pralsetinib and data for olutasidenib for the treatment of R/R isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukemia (AML).
Key Publication

A paper titled "Preclinical Characterization and Early Development of R835, a Novel, Selective Dual IRAK1 and IRAK4 Inhibitor," was published in Scientific Reports in July. R835, the active metabolite of the prodrug R289, potently and selectively inhibited toll-like receptor (TLR) and interleukin-1 receptor (IL-1R)-dependent proinflammatory cytokine production in multiple preclinical models, demonstrating efficacy in both prophylactic and treatment preclinical settings. Additionally, in a placebo-controlled, double-blind, Phase 1, first-in-human study in 82 healthy participants, R835 was well tolerated with a favorable pharmacokinetic profile across all dose levels evaluated, and markedly inhibited lipopolysaccharide (LPS)-induced peak cytokine concentrations by approximately 40-80% compared to placebo. These data provided clinical proof of mechanism of a dual IRAK1/4 inhibitor suppressing proinflammatory cytokine release in humans.
Second Quarter and Year-to-Date 2026 Financial Update
For the second quarter ended June 30, 2026, total revenues were $78.7 million, consisting of $67.0 million in net product sales and $11.7 million in contract revenues from collaborations. Net product sales increased 14% compared to $58.9 million in the same period of 2025. TAVALISSE net product sales were $47.4 million, an increase of 18% compared to $40.1 million in the same period of 2025. GAVRETO net product sales were $10.7 million, a decrease of 10% compared to $11.8 million in the same period of 2025. REZLIDHIA net product sales were $8.9 million, an increase of 27% compared to $7.0 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $5.8 million of revenue from Kissei, which included a $4.0 million regulatory milestone payment in connection with the marketing authorization application submission for olutasidenib in Japan and delivery of drug supplies; $5.0 million of revenue from Grifols S.A. (Grifols) related to earned royalties and delivery of drug supplies; and $0.3 million of revenue from Medison Pharma (Medison) related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability from Rigel’s collaboration agreement with Eli Lilly and Company (Lilly).

Total costs and expenses were $55.1 million, compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily driven by higher personnel-related costs, cost of product sales, and research and development costs, including the continued progress of the R289 program and costs associated with development activities under Rigel’s license agreement with Arvinas and Pfizer.

Income before income taxes was $23.6 million, compared to $60.0 million for the same period of 2025.

Rigel reported net income of $17.3 million, or $0.93 basic and $0.88 diluted per share, compared to $59.6 million, or $3.33 basic and $3.28 diluted per share, for the same period of 2025. As noted above, the prior year period included $40.0 million in non-cash revenue related to Rigel’s collaboration agreement with Lilly.

For the six months ended June 30, 2026, total revenues were $137.5 million, consisting of $121.9 million in net product sales and $15.6 million in contract revenues from collaborations. Net product sales increased 19% compared to $102.5 million in the same period of 2025. TAVALISSE net product sales were $84.7 million, an increase of 24% compared to $68.5 million in the same period of 2025. GAVRETO net product sales were $20.3 million, a decrease of 2% compared to $20.8 million in the same period of 2025. REZLIDHIA net product sales were $17.0 million, an increase of 29% compared to $13.1 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $7.6 million of revenue from Kissei, including a $4.0 million regulatory milestone and delivery of drug supplies; $6.8 million of revenue from Grifols related to earned royalties and delivery of drug supplies; and $0.5 million of revenue from Medison related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability from Rigel’s collaboration agreement with Lilly and a $3.0 million regulatory milestone in connection with the approval of TAVALISSE in the Republic of Korea.

Total costs and expenses were $102.1 million, compared to $81.1 million for the same period of 2025. The increase in costs and expenses was primarily driven by higher personnel-related costs; research and development costs, including the continued progress of the R289 program and costs associated with development activities under Rigel’s license agreement with Arvinas and Pfizer; cost of product sales, and commercial-related expenses.

Income before income taxes was $35.2 million, compared to $71.5 million for the same period of 2025.

Rigel reported net income of $25.9 million, or $1.40 basic and $1.32 diluted per share, compared to $71.1 million, or $3.98 basic and $3.91 diluted per share, for the same period of 2025. As noted above, the prior year period included $40.0 million in non-cash revenue related to Rigel’s collaboration agreement with Lilly.

Cash, cash equivalents and short-term investments as of June 30, 2026 was $95.3 million, compared to $155.0 million as of December 31, 2025.

2026 Outlook
Rigel has increased its 2026 total revenues guidance to approximately $285 to $295 million, from the prior range of approximately $275 to $290 million, which includes:

Net product sales of approximately $255 to $265 million.
Contract revenues of approximately $30 million, an increase from the prior range of approximately $20 to $25 million.
The above revenue guidance excludes VEPPANU.

The company also continues to anticipate it will report positive net income for the full year 2026, while funding existing and new clinical development programs.

Conference Call and Webcast with Slides Today at 4:30 p.m. Eastern Time
Rigel will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and will be accessible from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,720 new cases in the United States, most in adults, in 2026.4

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow. 5,6 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.7 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About ER+/HER2-, ESR1-mutated Metastatic Breast Cancer
Breast cancer is the most common cancer in women in the United States, except for skin cancers.8 The estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) patient population represents the majority (70%) of breast cancer, where treatment with endocrine therapies (aromatase inhibitors) is the standard of care. While endocrine therapy remains a cornerstone of metastatic ER+/HER2- breast cancer treatment, up to 50% of patients treated with endocrine therapy and a CDK4/6 inhibitor acquire estrogen receptor 1 gene (ESR1) mutations, resulting in endocrine resistance and poor prognosis. Treatment options in second-line and later ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer setting include chemotherapy, selective estrogen receptor degraders (SERDs), and as of May 2026, vepdegestrant, the first and only FDA-approved oral PROteolysis TArgeting Chimera (PROTAC).

About TAVALISSE
TAVALISSE (fostamatinib disodium hexahydrate) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

About GAVRETO
GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).*

*Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for GAVRETO.

About REZLIDHIA
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.

About VEPPANU
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Please click here for Important Safety Information and Full Prescribing Information for VEPPANU.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks and VEPPANU is a trademark of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, AUG 4, 2026, View Source [SID1234669667])