RegulationAccelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC27H32FN9O2

InChIKeyGBLBJPZSROAGMF-RWYJCYHVSA-N

CAS Registry2097132-94-8

Clinical Trials associated with Pralsetinib

ChiCTR2600116415

/ Not yet recruitingNot ApplicableIIT

A Prospective, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Pralsetinib in Conversion Surgery for Locally Advanced RET Fusion-Positive NSCLC

Start Date30 Dec 2025

Sponsor / Collaborator-

CTIS2025-523158-15-00

/ Not yet recruitingPhase 4

A multi-center, open-label, drug-drug interaction study to evaluate the effect of pralsetinib (Gavreto) on the pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 substrates, and hormones estradiol/norethisterone acetate in patients with advanced or metastatic solid tumors.

Start Date15 Oct 2025

Sponsor / Collaborator

Rigel Pharmaceuticals, Inc.

NCT07010393

/ Not yet recruitingPhase 4IIT

A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma

This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.

Start Date01 Jul 2025

Sponsor / Collaborator

Fujian Medical University

100 Clinical Results associated with Pralsetinib

100 Translational Medicine associated with Pralsetinib

100 Patents (Medical) associated with Pralsetinib

266

Literatures (Medical) associated with Pralsetinib

01 Dec 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

LC-MS/MS method development and validation for novel targeted anticancer therapies adagrasib, capmatinib, ensartinib, entrectinib, larotrectinib, lorlatinib, pralsetinib, selpercatinib and sotorasib

Article

Author: Beijnen, Jos H ; Meertens, Marinda ; Huitema, Alwin D R ; Rosing, Hilde ; de Vries, Niels ; de Jong, L Daniëlle

A reversed-phase liquid chromatography-tandem mass spectrometry method was developed and validated for quantifying nine novel oral targeted anticancer agents mainly indicated for non-small cell lung cancer: adagrasib, capmatinib, ensartinib, entrectinib, larotrectinib, lorlatinib, pralsetinib, selpercatinib and sotorasib in human plasma for therapeutic drug monitoring. Chromatographic separation used an Acquity BEH C18 column with step gradient of 0.1 % formic acid in water and acetonitrile-methanol (50:50, v/v), at a 0.5 mL/min flow rate. Plasma samples were pretreated via precipitation with acetonitrile and diluted in 0.1 % formic acid in water. The reversed-phase chromatography was coupled with tandem mass spectrometry in positive ion mode. The assay was successfully validated over the following ranges: 100 - 10,000 ng/mL for adagrasib, capmatinib, entrectinib, pralsetinib, selpercatinib; 50 - 50,000 ng/mL for ensartinib; 10 - 1000 ng/mL for larotrectinib, lorlatinib; and 10 - 10,000 ng/mL for sotorasib. Accuracy and precision met the predefined criteria. Stability tests confirmed that all analytes were stable in plasma for up to 157 days at -20°C except for entrectinib, which was stable for 35 days at -20°C. At room temperature, the analytes were at least stable in plasma for 7 days, however, for adagrasib, entrectinib and sotorasib, stability for up to 3 days could be demonstrated. We recommend sending these samples on dry ice or refrigerated. After the validation, 74 plasma samples were measured in the application phase and all results but one fell within the validated ranges. This assay allows simultaneous quantification of nine novel targeted therapies and supports therapeutic drug monitoring.

01 Nov 2025·Chemical Biology & Drug Design

Design and Synthesis of 2‐Aminopyrazolpyrimidopyridone Derivatives as RET ^V ^{804
M} and RET ^G ^{810
C} Kinase Inhibitors

Article

Author: Zhao, Xu ; Liu, Jihu ; Li, Yongdong ; Lin, Jieman ; Jia, Shuyu ; Shen, Jiayi ; Li, Anzhi ; Chen, Sheng

ABSTRACT:

Oncogenic conversion of the RET (rearranged during transfection) tyrosine kinase is associated with several cancers. The clinical therapeutic benefits of the second‐generation RET inhibitor pralsetinib are greatly compromised by acquired resistance mediated by solvent‐front mutations (e.g., RET G810R/S/C ). Herein, a class of 2‐aminopyrazolpyrimidopyridone derivatives as RET V804M and RET G810C solvent‐front mutant inhibitors were designed and synthesized for overcoming pralsetinib resistance. One of the optimal compounds, 7la , exhibited inhibitory potency against the proliferation of BaF3 cells harboring CCDC6‐RET V804M mutation with IC50 values of 0.271 μM. Interestingly, another one of these series compounds, 7qe , suppressed BaF3 cells harboring CCDC6‐RET V804M and CCDC6‐RET G810C mutations with IC 50 values of 0.841 and 0.272 μM, respectively. The compound also dose‐dependently suppressed the activation of RET and downstream signals. However, the relatively poor pharmacokinetic properties of these compounds will limit their further development. Therefore, compound 7qe might be a promising lead compound for the development of novel RET V804M and RET G810C inhibitors overcoming the clinical acquired resistance.

01 Oct 2025·Translational Lung Cancer Research

Pathological complete response in RET-positive non-small cell lung cancer: a case report of pralsetinib-based “sandwich” therapy

Article

Author: Zhang, Yalei ; Xu, Xin ; He, Qihua ; Li, DongMei

Background:

RET gene fusions define a distinct molecular subset of non-small cell lung cancer (NSCLC) that commonly affects younger and non-smoking individuals. Selective RET inhibitors such as pralsetinib have shown favorable outcomes in advanced or metastatic settings; however, their role in perioperative or locally advanced disease remains poorly defined. Integrating targeted therapy into a multidisciplinary "sandwich" strategy, which includes neoadjuvant, surgical, and adjuvant components, may offer improved outcomes and requires further exploration.

Case Description:

We report the case of a 34-year-old male patient with a 15-year smoking history, who presented with persistent right-sided chest pain. Imaging revealed a 3.4 cm × 2.4 cm × 4.4 cm mass in the right middle lobe with mediastinal and left supraclavicular lymphadenopathy. Supraclavicular node biopsy confirmed metastatic poorly differentiated adenocarcinoma. Immunohistochemistry supported a pulmonary origin, and molecular testing via amplification refractory mutation system-polymerase chain reaction (ARMS-PCR) detected a RET exon 12 fusion. The clinical stage was cT2N3M0 (stage IIIB). The patient declined chemotherapy and underwent neoadjuvant pralsetinib therapy. After 3 months, a partial response (PR) was observed. On April 13, 2023, the patient underwent video-assisted thoracoscopic surgery (VATS) with right middle lobectomy. Postoperative pathology revealed a pathological complete response (pCR) with 0% viable tumor cells. Pralsetinib was resumed as adjuvant therapy post-surgery. The patient also began elective regional radiotherapy targeting bilateral supraclavicular drainage areas, but the treatment was terminated early due to grade 3 acute esophagitis. At the 24-month follow-up, the patient remained disease-free on pralsetinib maintenance with preserved performance status.

Conclusions:

This case highlights the potential benefit of pralsetinib-based "sandwich" therapy in the treatment of RET fusion-positive NSCLC. Incorporating targeted therapy with surgery and tailored adjuvant treatment may lead to durable remission in selected patients with locally advanced disease. Prospective studies need to be conducted to further define the treatment sequencing and validate this multi-modal approach.

News (Medical) associated with Pralsetinib

12 Jan 2026

·www.biospace.com

Rigel Provides Business Update and 2026 Outlook

Preliminary fourth quarter 2025 total revenue of approximately $69.8 million, including net product sales of $65.4 million and contract revenues of $4.4 million In the dose escalation phase of the Phase 1b study of R289 in patients with lower-risk MDS, R289 continues to be generally well tolerated. RBC-TI was achieved by 33% (6/18) of evaluable transfusion dependent patients receiving R289 doses ≥500 mg QD, including 40% (2/5) in the 500 mg BID dose group Enrollment in the dose expansion phase of the Phase 1b study is ongoing and Rigel is on track to complete enrollment and select the recommended Phase 2 dose for future clinical studies in the second half of 2026 2026 Outlook: Rigel anticipates full-year total revenue of approximately $275 to $290 million, including net product sales of $255 to $265 million, and positive net income for the full year SOUTH SAN FRANCISCO, Calif. , Jan. 12, 2026 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today provided a business update including preliminary total revenue and net product sales for the fourth quarter of 2025, ongoing activity from the commercial business and development pipeline, and its financial outlook for 2026. "2025 was an excellent year for Rigel, marked by strong commercial execution with record net product sales; significant financial progress, including continued profitability and generation of $77 million in cash; and meaningful clinical advancement of R289 in lower-risk MDS, where we shared encouraging Phase 1b data," said Raul Rodriguez, Rigel's president and CEO. "In 2026, we plan to continue to execute across all areas of the business — driving sustained commercial performance, supporting our expanding clinical programs with a solid financial foundation, delivering preliminary results from the dose expansion phase of our R289 study and continuing to explore opportunities to add new products to our portfolio." Preliminary 2025 Financial Results and Business Update Preliminary Financial Results While Rigel is still determining final results for the fourth quarter of 2025, the company expects to report fourth quarter total revenue of $69.8 million, compared to $57.6 million for the same period of 2024. Rigel expects to report fourth quarter of 2025 gross product sales of $84.5 million. Net product sales are expected to be $65.4 million, compared to $46.5 million for the same period of 2024, including: TAVALISSE ® (fostamatinib disodium hexahydrate) net product sales of $45.6 million compared to $31.0 million for the same period of 2024. GAVRETO ® (pralsetinib) net product sales of $10.2 million compared to $8.1 million for the same period of 2024. REZLIDHIA ® (olutasidenib) net product sales of $9.6 million compared to $7.4 million for the same period of 2024. Contract revenues for the fourth quarter of 2025 are expected to be approximately $4.4 million, consisting of $4.1 million in contract revenues from collaborations and $0.3 million in government contract revenue. Contract revenue from collaborations is expected to include $3.4 million of revenue from Grifols S.A. related to delivery of drug supplies and earned royalties, $0.3 million of revenue from Kissei Pharmaceutical Co., Ltd. related to delivery of drug supplies and $0.2 million of revenue from Medison Pharma Trading AG related to earned royalties. For the full year, Rigel expects to report total revenue of $294.3 million, including net product sales of $232.0 million and contract revenues of $62.3 million, compared to total revenue of $179.3 million in 2024, which included net product sales of $144.9 million and contract revenues of $34.4 million. Expected 2025 contract revenues and total revenue include $40.0 million in non-cash revenue recognized in the second quarter of 2025 resulting from the release of the remaining cost share liability related to the agreement with Lilly for the development and commercialization of ocadusertib. Rigel expects to report cash, cash equivalents, and short-term investments of approximately $154.6 million as of December 31, 2025, compared to $77.3 million as of December 31, 2024. The above information is preliminary, has not been audited, and is subject to change upon the audit of Rigel's financial statements for the fourth quarter and year ended December 31, 2025. Rigel expects to provide complete fourth quarter and full year 2025 financial results in March 2026. Commercial Rigel's commercial portfolio is expected to report preliminary full-year net product sales of $232.0 million, growth of 60% compared to 2024. Clinical Development and Regulatory Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R289 1 , 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). In October 2025, Rigel announced enrollment of the first patient in the dose expansion phase of the study, where up to 40 patients will be randomized to receive either 500 mg once daily (QD) or twice daily (BID) to determine the recommended Phase 2 dose for future clinical trials. Rigel is on track to complete enrollment of the dose expansion phase of the Phase 1b study and select the recommended Phase 2 dose for future clinical studies in the second half of 2026. The company anticipates sharing preliminary data from the dose expansion phase of the study by the end of 2026. Rigel announced updated data from the dose escalation phase of the ongoing Phase 1b clinical study of R289 at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition in December, indicating that R289 continued to be generally well tolerated in a heavily pretreated R/R lower-risk MDS patient population, the majority of whom were high transfusion burden (HTB) at baseline. Furthermore, red blood cell transfusion independence (RBC-TI ≥8 weeks) was achieved by 33% (6/18) of evaluable transfusion dependent patients receiving R289 doses of at least 500 mg QD and higher. Also at the ASH Annual Meeting, four posters were presented on olutasidenib, which included data that add to the growing body of evidence supporting the benefits of its use in patients with R/R mutated isocitrate dehydrogenase-1 (m IDH1 ) acute myeloid leukemia (AML). In October 2025, the first patient was enrolled in the CONNECT Phase 2 TarGeT-D study evaluating olutasidenib in combination with temozolomide, followed by olutasidenib monotherapy as a maintenance regimen for newly-diagnosed adolescent and young adult patients with a high-grade glioma harboring an IDH1 mutation ( NCT06161974 ). Rigel presented sub-analysis data from the ARROW study evaluating pralsetinib for the treatment of metastatic rearranged during transfection ( RET ) fusion-positive non-small cell lung cancer (NSCLC) at the 2025 North America Conference on Lung Cancer (NACLC) in December. The two poster presentations included efficacy and safety data for patients previously treated with immunotherapy and for patients from the United States. In the trial, median overall survival (OS) was 44.3 months for the overall patient population. Longer median OS was seen in patients treated in the United States (62.4 months). Rigel presented the first data release for pralsetinib from the TAPISTRY study ( NCT04589845 ) in a poster presentation at the 2026 American Society of Clinical Oncology – Gastrointestinal Cancers Symposium (ASCO-GI) in January. The analysis reported results from the Phase 2 global, open-label, multicohort study, in which the efficacy and safety of pralsetinib was evaluated in a cohort of patients with RET fusion-positive solid tumors, including pancreatic, colorectal, and hepatobiliary cancers. Pralsetinib demonstrated robust and durable activity against RET fusion-positive solid tumors, including gastrointestinal (GI) tumors, and in the efficacy evaluable population showed an overall response rate (ORR) of 67% (26/39). These data validate RET fusions as a tissue-agnostic target with sensitivity to RET inhibition, suggesting the potential therapeutic utility of pralsetinib in these patients. On December 22, 2025, the U.S. Food and Drug Administration (FDA) notified Rigel of the approval of a Prior Approval supplemental New Drug Application, which updated the U.S. Prescribing Information to add a boxed warning regarding serious infections, including opportunistic infections. Rigel previously communicated this risk information to healthcare providers via a Dear Healthcare Provider letter in October 2024. The FDA also notified Rigel that it has met its postmarketing commitment for GAVRETO from its September 2020 accelerated approval to submit the final report for the AcceleRET-Lung study. Publication A paper titled " Olutasidenib for Mutated IDH1 Acute Myeloid Leukemia: Final Five-Year Results from the Phase 2 Pivotal Cohort " was published in November 2025 by Jorge E. Cortes, M.D., Phase 2 trial investigator and Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, in the Journal of Hematology & Oncology . The publication reports the final 5-year data from the pivotal cohort of the registrational trial evaluating olutasidenib for the treatment of patients with R/R m IDH1 AML, which includes an additional two years of efficacy and safety data. These 5-year data further support the durable responses and manageable safety pro with olutasidenib in patients with R/R m IDH1 AML, including those previously treated with venetoclax-based regimens. 2026 Outlook Rigel anticipates 2026 total revenue of approximately $275 to $290 million, including: Net product sales of approximately $255 to $265 million. Contract revenues of approximately $20 to $25 million. The company anticipates it will report positive net income for the full year 2026, while funding existing and new clinical development programs. Upcoming Investor Event Raul Rodriguez, Rigel's president and CEO, will present a company overview at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 14, 2026 at 3:00 p.m. PT (6:00 p.m. ET). To access the live webcast or archived recording, visit the Investor Relations section of the company's website at . 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 226,000 adults in the U.S. will be diagnosed with lung cancer in 2025. 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 85-90% 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 22,010 new cases in the United States, most in adults, in 2025. 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 TAVALISSE ® TAVALISSE (fostamatinib disodium hexahydrate) tablets 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. To report side effects of prescription drugs to the FDA, visit or call 1-800-FDA-1088 (800-332-1088). TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc. About Rigel Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit . R289 is an investigational compound not approved by the FDA. The American Cancer Society. Key Statistics for Lung Cancer. Revised January 16, 2025. Accessed January 2, 2026: Kato, S. et al. RET Aberrations in Diverse Cancers: Next-Generation Sequencing of 4,871 Patients. Clin Cancer Res. 2017;23(8):1988-1997 doi: 10.1158/1078-0432.CCR-16-1679 The American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised March 4, 2025. Accessed January 2, 2026: Patel, A, et al. Outcomes of Patients With Acute Myeloid Leukemia Who Relapse After 5 Years of Complete Remission . 2021 Sep 7;28(7):811-814. doi: Thol F, Ganser, A. Treatment of Relapsed Acute Myeloid Leukemia . Curr. Treat. Options on Oncol. (2020) 21: 66. doi: Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia . Blood (2015) 126 (3): 319-27. doi: Forward Looking Statements Thi s press release contains forward-looking statements relating to, among other things, expected commercial, financial and clinical results, increased projections of financial performance and outlook for 2026, expectations for growing our commercial business , continued enrollment of our R289 study, presentation of study data, expectation of clinical outcomes, continued ability for developing and commercializing TAVALISSE, GAVRETO, REZLIDHIA and R289 domestically and in certain international markets, and expectations for Rigel's partnering and collaboration efforts. A ny statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "anticipates", "plan", "outlook", "potential", "may", "look to", "expects", "will", "initial", "promising", and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, the finalization and audit of Rigel's fourth quarter and 2025 fiscal year financial results which could potentially result in changes or adjustments to the selected preliminary financial results and projections presented herein; risks and uncertainties associated with the commercialization and marketing of TAVALISSE, GAVRETO, and REZLIDHIA; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding TAVALISSE, GAVRETO, REZLIDHIA or R289; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE, GAVRETO, REZLIDHIA or R289 may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop or market Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. Contact for Investors & Media: Investors: Rigel Pharmaceuticals, Inc. 650.624.1232 ir@rigel.com Media: David Rosen Argot Partners 646.461.6387 david.rosen@argotpartners.com View original content to download multimedia: SOURCE Rigel Pharmaceuticals, Inc.

Phase 2Clinical ResultPhase 1ASCO

04 Nov 2025

·www.prnewswire.com

Rigel Reports Third Quarter 2025 Financial Results and Provides Business Update

Third quarter 2025 total revenue of approximately $69.5 million, including record net product sales of $64.1 million and contract revenues from collaborations of $5.4 million Generated $27.9 million of net income in the third quarter of 2025 Completed enrollment in the dose escalation phase and enrolled the first patient in the dose expansion phase of the ongoing Phase 1b study evaluating R289, Rigel's dual IRAK1/4 inhibitor, in lower-risk MDS Oral presentation featuring updated data from the dose escalation phase of the R289 Phase 1b study to be presented at the ASH Annual Meeting in December Updated 2025 Outlook: Total revenue of approximately $285 to $290 million, which includes net product sales of $225 to $230 million Conference call and webcast scheduled today at 4:30 p.m. Eastern Time SOUTH SAN FRANCISCO, Calif., Nov. 4, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today reported financial results for the third quarter ended September 30, 2025, including sales of TAVALISSE® (fostamatinib disodium hexahydrate), GAVRETO® (pralsetinib) and REZLIDHIA® (olutasidenib), and recent business progress. "Our strong third-quarter performance demonstrates our strategic focus on commercial execution, pipeline development, and financial discipline. We are raising our full-year 2025 guidance due to our outstanding commercial performance year-to-date," said Raul Rodriguez, Rigel's president and CEO. "Our development pipeline continues to advance, including our ongoing Phase 1b study evaluating R289 for the treatment of patients with lower-risk MDS. With enrollment complete in the dose escalation phase of the study, we look forward to presenting updated data in an oral presentation at ASH in December. We're also excited to have reached the next milestone of this program with the initiation of the dose expansion phase of the study." Third Quarter 2025 Business Update Commercial Net product sales were $64.1 million, an increase of 65% from the same period of 2024. TAVALISSE was commercially launched in South Korea in July by JW Pharmaceutical Corporation, the licensing partner of Kissei Pharmaceutical Co., Ltd. (Kissei), Rigel's partner in certain Asian countries. Clinical Development Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a potent and selective dual interleukin receptor-associated kinases 1 and 4 (IRAK1/4) inhibitor, in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the dose escalation phase of the study was completed in July. In October, Rigel announced the first patient was enrolled in the dose expansion phase of the study, where up to 40 patients will be randomized to either 500 mg once daily or 500 mg twice daily to determine the recommended Phase 2 dose for future clinical trials. Rigel announced one oral presentation and four poster presentations highlighting data from its commercial and clinical-stage hematology and oncology portfolio at the upcoming 67th American Society of Hematology (ASH) Annual Meeting and Exposition. The abstract with updated data from the ongoing Phase 1b study of R289 showed R289 continues to be generally well tolerated in a heavily pretreated lower-risk MDS patient population, the majority of whom were high transfusion burden at study entry, and preliminary signs of efficacy in dose levels of at least 500 mg once daily and higher. Updated data as of an October 28, 2025, data cut off will be presented in the oral presentation. The company will also present additional data for olutasidenib in patients with R/R mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML). The fifth study under the strategic alliance between Rigel and The University of Texas MD Anderson Cancer Center opened for enrollment in September. This Phase 2 multi-arm, multi-center, open-label, non-randomized clinical study will evaluate olutasidenib in combination with co-targeted therapies in patients with R/R IDH1-mutated myeloid malignancies harboring activated signaling pathway mutations (NCT07032727). The primary objectives of the study are to evaluate safety and the composite complete remission rate. In October, the first patient was enrolled in the CONNECT Phase 2 TarGeT-D study evaluating olutasidenib in combination with temozolomide, followed by olutasidenib monotherapy as a maintenance regimen for newly-diagnosed adolescent and young adult patients with a high-grade glioma harboring an IDH1 mutation (NCT06161974). Corporate Eli Lilly and Company (Lilly) continues to advance ocadusertib (previously R552 or LY3871801), an investigational, potent and selective receptor-interacting protein kinase 1 (RIPK1) inhibitor. Enrollment in the Phase 2a clinical trial in adult patients with moderately to severely active rheumatoid arthritis is ongoing. Rigel will continue to be entitled to receive milestones and tiered royalty payments on future net sales of ocadusertib. In early October, Rigel received notification from Lilly that it will terminate the central nervous system (CNS) disease program related to the collaboration between the two companies, which will become effective 60 days following notification. Third Quarter 2025 and Year-to-Date Financial Update For the third quarter ended September 30, 2025, total revenues were $69.5 million, consisting of $64.1 million in net product sales and $5.4 million in contract revenues from collaborations. Net product sales grew 65% compared to $38.9 million in the same period of 2024. TAVALISSE net product sales were $44.7 million, growth of 70% compared to $26.3 million in the same period of 2024. GAVRETO net product sales were $11.1 million, growth of 56% compared to $7.1 million in the same period of 2024. REZLIDHIA net product sales were $8.3 million, growth of 50% compared to $5.5 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $3.1 million of revenue from Grifols S.A. (Grifols) related to delivery of drug supplies and earned royalties, $1.8 million of revenue from Kissei related to the delivery of drug supplies, and $0.2 million of revenue from Medison Pharma (Medison) related to delivery of drug supplies and earned royalties. Total costs and expenses were $41.0 million compared to $41.3 million for the same period of 2024. The decrease in costs and expenses was mainly due to lower cost of product sales, as the prior period included a sublicensing fee. This decrease was partially offset by increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289 and higher personnel-related costs. Rigel reported net income of $27.9 million, or $1.55 basic and $1.46 diluted per share, compared to $12.4 million, or $0.71 basic and $0.70 diluted per share, for the same period of 2024. For the nine months ended September 30, 2025, total revenues were $224.5 million, consisting of $166.6 million in net product sales and $57.9 million in contract revenues from collaborations. Net product sales grew 69% compared to $98.4 million in the same period of 2024. TAVALISSE net product sales were $113.3 million, growth of 54% compared to $73.8 million in the same period of 2024. GAVRETO net product sales were $31.9 million, growth of 252% compared to $9.0 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $21.4 million, growth of 38% compared to $15.6 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability related to the agreement with Lilly for the development and commercialization of ocadusertib, $9.9 million of revenue from Grifols related to delivery of drug supplies and earned royalties, $6.9 million of revenue from Kissei related to a milestone payment and delivery of drug supplies and $0.8 million of revenue from Medison related to delivery of drug supplies and earned royalties. Total costs and expenses were $122.2 million compared to $114.1 million for the same period of 2024. The increase in costs and expenses was mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289, and higher personnel-related costs. Rigel reported net income of $99.0 million, or $5.52 basic and $5.38 diluted per share, compared to $3.1 million, or $0.18 basic and diluted per share, for the same period of 2024. Cash, cash equivalents and short-term investments as of September 30, 2025 was $137.1 million, compared to $77.3 million as of December 31, 2024. 2025 Outlook Rigel is updating its 2025 total revenue guidance to approximately $285 to $290 million, an increase from the previous range of approximately $270 to $280 million, which includes: Net product sales of approximately $225 to $230 million, an increase from the previous range of approximately $210 to $220 million. Contract revenues from collaborations of approximately $60 million. The company anticipates it will report positive net income for the full year 2025, while funding existing and new clinical development programs. Conference Call and Webcast with Slides Today at 4:30pm Eastern Time Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm 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 can be accessed from the Investor Relations section of the company's website at . 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 226,000 adults in the U.S. will be diagnosed with lung cancer in 2025. 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 85-90% 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 22,010 new cases in the United States, most in adults, in 2025.4 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 TAVALISSE® TAVALISSE (fostamatinib disodium hexahydrate) tablets 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 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. To report side effects of prescription drugs to the FDA, visit or call 1-800-FDA-1088 (800-332-1088). TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc. About Rigel Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit . R289 is an investigational compound not approved by the FDA. The American Cancer Society. Key Statistics for Lung Cancer. Revised January 16, 2025. Accessed September 30, 2025: Kato, S. et al. RET Aberrations in Diverse Cancers: Next-Generation Sequencing of 4,871 Patients. Clin Cancer Res. 2017;23(8):1988-1997 doi: 10.1158/1078-0432.CCR-16-1679 The American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised March 4, 2025. Accessed September 30, 2025: Patel, A, et al. Outcomes of Patients With Acute Myeloid Leukemia Who Relapse After 5 Years of Complete Remission. 2021 Sep 7;28(7):811-814. doi: Thol F, Ganser, A. Treatment of Relapsed Acute Myeloid Leukemia. Curr. Treat. Options on Oncol. (2020) 21: 66. doi: Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood (2015) 126 (3): 319-27. doi: Forward Looking Statements Thi s press release contains forward-looking statements relating to, among other things, expected commercial and financial results, increased projections of financial performance and outlook for 2025, expectations for growing our commercial business , continued enrollment of our R289 study, presentation of study data, development of ocadusertib, expectation of clinical outcomes, continued ability for developing and commercializing TAVALISSE, GAVRETO, and REZLIDHIA domestically and in certain international markets, and expectations for Rigel's partnering and collaboration efforts. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "anticipates", "plan", "outlook", "potential", "may", "look to", "expects", "will", "initial", "promising", and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib, olutasidenib and pralsetinib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding fostamatinib, pralsetinib, ocadusertib or olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib, pralsetinib, ocadusertib or olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. Contact for Investors & Media: Investors: Rigel Pharmaceuticals, Inc. 650.624.1232 [email protected] Media: David Rosen Argot Partners 646.461.6387 [email protected] SOURCE Rigel Pharmaceuticals, Inc. 21% more press release views with Request a Demo

Phase 1Phase 2Drug ApprovalASHFinancial Statement

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April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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KEGG	Wiki	ATC	Drug Bank
D11712	Pralsetinib	L01XE	DB15822

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Switzerland	Blueprint Medicines Corp.	06 Aug 2021
RET fusion-positive Thyroid Cancer	United States	Blueprint Medicines Corp.	01 Dec 2020
RET Mutation-Positive Medullary Thyroid Cancer	United States	Blueprint Medicines Corp.	01 Dec 2020
RET fusion-positive Non-Small Cell Lung Cancer	United States	Rigel Pharmaceuticals, Inc.	04 Sep 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Thyroid Cancer	NDA/BLA	European Union	Roche Registration GmbH	-
metastatic non-small cell lung cancer	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	27 Apr 2023
metastatic non-small cell lung cancer	Phase 3	China	Blueprint Medicines Corp.	27 Apr 2023
Adenocarcinoma	Phase 3	Japan	-	24 Jul 2020
Adenocarcinoma	Phase 3	Argentina	-	24 Jul 2020
Adenocarcinoma	Phase 3	Australia	-	24 Jul 2020
Adenocarcinoma	Phase 3	Belgium	-	24 Jul 2020
Adenocarcinoma	Phase 3	Brazil	-	24 Jul 2020
Adenocarcinoma	Phase 3	Costa Rica	-	24 Jul 2020
Adenocarcinoma	Phase 3	France	-	24 Jul 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


RET MAP registry (ASCO2025)	Not Applicable	Non-Small Cell Lung Cancer	354	Selpercatinib	eylbdhhfpg(ydalzvjume) = recurrent toxicity may occur in one-third of patients aolncwzzxd (jtkouhvujr ) View more	Negative	30 May 2025
				Pralsetinib
NCT03037385 (ARROW, ASCO2025)	Phase 2	RET mutation Solid Tumors \| Colonic Cancer \| Advanced Malignant Solid Neoplasm ... RET fusion View more	29	Pralsetinib	ggoaiuyyaq(guicgvltpr) = gmgnszjxrh zgpqdntkpl (cynjxvqvwn ) View more	Positive	30 May 2025
NCT03037385 (ARROW, ASCO2025)	Phase 1/2	RET mutation Solid Tumors \| Colonic Cancer \| Advanced Malignant Solid Neoplasm ... RET-fusion-positive View more	281	Pralsetinib 400 mg QD	yjdrwdntrx(rpmpewrlrf) = qqzgzhfkub kaorxopdlt (jsuzkangly, 64.3 - 75.8) View more	Positive	30 May 2025
NCT03037385 (ARROW, Pubmed \| Future Oncol)	Phase 1/2	RET fusion-positive Non-Small Cell Lung Cancer RET fusion+	281	Pralsetinib	uwlzkvmdhy(anqzuxxhts) = severe side effect in untreated patients zvwgyeyiae (fqdughcmss ) View more	Positive	01 Feb 2024
NCT03037385 (ARROW, Pubmed) Manual	Phase 1/2	RET fusion-positive Thyroid Cancer Rearranged During Transfection -Altered	145	Pralsetinib 400 mg once daily	kycljnydfe(hwugzrfdkm) = csxegxwqqy ebpnqeoefa (qwhqungfbg, 42.4 - 68.5) View more	Positive	01 Jan 2024
				PralsetinibPralsetinib 400 mg (treatment-naïve patients with RET-mutant MTC)	kycljnydfe(hwugzrfdkm) = esaoznftlt ebpnqeoefa (qwhqungfbg, 65.0 - 87.1) View more
NCT03037385 (ARROW, Pubmed)	Phase 1/2	RET fusion-positive Non-Small Cell Lung Cancer	68	Pralsetinib 400-mg once-daily oral	sjnvaighme(kevrqaxkww) = wnjvjtcxar mnjczhzyon (ydyfmuqadb, 48.2 - 82.0) View more	Positive	06 Jun 2023
NCT03037385 (ARROW, ESMO_ASIA2022) Manual	Phase 1/2	RET fusion-positive Non-Small Cell Lung Cancer RET fusion+	68	pralsetinib,400 mg (previously treated with platinum-based chemotherapy)	dzumxixorc(nrjlssfzju) = chzvugjixf gvzvgkbyhc (whzxviykzk, 48 - 82) View more	Positive	03 Dec 2022
				pralsetinib,400 mg (treatment-naïve)	dzumxixorc(nrjlssfzju) = lkbqbdvkfo gvzvgkbyhc (whzxviykzk, 65 - 94) View more
Pubmed Manual	Not Applicable	RET fusion-positive Non-Small Cell Lung Cancer RET fusion-positive	59	Pralsetinib (overall)	hmyawdbehw(gwpgfojlmh) = zakvrimnec veurmivxqk (jewrxuqaeu, 4.7 - NA) View more	Positive	09 Nov 2022
				Pralsetinib (patients with measurable brain metastases)	fyselcasoh(zkvkdmngxf) = oitnzybnsf yquxloecct (dnpyyiiwlo ) View more
NCT03037385 (ARROW, ESMO2022) Manual	Phase 1/2	Thyroid Cancer RET-altered	175	pralsetinib,400 mg QD ( Pts with RETm MTC previously treated with C/V)	jgpwcklyjx(rquzsmsgqr) = wmakxucndi gwhprwppil (codtxjxqro, 39.7 - 64.6) View more	Positive	10 Sep 2022
				pralsetinib,400 mg QD (Treatment-naïve pts with RETm MTC)	jgpwcklyjx(rquzsmsgqr) = hbznoxmpun gwhprwppil (codtxjxqro, 59.3 - 82.0) View more
NCT03037385 (ARROW, ESMO2022) Manual	Phase 1/2	RET fusion-positive Non-Small Cell Lung Cancer CCDC6-RET Fusion \| KIF5B-RET Fusion \| RET Fusion	233	Pralsetinib 400mg/day (KIF5B)	qdetnjhfgy(wsjykncvto) = isqvynitny bdbmhvfjdi (poegwkpzyz, 60.0 - 74.8) View more	Positive	10 Sep 2022
				Pralsetinib 400mg/day (CCDC6)	qdetnjhfgy(wsjykncvto) = bhrcdowhnq bdbmhvfjdi (poegwkpzyz, 51.9 - 81.9) View more

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