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

Structure/Sequence

Molecular FormulaC27H32FN9O2

InChIKeyGBLBJPZSROAGMF-RWYJCYHVSA-N

CAS Registry2097132-94-8

Clinical Trials associated with Pralsetinib

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

NCT06563999

/ RecruitingPhase 2IIT

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

Start Date01 Nov 2024

Sponsor / Collaborator

Sun Yat-Sen University

NCT04760288

/ WithdrawnPhase 3

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.

A study to evaluate the efficacy and safety of pralsetinib compared with SOC treatment (cabozantinib or vandetanib) for participants with RET (rearranged during transfection)-mutant MTC who have not previously received a SOC MultiKinase Inhibitor (MKI) therapy. Participants will be randomized in a 1:1 ratio into one of two treatment arms: Arm A (pralsetinib) or Arm B (investigator's choice of either cabozantinib or vandetanib for adults and vandetanib for adolescents). Participants whose disease progresses during SOC treatment will be offered the option to cross over to receive pralsetinib after confirmation of progressive disease by blinded independent central review (BICR).

Start Date30 Nov 2023

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Pralsetinib

100 Translational Medicine associated with Pralsetinib

100 Patents (Medical) associated with Pralsetinib

294

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 Oct 2025·International Journal of Surgery

Dynamic risk stratification-guided management of medullary thyroid carcinoma: integrating surgical precision with RET-targeted therapies and molecular surveillance

Review

Author: Zhang, Jiao ; Dionigi, Gianlorenzo ; Sun, Hui ; Li, Changlin ; Kim, Hoon Yub

Medullary thyroid carcinoma (MTC) is a rare neuroendocrine neoplasm derived from parafollicular C cells of the thyroid gland, primarily driven by alterations in the rearranged during transfection (RET) oncogene. This review focuses on the current advances in treatment modalities for MTCs, encompassing surgical interventions, targeted therapy, postoperative surveillance, and future challenges. Total thyroidectomy is the primary curative approach for MTCs. However, the extent of lymph node dissection, particularly lateral neck dissection, remains controversial. Postoperative surveillance involves monitoring serum calcitonin and carcinoembryonic antigen levels, imaging assessments, and dynamic risk stratification to detect recurrence. Drug therapy offers an alternative approach in cases of challenging surgical scenarios or advanced MTCs. Multi-kinase inhibitors (e.g. vandetanib and cabozantinib) have shown increased survival outcomes for metastatic MTCs and are approved as effective treatment options. More recently, selective rearranged during transfection inhibitors like selpercatinib and pralsetinib have demonstrated higher efficacy and better tolerability. Despite these advances, challenges persist in managing MTCs, including addressing biochemical recurrence, determining surgical scope, considering immunotherapy, and treating advanced cases. Personalized medicine approaches, incorporating genetic screening, and innovative therapies, are essential for improving survival and quality of life in MTC patients.

31 Jul 2025·ENDOCRINE-RELATED CANCER

Targeting RET in medullary thyroid cancer

Review

Author: Cheng, Leslie ; Newbold, Kate

Graphical Abstract:

Abstract:

Medullary thyroid cancer (MTC) is a rare cancer, accounting for 2–3% of all thyroid cancers. Point mutations in the RET proto-oncogene can be detected in 25–65% of MTC. These mutations commonly occur in the cysteine-rich or tyrosine kinase domains, leading to constitutively active tyrosine kinase activity in RET. In the last decade, significant advancements have been made in treating MTC with the advent of tyrosine kinase inhibitors, especially in RET-mutated MTC. Multikinase inhibitors such as vandetanib and cabozantinib were the first few effective inhibitors, which have been shown to slow disease progression in the treatment of advanced MTC. In more recent years, these have been followed by highly selective RET inhibitors selpercatinib and pralsetinib, which have made their way into the clinic, demonstrating high efficacy and a more favourable side-effect profile due to their reduction in off-target effects. In spite of these successes, there remains a continued need to develop strategies to overcome treatment resistance.

News (Medical) associated with Pralsetinib

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

30 Sep 2025

·www.einpresswire.com

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

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. Crysvita labeling Dexmedetomidine-containing products Dexmedetomidine injection Precedex (dexmedetomidine hydrochloride) injection Igalmi (dexmedetomidine) sublingual film Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action. Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action. Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

05 Aug 2025

·www.prnewswire.com

Rigel Reports Second Quarter 2025 Financial Results and Provides Business Update

Second quarter 2025 total revenue of approximately $101.7 million, which includes net product sales of $58.9 million and contract revenues from collaborations of $42.7 million Completed enrollment in the dose escalation part of the ongoing Phase 1b study evaluating R289, a dual IRAK1/4 inhibitor, in patients with R/R lower-risk MDS Generated $59.6 million of net income in the second quarter of 2025 Updated 2025 Outlook: Total revenue of approximately $270 to $280 million, which includes net product sales of $210 to $220 million Total revenue and net income are inclusive of $40 million in non-cash contract revenue related to Rigel's agreement with Lilly Conference call and webcast scheduled today at 4:30 p.m. Eastern Time SOUTH SAN FRANCISCO, Calif., Aug. 5, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today reported financial results for the second quarter ended June 30, 2025, including sales of TAVALISSE® (fostamatinib disodium hexahydrate), GAVRETO® (pralsetinib) and REZLIDHIA® (olutasidenib), and recent business progress. "Our strategic and disciplined approach to building our business has generated another strong quarter for the company. In the second quarter, we grew net product sales by 76% year-over-year, generated $59.6 million in net income and increased our cash balance to $108.4 million. This strong performance has enabled us to raise our 2025 financial guidance," said Raul Rodriguez, Rigel's president and CEO. "We're also excited by the continued advancement of our hematology and oncology development pipeline. In July, we completed enrollment in the dose escalation part of our ongoing Phase 1b study evaluating R289 in patients with relapsed or refractory lower-risk MDS. Later this year, we plan to share updated data from that study and initiate the dose expansion part of the study." Second Quarter 2025 Business Update Commercial Net product sales were $58.9 million, an increase of 76% from the same period of 2024. Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced that its licensing partner, JW Pharmaceutical Corporation, commercially launched TAVALISSE in South Korea in early July. Corporate In April, Rigel notified Eli Lilly and Company (Lilly) that it would not exercise its opt-in right related to the development and commercialization of ocadusertib (previously R552) for the treatment of non-central nervous system (CNS) diseases. As a result of the notification, Rigel recognized $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability in the second quarter. Per the agreement with Lilly, Rigel will continue to be entitled to receive milestone and tiered royalty payments on future net sales of ocadusertib and the companies' CNS penetrant program. Clinical Development Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a novel 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 part of the study was completed in July. The company expects to share updated data from the study later this year and plans to initiate the dose expansion part of the study in the second half of this year. Rigel presented 4 posters at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and 3 posters at the European Hematology Association (EHA) 2025 Congress. Presentations included the final data from the GAVRETO (pralsetinib) Phase 1/2 ARROW study in RET fusion-positive non-small cell lung cancer (NSCLC) and other solid tumors, and supportive data for REZLIHDIA (olutasidenib) in patients with mutated isocitrate dehydrogenase-1 (mIDH1) relapsed or refractory (R/R) acute myeloid leukemia (AML). Key Publications A paper titled "Effectiveness of Olutasidenib versus Ivosidenib in Patients With Mutated Isocitrate Dehydrogenase 1 Acute Myeloid Leukemia Who Are Relapsed or Refractory to Venetoclax: The 2102-HEM-101 Trial Versus a US Electronic Health Record-Based External Control Arm," was published in June by Catherine Lai, M.D., MPH, lead author and associate professor of Clinical Medicine, Division of Hematology-Oncology, Department of Medicine at University of Pennsylvania, in Leukemia & Lymphoma. A paper titled "Olutasidenib Alone or Combined with Azacitidine in Patients with Mutant IDH1 Myelodysplastic Syndrome," was published in July by Jorge E. Cortes, M.D., lead author and director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, in Blood Advances. This is the first full report of the safety and clinical activity of an mIDH1 inhibitor plus hypomethylating agent (HMA) combination in patients with treatment-naïve and R/R MDS. The paper showed olutasidenib, alone or in combination with azacitidine, induced a high rate of clinically meaningful complete remission and hematologic improvement responses with durable remission duration, accompanied by low rates of serious treatment-emergent-adverse events in patients with intermediate-, high- or very high-risk MDS harboring mIDH1. Second Quarter 2025 and Year-to-Date Financial Update For the second quarter ended June 30, 2025, total revenues were $101.7 million, consisting of $58.9 million in net product sales and $42.7 million in contract revenues from collaborations. Net product sales grew 76% compared to $33.5 million in the same period of 2024. TAVALISSE net product sales were $40.1 million, growth of 52% compared to $26.4 million in the same period of 2024. GAVRETO net product sales were $11.8 million compared to $1.9 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $7.0 million, growth of 36% compared to $5.2 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, $2.0 million of revenue from Grifols S.A. (Grifols) related to delivery of drug supplies and earned royalties, $0.4 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 $40.6 million compared to $36.4 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 and stock-based compensation expense. Rigel reported net income of $59.6 million, or $3.33 basic and $3.28 diluted per share, compared to a net loss of $1.0 million, or $0.06 basic and diluted per share, for the same period of 2024. For the six months ended June 30, 2025, total revenues were $155.0 million, consisting of $102.5 million in net product sales and $52.5 million in contract revenues from collaborations. Net product sales grew 72% compared to $59.5 million in the same period of 2024. TAVALISSE net product sales were $68.5 million, growth of 44% compared to $47.5 million in the same period of 2024. GAVRETO net product sales were $20.8 million compared to $1.9 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $13.1 million, growth of 31% compared to $10.0 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, $6.7 million of revenue from Grifols related to delivery of drug supplies and earned royalties, $5.1 million of revenue from Kissei related to a milestone payment and delivery of drug supplies and $0.6 million of revenue from Medison related to delivery of drug supplies and earned royalties. Total costs and expenses were $81.1 million compared to $72.9 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. These increases were partially offset by decreased stock-based compensation expense primarily from performance-based stock awards. Rigel reported net income of $71.1 million, or $3.98 basic and $3.91 diluted per share, compared to a net loss of $9.3 million, or $0.53 basic and diluted per share, for the same period of 2024. Cash, cash equivalents and short-term investments as of June 30, 2025 was $108.4 million, compared to $77.3 million as of December 31, 2024. 2025 Outlook Rigel is updating its 2025 total revenue guidance to approximately $270 to $280 million, an increase from the previous range of approximately $200 to $210 million, which includes: Net product sales of approximately $210 to $220 million, an increase from the previous range of approximately $185 to $192 million. Contract revenues from collaborations of approximately $60 million, an increase from the previous range of approximately $15 to $18 million. The company anticipates it will report positive net income for the full year 2025, while funding existing and new clinical development programs. The above total revenues and contract revenues from collaborations are inclusive of $40 million in non-cash contract revenue related to Rigel's agreement with Lilly. 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 March 31, 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 March 31, 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 This press release contains forward-looking statements relating to, among other things, expected commercial and financial results, projected financial performance and outlook for 2025, expectations for growing our commercial business, potential investment in our pipeline, continued advancement and updated results of the dose escalation portion of our R289 study, 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 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 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 March 31, 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1License out/inFinancial StatementDrug ApprovalAccelerated Approval

100 Deals associated with Pralsetinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11712	Pralsetinib	L01XE	DB15822

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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	United States	-	24 Jul 2020
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


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	kmuzrkaxjk(xpikwlutat) = yylongszqg dzorlitybu (gbjvkcvetm, 64.3 - 75.8) View more	Positive	30 May 2025
RET MAP registry (ASCO2025)	Not Applicable	Non-Small Cell Lung Cancer	354	Selpercatinib	qekovnbgzq(jhjwioscwf) = recurrent toxicity may occur in one-third of patients ieszohikqf (viqgbjsfdd ) 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	mtsecdkjem(udmoryyaik) = nawsghwhtt owjviuyhdv (oivdsyuxwc ) 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	gjczywzdcr(rkusmpzhhr) = severe side effect in untreated patients fsfmkowzer (lidaflethv ) 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	kbkupxnbks(bcfkvqdpij) = dzwejnrqrv mcbuzctjbm (iefjqabyaz, 42.4 - 68.5) View more	Positive	01 Jan 2024
				PralsetinibPralsetinib 400 mg (treatment-naïve patients with RET-mutant MTC)	kbkupxnbks(bcfkvqdpij) = udwchrvxeb mcbuzctjbm (iefjqabyaz, 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	kubjhrmvby(gkweumccle) = ewqscnlgze ouywivmpfz (fgiazpwhyp, 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)	dpnwusdpgt(vgswukaevp) = qxylqtlyjf jhaowcwomo (tpsifgmmzo, 48 - 82) View more	Positive	03 Dec 2022
				pralsetinib,400 mg (treatment-naïve)	dpnwusdpgt(vgswukaevp) = aarjpddlgk jhaowcwomo (tpsifgmmzo, 65 - 94) View more
Pubmed Manual	Not Applicable	RET fusion-positive Non-Small Cell Lung Cancer RET fusion-positive	59	Pralsetinib (overall)	hseirqkepe(dudcagmryj) = yuiwjzwnix bsalqrzowa (vcqxshvqub, 4.7 - NA) View more	Positive	09 Nov 2022
				Pralsetinib (patients with measurable brain metastases)	bjhffsmlri(swnmjvmmce) = xlcrkuupjn skoaebhhji (bnmqnmoqig ) 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)	dkfvajekdo(rdinzrdcpj) = oeapnkaqkl voesfdlmmx (nshbdghtpn, 60.0 - 74.8) View more	Positive	10 Sep 2022
				Pralsetinib 400mg/day (CCDC6)	dkfvajekdo(rdinzrdcpj) = irgonwxszj voesfdlmmx (nshbdghtpn, 51.9 - 81.9) 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)	nfdccsfylt(fzlhagjmaq) = cpheeumzon elbxjwatug (zzmurutoaj, 39.7 - 64.6) View more	Positive	10 Sep 2022
				pralsetinib,400 mg QD (Treatment-naïve pts with RETm MTC)	nfdccsfylt(fzlhagjmaq) = jliicshimo elbxjwatug (zzmurutoaj, 59.3 - 82.0) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

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

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis