Rigel Reports Third Quarter 2025 Financial Results and Provides Business Update
Rigel (Nasdaq: RIGL) reported Q3 2025 total revenue of $69.5M, including record net product sales of $64.1M (+65% YoY), and net income of $27.9M for the quarter. Year-to-date revenue was $224.5M. Cash, cash equivalents and short-term investments totaled $137.1M as of September 30, 2025.
The company completed dose escalation and began dose expansion in its Phase 1b R289 IRAK1/4 program and will present updated R289 data at ASH in December. Rigel raised 2025 revenue guidance to $285–$290M, including net product sales of $225–$230M, and expects positive net income for full-year 2025.
Rigel (Nasdaq: RIGL) ha riportato entrate totali nel terzo trimestre 2025 di 69,5 milioni di dollari, inclusi ricavi netti da prodotti record di 64,1 milioni di dollari (+65% rispetto all'anno precedente), e utile netto di 27,9 milioni di dollari per il trimestre. Le entrate da inizio anno ammontavano a 224,5 milioni di dollari. La liquidità, equivalenti di cassa e investimenti a breve termine ammontavano a 137,1 milioni di dollari al 30 settembre 2025.
L'azienda ha completato l'aumento della dose e ha iniziato l'espansione della dose nel suo programma di Fase 1b R289 IRAK1/4 e presenterà dati aggiornati di R289 all'ASH di dicembre. Rigel ha aumentato la guidance delle entrate per il 2025 a 285–290 milioni di dollari, inclusi ricavi netti da prodotti di 225–230 milioni di dollari, e si aspetta un utile netto positivo per l'intero anno 2025.
Rigel (Nasdaq: RIGL) reportó ingresos totales del tercer trimestre de 2025 de 69,5 millones de dólares, incluyendo ventas netas de productos récord de 64,1 millones de dólares (+65% interanual), y una ganancia neta de 27,9 millones de dólares para el trimestre. Los ingresos acumulados del año fueron 224,5 millones de dólares. E al 30 de septiembre de 2025, el efectivo, equivalentes de efectivo e inversiones a corto plazo totalizaban 137,1 millones de dólares.
La compañía completó la escalada de dosis y comenzó la expansión de dosis en su programa de Fase 1b R289 IRAK1/4 y presentará datos actualizados de R289 en el ASH en diciembre. Rigel elevó la guía de ingresos para 2025 a 285–290 millones de dólares, incluyendo ventas netas de productos de 225–230 millones de dólares, y espera un ingreso neto positivo para el año completo 2025.
Rigel (나스닥: RIGL)은(2025년 3분기 총 매출 6,950만 달러), 기록적인 순제품 매출 6,410만 달러 (+전년 동기 대비 65%) 및 분기 순이익 2,790만 달러를 보고했습니다. 연간 누적 매출은 2억 2,450만 달러였고, 2025년 9월 30일 기준 현금 및 현금성자산과 단기투자액은 1억 3,710만 달러였습니다.
회사는 1상 1b R289 IRAK1/4 프로그램에서 용량 증가를 완료했고 용량 확장을 시작하였으며 12월 ASH에서 R289 데이터를 업데이트 발표할 예정입니다. Rigel은 2025년 매출 가이던스를 2억 8,500만~2억 9,000만 달러로 상향했으며, 그 중 순제품 매출은 2억 2,500만~2억 3,000만 달러를 포함하고, 2025년 전체년 순이익 흑자를 기대합니다.
Rigel (NYSE: RIGL) a publié un chiffre d'affaires total du T3 2025 de 69,5 M$, dont des ventes nettes de produits records de 64,1 M$ (+65% sur un an), et un résultat net de 27,9 M$ pour le trimestre. Le chiffre d'affaires cumulé depuis le début de l'année s'élevait à 224,5 M$. La trésorerie, les équivalents de trésorerie et les placements à court terme s'élevaient à 137,1 M$ au 30 septembre 2025.
La société a terminé l'augmentation de dose et a commencé l'expansion de dose dans son programme de Phase 1b R289 IRAK1/4 et présentera des données mises à jour de R289 à l'ASH en décembre. Rigel a relevé la prévision des revenus pour 2025 à 285–290 M$, dont 225–230 M$ de ventes nettes de produits, et prévoit un résultat net positif pour l'année complète 2025.
Rigel (Nasdaq: RIGL) meldete den Gesamtumsatz im Q3 2025 von 69,5 Mio. USD, darunter Rekordverkäufe von Produkten in Höhe von 64,1 Mio. USD (+65% YoY), und Nettoeinkommen von 27,9 Mio. USD für das Quartal. Der Umsatz des Jahres bis dato betrug 224,5 Mio. USD. Barmittel, Baräquivalente und kurzfristige Investitionen summierten sich zum 30. September 2025 auf 137,1 Mio. USD.
Das Unternehmen schloss die Dosiseskalation ab und begann mit der Dosiserweiterung in seinem Phase-1b-R289-IRAK1/4-Programm und wird aktualisierte R289-Daten auf der ASH im Dezember vorstellen. Rigel hob die Umsatzprognose für 2025 auf 285–290 Mio. USD an, einschließlich Nettoumsatz aus Produkten von 225–230 Mio. USD, und erwartet für das Gesamtjahr 2025 einen positiven Nettogewinn.
Rigel (ناسداك: RIGL) أبلغت إيرادات الإجماليات في الربع الثالث من 2025 بلغت 69.5 مليون دولار، بما في ذلك مبيعات صافية من المنتجات القياسية بلغت 64.1 مليون دولار (+65% على أساس سنوي)، و صافي دخل قدره 27.9 مليون دولار للربع. الإيرادات حتى تاريخه للسنة كانت 224.5 مليون دولار. النقد وما يعادله من النقد والاستثمارات قصيرة الأجل بلغت 137.1 مليون دولار حتى 30 سبتمبر 2025.
أكملت الشركة تصعيد الجرعة وبدأت توسيع الجرعة في برنامجها من المرحلة 1b R289 IRAK1/4 وسيتم عرض بيانات R289 المحدثة في ASH في ديسمبر. رفعت Rigel توجيهات الإيرادات لعام 2025 إلى 285–290 مليون دولار، بما في ذلك المبيعات الصافية للمنتجات من 225–230 مليون دولار، وتتوقع صافي دخل إيجابي للسنة الكاملة 2025.
- Q3 total revenue of $69.5M
- Net product sales of $64.1M (+65% YoY)
- Q3 net income of $27.9M
- Raised 2025 revenue guidance to $285–$290M
- Cash and short-term investments of $137.1M
- R289 progressed to dose expansion; ASH oral presentation planned
- Lilly notified termination of the CNS program, effective in 60 days
- Year-to-date R&D and personnel costs increased versus prior year
Insights
Strong commercial execution drove record product sales, clear guidance raise, and positive net income for 2025.
Rigel reported third quarter 2025 total revenue of
Business drivers are explicit: meaningful growth across key marketed products—TAVALISSE (
Clinical updates are concrete: enrollment completed in the dose-escalation phase of the Phase 1b R289 study with the first patient dosed in the expansion phase and an oral ASH presentation with an
Key items to watch over the next 3–12 months include the ASH oral presentation in
-
Third quarter 2025 total revenue of approximately
$69.5 million $64.1 million $5.4 -
Generated
$27.9 million - 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 $290 million $225 $230 million - Conference call and webcast scheduled today at 4:30 p.m. Eastern Time
"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 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
Total costs and expenses were
Rigel reported net income of
For the nine months ended September 30, 2025, total revenues were
Total costs and expenses were
Rigel reported net income of
Cash, cash equivalents and short-term investments as of September 30, 2025 was
2025 Outlook
Rigel is updating its 2025 total revenue guidance to approximately
- Net product sales of approximately
$225 $230 million $210 $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 www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.
About ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
About NSCLC
It is estimated that over 226,000 adults in the
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
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 www.fda.gov/medwatch 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
- 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: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
- 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: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html
- 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: https://doi.org/10.3727/096504020X15965357399750
- Thol F, Ganser, A. Treatment of Relapsed Acute Myeloid Leukemia. Curr. Treat. Options on Oncol. (2020) 21: 66. doi: https://doi.org/10.1007/s11864-020-00765-5
- 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: https://doi.org/10.1182/blood-2014-10-551911
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
ir@rigel.com
Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com
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RIGEL PHARMACEUTICALS, INC. |
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STATEMENTS OF OPERATIONS |
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(in thousands, except per share amounts) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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(unaudited) |
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Revenues: |
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Product sales, net |
$ 64,067 |
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$ 38,927 |
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$ 166,565 |
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$ 98,380 |
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Contract revenues from collaborations |
5,395 |
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16,380 |
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57,915 |
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23,302 |
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Total revenues |
69,462 |
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55,307 |
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224,480 |
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121,682 |
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Costs and expenses: |
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Cost of product sales |
4,753 |
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8,026 |
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13,666 |
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12,858 |
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Research and development (see Note A) |
7,353 |
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6,182 |
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22,610 |
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17,748 |
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Selling, general and administrative (see Note A) |
28,936 |
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27,043 |
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85,908 |
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83,539 |
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Total costs and expenses |
41,042 |
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41,251 |
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122,184 |
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114,145 |
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Income from operations |
28,420 |
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14,056 |
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102,296 |
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7,537 |
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Interest income |
1,094 |
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425 |
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2,438 |
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1,570 |
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Interest expense |
(1,894) |
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(2,060) |
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(5,621) |
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(5,963) |
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Income before income taxes |
27,620 |
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12,421 |
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99,113 |
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3,144 |
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(Benefit from) provision for income taxes |
(280) |
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— |
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154 |
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— |
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Net income |
$ 27,900 |
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$ 12,421 |
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$ 98,959 |
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$ 3,144 |
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Net income per share |
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Basic |
$ 1.55 |
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$ 0.71 |
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$ 5.52 |
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$ 0.18 |
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Diluted |
$ 1.46 |
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$ 0.70 |
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$ 5.38 |
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$ 0.18 |
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Weighted average shares used in computing net income per share |
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Basic |
18,038 |
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17,600 |
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17,912 |
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17,556 |
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Diluted |
19,156 |
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17,648 |
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18,379 |
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17,599 |
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Note A |
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Stock-based compensation expense included in: |
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Selling, general and administrative |
$ 2,961 |
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$ 2,360 |
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$ 8,172 |
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$ 9,067 |
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Research and development |
402 |
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284 |
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1,791 |
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1,239 |
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$ 3,363 |
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$ 2,644 |
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$ 9,963 |
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$ 10,306 |
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SUMMARY BALANCE SHEET DATA |
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(in thousands) |
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As of September 30, |
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As of December 31, |
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2025 |
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2024 (1) |
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(unaudited) |
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Cash, cash equivalents and short-term investments |
$ 137,143 |
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$ 77,321 |
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Total assets |
242,534 |
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163,976 |
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Stockholders' equity |
117,609 |
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3,288 |
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(1) |
Derived from audited financial statements |
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SOURCE Rigel Pharmaceuticals, Inc.
FAQ
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