Pralsetinib

CS2009 Achieved Key Clinical Validations for Efficacy and Safety As of August 2026, updated data further confirmed the favorable safety profile of CS2009 and demonstrated strengthened efficacy across multiple key cohorts compared with the data presented at ASCO in May 2026. With expanded patient enrollment and longer follow-up, improvements were observed in both the objective response rate (ORR) and duration of response (DOR): Compelling monotherapy efficacy in first-line non-small cell lung cancer (NSCLC) At the 30 mg/kg dose level, CS2009 achieved an ORR of 100% and a disease control rate (DCR) of 100% in patients with PD-L1 TPS ≥50%. In the broader PD‑L1 TPS ≥1% population, the ORR was 70.8% and DCR was 91.7%. Monotherapy efficacy in Immunotherapy (IO)-pretreated NSCLC and IO-nonresponsive "cold tumors" further validates CTLA-4 activity and efficacy In second-line NSCLC patients (all previously treated with IO plus chemotherapy), CS2009 monotherapy (30 mg/kg dose level) yielded an ORR of 38.5% and a DCR of 84.6%; In patients with heavily pretreated metastatic colorectal cancer (mCRC), CS2009 monotherapy (30 mg/kg dose level) achieved an ORR of 20% and a DCR of 93.3%; In patients with heavily pretreated soft tissue sarcoma (STS) and non-clear cell renal cell carcinoma (nccRCC), CS2009 monotherapy delivered ORR of 38.5% and 42.9%, respectively. CStone will present additional more mature Phase I/II clinical data for CS2009 in patients with advanced NSCLC and mCRC via two rapid oral presentations at ESMO 2026 in October. The Company also expects to reach consensus with global regulatory authorities including the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), on the global Phase III registrational trial protocol in the fourth quarter of 2026. Pralsetinib Delivers Strong Sales Growth Following its effective inclusion in the National Reimbursement Drug List (NRDL) on January 1, 2026, pralsetinib's in-market sales volume increased by almost 500% year-over-year in the seven‑month period ending July 2026. Solid Cash Position As of June 30, 2026, cash and cash equivalents and time deposits totaled RMB1,560.2 million. SUZHOU, China, Aug. 27, 2026 /PRNewswire/ -- CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, today announced its 2026 interim results and recent business highlights. Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented, "In the first half of 2026, CStone entered a pivotal stage of transition from innovation-driven accumulation to global value realization. Our lead asset, CS2009, continues to advance rapidly through global clinical development. To date, we have accumulated clinical data from more than 300 patients, consistently demonstrating three key clinical validations: first, proof of safety; second, multidimensional confirmation of CTLA‑4 target activity and efficacy, evidenced by pharmacodynamic biomarkers and clinical activity in "cold tumors" and IO‑pretreated NSCLC; and third, broad‑spectrum and highly competitive antitumor efficacy across multiple tumor types. The most recent data show that CS2009's antitumor activity continues to deepen and strengthen with longer follow-up, exhibiting particularly competitive efficacy and a well-tolerated safety profile in key patient populations, including NSCLC and mCRC. These robust data provide strong support for the upcoming global Phase III registrational trials. We look forward to presenting additional more mature clinical data on CS2009 in oral presentations at the ESMO Congress this October. Beyond CS2009, other Pipeline 2.0 candidates are also progressing steadily toward clinical stage. CS5007, built on our proprietary ADC platform, has initiated a global Phase I clinical trial in both China and Australia. In addition, more than ten early-stage programs spanning next-generation ADCs, immunology & inflammation and other areas are advancing smoothly. The successive entry of these differentiated innovative assets into clinical development will serve as a critical driver for the Company's sustained growth and global expansion. On the commercial front, our three key products, sugemalimab, pralsetinib, and avapritinib, continued to achieve breakthroughs across domestic and international markets, contributing significant momentum to revenue growth. Notably, following pralsetinib's first-time inclusion in the NRDL earlier this year, its in-market sales volume increased by almost 500% year-over-year during the first seven months of 2026, making it the primary driver of the Company's revenue growth in the first half of 2026. Looking ahead, CStone will focus on advancing the clinical value of its Pipeline 2.0 assets and actively pursue global partnerships to accelerate their development. Concurrently, the Company will continue to maximize the commercial potential of its marketed products through strategic partnerships and resource integration. Our goal is to foster a sustainable growth model where R&D and commercialization reinforce each other, creating a virtuous cycle between innovation and business operations." Business Highlights For the six months ended June 30, 2026 and up to the date of this results announcement, CStone made significant progress across both its proprietary Pipeline 2.0 portfolio and its commercial franchise, advancing the Company's strategy to build a fully integrated, globally competitive biopharmaceutical company. Clinical Stage Core Asset CS2009, PD-1/VEGF/CTLA-4 trispecific antibody Accelerating global clinical development toward Phase III registrational trials by year end The ongoing global Phase I/II trial has enrolled more than 300 patients across China and Australia, with U.S. Investigational New Drug (IND) clearance obtained in February 2026. CStone plans to initiate the first wave of global Phase III multi-regional clinical trials (MRCTs) for CS2009 by the end of 2026. Planned registrational studies include first-line non-small cell lung cancer (NSCLC) in combination with chemotherapy (versus pembrolizumab plus chemotherapy), and first-line mCRC in combination with chemotherapy (versus bevacizumab plus chemotherapy), with additional registrational studies planned for 2027 and following years. CS2009 validates its potential as a next-generation I/O backbone At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, CStone presented comprehensive Phase I/II data from the ongoing global multicenter trial. As of the data cutoff date of August 2026, updated monotherapy efficacy data from the ongoing global Phase I/II trial of CS2009, reflecting a longer follow-up and larger sample size than the ASCO 2026 presentation continued to demonstrate robust and deepening antitumor activity across multiple tumor types. Three important key clinical validations are achieved from over 300 patient data: Proof of safety Across all dose levels, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. In the ASCO 2026, the incidence of Grade ­3 treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs) were 24.6% and 12.7%, respectively. Notably, the incidence of Grade ­3 VEGF-related TRAEs was only 5.1%. No excessive toxicities typically associated with CTLA-4/PD-(L)1 combinations were observed. As of August 2026, the safety profile of CS2009 remained consistent with that presented at the 2026 ASCO Annual Meeting, with no new safety signals identified. Proof of CTLA-4 activities and efficacy Dose-dependent upregulation of ICOS on CD4+ T cells was observed as a pharmacodynamic biomarker of CTLA-4 blockade. Activity was also seen in "cold tumor" not sensitive to PD-(L)1 mAb: Later-line monotherapy for mCRC (30 mg/kg): the objective response rate (ORR) was 20.0% (3/15) and the disease control rate (DCR) was 93.3% (14/15). Later-line monotherapy for soft-tissue sarcoma (STS): the ORR was 38.5% (5/13) and the DCR was 69.2% (9/13). Later-line monotherapy for non-clear cell renal cell carcinoma (nccRCC): the ORR was 42.9% (3/7) and the DCR was 100.0% (7/7). Promising anti-tumor activity in later-line post immuno-oncology (IO) NSCLC monotherapy: ORR was 23.8% (5/21), DCR was 61.9% (13/21). Among patients who had previously received immunotherapy plus platinum-based chemotherapy (n=13), ORR was 38.5% (5/13) and DCR was 84.6% (11/13). Proof of broad efficacy Monotherapy and chemo-combination activity in first-line and later-line NSCLC: First-line NSCLC monotherapy (PD-L1 tumor proportion score [TPS]­ ≥1%; enrollment completed): ORR of 61.7% (29/47) and DCR of 93.6% (44/47), including ORR of 70.8% (17/24), DCR 91.7% (22/24) in patients treated at 30 mg/kg; in the PD-L1 TPS ≥­50% group (n=24), ORR was 83.3% (20/24) and DCR was 95.8% (23/24) (versus ORR of 81.3% [13/16] at the 2026 ASCO cutoff), including ORR of 100.0% (11/11) and DCR of 100.0% (11/11) in patients treated at 30 mg/kg. After median follow up of 6 months, median progression-free survival (PFS) and DOR have not been reached. Second-line or later NSCLC monotherapy (30 mg/kg): ORR of 28.0% (7/25) and DCR of 60.0% (15/25), with a 6-month DOR rate of 83.3% (versus ORR of 24.0% and a 6-month DOR rate of 80.0% at the 2026 ASCO cutoff). Across all evaluated dose levels (n=54), ORR was 16.7% (9/54) and DCR was 68.5% (37/54), with a 6-month DOR rate of 87.5% (versus 85.7% at the 2026 ASCO cutoff). Later-line NSCLC (second/third-line combination therapy, n=6): ORR of 66.7% (4/6), DCR of 100.0% (6/6). Data are as of the 2026 ASCO data cutoff and will be updated at ESMO 2026. First-line squamous NSCLC combination therapy (PD-L1-low/negative, TPS ≤5%, n=8): ORR of 75.0% (6/8), DCR of 100.0% (8/8); notably, the ORR reached 100.0% (4/4) in the PD-L1-negative subgroup. Data are as of the ASCO 2026 data cutoff and will be updated at ESMO 2026. Robust Chemo-combo efficacy in the first-line mCRC, mostly proficient mismatch repair or microsatellite stable (pMMR/MSS): First-line mCRC (with XELOX, n=6): ORR of 66.7% (4/6), DCR of 100.0% (6/6). Data as of 2026 ASCO cutoff, will be updated at ESMO 2026. Promising monotherapy activity observed in metastatic castration-resistant prostate cancer (mCRPC), ovarian cancer, triple-negative breast cancer, gastric cancer, esophageal cancer, as well as STS and nccRCC. Upcoming two oral presentations of CS2009 at ESMO 2026 The clinical research results of CS2009 have been accepted for two Rapid Oral presentations at the 2026 European Society for Medical Oncology (ESMO) Congress. The presentations will feature Phase I/II clinical data of CS2009 in patients with advanced NSCLC and mCRC. Other Clinical Stage Asset CS5007, EGFR/HER3 ADC Global Phase I trial initiated in China and Australia The Company initiated the Phase I first-in-human study in June 2026. This trial consists of dose-escalation and dose-expansion cohorts evaluating CS5007 as a monotherapy in patients with advanced solid tumors, and will be conducted concurrently in Australia and China. CStone presented preclinical data for CS5007 at the 2026 American Association for Cancer Research (AACR) Annual Meeting, further supporting its broad-spectrum anti-tumor potential. Commercial Products CEJEMLY ® (sugemalimab), anti-PD-L1 antibody Global regulatory and scientific recognition Following the initial marketing authorizations of sugemalimab in the European Union (EU) and the United Kingdom (U.K.) for Stage IV NSCLC, sugemalimab received additional approvals in the EU in November 2025 and subsequently in the U.K. in February 2026 as monotherapy for adults with unresectable Stage III NSCLC whose disease has not progressed following platinum-based chemoradiotherapy (CRT). Meanwhile, marketing authorization applications for sugemalimab have either been approved or are under active review in nearly 30 countries worldwide. In March 2026, CEJEMLY® (sugemalimab) was included in the ESMO Early and Locally Advanced NSCLC Living Guideline. Sugemalimab received a Level [I, A] recommendation for consolidation therapy in patients with unresectable Stage III NSCLC who have not progressed after concurrent or sequential chemoradiotherapy. Secured fifth international commercial partnership In June 2026, CStone entered into an exclusive commercialization agreement with Arrotex Pharmaceuticals Pty Ltd (Arrotex), Australia's largest privately owned pharmaceutical company with established oncology commercialization capabilities and distribution infrastructure across Australia and New Zealand. This milestone expands sugemalimab's global commercialization network to five strategic partnerships, covering more than 60 countries and regions across Europe, the Middle East and Africa, Latin America, and Oceania. Pralsetinib capsules, RET inhibitor NRDL inclusion and accelerated commercial growth Following the inclusion of pralsetinib capsules (100 mg) in China's NRDL in late 2025, effective January 1, 2026, patient access has improved significantly. In the seven‑month period ending July  2026, pralsetinib's in-market sales volume increased by almost 500% year-over-year. Localized manufacturing approval supporting commercial scalability Following the approval by China's NMPA of the manufacturing localization application for pralsetinib capsules (100 mg), the first batch of locally-manufactured pralsetinib was released in China in 2026. Preclinical/IND-enabling Stage Programs A balanced, differentiated early-stage portfolio spanning oncology and immunology/inflammation CStone's preclinical Pipeline 2.0 comprises innovative candidates across multispecific antibodies, ADCs and other next-generation modalities, with potential first-in-class (FIC) or best-in-class (BIC) opportunities spanning oncology, immunology, inflammation and other high-value therapeutic areas. The Company's proprietary ADC platform incorporates optimized linker technologies designed to enable tumor-selective payload release and supports multiple Pipeline 2.0 ADC candidates, including CS5007 (EGFR and HER3 bispecific ADC), CS5006 (ITGB4 ADC), CS5008 (DLL3 and SSTR2 bispecific ADC), etc. The Company is also exploring next-generation ADC technologies, including dual-payload ADCs (e.g., CS5009, a B7H3/PD-L1 bispecific dual-payload ADC, and CS5010, a HER2-targeting dual-payload ADC) and novel-payload ADCs (e.g., CS5012, a HER2-targeting novel-payload ADC). In April 2026, CStone presented preclinical data for CS5007, CS5006 and CS5008 at the 2026 AACR Annual Meeting, highlighting the breadth and differentiation of its next-generation ADC pipeline. Beyond oncology, CStone has expanded Pipeline 2.0 into immunology and inflammation by leveraging its proprietary multispecific antibody platform. The Company has developed CS2015 (OX40L/TSLP bispecific antibody) targeting Type 2 inflammatory diseases, CS2013 (BAFF/APRIL bispecific antibody) targeting B cell-mediated autoimmune diseases, CS2016 (TL1A/α4β7 bispecific antibody), and CS1016 (PD-1 agonist antibody). Future and Outlook Our mission is to deliver transformative therapies through scientific excellence and technological innovation, making high-quality treatments accessible worldwide to benefit patients and their families. We reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments, while executing strategic partnerships to unlock the global value of our in-market products. Key catalysts for the second half of 2026 include: Clinical milestones Accelerate global development of CS2009 by advancing interactions with global regulatory authorities, including the U.S. FDA and the CDE of NMPA, on Phase III registrational trial design, with the first wave of global Phase III MRCTs planned to be initiated by the end of 2026, while continuing to pursue global partnerships. Advance clinical development of CS5007 (EGFR/HER3 bispecific ADC), CS5006 (ITGB4 ADC), CS5008 (SSTR2/DLL3 ADC) and other early-stage candidates. Innovation and technology Further strengthen proprietary technology platforms, including multi-specific antibody and next-generation ADC technologies, to support sustained expansion of the preclinical pipeline. Present key clinical data, including updated CS2009 data, at major international scientific conferences, including two Rapid Oral presentations of CS2009 Phase I/II data at the 2026 ESMO Congress. Financial Highlights International Financial Reporting Standards (IFRS) Measures: Revenue was RMB205.1 million for the six months ended June 30, 2026. The revenue is composed of RMB183.2 million from sales of pharmaceutical products (avapritinib, pralsetinib and sugemalimab), RMB6.9 million from license fee income and RMB15.0 million from royalty income of sugemalimab. The substantial revenue growth was primarily driven by a significant increase in sales of pharmaceutical products, particularly pralsetinib, following its successful inclusion in the NRDL effective from January 2026, which led to a marked sales ramp-up. Cost of revenue was RMB110.9 million for the six months ended June 30, 2026. Research and development expenses were RMB205.5 million for the six months ended June 30, 2026, primarily due to increased costs for clinical trials. Administrative expenses were RMB51.3 million for the six months ended June 30, 2026. Selling and marketing expenses were RMB73.1 million for the six months ended June 30,2026. Loss for the period was RMB252.3 million for the six months ended June 30, 2026. Cash and cash equivalents and time deposits were RMB1,560.2 million as of June 30, 2026. Non-International Financial Reporting Standards (Non-IFRS) Measures: Research and development expenses excluding the share-based payment expenses were RMB193.4 million for the six months ended June 30, 2026, primarily due to increased costs for clinical trials. Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB115.2 million for the six months ended June 30, 2026. Loss for the period excluding the share-based payment expenses was RMB230.9 million for the six months ended June 30, 2026. 2026 Interim Results Conference Call The Company will host its 2026 Interim results earnings call at 9:00 a.m. (Beijing Time) on Friday August 28, 2026. Please register for the conference in advance through the link: . About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 21 new drug applications covering 9 indications. The company's pipeline is balanced by 13 promising innovative candidates, featuring antibody-drug conjugates (ADCs), mono-/multi-specific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit: . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals 21% more press release views with Request a Demo

Second quarter 2026 total revenues of $78.7 million, including net product sales of $67.0 million and contract revenues from collaborations of $11.7 million, and net income of $17.3 million Expanded commercial portfolio with the in-license of VEPPANU™ (vepdegestrant), with U.S. commercial availability expected in mid-August Advanced R289 development program; Phase 1b study in patients with lower-risk MDS remains on track to complete enrollment in the dose expansion portion and select the recommended Phase 2 dose in the second half of 2026 Updated 2026 Outlook: Total revenues of approximately $285 to $295 million, which includes net product sales, excluding VEPPANU, of $255 to $265 million and contract revenues from collaborations of approximately $30 million Conference call and webcast scheduled today at 4:30 p.m. Eastern Time SOUTH SAN FRANCISCO, Calif., Aug. 4, 2026 /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, 2026, including sales of TAVALISSE® (fostamatinib disodium hexahydrate), GAVRETO® (pralsetinib) and REZLIDHIA® (olutasidenib), and recent business progress, including the in-license of VEPPANU™ (vepdegestrant), a PRoteolysis TArgeting Chimera (PROTAC). "Rigel delivered a strong second quarter, highlighted by record net product sales, continued profitability and the in-license of VEPPANU, the first and only FDA-approved PROTAC for patients with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. We expect VEPPANU to be commercially available later this month, further expanding our commercial business in hematology and oncology," said Raul Rodriguez, Rigel's president and CEO. "We are also advancing the development of R289 in our ongoing Phase 1b study in patients with R/R lower-risk MDS, and remain on track to complete enrollment in the dose expansion phase of the study, select a recommended Phase 2 dose in the second half of 2026 and share preliminary data by year end." Second Quarter 2026 Business Update Corporate Rigel entered into an exclusive, global licensing agreement with Arvinas, Inc. (Arvinas) and Pfizer Inc. (Pfizer) to develop, manufacture and commercialize VEPPANU (vepdegestrant). VEPPANU is the first and only PROTAC approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer (mBC), as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. The agreement became effective on June 11, 2026, and Rigel paid the upfront payment of $70.0 million to Arvinas and Pfizer in the second quarter. Upon close of the transaction, Rigel immediately initiated launch activities and expects VEPPANU to be commercially available in the United States for the treatment of second line-plus (2L+) ER+/HER2-, ESR1-mutated mBC in mid-August 2026. In July, Rigel announced the appointment of Alison L. Hannah, M.D. to the role of Executive Vice President and Chief Medical Officer. Dr. Hannah has decades of oncology drug development experience and served on Rigel's Board of Directors since 2021. She resigned from Rigel's Board of Directors in connection with her appointment. Commercial Second quarter net product sales were $67.0 million, an increase of 14% from the same period of 2025. Rigel's partner Knight Therapeutics Inc. (Knight) received regulatory approval from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) in May for TAVALISSE for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Also in May, Knight commercially launched TAVALISSE in Mexico. Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) submitted a new drug application for manufacturing and marketing approval in Japan for olutasidenib in May. In connection with the submission, Rigel received a $4.0 million regulatory milestone payment from Kissei during the second quarter. Clinical Development Rigel continues to advance its Phase 1b clinical study of R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS), with enrollment in the dose expansion phase ongoing and on track to be completed in the second half of 2026. The company expects to select the recommended Phase 2 dose in the second half of 2026 and share preliminary dose expansion data by year end. The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) 2026 Congress featured an oral presentation and several poster presentations for pralsetinib and olutasidenib. The final data from the Phase 3 AcceleRET-Lung clinical trial of pralsetinib as first-line treatment of rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) were presented in an oral session at ASCO. In addition, ASCO and EHA featured poster presentations that included additional data for pralsetinib and data for olutasidenib for the treatment of R/R isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukemia (AML). Key Publication A paper titled "Preclinical Characterization and Early Development of R835, a Novel, Selective Dual IRAK1 and IRAK4 Inhibitor," was published in Scientific Reports in July. R835, the active metabolite of the prodrug R289, potently and selectively inhibited toll-like receptor (TLR) and interleukin-1 receptor (IL-1R)-dependent proinflammatory cytokine production in multiple preclinical models, demonstrating efficacy in both prophylactic and treatment preclinical settings. Additionally, in a placebo-controlled, double-blind, Phase 1, first-in-human study in 82 healthy participants, R835 was well tolerated with a favorable pharmacokinetic profile across all dose levels evaluated, and markedly inhibited lipopolysaccharide (LPS)-induced peak cytokine concentrations by approximately 40-80% compared to placebo. These data provided clinical proof of mechanism of a dual IRAK1/4 inhibitor suppressing proinflammatory cytokine release in humans. Second Quarter and Year-to-Date 2026 Financial Update For the second quarter ended June 30, 2026, total revenues were $78.7 million, consisting of $67.0 million in net product sales and $11.7 million in contract revenues from collaborations. Net product sales increased 14% compared to $58.9 million in the same period of 2025. TAVALISSE net product sales were $47.4 million, an increase of 18% compared to $40.1 million in the same period of 2025. GAVRETO net product sales were $10.7 million, a decrease of 10% compared to $11.8 million in the same period of 2025. REZLIDHIA net product sales were $8.9 million, an increase of 27% compared to $7.0 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $5.8 million of revenue from Kissei, which included a $4.0 million regulatory milestone payment in connection with the marketing authorization application submission for olutasidenib in Japan and delivery of drug supplies; $5.0 million of revenue from Grifols S.A. (Grifols) related to earned royalties and delivery of drug supplies; and $0.3 million of revenue from Medison Pharma (Medison) related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability from Rigel's collaboration agreement with Eli Lilly and Company (Lilly). Total costs and expenses were $55.1 million, compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily driven by higher personnel-related costs, cost of product sales, and research and development costs, including the continued progress of the R289 program and costs associated with development activities under Rigel's license agreement with Arvinas and Pfizer. Income before income taxes was $23.6 million, compared to $60.0 million for the same period of 2025. Rigel reported net income of $17.3 million, or $0.93 basic and $0.88 diluted per share, compared to $59.6 million, or $3.33 basic and $3.28 diluted per share, for the same period of 2025. As noted above, the prior year period included $40.0 million in non-cash revenue related to Rigel's collaboration agreement with Lilly. For the six months ended June 30, 2026, total revenues were $137.5 million, consisting of $121.9 million in net product sales and $15.6 million in contract revenues from collaborations. Net product sales increased 19% compared to $102.5 million in the same period of 2025. TAVALISSE net product sales were $84.7 million, an increase of 24% compared to $68.5 million in the same period of 2025. GAVRETO net product sales were $20.3 million, a decrease of 2% compared to $20.8 million in the same period of 2025. REZLIDHIA net product sales were $17.0 million, an increase of 29% compared to $13.1 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $7.6 million of revenue from Kissei, including a $4.0 million regulatory milestone and delivery of drug supplies; $6.8 million of revenue from Grifols related to earned royalties and delivery of drug supplies; and $0.5 million of revenue from Medison related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability from Rigel's collaboration agreement with Lilly and a $3.0 million regulatory milestone in connection with the approval of TAVALISSE in the Republic of Korea. Total costs and expenses were $102.1 million, compared to $81.1 million for the same period of 2025. The increase in costs and expenses was primarily driven by higher personnel-related costs; research and development costs, including the continued progress of the R289 program and costs associated with development activities under Rigel's license agreement with Arvinas and Pfizer; cost of product sales, and commercial-related expenses. Income before income taxes was $35.2 million, compared to $71.5 million for the same period of 2025. Rigel reported net income of $25.9 million, or $1.40 basic and $1.32 diluted per share, compared to $71.1 million, or $3.98 basic and $3.91 diluted per share, for the same period of 2025. As noted above, the prior year period included $40.0 million in non-cash revenue related to Rigel's collaboration agreement with Lilly. Cash, cash equivalents and short-term investments as of June 30, 2026 was $95.3 million, compared to $155.0 million as of December 31, 2025. 2026 Outlook Rigel has increased its 2026 total revenues guidance to approximately $285 to $295 million, from the prior range of approximately $275 to $290 million, which includes: Net product sales of approximately $255 to $265 million. Contract revenues of approximately $30 million, an increase from the prior range of approximately $20 to $25 million. The above revenue guidance excludes VEPPANU. The company also continues to anticipate it will report positive net income for the full year 2026, while funding existing and new clinical development programs. Conference Call and Webcast with Slides Today at 4:30 p.m. Eastern Time Rigel will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and will be accessible from the Investor Relations section of the company's website at . The webcast will be archived and available for replay after the call via the Rigel website. About ITP In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP. About NSCLC It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3 About AML Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,720 new cases in the United States, most in adults, in 2026.4 Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow. 5,6 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.7 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need. About ER+/HER2-, ESR1 -mutated Metastatic Breast Cancer Breast cancer is the most common cancer in women in the United States, except for skin cancers.8 The estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) patient population represents the majority (70%) of breast cancer, where treatment with endocrine therapies (aromatase inhibitors) is the standard of care. While endocrine therapy remains a cornerstone of metastatic ER+/HER2- breast cancer treatment, up to 50% of patients treated with endocrine therapy and a CDK4/6 inhibitor acquire estrogen receptor 1 gene (ESR1) mutations, resulting in endocrine resistance and poor prognosis. Treatment options in second-line and later ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer setting include chemotherapy, selective estrogen receptor degraders (SERDs), and as of May 2026, vepdegestrant, the first and only FDA-approved oral PROteolysis TArgeting Chimera (PROTAC). About TAVALISSE ® TAVALISSE (fostamatinib disodium hexahydrate) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE. About GAVRETO ® GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).* *Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for GAVRETO. About REZLIDHIA ® REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA. About VEPPANU™ VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. Please click here for Important Safety Information and Full Prescribing Information for VEPPANU. To report side effects of prescription drugs to the FDA, visit or call 1-800-FDA-1088 (800-332-1088). TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks and VEPPANU is a trademark of Rigel Pharmaceuticals, Inc. 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 13, 2026. Accessed June 30, 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 January 13, 2026. Accessed June 30, 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: The American Cancer Society. Key Statistics for Breast Cancer. Revised June 24, 2026. Accessed June 30, 2026: Forward Looking Statements This press release contains forward-looking statements relating to, among other things, expected commercial launches and commercial availability, commercial, financial and clinical results, projections of financial performance and outlook for 2026, expectations for growing our commercial business and successfully executing our commercial strategy, continued enrollment of our R289 study, presentation of study data, expectation of clinical outcomes, continued ability to develop and commercialize VEPPANU, TAVALISSE, GAVRETO, REZLIDHIA, and R289 domestically and in certain international markets, the Company's ability to fund its existing and future clinical development programs, and expectations for our partnering, licensing, commercialization 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. These forward-looking statements include, without limitation, anticipated financial performance and profitability for 2026; expected product sales and commercial growth; the anticipated timing, progress and results of clinical development activities for R289, including enrollment, dose selection and data readouts; the Company's ability to fund its existing and future development programs; the anticipated commercial launch and commercialization of VEPPANU; the Company's ability to execute its commercial strategy and its partnering, licensing, commercialization, collaboration and potential business development activities. 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 VEPPANU, TAVALISSE, GAVRETO and REZLIDHIA, including uncertainties relating to physician adoption, patient demand, market acceptance, reimbursement and pricing; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding VEPPANU, TAVALISSE, GAVRETO, REZLIDHIA or R289; operational, regulatory or other risks that can affect the timing of enrollment and data availability for R289 clinical development; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that VEPPANU, TAVALISSE, GAVRETO, REZLIDHIA or R289 may have unintended side effects, adverse reactions or incidents of misuse; the availability of resources to develop or market Rigel's product candidates; market competition; product demand variability; pricing/reimbursement dynamics; unanticipated business needs and other developments, including potential partnering, licensing or other collaboration arrangements, which could impact Rigel's funding needs or other internal resource demands, 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, 2026 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