Core Insights - Rigel Pharmaceuticals reported strong financial performance in 2025, with record net product sales and significant cash generation, anticipating continued growth in 2026 [2][4][11] Financial Performance - Preliminary total revenue for Q4 2025 is expected to be approximately $69.8 million, a 21% increase from $57.6 million in Q4 2024 [5] - For the full year 2025, total revenue is projected to be $294.3 million, up from $179.3 million in 2024, representing a growth of 64% [5] - Net product sales for 2025 are expected to be $232.0 million, a 60% increase compared to 2024 [7] Product Sales Breakdown - Q4 2025 net product sales include: - TAVALISSE: $45.6 million, up from $31.0 million in Q4 2024 - GAVRETO: $10.2 million, up from $8.1 million in Q4 2024 - REZLIDHIA: $9.6 million, up from $7.4 million in Q4 2024 [5] Clinical Development - Rigel is advancing its Phase 1b clinical study of R289 for lower-risk MDS, with preliminary data indicating 33% of patients achieved red blood cell transfusion independence [9] - The company plans to complete enrollment in the dose expansion phase of the R289 study by the second half of 2026 and share preliminary results by the end of 2026 [9][11] 2026 Outlook - Rigel anticipates total revenue for 2026 to be between $275 million and $290 million, with net product sales projected at $255 million to $265 million [11] - The company expects to report positive net income for the full year 2026 while funding existing and new clinical development programs [11]

Core Insights - Rigel Pharmaceuticals announced the publication of five-year data from a Phase 2 trial of REZLIDHIA (olutasidenib) for treating relapsed or refractory mutant isocitrate dehydrogenase-1 acute myeloid leukemia (mIDH1 AML) [1][2] Efficacy and Safety Data - The five-year follow-up analysis supports the durable responses and manageable safety profile of olutasidenib, including efficacy in patients previously treated with venetoclax [2][5] - Among 147 efficacy evaluable patients, the complete remission (CR) or CR with partial hematologic recovery (CRh) rate was 35%, with a median duration of 25.3 months [5] - The overall response rate (ORR) was 48%, with a median duration of 15.5 months, and median overall survival (OS) was 11.5 months [5] - Transfusion independence was achieved in 39% of patients dependent on red blood cells and 41% of those dependent on platelets at baseline [5] Patient Response Insights - 66% of patients who achieved an overall response did so within 2 months, while 10% required at least 4.6 months of therapy [5] - Patients with one to two prior regimens had a higher CR/CRh rate of 41% and a median OS of 13 months compared to those with three prior regimens [5] - In patients R/R to prior venetoclax, 33% achieved a CR/CRh, with a median OS of 16.2 months [5] Ongoing Research and Collaborations - Rigel is evaluating olutasidenib in other disease areas and has strategic collaborations with The University of Texas MD Anderson Cancer Center [4][12] - A fifth study under the strategic alliance with MD Anderson has opened for enrollment, focusing on olutasidenib in combination with co-targeted therapies [12] Industry Context - Acute myeloid leukemia (AML) is a rapidly progressing cancer affecting myeloid cells, with an estimated 22,010 new cases in the U.S. in 2025 [6] - Relapsed AML affects about half of all patients post-treatment, while refractory AML occurs in 10-40% of newly diagnosed patients [7]

Financial Performance & Guidance - Rigel increased its 2025 net product sales guidance from approximately $210 million - $220 million to approximately $225 million - $230 million[15, 89] - Q3 2025 net portfolio sales grew by $25.2 million, a 65% increase compared to Q3 2024[24] - Q3 2025 net product sales were $64.1 million[84] - Rigel anticipates 2025 total revenue of approximately $285 million to $290 million, an increase from the previous guidance of approximately $270 million to $280 million[88] - Cash, cash equivalents, and short-term investments as of September 30, 2025, were $137.1 million, compared to $77.3 million as of December 31, 2024[87] Product Sales Performance - TAVALISSE Q3 2025 net product sales were $44.7 million[27, 86] - GAVRETO Q3 2025 net product sales were $11.1 million[27, 86] - REZLIDHIA Q3 2025 net product sales were $8.3 million[27, 86] R289 Clinical Development - R289 is under evaluation in a Phase 1b study for patients with lower-risk MDS[14, 43] - The FDA granted Fast Track designation for R289 for previously-treated transfusion-dependent lower-risk MDS and Orphan Drug designation for MDS[42, 43] Strategic Collaborations - Grifols collaboration revenues were $3.1 million in Q3 2025[34, 86] - Kissei collaboration revenues were $1.8 million in Q3 2025[34, 86] - Medison collaboration revenues were $0.2 million in Q3 2025[34, 86]

Core Insights - Rigel Pharmaceuticals is set to present data from its ongoing Phase 1b study of R289, a dual IRAK1/4 inhibitor, at the 67th American Society of Hematology (ASH) Annual Meeting on December 7, 2025, focusing on patients with relapsed or refractory lower-risk myelodysplastic syndrome (MDS) [1][2][5] - The ASH Annual Meeting will also feature four poster presentations regarding REZLIDHIA (olutasidenib) for treating relapsed or refractory mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML) [1][5] R289 Study Details - The Phase 1b study of R289 has enrolled 33 patients as of July 15, 2025, with a median age of 75 and a median of 3 prior therapies; 61% of these patients had a high transfusion burden at baseline [6] - R289 was administered at doses ranging from 250 mg once daily to 500 mg twice daily, with the most common treatment-emergent adverse events being diarrhea (28.1%), constipation (25%), and increased creatinine/ALT (21.9%) [6] - Among evaluable transfusion-dependent patients receiving doses of at least 500 mg, 31% achieved durable red blood cell transfusion independence for over 8 weeks, with a median time to onset of 2.2 months and a median duration of 24.3 weeks [6] REZLIDHIA Data Highlights - In a pivotal cohort of the Phase 2 registrational study involving 147 patients with R/R mIDH1 AML, 24% maintained stable disease after two treatment cycles, with a subsequent response rate of 33% [9] - The median overall survival for late responders was reported at 23.9 months, indicating that patients with stable disease after two cycles may benefit from continued treatment [9][10] - The overall response rate in a real-world cohort of olutasidenib-treated patients was 50%, supporting its use as a viable therapeutic option in post-venetoclax treatment settings [9][10] Company Overview - Rigel Pharmaceuticals, Inc. is a biotechnology company focused on developing therapies for hematologic disorders and cancer, founded in 1996 and based in South San Francisco, California [26]

Financial Performance & Guidance - Q2 2025 net product sales reached $58.9 million[81] - Q2 2025 contract revenues from collaborations totaled $42.7 million[81] - Rigel increased its 2025 net product sales guidance to a range of $210 million to $220 million, up from the previous guidance of $185 million to $192 million[14, 86] - The company anticipates total revenue for 2025 to be approximately $270 million to $280 million, revised from the initial estimate of $200 million to $210 million[85] - Rigel reported net product sales of $102.5 million YTD[15] Product Performance - Q2 2025 net product sales for TAVALISSE were $40.1 million[26, 83] - Q2 2025 net product sales for GAVRETO were $11.8 million[29, 83] - Q2 2025 net product sales for REZLIDHIA were $7.0 million[29, 83] R&D and Clinical Development - Rigel is evaluating R289, a dual IRAK1/4 inhibitor, in a Phase 1b study for relapsed/refractory lower-risk MDS[13] - The company plans to initiate a Phase 2 study of olutasidenib in recurrent glioma[13] Strategic Collaborations - Collaboration revenues included $40.0 million from Eli Lilly[83] - Grifols contributed $2.0 million in collaboration revenue[35, 83] - Kissei contributed $0.4 million in collaboration revenue[35, 83] - Medison contributed $0.2 million in collaboration revenue[35, 83]

Financial Performance - Total net product sales for Q2 2024 were $33.5 million[148] - TAVALISSE net product sales for Q2 2024 were $26.4 million[34, 148], representing a 25% growth compared to Q2 2023[34] and 8% growth compared to Q1 2024[34] - REZLIDHIA net product sales for Q2 2024 were $5.2 million[65, 148], a 102% increase compared to Q2 2023[65] and a 5% increase compared to Q1 2024[65] - GAVRETO net product sales for Q2 2024 were $1.9 million[96, 148] Product Sales and Growth - TAVALISSE bottles shipped to patients and clinics in Q2 2024 totaled 2,672[34], an 18% increase compared to Q2 2023[33] and a 24% increase compared to Q1 2024[34] - REZLIDHIA bottles shipped to patients and clinics in Q2 2024 totaled 424[64], a 127% increase compared to Q2 2023[64] and a 30% increase compared to Q1 2024[64] - 228 GAVRETO 60 ct eq bottles were sold in Q2 2024[96] Clinical Development and Collaborations - Rigel and The University of Texas MD Anderson Cancer Center will evaluate olutasidenib in combination with other agents to treat newly-diagnosed and relapsed/refractory patients with IDH1-mutated AML[106] - Rigel will provide funding up to $3 million and study material over the 4-year collaboration with CONNECT to Advance Olutasidenib in Glioma[115]