Rigel’s latest publication in the Journal of Hematology & Oncology presents the final five‑year results for REZLIDHIA (olutasidenib) in patients with relapsed or refractory IDH1‑mutated acute myeloid leukemia. The data, derived from a pivotal Phase 2 registrational trial, show that 35 % of 147 efficacy‑evaluable patients achieved complete remission or CR with partial hematologic recovery, with a median duration of 25.3 months. Overall response rates reached 48 %, and median overall survival was 11.5 months, with no new safety signals identified. Importantly, 33 % of the 12 patients who had previously received venetoclax also achieved CR/CRh, underscoring the drug’s activity in a challenging subgroup.
Rigel’s commercial performance has accelerated alongside the clinical data. REZLIDHIA sales grew 107 % year‑over‑year in Q3 2024 to $5.5 million and 118 % for the full year 2024 to $23.0 million. In Q3 2025, sales reached $8.3 million, a 50 % increase from the prior year, reflecting expanding market penetration and a growing payer base. The company’s total revenue for Q3 2025 was $69.5 million, up from $59.8 million in Q3 2024, driven largely by the robust performance of its oncology portfolio and the continued uptake of REZLIDHIA.
Guidance for 2025 has been raised to a revenue range of $285–$290 million, up from the previous $275–$280 million outlook. The increase reflects management’s confidence in sustained demand for REZLIDHIA, supported by the new long‑term data that strengthen payer coverage and may open labeling opportunities. Operating income guidance was also lifted, indicating that the company expects to maintain healthy margins as sales scale and as the cost base stabilizes after the initial investment in clinical development.
The publication reinforces Rigel’s competitive positioning against other IDH inhibitors such as ivosidenib. The durability of responses and the demonstrated efficacy in venetoclax‑pretreated patients provide a differentiator that can be leveraged in marketing and payer negotiations. The data also support potential label expansion into other IDH1‑mutated malignancies, which could broaden the drug’s market beyond AML. Rigel’s strategic alliances with MD Anderson Cancer Center and CONNECT are poised to accelerate these efforts by exploring olutasidenib in newly diagnosed AML, high‑risk MDS, and myeloproliferative neoplasms.
Rigel’s CEO Raul Rodriguez highlighted that the five‑year data “confirm the long‑term benefit and manageable safety profile of REZLIDHIA, reinforcing our commitment to delivering durable outcomes for patients with limited treatment options.” The company’s focus on commercial execution, pipeline development, and financial discipline is expected to sustain growth momentum as the drug’s clinical evidence base expands.
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