Nuvation Bio disclosed that its Phase 2 study of safusidenib in chemotherapy‑ and radiotherapy‑naïve grade 2 IDH1‑mutant glioma patients has been published in Neuro‑Oncology on November 8, 2025, and the company announced the release on December 3, 2025.
The 27‑patient trial achieved an objective response rate of 44.4 % and 87.9 % of patients remained progression‑free at 24 months. No grade 5 adverse events were reported, and only 18.5 % of patients experienced grade 3 or higher treatment‑related events. As of September 15, 2025, 12 patients were still receiving safusidenib, underscoring the durability of the response.
These outcomes support the company’s plan to transition the ongoing G203 study into a global Phase 3 trial focused on high‑grade disease, potentially expanding the regulatory pathway and market reach for safusidenib. The data also reinforce the therapeutic promise of IDH1 inhibition in glioma, a field that now includes FDA‑approved vorasidenib and other investigational agents.
Financially, Nuvation reported Q3 2025 revenue of $13.1 million, a 1,800 % year‑over‑year increase driven largely by the commercial launch of taletrectinib (IBTROZI™). Net loss widened to $55.8 million from $41.2 million in Q3 2024, but the company’s cash position remains strong at $549 million as of September 30, 2025. The company’s gross margin of 54.3 % reflects the high‑margin commercial product, while operating losses are driven by ongoing pipeline development and regulatory expenses.
CEO David Hung said, “The published results confirm the long‑term durability of safusidenib and provide a strong foundation for the next phase of clinical development. We are also pleased with the commercial momentum of IBTROZI, which has helped strengthen our financial position.” He added that the company has addressed a previously identified GCP compliance issue related to adverse‑event documentation, ensuring the integrity of the safety data.
In the broader IDH‑mutant glioma market, safusidenib competes with FDA‑approved vorasidenib and other investigational IDH inhibitors such as ivosidenib and olutasidenib. The positive Phase 2 data position Nuvation as a serious contender, potentially expanding its share of a growing therapeutic niche that is expected to reach several hundred million dollars in annual sales over the next decade.
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