Noticias y eventos de Nuvation Bio Inc (NUVB)NUVBNuvation Bio Inc

Nuvation Bio Receives FDA Fast Track Designation

Nuvation Bio announced that the FDA has granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1. The designation was granted based on favorable data from the safusidenib clinical program to date. Most recently, Nuvation Bio announced updated data from the Phase 2 J201 study demonstrating durable responses and a favorable risk-benefit profile over long-term follow-up. No new safety signals have been identified with longer-term follow-up.

Nuvation Bio Q2 Revenue $31.7M Beats Expectations

Reports Q2 revenue $31.7M, consensus $27.47M. "IBTROZI is now the most prescribed ROS1 TKI in both first-line and overall new patient starts in 2026, based on IQVIA claims data from the first five months of the year, reflecting the medical community's growing conviction that IBTROZI's durability profile belongs at the front of the treatment sequence. Consistent with this, approximately 85% of new prescriptions this quarter were for TKI-naive patients who have the potential to be on therapy for many years. The continued shift toward TKI-naive use highlights the increasing recognition of our long-term follow-up data in TRUST-I, which show a confirmed 90% response rate and a median duration of response of 50 months," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "This efficacy profile, combined with a generally tolerable safety profile and as the only brain-penetrant ROS1 inhibitor today without a CNS warning and precaution in its label, reinforces our belief that IBTROZI is becoming the standard of care for patients with advanced ROS1-positive NSCLC." Dr. Hung continued, "We are equally excited about the progress of safusidenib, with our updated Phase 2 data showing further deepening and durable responses in IDH1-mutant gliomas. We now plan to evaluate the potential of this investigational medicine across the broad spectrum of patients in hopes of fulfilling our ultimate goal of providing an effective therapy for nearly every patient with this disease. During the second quarter, we also strengthened our balance sheet through our convertible notes offering, providing us with the financial flexibility to continue to invest in growing our portfolio."

Nuvation Bio Updates Safusidenib Clinical Data, Expands Research Program

Nuvation Bio announced updated positive long-term follow-up data from the Phase 2, or J201, study of safusidenib in patients with chemotherapy- and radiotherapy-naive grade 2 IDH1-mutant glioma. With an additional year of follow-up, responses to safusidenib increased and further deepened, and its safety profile remained consistent and manageable. Nuvation Bio also announced a significant expansion of the clinical development program for safusidenib, its selective investigational inhibitor of mutant IDH1, supported by the updated long-term follow-up data from the Phase 2, or J201, study. The company will initiate two new studies to evaluate safusidenib across the broader landscape of IDH1-mutant glioma: a pivotal Phase 3 study in patients with grade 2 IDH1-mutant glioma outside the U.S. and a Phase 2 study in patients with IDH1-mutant glioma that has progressed after prior treatment with vorasidenib in the U.S. The updated results from the Phase 2 study, from 27 patients in Japan, further support this clinical expansion. Highlights of the findings, at a median of 38.8 months of follow-up, include the following: The centrally assessed confirmed overall response rate, or ORR, per Response Assessment in Neuro-Oncology, or RANO, for low grade gliomas criteria, was 51.9%; Median progression-free survival, or PFS, was not reached, and the 36-month PFS rate was 79.1%; Responses were durable, with only one patient who had previously responded experiencing subsequent disease progression; No new safety signals were identified. The two new studies are designed to broaden the potential number of patients with IDH1-mutant glioma who could benefit from safusidenib: G307: A Phase 3, randomized, placebo-controlled study that will enroll approximately 140 patients with newly diagnosed grade 2 IDH1-mutant glioma who have not yet received chemotherapy or radiation. The primary endpoint is PFS as assessed by blinded independent central review (BICR). Secondary endpoints include ORR, time to next intervention, duration of response, and time to response. G209: A Phase 2, multicenter study that will enroll up to 40 patients in the U.S. with grade 2 or 3 IDH1-mutant glioma who have experienced disease progression after treatment with vorasidenib and who remain in need of another option to delay radiation or chemotherapy. This study seeks to establish proof-of-concept for safusidenib in a setting of high unmet need. The primary endpoint is ORR by BICR, with a number of secondary endpoints, including tumor growth rate, an emerging way of assessing early anti-tumor activity.