Nuvation Bio Inc Stock Price, News & Analysis

Nuvation Bio (NYSE:NUVB) published positive Phase 2 results for safusidenib in chemotherapy- and radiotherapy‑naïve grade 2 IDH1‑mutant glioma.

Key results: ORR 44.4%, median follow-up 28 months, median PFS not reached, and 87.9% progression‑free at 24 months. Adverse events were mostly mild; grade ≥3 treatment‑related events occurred in 18.5% and 11.1% discontinued due to TEAEs. A GCP noncompliance in AE collection led to a re‑investigation and re‑collection of safety data.

The company said G203 will be amended to a global Phase 3 with PFS by blinded independent central review as the primary endpoint, and the FDA agreed that PFS by BICR could support full approval.

Nuvation Bio (NYSE: NUVB) announced that CEO David Hung, M.D., and CFO Philippe Sauvage will take part in fireside chats at two investor conferences in Miami on Dec 2–3, 2025. The events are the 8th Annual Evercore Healthcare Conference (Dec 2 at 9:35 a.m. ET) and the Citi 2025 Global Healthcare Conference (Dec 3 at 9:00 a.m. ET).

Live webcasts will be available on Nuvation Bio's Investor Relations website, and archived recordings will be accessible for 90 days after each event.

Nuvation Bio (NYSE:NUVB) reported Q3 2025 results and operational milestones on November 3, 2025. Key commercial and clinical updates include 204 new patients started on IBTROZI in Q3, updated pooled TRUST-I/II median Duration of Response 50 months (Aug 2025 cut-off), first-patient enrollment in TRUST-IV adjuvant IBTROZI study and in the global safusidenib G203 registrational study, and partner Nippon Kayaku’s approval in Japan with a $25.0M milestone expected upon reimbursement price establishment.

Financials: $549.0M cash and marketable securities, $7.7M Q3 net product revenue, collaboration revenue $5.4M, and net loss $55.8M for Q3 2025.

Nuvation Bio (NYSE: NUVB) announced that CEO David Hung, M.D., and CFO Philippe Sauvage will participate in three investor conferences in November–December 2025.

• Jefferies Global Healthcare Conference: Wednesday, November 19, 2025 at 10:00 a.m. ET / 3:00 p.m. GMT in London (fireside chat)
• Truist Securities BioPharma Symposium: Thursday, November 6, 2025 in New York (one-on-one meetings)
• 8th Annual Evercore Healthcare Conference: Tuesday, December 2, 2025 at 9:35 a.m. ET in Miami (fireside chat)

Live webcasts of the two fireside chats will be available on the company's Investor Relations website, with archived recordings accessible for 90 days after each event.

Nuvation Bio (NYSE: NUVB) announced enrollment of the first patient in part 2 of G203 (NCT05303519), a global, randomized study of safusidenib versus placebo as maintenance therapy for newly diagnosed high-grade IDH1-mutant astrocytoma following surgery, radiation/chemoradiation, and adjuvant temozolomide.

A protocol amendment aligned with the FDA converts G203 part 2 to a planned Phase 3 study enrolling ~300 patients in the U.S., Australia, and China. Patients will be randomized 1:1 to 250 mg safusidenib or placebo twice daily. The primary endpoint is progression-free survival (PFS) by BICR per RANO 2.0, which FDA agreed could support full approval; secondary endpoints include overall survival and objective response rate. Nuvation will provide program updates on its Nov 3, 2025 earnings call.

Nuvation Bio (NYSE: NUVB) will report third quarter 2025 financial results and provide a business update on Monday, November 3, 2025 at 4:30 p.m. ET. The company will host a live conference call and webcast; investors may register via the company's Investor Relations website. To join the call by phone dial +1 833-470-1428 (U.S. toll-free) and enter access code 405112. An archived recording will be available on Nuvation Bio's website for 90 days after the event.

Nuvation Bio (NYSE:NUVB) has enrolled its first patient in the TRUST-IV Phase 3 study evaluating IBTROZI™ (taletrectinib) for adjuvant treatment of ROS1-positive early-stage non-small cell lung cancer (NSCLC). The trial follows IBTROZI's recent approval for advanced ROS1-positive NSCLC.

The study will enroll approximately 180 patients across multiple countries, randomized 2:1 to receive either taletrectinib or placebo. The trial targets patients with ROS1+ stage IB, II or IIIA NSCLC who have undergone surgery. The primary endpoint is disease-free survival, with completion expected in 2033.

Nuvation Bio (NYSE:NUVB) has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for IBTROZI™ (taletrectinib) to treat adult patients with ROS1-positive unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC). The approval is based on the pivotal Phase 2 TRUST clinical program data.

This marks the third major regulatory approval for IBTROZI, following U.S. FDA approval in June 2025 and China's NMPA approval in January 2025. Nippon Kayaku will commercialize the drug in Japan under an exclusive license agreement. The MHLW also approved the AmoyDx® PLC Panel as a companion diagnostic.

Nuvation Bio expects to receive a $25 million milestone payment upon establishing reimbursement pricing in Japan, anticipated in Q4 2025. The drug has been designated as a Preferred Agent in the NCCN Guidelines® for both first-line and subsequent therapy for ROS1+ NSCLC.

Nuvation Bio (NYSE:NUVB) has presented new data from its pivotal TRUST-I and TRUST-II clinical studies of IBTROZI™ (taletrectinib) for ROS1-positive non-small cell lung cancer (NSCLC) at the 2025 World Conference on Lung Cancer.

In the TRUST-II study, TKI-naïve patients showed a confirmed objective response rate (cORR) of 85.2% at 20.5 months median follow-up, with median progression-free survival (PFS) not yet reached. For TRUST-I, TKI-naïve patients demonstrated a cORR of 90.3% with an impressive median PFS of 44.6 months.

The integrated safety analysis across trials (N=337) revealed a favorable profile with manageable adverse events. Notable intracranial responses were observed in patients with brain metastases: 66.7% in TRUST-II and 87.5% in TRUST-I for TKI-naïve patients.