Nuvation Bio Announces Acquisition of Japan Rights to Safusidenib from Daiichi Sankyo Nuvation Bio (NYSE: NUVB) amended its safusidenib license with Daiichi Sankyo to acquire Japan rights, securing exclusive global development and commercialization rights for the investigational IDH1 inhibitor. The deal enables expansion of the Phase 3 SIGMA study into Japan and grants rights to prior and future clinical data and publications.Safusidenib is an oral, brain-penetrant mutant IDH1 inhibitor with encouraging Phase 1/2 activity in IDH1-mutant glioma; Phase 2 Japan data include a median follow-up of over five years for 12 patients still on treatment.

#NUVB Nuvation Bio Announces Acquisition of Japan Rights to Safusidenib from Daiichi Sankyo

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Nuvation Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Nuvation Bio (NYSE: NUVB) reported Q4 and full‑year 2025 results and a business update on March 2, 2026. Key items: 216 new patient starts on IBTROZI in Q4 (432 since June 2025 launch), an exclusive license with Eisai (Jan 11, 2026), Phase 2 safusidenib data (ORR 44%; 88% PFS at 24 months), $529.2M cash as of Dec 31, 2025, Q4 net loss $36.6M, FY net loss $204.6M.

#NUVB Nuvation Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

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BREAKING NEWS: ( NYSE: #NUVB ) Innovent Announces Inclusion of Seven Innovative Drugs including TYVYT New Indication and SYCUME in China's National Reimbursement Drug List

BREAKING NEWS: ( NYSE: #NUVB ) Nuvation Bio Announces Publication of Positive Phase 2 Study Results for Safusidenib for the Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology

Nuvation Bio Announces Publication of Positive Phase 2 Study Results for Safusidenib for the Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology 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.

#NUVB Nuvation Bio Announces Publication of Positive Phase 2 Study Results for Safusidenib for the Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology

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#NUVB Nuvation Bio Reports Third Quarter 2025 Financial Results and Provides Business Update

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Nuvation Bio Enrolls First Patient in Global, Randomized Study of Safusidenib for Maintenance Treatment of High-Grade IDH1-Mutant Glioma 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.

#NUVB Nuvation Bio Enrolls First Patient in Global, Randomized Study of Safusidenib for Maintenance Treatment of High-Grade IDH1-Mutant Glioma

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Just In: ( NYSE: #NUVB ) Nuvation Bio Announces New Data from Pivotal Clinical Studies of IBTROZI(TM) (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at 2025 World Conference on Lung Cancer

New Lung Cancer Drug IBTROZI Gains FDA Approval, Reaches 70 Patients in First 7 Weeks Nuvation Bio's IBTROZI receives FDA approval for ROS1+ lung cancer. Early adoption shows strong momentum with 70 patient starts. See launch performance details.

#NUVB Nuvation Bio Reports Second Quarter 2025 Financial Results and Provides Business Update

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Nuvation Bio Wins FDA Approval for IBTROZI in ROS1+ Lung Cancer, but Shares Slide on Investor Uncertainty Nuvation Bio (NYSE: NUVB) announced that the U.S. Food and Drug Administration has approved IBTROZI (taletrectinib) for the treatment of adult patients with adv

#NUVB fell 16% despite FDA approved IBTROZI (taletrectinib) for adults with ROS1-positive non-small cell lung cancer.
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U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer The FDA has approved Nuvation Bio's IBTROZI (taletrectinib) for treating adult patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). IBTROZI, a next-generation oral ROS1 tyrosine kinase inhibitor, demonstrated impressive efficacy in the TRUST clinical trials with confirmed overall response rates of 90% and 85% in TKI-naïve patients in TRUST-I and TRUST-II respectively. The drug showed strong brain-penetrant efficacy with intracranial response rates of 73% in TKI-naive patients and 63% in TKI-pretreated patients. The safety profile was favorable, with most adverse events being low grade and manageable. ROS1+ NSCLC affects approximately 3,000 new patients annually in the U.S., primarily younger individuals around age 50. The approval follows Priority Review and is supported by one of the largest clinical trial programs in ROS1+ NSCLC, involving over 300 patients.

#NUVB U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer

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Nuvation Bio Reports First Quarter 2025 Financial Results and Provides Business Update Nuvation Bio (NYSE: NUVB) reported its Q1 2025 financial results and provided key business updates. The company's lead drug taletrectinib for ROS1-positive non-small cell lung cancer is under FDA Priority Review with a PDUFA date of June 23, 2025. The drug received approval in China in January 2025 and is pending review in Japan.Financial highlights include $461.7 million in cash and equivalents, and the company secured up to $250 million in non-dilutive financing from Sagard Healthcare Partners. Q1 2025 showed a net loss of $53.2 million ($0.16 per share), compared to $14.8 million in Q1 2024. R&D expenses increased to $24.6 million, while SG&A expenses rose to $35.4 million.

#NUVB Nuvation Bio Reports First Quarter 2025 Financial Results and Provides Business Update

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Can Nuvation Bio's Lung Cancer Drug Breakthrough Offset Rising R&D Costs? FDA fast-tracks taletrectinib review while $250M financing deal strengthens $502M cash position. China approval secured as R&D investment accelerates.

#NUVB Nuvation Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

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Nuvation Bio Secures Up to $250 Million in Non-Dilutive Financings from Sagard Healthcare Partners Nuvation Bio (NYSE: NUVB) has secured up to $250 million in non-dilutive financing from Sagard Healthcare Partners, comprising a $150 million royalty interest financing and up to $100 million in senior term loans. The financing is contingent on FDA approval of taletrectinib by September 30, 2025.Upon FDA approval, Sagard will provide $150 million upfront in exchange for tiered royalties on U.S. taletrectinib sales: 5.5% for annual sales up to $600 million and 3.0% for sales between $600 million and $1 billion. Nuvation Bio retains all sales above $1 billion. The royalty agreement terminates when payments reach 1.6-2.0 times Sagard's investment.The term loan includes $50 million available upon FDA approval and an additional $50 million option until June 30, 2026, following first U.S. commercial sale. The loan carries SOFR + 6.00% interest with a 4.00% floor and matures in 5 years.

#NUVB Nuvation Bio Secures Up to $250 Million in Non-Dilutive Financings from Sagard Healthcare Partners

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Revolutionary Lung Cancer Treatment Now Available: FDA Grants Special Access to Nuvation's Taletrectinib Nuvation Bio initiates FDA-authorized Expanded Access Program for taletrectinib in ROS1+ NSCLC patients, while awaiting June 2025 PDUFA decision on Priority Review application.

#NUVB Nuvation Bio Announces Expanded Access Program in the U.S. for Taletrectinib in Advanced ROS1-positive Non-Small Cell Lung Cancer

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Nuvation Bio's Lung Cancer Drug DOVBLERON Wins China Approval, FDA Decision Coming June Nuvation Bio's taletrectinib receives NMPA approval for ROS1+ lung cancer in China, with FDA Priority Review decision expected June 2025. Drug shows promise in Phase 2 trials.

#NUVB Nuvation Bio Receives Approval from China’s National Medical Products Administration for Taletrectinib for Patients with Advanced ROS1-positive Non-Small Cell Lung Cancer

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Innovent Biologics Secures Crucial NMPA Approval for Novel Lung Cancer Drug DOVBLERON® Groundbreaking ROS1 inhibitor shows promising results for advanced NSCLC patients, particularly effective against brain metastases. Key expansion of cancer treatment portfolio.

#IVBIY #NUVB Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China's National Medical Products Administration

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#NUVB Nuvation Bio to Present at the 7th Annual Evercore ISI HealthCONx Conference

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Breaking News: ( NYSE: #NUVB ) Nuvation Bio to Present at the Cantor Global Healthcare Conference

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