Nuvation Bio Inc. logo NUVB - Nuvation Bio Inc.

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Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma

Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma

Designation offers pathway to expedite regulatory review, pending positive data, and reinforces safusidenib's potential to address significant medical needs for patients with IDH1-mutant glioma Pivotal Phase 3 SIGMA study enrollment underway NEW YORK, Aug. 20, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1. "People with IDH1-mutant glioma urgently need additional treatment options.

Aug 20, 2026 04:00 AM • prnewswire.com
Critical Analysis: Pathfinder Cell Therapy (OTCMKTS:PFND) and Nuvation Bio (NYSE:NUVB)

Critical Analysis: Pathfinder Cell Therapy (OTCMKTS:PFND) and Nuvation Bio (NYSE:NUVB)

Nuvation Bio (NYSE: NUVB - Get Free Report) and Pathfinder Cell Therapy (OTCMKTS:PFND - Get Free Report) are both healthcare companies, but which is the superior stock? We will contrast the two companies based on the strength of their institutional ownership, profitability, analyst recommendations, risk, dividends, earnings and valuation. Insider and Institutional Ownership 61.7% of Nuvation

Aug 15, 2026 11:46 PM • defenseworld.net
Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

Achieved $31.7 million in second quarter 2026 total revenue, including $23.2 million in net product revenue for IBTROZI ® (taletrectinib) IBTROZI is the most prescribed ROS1 TKI in in both first-line and overall new patient starts in 2026 based on IQVIA claims from first five months of the year ~85% of the approximately 160 new patients were TKI-naïve, representing QoQ growth of ~30% in this setting Announced positive updated long-term Phase 2 data for safusidenib and significant expansion of clinical program to address broad spectrum of IDH1-mutant glioma Robust balance sheet with cash, cash equivalents, and marketable securities of $661.0 million as of June 30, 2026; additional $36.5 million in net proceeds secured in July 2026 from exercise of the convertible senior notes overallotment option Company to host a conference call today at 8:00 am ET NEW YORK, Aug. 6, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. "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.

Aug 06, 2026 03:30 AM • prnewswire.com
Nuvation Bio to Present New Subgroup Analyses of Pivotal Data for IBTROZI® (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at WCLC and ESMO Annual Congresses

Nuvation Bio to Present New Subgroup Analyses of Pivotal Data for IBTROZI® (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at WCLC and ESMO Annual Congresses

Analyses of long-term TRUST-I and TRUST-II data will examine consistency of efficacy across key patient subgroups NEW YORK, Aug. 4, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new analyses of long-term Phase 2 TRUST-I and TRUST-II data will be presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) taking place September 12–15, 2026, in Seoul, South Korea, and at the European Society of Medical Oncology Congress (ESMO) October 23–27, 2026, in Madrid, Spain. These findings from the pivotal Phase 2 studies will feature the efficacy and safety of IBTROZI® (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) across key patient subgroups.

Aug 04, 2026 04:00 AM • prnewswire.com
Nuvation Bio to Report Second Quarter 2026 Financial Results and Provide Business Update on August 6, 2026

Nuvation Bio to Report Second Quarter 2026 Financial Results and Provide Business Update on August 6, 2026

NEW YORK, July 22, 2026 /PRNewswire/ -- Nuvation Bio Inc. ("Nuvation Bio") (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced it will host a conference call and webcast on Thursday, August 6, 2026, at 8:00 a.m. ET to discuss its financial results and business updates for the second quarter of 2026.

Jul 22, 2026 12:05 PM • prnewswire.com
Nuvation Bio Announces Positive Updated Phase 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma

Nuvation Bio Announces Positive Updated Phase 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma

Updated data from Phase 2 study show confirmed objective response rate of 52% and 36-month progression-free survival rate of 79% with nearly 40 months of follow-up New Phase 3 study to evaluate safusidenib in newly diagnosed grade 2 glioma patients outside the U.S. New Phase 2 study to evaluate safusidenib in patients whose glioma has progressed following treatment with vorasidenib in U.S. NEW YORK, July 20, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced updated positive long-term follow-up data from the Phase 2 (J201) study of safusidenib in patients with chemotherapy- and radiotherapy-naïve 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.

Jul 20, 2026 04:00 AM • prnewswire.com
Nuvation Bio Inc. Announces Full Exercise of Greenshoe Option in $287.5 Million Convertible Senior Notes Offering

Nuvation Bio Inc. Announces Full Exercise of Greenshoe Option in $287.5 Million Convertible Senior Notes Offering

NEW YORK, July 6, 2026 /PRNewswire/ -- Nuvation Bio Inc. ("Nuvation Bio") (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the underwriters have exercised in full their over-allotment option (the "Greenshoe Exercise") to purchase an additional $37.5 million aggregate principal amount of its 0.75% Convertible Senior Notes due 2032 (the "Notes").  The aggregate principal amount of Notes sold in the offering was $287.5 million, inclusive of the $37.5 million aggregate principal amount of Notes issued pursuant to the Greenshoe Exercise.

Jul 06, 2026 01:09 PM • prnewswire.com
Nuvation Bio Announces Pricing of Upsized Offering of $250.0 million of Convertible Senior Notes

Nuvation Bio Announces Pricing of Upsized Offering of $250.0 million of Convertible Senior Notes

NEW YORK, June 25, 2026 Nuvation Bio Inc. ("Nuvation Bio") (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the pricing of its underwritten offering (the "Offering") of $250.0 million aggregate principal amount of 0.75% Convertible Senior Notes due in 2032 (the "Notes"). The aggregate principal amount of the Offering was increased from the previously announced offering size of $200.0 million.

Jun 25, 2026 07:58 PM • prnewswire.com
Nuvation Bio Announces Proposed Convertible Senior Notes Offering

Nuvation Bio Announces Proposed Convertible Senior Notes Offering

NEW YORK, June 25, 2026 /PRNewswire/ -- Nuvation Bio Inc. ("Nuvation Bio") (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced its intent to offer, subject to market conditions and other factors, $200.0 million aggregate principal amount of Convertible Senior Notes due in 2032 (the "Notes") in an underwritten offering (the "Offering"). Nuvation Bio also intends to grant the underwriters of the Notes a right to purchase, exercisable within 30 days of the date of the prospectus supplement relating to the Offering, up to an additional $30.0 million aggregate principal amount of Notes, solely to cover over-allotments, if any.

Jun 25, 2026 03:00 AM • prnewswire.com

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