Earnings summaries and quarterly performance for Nuvation Bio.
Executive leadership at Nuvation Bio.
David Hung
Detailed
President and Chief Executive Officer
CEO
CS
Colleen Sjogren
Detailed
Chief Commercial Officer
DH
David Hanley
Detailed
Chief Technical Operations Officer
DL
David Liu
Detailed
Chief Medical Officer
GH
Gary Hattersley
Detailed
Chief Scientific Officer
KW
Kerry Wentworth
Detailed
Chief Regulatory Officer
MM
Moses Makunje
Detailed
Vice President, Finance and Principal Accounting Officer
PS
Philippe Sauvage
Detailed
Chief Financial Officer
SM
Stacy Markel
Detailed
Chief People Officer
Board of directors at Nuvation Bio.
Research analysts who have asked questions during Nuvation Bio earnings calls.
KP
Kaveri Pohlman
BTIG, LLC
4 questions for NUVB
Also covers: MDGL, MGNX, RCUS +3 more
AN
Anish Nikhanj
RBC Capital Markets
2 questions for NUVB
Also covers: APTO, CRMD, EXEL +6 more
David Nierengarten
Wedbush Securities
2 questions for NUVB
Also covers: ARGX, ITOS, KNSA +4 more
Farzin Haque
Jefferies
2 questions for NUVB
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GR
Greg Renza
Truist Securities
2 questions for NUVB
Leonid Timashev
RBC Capital Markets
2 questions for NUVB
Also covers: ADCT, ALKS, AXSM +11 more
MT
Matthew Taylor
Jefferies
2 questions for NUVB
Also covers: ALUR, BDX, BSX +21 more
Mayank Mamtani
B. Riley Securities
2 questions for NUVB
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ST
Silvan Tuerkcan
Citizens JMP
2 questions for NUVB
Also covers: CLLS, EXEL, MGNX +2 more
SR
Soumit Roy
JonesTrading
2 questions for NUVB
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SM
Steven Mah
TD Cowen
2 questions for NUVB
Also covers: EVO, ME
YW
Yaron Werber
TD Cowen
2 questions for NUVB
Also covers: ALEC, AMGN, ARGX +15 more
ST
Sylvan Tuerkcan
Citizens JMP Securities
1 question for NUVB
Recent press releases and 8-K filings for NUVB.
Nuvation Bio Discusses IBTROZI Launch Progress and Safusidenib Development
NUVB
Guidance Update
Product Launch
New Projects/Investments
- Nuvation Bio reported robust new patient starts for IBTROZI, reaching 216 patients in Q4 2025, which is 6x the BMS launch. The company maintains its consensus revenue guidance of $147 million for the year (2026), anticipating stronger revenue in the second half.
- The company clarified that the previously mentioned "75% discontinuation rate" was a misunderstanding, explaining that 75% of discontinuations occurred in the third line or later setting. IBTROZI shows a 90%+ response rate in first-line patients with 4+ years durability and a 0.3% discontinuation rate for the top 6 adverse events.
- For Safusidenib, a Phase 3 SIGMA study is enrolling 300 patients for IDH1 mutant glioma, with a PFS readout expected in 2029. A separate study for grade 3 oligodendroglioma is enrolling 40 patients with measurable disease, with a readout anticipated next year (2027).
- Nuvation Bio expects to receive an additional EUR 25 million milestone payment from Eisai upon European approval for IBTROZI (early next year), which will increase its cash balance to approximately $620 million.
7 days ago
Nuvation Bio Discusses Taletrectinib Launch Dynamics and Safusidenib Development
NUVB
Guidance Update
Product Launch
New Projects/Investments
- Nuvation Bio's Taletrectinib (IBTROZI) launch is progressing well, with new patient starts 6 times higher than the BMS launch. The company expects the gap between new patient starts and revenue to narrow as the patient mix shifts towards earlier lines of therapy, with a 50-month duration of response in the first-line setting.
- The company clarified that the previously mentioned 75% discontinuation rate refers to discontinuations in the third-line or later setting, not an overall discontinuation rate, which is very low and consistent with clinical trial results.
- Nuvation Bio is comfortable with the $147 million consensus revenue for the year, anticipating stronger revenue in the second half due to the shift towards first-line patients.
- For Safusidenib, the SIGMA Phase 3 study for IDH1 mutant glioma is expected to read out in 2029, while a smaller study for grade 3 oligodendroglioma with measurable disease could provide earlier data next year.
- Nuvation Bio expects to have approximately $620 million in cash after receiving the next EUR 25 million milestone payment from Eisai upon European approval of Taletrectinib, which is anticipated early next year.
7 days ago
Nuvation Bio Reports Q4 and Full Year 2025 Financial Results, Highlights IBTROZI Launch and Safusidenib Progress
NUVB
Earnings
Product Launch
New Projects/Investments
- Nuvation Bio reported total revenue of $41.9 million for Q4 2025 and $62.9 million for the full year 2025, with IBTROZI net U.S. product revenue reaching $15.7 million in Q4 and $24.7 million for the full year.
- IBTROZI, approved by the U.S. FDA on June 11, 2025, for advanced ROS1-positive NSCLC, saw 432 new patients start therapy by year-end 2025, including 216 in Q4, with prescription rates approximately 6 times faster than prior ROS1 TKI launches.
- The company highlighted IBTROZI's strong efficacy, with a median duration of response of 50 months in TKI-naive patients as of August 2025 data.
- Nuvation Bio initiated a pivotal Phase 3 study (SIGMA) for safusidenib in high-risk and high-grade IDH1 mutant glioma, with results expected in 2029, and a non-pivotal cohort for grade 3 oligodendroglioma with a potential readout in 2027.
- A strategic partnership with Eisai for IBTROZI in Europe and other ex-U.S. territories secured an upfront payment of $60 million, and the company confirmed it has sufficient cash to reach profitability.
Mar 2, 2026, 9:30 PM
Nuvation Bio Reports Q4 and Full Year 2025 Financial Results and IBTROZI Launch Progress
NUVB
Earnings
Product Launch
Guidance Update
- Nuvation Bio reported $41.9 million in total revenue for Q4 2025 and $62.9 million for the full year 2025, ending the year with $529.2 million in cash, equivalents, and marketable securities.
- The company's first therapy, IBTROZI, generated $15.7 million in net U.S. product revenue in Q4 2025 and $24.7 million for the full year 2025. By the end of 2025, 432 new patients had started IBTROZI, with 216 of those in Q4, representing a launch rate approximately 6 times faster than prior ROS1 TKI launches.
- IBTROZI's median duration of response reached 50 months in TKI-naive patients as of August 2025. The company also secured a strategic partnership with Eisai for Europe and other ex-U.S. territories, receiving an upfront payment of approximately $60 million, and a $25 million milestone payment from Nippon Kayaku.
- Nuvation Bio does not anticipate the need for additional external financing to reach profitability, based on its current operating plan and revenue trajectory.
Mar 2, 2026, 9:30 PM
Nuvation Bio Reports Q4 and Full Year 2025 Financial Results, Highlights IBTROZI Launch Success, and Initiates Pivotal Safusidenib Study
NUVB
Earnings
Product Launch
New Projects/Investments
- Nuvation Bio reported total revenue of $41.9 million for Q4 2025 and $62.9 million for the full year 2025, with IBTROZI net U.S. product revenue reaching $15.7 million in Q4 and $24.7 million for the full year.
- The company's first therapy, IBTROZI, received full U.S. FDA approval on June 11th, 2025, and by year-end, 432 new patients had started treatment, including 216 in Q4, with patient starts approximately 6 times faster than prior ROS1 TKI launches.
- A pivotal phase 3 study (SIGMA) for safusidenib in high-risk and high-grade IDH1 mutant glioma was initiated in February 2026, with results anticipated in 2029. A non-pivotal cohort for grade 3 oligodendroglioma is expected to read out in 2027.
- Strategic partnerships generated significant funds, including a $25 million milestone payment from Nippon Kayaku for IBTROZI approval in Japan and a $60 million upfront payment from Eisai for European and other ex-U.S. rights, with an additional $30 million expected upon European approval.
- Nuvation Bio concluded 2025 with $529.2 million in cash, equivalents, and marketable securities and does not anticipate the need for additional external financing to reach profitability.
Mar 2, 2026, 9:30 PM
Nuvation Bio Reports Q4 and Full Year 2025 Financial Results, Highlights IBTROZI Adoption and Licensing Deal
NUVB
Earnings
Product Launch
New Projects/Investments
- Nuvation Bio reported a net loss of $36.6 million, or $(0.11) per share, for the fourth quarter of 2025 and a full-year 2025 net loss of $204.6 million, or $(0.60) per share. As of December 31, 2025, the company maintained a strong balance sheet with $529.2 million in cash, cash equivalents, and marketable securities.
- The company saw significant adoption of IBTROZI (taletrectinib), with 216 new patients starting treatment in Q4 2025, contributing to a total of 432 new patient starts since its launch in the second half of June 2025. Net product revenue from U.S. sales of IBTROZI was $15.7 million for Q4 2025 and $24.7 million for the full year 2025.
- Nuvation Bio entered an exclusive licensing and collaboration agreement with Eisai on January 11, 2026, for taletrectinib in Europe and additional countries outside the U.S., China, and Japan. Additionally, the company received a $25 million milestone payment from Nippon Kayaku in Q4 2025 due to the establishment of the reimbursement price for IBTROZI in Japan.
- The company also progressed its pipeline, with safusidenib demonstrating durable responses in positive Phase 2 study results for grade 2 IDH1-mutant glioma, leading to its evaluation in the pivotal Phase 3 SIGMA trial, which enrolled its first patient in October 2025.
Mar 2, 2026, 9:22 PM
Nuvation Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates
NUVB
Earnings
Product Launch
New Projects/Investments
- Nuvation Bio reported a net loss of $36.6 million or $(0.11) per share for the fourth quarter of 2025 and a net loss of $204.6 million or $(0.60) per share for the full year 2025.
- The company ended December 31, 2025, with a strong balance sheet, holding $529.2 million in cash, cash equivalents, and marketable securities.
- Product revenue from U.S. sales of IBTROZI was $15.7 million for the fourth quarter of 2025, contributing to $24.7 million for the full year 2025, with 216 new patients started on IBTROZI in Q4 2025.
- Collaboration and license agreements revenue for Q4 2025 was $26.2 million, which included a $25 million milestone payment from Nippon Kayaku, and Nuvation Bio entered an exclusive licensing agreement with Eisai on January 11, 2026, for taletrectinib in Europe and other international markets.
Mar 2, 2026, 9:05 PM
Nuvation Bio Expands Safusidenib SIGMA Study to Pivotal Global Phase 3 Trial
NUVB
New Projects/Investments
- Nuvation Bio announced a protocol amendment to expand its ongoing SIGMA study (G203) for safusidenib from a Phase 2 to a Pivotal Global Phase 3 trial for IDH1-mutant glioma.
- The expanded trial will now include patients with grades 2, 3, and 4 IDH1-mutant astrocytoma and will increase enrollment from 100 to 300 patients across the U.S., Australia, and China.
- A new exploratory cohort has been added to enroll approximately 40 patients with grade 3 IDH1-mutant oligodendroglioma, with initial data for this cohort expected in 2027.
- This expansion reflects alignment with U.S. regulators and aims to support regulatory submissions for a patient population that currently lacks FDA-approved targeted treatment options.
Feb 9, 2026, 1:00 PM
Nuvation Bio Updates on Commercial Performance, Pipeline, and Financial Outlook
NUVB
Product Launch
New Projects/Investments
M&A
- Nuvation Bio reported a current cash balance of approximately $589 million, with an expected increase to $620 million upon European approval of Ibtrozi, and anticipates a path to profitability without requiring further funding.
- The company's commercial asset, Ibtrozi (taletrectinib), a ROS1 inhibitor for non-small cell lung cancer, achieved 216 new patient starts in its second full quarter (Q4), representing a 6% increase quarter-over-quarter, and is already the market leader in ROS1 TKIs.
- Nuvation Bio recently announced a deal with Eisai for Ibtrozi in Europe and other territories, including an upfront payment of $60 million and a $30 million near-term milestone upon European approval, with high double-digit royalties.
- The company's mutant IDH1 inhibitor, safusidenib, is in pivotal studies for gliomas, with a new study initiated for Grade 3 oligodendroglioma expected to provide response rate data starting this year (2026) and into 2027.
- Nuvation Bio is actively seeking new late-stage or commercial asset acquisition opportunities, following the successful AnHeart Therapeutics acquisition which generated significant upfront and milestone payments.
Jan 13, 2026, 11:45 PM
Nuvation Bio Provides Business Update at J.P. Morgan Healthcare Conference
NUVB
Product Launch
New Projects/Investments
M&A
- Nuvation Bio reported a current cash balance of approximately $589 million and expects to reach $620 million with a near-term milestone payment, projecting a path to profitability without requiring further funding.
- The company announced a deal with AZI for its commercial asset, Iptrozi (talotrectinib), in Europe and other selected territories, receiving an upfront payment of $60 million and anticipating a $30 million near-term milestone upon European approval, along with high double-digit royalties on net sales.
- Iptrozi, approved in the U.S., Japan, and China, demonstrated strong commercial performance with new patient starts increasing by 6% quarter-over-quarter in Q4 to 216 new patients, and is already the market leader in ROS1 TKIs, having achieved a launch 6X faster than competitors.
- Nuvation Bio is advancing Safusidenib, a mutant IDH1 inhibitor for gliomas, through two pivotal studies, with response rate data for a study in grade 3 oligodendroglioma expected to begin reading out this year and into 2027.
- Strategic priorities for 2026 include continuing to accelerate the Iptrozi launch, rapidly developing Safusidenib, and actively seeking opportunities for further M&A of late-stage or commercial assets.
Jan 13, 2026, 11:45 PM
Quarterly earnings call transcripts for Nuvation Bio.
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