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.
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
KP
Kaveri Pohlman
BTIG, LLC
2 questions for NUVB
Also covers: MDGL, MGNX, RCUS +3 more
ST
Silvan Tuerkcan
Citizens JMP
2 questions for NUVB
Also covers: CLLS, EXEL, MGNX +2 more
SR
Soumit Roy
JonesTrading
2 questions for NUVB
Also covers: AVXL, CMRX, CRIS +4 more
YW
Yaron Werber
TD Cowen
2 questions for NUVB
Also covers: ALEC, AMGN, ARGX +14 more
Recent press releases and 8-K filings for NUVB.
Nuvation Bio Becomes Commercial-Stage Company with Iptrozi Launch and Strong Pipeline Progress
NUVB
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Nuvation Bio has become a commercial-stage company with the June 11, 2025, approval and launch of Iptrozi (Taltrectinib) for ROS1 non-small cell lung cancer. In its first full quarter, Iptrozi achieved 204 new patient starts.
- Iptrozi demonstrates a duration of response of 50 months and is considered a preferred agent in NCCN guidelines for 2025. The US market opportunity for Iptrozi is estimated to be over $5 billion annually with revenue stacking, driven by its efficacy and tolerability.
- The company's second asset, safusidenib, a mutant IDH1 inhibitor for glioma, showed a 44% response rate in low-grade glioma with only 12% progression at two years, and has now entered a pivotal study for both high-grade and low-grade glioma. This program targets a large oncology market with potential for long-term revenue stacking.
- Nuvation Bio reported a strong financial position with $550 million in cash as of its last quarter, and believes it is well-capitalized to reach profitability and explore further asset acquisitions.
Dec 3, 2025, 2:00 PM
Nuvation Bio Provides Update on Commercial Launch, Pipeline, and Financial Position
NUVB
Product Launch
New Projects/Investments
Guidance Update
- Nuvation Bio has transitioned to a commercial-stage company with the launch of Iptrozi (Taltrectinib) for ROS1 non-small cell lung cancer, reporting 204 new patient starts in its first full quarter and a 50-month duration of response.
- The company announced compelling clinical data for Safusidenib, an IDH1 inhibitor for glioma, demonstrating a 44% response rate and only 12% progression at two years in low-grade glioma, significantly surpassing competitor performance, and has commenced a pivotal study.
- Nuvation Bio is well-capitalized with approximately $550 million in cash as of its last quarter, bolstered by a $150 million non-dilutive financing in March, and anticipates reaching profitability.
- The market opportunity for Iptrozi is projected to exceed $5 billion annually with RNA testing, supported by its inclusion as a preferred agent in NCCN guidelines and an ongoing adjuvant study to expand its reach.
Dec 3, 2025, 2:00 PM
Nuvation Bio Provides Update on Iptrozi Launch and Safusidenib Development
NUVB
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Nuvation Bio has transitioned to a commercial-stage company following the June 11th approval of Iptrozi (Taltrectinib). In its first full quarter, Iptrozi achieved 204 new patient starts for ROS1 non-small cell lung cancer, which is six times the prior generation drug's performance, and boasts a 50-month duration of response. The market opportunity for Iptrozi is estimated to be over $4 billion a year with DNA testing, potentially over $5 billion a year with RNA testing.
- The company's second key asset, Safusidenib, an IDH1 inhibitor for glioma, demonstrated a 44% response rate and 12% progression at two years in low-grade glioma, significantly outperforming the only other approved drug. It has entered a pivotal study for both high-grade and low-grade glioma, targeting a market where the competitor already generates $1 billion in annual sales.
- Nuvation Bio maintains a strong financial position with $550 million in cash as of its last quarter and expects to reach profitability.
Dec 3, 2025, 2:00 PM
Nuvation Bio Reports Strong Ibtrozy Launch and Positive Safusidenib Data
NUVB
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
- Nuvation Bio became a commercial-stage company in 2025 following the acquisition of AnHeart and the FDA approval and launch of Ibtrozy.
- Ibtrozy demonstrated strong initial performance with 204 patient starts in its first full quarter, and boasts a 90% response rate and 50-month progression-free survival (PFS) in ROS1 lung cancer, with potential annual sales exceeding $5 billion with RNA testing.
- The NCCN guidelines were updated, making ROS1 agents mandatory and IO chemo contraindicated for ROS1 lung cancer, providing a significant tailwind for Ibtrozy.
- The company presented compelling data for safusidenib in low-grade glioma, showing a 44% response rate and only 12% progression at two years, and has initiated a pivotal study for both high-grade and low-grade glioma.
- Nuvation Bio ended its last quarter with $550 million in cash and anticipates continued strong Ibtrozy sales and robust enrollment for safusidenib in 2026.
Dec 2, 2025, 2:35 PM
Nuvation Bio Discusses Strong Ibtrozy Launch and Safusidenib Progress
NUVB
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Nuvation Bio became a commercial-stage company in 2025 following the FDA approval and launch of Ibtrozy, a ROS1 inhibitor.
- Ibtrozy demonstrated a 90% response rate and 50-month progression-free survival (PFS) in the first-line setting, with a 0.3% discontinuation rate. The company reported 204 patient starts in its first full quarter of sales.
- On January 7, 2025, NCCN guidelines changed, making a ROS1 agent mandatory for ROS1 lung cancer and contraindicating IO chemo, which is expected to be a significant tailwind for Ibtrozy.
- Safusidenib, an IDH1 inhibitor, showed a 44% response rate in low-grade glioma and a 17% response rate in high-grade glioma, with a pivotal study underway and data expected by 2029 at the latest.
- The company holds $550 million in cash as of its last quarter and plans to continue business development and internal program development.
Dec 2, 2025, 2:35 PM
Nuvation Bio Highlights Strong Ibtrozi Launch and Promising Safusidenib Data at HealthCONx Conference
NUVB
Product Launch
New Projects/Investments
M&A
- Nuvation Bio became a commercial-stage company in 2025 with the acquisition of AnHeart and FDA approval of Ibtrozi, a ROS1 inhibitor for lung cancer, which recorded 204 patient starts in its first full quarter of sales.
- Ibtrozi demonstrated a 90% response rate and 50 months progression-free survival (PFS) in the first-line setting, with potential annual sales projected to exceed $5 billion with RNA testing. The NCCN guidelines were updated in January 2025, making ROS1 agents mandatory for ROS1 lung cancer.
- The company's IDH1 inhibitor, Safusidenib, showed a 44% response rate in low-grade glioma and a 17% response rate in high-grade glioma, with a pivotal study underway and data expected by 2029.
- Nuvation Bio reported $550 million in cash as of its last quarter and plans to continue strong Ibtrozi sales and pursue business development opportunities, while also continuing development of its DDC platform despite discontinuing NUV1511.
Dec 2, 2025, 2:35 PM
Nuvation Bio Provides Update on IBTROZI Launch, Pipeline, and Financial Position
NUVB
Product Launch
New Projects/Investments
Guidance Update
- Nuvation Bio's IBTROZI (taletrectinib), a next-generation ROS1 inhibitor, was approved in June 2025 for advanced ROS1+ NSCLC in the U.S., Japan, and China, and saw 204 new patient starts in Q3 2025.
- On November 26, 2025, the company announced the discontinuation of NUV-1511 development due to inconsistent efficacy, reallocating $100-150 million in budgeted resources to other pipeline molecules and next-generation Drug-drug conjugate (DDC) candidates.
- The company reported a robust cash balance of $549 million as of September 30, 2025, which is expected to provide a path to profitability without the need for additional funding.
- Additionally, safusidenib, an mIDH1 inhibitor, is entering a pivotal study for high-grade IDH1-mutant glioma.
Nov 26, 2025, 1:34 PM
Nuvation Bio discusses Ibtrozi sales, pipeline, and financial outlook at Jefferies conference
NUVB
Product Launch
Guidance Update
New Projects/Investments
- Nuvation Bio's ROS1 inhibitor, Ibtrozi, achieved 204 new patient starts in its first full quarter of sales (Q3), significantly surpassing competitor launches. The company is comfortable with consensus sales estimates of $14.4 million for Q4 and $142 million for 2026.
- Updated data for Ibtrozi shows a 90% response rate and a 50-month duration of response (DOR) and progression-free survival (PFS), which is unprecedented for solid tumor indications.
- New data for Safucitinib, an IDH1 inhibitor, in low-grade glioma demonstrated a 44% overall response rate and 88% 24-month progression-free survival, substantially outperforming a competitor. A pivotal study for high-grade and high-risk low-grade glioma has commenced, with data anticipated by 2029.
- The company expects to announce an ex-U.S. partnership before year-end and recently received approval in Japan, triggering a $25 million milestone.
- Nuvation Bio reported $549 million in cash at the end of the last quarter and recently secured $200 million in royalty financing for business development opportunities.
Nov 19, 2025, 3:00 PM
Nuvation Bio Reports Strong IBTROZI Sales and Positive Safusidenib Data
NUVB
Product Launch
Guidance Update
New Projects/Investments
- IBTROZI, Nuvation Bio's ROS1 inhibitor, achieved 204 new patient starts in its first full quarter of sales, significantly outperforming competitor launches. It boasts a 90% response rate and 50-month progression-free survival (PFS).
- The company is comfortable with consensus sales estimates for IBTROZI, projecting $14.4 million for the fourth quarter and $142 million for FY 2026.
- Safusidenib, Nuvation Bio's IDH1 inhibitor, demonstrated a 44% overall response rate and 88% 24-month landmark PFS in low-grade glioma, which is significantly higher than vorasidenib's 11% ORR and 59% PFS in the same patient population. A pivotal study is now underway for both high and low-grade gliomas.
- Nuvation Bio expects to announce an ex-U.S. partnership for IBTROZI before year-end and received a $25 million milestone for its approval in Japan.
- The company reported $549 million in cash at the end of the last quarter and believes it has enough cash to reach profitability.
Nov 19, 2025, 3:00 PM
Nuvation Bio Reports Strong Ibtrozi Launch and Promising Safucitinib Data at Jefferies Conference
NUVB
Product Launch
Guidance Update
New Projects/Investments
- Ibtrozi, Nuvation Bio's ROS1 inhibitor, reported 204 new patient starts in its first full quarter of sales (Q3 2025). The drug has demonstrated a 90% response rate and a 50-month duration of response.
- Nuvation Bio is comfortable with consensus sales estimates of $14.4 million for Q4 2025 and $142 million for FY 2026 for Ibtrozi. A supplemental NDA for a label amendment reflecting the 50-month median PFS has been submitted.
- New data for Safucitinib, an IDH1 inhibitor, showed a 44% overall response rate and 88% 24-month progression-free survival in low-grade glioma, significantly outperforming a competitor. A pivotal study has commenced for both high-grade and low-grade gliomas, with results anticipated by 2029.
- The company ended the last quarter with $549 million in cash and expects to reach profitability. An ex-U.S. partnership is expected to be announced before year-end, and a $25 million milestone payment was triggered by Japan approval.
Nov 19, 2025, 3:00 PM
Quarterly earnings call transcripts for Nuvation Bio.
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more