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Nuvation Bio (NUVB)

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Earnings summaries and quarterly performance for Nuvation Bio.

Recent press releases and 8-K filings for NUVB.

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
Nuvation Bio Presents Commercial Progress and Pipeline Updates at J.P. Morgan Healthcare Conference
NUVB
Product Launch
New Projects/Investments
M&A
  • Nuvation Bio reported a cash balance of $589 million after announcing a deal with AZI, with an expected increase to $620 million upon European approval, and anticipates a path to profitability without further funding.
  • The company's commercial asset, Iptrozi (talotrectinib), a ROS1 inhibitor for NSCLC, achieved 216 new patient starts in Q4, a 6% increase quarter-over-quarter, and is already the market leader in ROS1 TKIs with 432 new patient starts since launch.
  • Iptrozi demonstrates an 89% response rate and a 50-month duration of response, with a low 6.5% discontinuation rate, and the market opportunity could reach $5 billion annually with increased RNA testing.
  • Safusidenib, a mutant IDH1 inhibitor for gliomas, shows superior efficacy compared to vorasidenib, with 4% progression at one year (vs. 23%) and a 44% response rate in low-grade glioma (vs. 11%), and has initiated two pivotal studies with response rate data expected starting this year and into 2027 for one of them.
Jan 13, 2026, 11:45 PM
Nuvation Bio Reports Preliminary Q4 and Full Year 2025 Results and Announces Licensing Agreement
NUVB
Earnings
Product Launch
M&A
  • Nuvation Bio reported preliminary unaudited IBTROZI net product revenue of $15.7 million for Q4 2025 and $24.7 million since its launch in mid-June 2025. The company's cash, cash equivalents, and marketable securities were approximately $529.2 million as of December 31, 2025.
  • IBTROZI saw 216 new patient starts in Q4 2025, totaling 432 new patient starts since launch, demonstrating a treatment adoption rate approximately six times faster than prior ROS1 TKI launches.
  • On January 11, 2026, Nuvation Bio entered an exclusive license agreement with Eisai Co., Ltd. for taletrectinib in Europe and other regions, securing an upfront payment of €50 million (approx. USD $60 million) and up to €145 million (approx. USD $170 million) in potential milestone payments, plus double-digit tiered royalties.
  • The company's 2026 priorities include expanding IBTROZI patient starts globally and advancing its pipeline, including safusidenib and its Drug-Drug Conjugate (DDC) platform.
Jan 12, 2026, 1:07 PM
Nuvation Bio Reports Preliminary Q4 and Full Year 2025 Results and Announces 2026 Outlook
NUVB
Earnings
Guidance Update
New Projects/Investments
  • Nuvation Bio reported preliminary Q4 2025 IBTROZI net product revenue of $15.7 million and $24.7 million since launch in mid-June 2025, with 432 new patient starts for IBTROZI.
  • Preliminary unaudited cash, cash equivalents, and marketable securities were approximately $529.2 million as of December 31, 2025, including a $25 million milestone payment received in Q4 2025.
  • On January 11, 2026, the company entered an exclusive license and collaboration agreement with Eisai Co., Ltd. for taletrectinib in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India.
  • For 2026, Nuvation Bio's priorities include continuing to grow IBTROZI new patient starts and advancing its pipeline.
Jan 12, 2026, 1:00 PM
Nuvation Bio and Eisai Announce Taletrectinib Licensing Agreement
NUVB
M&A
New Projects/Investments
Product Launch
  • Nuvation Bio and Eisai Co., Ltd. have entered into an exclusive licensing agreement for taletrectinib, an oral treatment for advanced ROS1-positive non-small cell lung cancer (NSCLC).
  • Eisai will receive exclusive development, registration, and commercialization rights for taletrectinib in Europe and additional countries outside the U.S., China, and Japan.
  • Nuvation Bio is set to receive an upfront payment of €50 million (approx. USD $60 million), up to €145 million (approx. USD $170 million) in regulatory and commercial milestone payments, and double-digit tiered royalties up to the high-teens on future net sales in the licensed territories.
  • Taletrectinib is currently approved in the U.S., China, and Japan, with a Marketing Authorization Application (MAA) expected to be filed in Europe in the first half of 2026.
Jan 12, 2026, 12:30 PM
Nuvation Bio Provides Commercial and Pipeline Update
NUVB
Product Launch
New Projects/Investments
M&A
  • Nuvation Bio is a commercial-stage oncology company with a robust pro forma cash balance of approximately $589 million.
  • Its lead product, IBTROZI (taletrectinib), approved by the U.S. FDA in June 2025, has achieved 432 new patient starts and approximately $25 million in U.S. net revenue since launch as of December 31, 2025.
  • Nuvation Bio secured an exclusive licensing agreement with Eisai for IBTROZI in Europe and other territories, involving an upfront payment of ~$60 million and potential milestone payments of ~$30 million.
  • The company is also advancing safusidenib, a mIDH1 inhibitor, in a pivotal study for high-grade and high-risk IDH1-mutant glioma, with a new cohort potentially yielding data by 2028.
Jan 12, 2026, 12:00 PM
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