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Nuvation Bio Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 4 November 2026: press release. The quarter’s numbers.

Key takeaways

  • IBTROZI net product revenue up 18%: Net product revenue from IBTROZI was $27.5 million, up 18% from the second quarter's $23.2 million. Nine-month product revenue was $69.2 million. Source
  • New patient starts held near 160: New patient starts were about 160, flat on the second quarter, while total ROS1+ NSCLC TKI new starts fell about 15%, per IQVIA claims data. Source
  • TKI-naïve share of starts fell: Of Q3 starts, 65% were TKI-naïve, against about 85% of starts in the second quarter, when TKI-naïve starts were reported as about 30% quarter-over-quarter growth. Source
  • Net loss compared with prior-year quarter: Net loss was $41.9 million, or $(0.12) per share, against $55.8 million, or $(0.16) per share, in the third quarter of 2025. Source
  • FDA approved IBTROZI label update: The sNDA approval came four months before the January 4, 2027 target action date. Source
  • J201 long-term efficacy reported: Centrally assessed ORR was 51.9% at 38.8 months median follow-up. Median PFS was not reached, and the 36-month PFS rate was 79.1%. Source
  • Cash and securities totaled $663.4M: Cash, equivalents and marketable securities were $663.4 million at September 30, 2026, including $36.5 million from the July overallotment exercise. Source

“Just over one year after launch, IBTROZI was established as the market leader in advanced ROS1+ NSCLC, for both new patient starts and active patients across all lines of therapy combined, based on IQVIA claims data,”

David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio

What changed from last quarter

  • New: FDA approved the IBTROZI sNDA, which was accepted in May 2026 with a January 4, 2027 target action date. Source
  • New: FDA granted Fast Track Designation to safusidenib for IDH1-mutant glioma. Source
  • New: The pivotal Phase 3 SIGMA study was expanded to study sites in six European countries. Source

Revenue and IBTROZI product sales

  • Total revenue reached $45.0 million: Total revenues were $44,951 thousand, against $13,120 thousand a year earlier. Nine-month total revenue was $159,866 thousand. Source
  • IBTROZI net product revenue up 18%: Net product revenue from IBTROZI was $27.5 million, up 18% from the second quarter's $23.2 million. Nine-month product revenue was $69.2 million. Source
  • IBTROZI is the only product revenue source: All product revenue to date comes from U.S. sales of IBTROZI, distributed to U.S. customers since June 2025. Source

IBTROZI patients and market share

  • New patient starts held near 160: New patient starts were about 160, flat on the second quarter, while total ROS1+ NSCLC TKI new starts fell about 15%, per IQVIA claims data. Source
  • TKI-naïve share of starts fell: Of Q3 starts, 65% were TKI-naïve, against about 85% of starts in the second quarter, when TKI-naïve starts were reported as about 30% quarter-over-quarter growth. Source
  • Market leadership cited on IQVIA data: Management said IBTROZI is the most prescribed ROS1 TKI and the market leader in new starts and active patients, based on IQVIA claims data. Source
  • Pretreated patients still starting therapy: The remaining new starts were TKI-pretreated patients, which management said shows continued prescribing of IBTROZI in later lines. Source

“Our rapid rise to market leadership reflects growing provider confidence in IBTROZI’s durability of more than four years in TKI-naïve patients and a generally favorable safety profile that helps patients stay on therapy.”

David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio

Collaboration revenue and China royalties

  • Collaboration revenue rose to $17.5 million: Collaboration and license revenue was $17.5 million, against $5.4 million a year earlier. Source
  • Supply, milestone and royalty drove increase: Product supply revenue rose $7.6 million, an Innovent sales milestone added $5.0 million, and royalties rose $2.4 million. R&D service revenue fell $2.9 million. Source
  • China reimbursement listing took effect: Taletrectinib entered China's reimbursement list from January 1, 2026. China and Japan royalty revenue for the quarter was $2.7 million. Source

Operating costs and net loss

  • R&D expense rose on trial costs: R&D expense was $32.7 million, up from $28.8 million a year earlier, mainly on higher third-party clinical trial costs and personnel costs. Source
  • SG&A rose on pay and sales spend: SG&A expense was $42.6 million, up from $37.4 million, with higher salaries, sales and marketing, and miscellaneous expense, partly offset by lower legal fees. Source
  • Net loss compared with prior-year quarter: Net loss was $41.9 million, or $(0.12) per share, against $55.8 million, or $(0.16) per share, in the third quarter of 2025. Source

“We are moving quickly to advance our comprehensive development program, with two Phase 2 and two pivotal Phase 3 studies spanning multiple IDH1 -mutant glioma subpopulations, designed to reach a broad spectrum of patients with this disease.”

David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio

Regulatory and clinical progress

  • FDA approved IBTROZI label update: The sNDA approval came four months before the January 4, 2027 target action date. Source
  • Label now shows 49.7-month response: The label reports 49.7 months median duration of response in TKI-naïve patients, based on 51 months median follow-up in TRUST-I. Safety sections were not changed. Source
  • Subgroup and TRUST-II data presented: Subgroup analyses from TRUST-I and TRUST-II were presented at WCLC in September. Updated TRUST-II data in entrectinib-pretreated patients were presented at ESMO in October. Source
  • Safusidenib granted Fast Track Designation: FDA granted Fast Track Designation to safusidenib in August 2026. It was supported by updated long-term J201 results and allows more frequent FDA interactions. Source

Safusidenib development program

  • J201 long-term efficacy reported: Centrally assessed ORR was 51.9% at 38.8 months median follow-up. Median PFS was not reached, and the 36-month PFS rate was 79.1%. Source
  • Two new safusidenib studies started: The Phase 3 G307 study began outside the U.S. and the Phase 2 G209 study began in the U.S. in July 2026, both in IDH1-mutant glioma. Source
  • SIGMA adds European study sites: The pivotal Phase 3 SIGMA study added sites in the UK, France, Sweden, Germany, Italy and Spain, extending it beyond the U.S., Australia, China, Canada and Japan. Source
  • SIGMA pivotal enrollment target: The pivotal portion of SIGMA will enroll about 300 patients, and a separate exploratory oligodendroglioma cohort will enroll about 40. Source

Capital and platform updates

  • Cash and securities totaled $663.4M: Cash, equivalents and marketable securities were $663.4 million at September 30, 2026, including $36.5 million from the July overallotment exercise. Source
  • Convertible notes reached $287.5 million: After the overallotment purchase, aggregate principal of the 0.75% convertible senior notes due 2032 was $287.5 million, with net proceeds of about $279.1 million. Source
  • Drug-drug conjugate platform continues: The company continues exploring new preclinical candidates for its drug-drug conjugate platform in solid tumors. Source

Coming up, as management said on 4 November 2026

  • Four posters at SNO annual meeting: Four posters, including updated Phase 2 J201 data, are to be presented at the Society for Neuro-Oncology meeting in Philadelphia. Source
  • Drug-drug conjugate update by year-end: The company aims to provide further updates on its drug-drug conjugate preclinical candidates by year-end 2026. Source

Figures management reported

FigureReported
Product sales, IBTROZI net Source$27.5 million, third quarter 2026
Regulatory approval SourcesNDA approved, September 2026
Fast Track designation SourceSafusidenib, August 2026
Trial readout, J201 ORR Source51.9% centrally assessed ORR
R&D expenses Source$32.7 million, third quarter 2026

Earlier plans management reported on

  • Ahead: The sNDA approval came four months before the target action date that had been accepted in May 2026. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.