Achieved $31.7 million in second quarter 2026 total revenue, including $23.2 million in net product revenue for IBTROZI$(R)$ (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. Consistent with this, approximately 85% of new prescriptions this quarter were for TKI-naïve patients who have the potential to be on therapy for many years. The continued shift toward TKI-naïve use highlights the increasing recognition of our long-term follow-up data in TRUST-I, which show a confirmed 90% response rate and a median duration of response of 50 months," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "This efficacy profile, combined with a generally tolerable safety profile and as the only brain-penetrant ROS1 inhibitor today without a CNS warning and precaution in its label, reinforces our belief that IBTROZI is becoming the standard of care for patients with advanced ROS1-positive NSCLC."
Dr. Hung continued, "We are equally excited about the progress of safusidenib, with our updated Phase 2 data showing further deepening and durable responses in IDH1-mutant gliomas. We now plan to evaluate the potential of this investigational medicine across the broad spectrum of patients in hopes of fulfilling our ultimate goal of providing an effective therapy for nearly every patient with this disease. During the second quarter, we also strengthened our balance sheet through our convertible notes offering, providing us with the financial flexibility to continue to invest in growing our portfolio."
Second Quarter 2026 and Recent Highlights:
IBTROZI(R) (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC
-- In the second quarter of 2026, Nuvation Bio reported $23.2 million in net
product revenues for IBTROZI, and a 25% quarter-over-quarter growth that
reflects the continued adoption and durability of treatment.
-- Importantly, about 85% of the approximately 160 new patient starts
were TKI-naïve, which is about a 30% quarter-over-quarter
growth in this treatment setting.
-- In June 2026, Nuvation Bio announced that the UK Medicines and Healthcare
products Regulatory Agency (MHRA) validated the Marketing Authorisation
Application $(MAA)$ submitted by partner Eisai Co., Ltd. for taletrectinib
for the treatment of advanced ROS1-positive non-small cell lung cancer
(ROS1+ NSCLC).
-- In May 2026, Nuvation Bio announced that the U.S. Food and Drug
Administration (FDA) accepted a supplemental New Drug Application (sNDA)
for IBTROZI with updated efficacy data in TKI-naïve and
TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January
4, 2027. The submission includes an additional 10 months of data from the
pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff,
demonstrating a median duration of response (mDOR) of 49.7 months and
median progression-free survival (mPFS) of 49.6 months in TKI-naïve
patients in TRUST-I and mDOR of 19.4 months in TKI-pretreated patients in
TRUST-II. In the TRUST-II study, the mDOR had not yet been reached in
TKI-naïve patients at the time of the data cutoff and is subject to
change as the data mature. Importantly, the safety profile remained
consistent with prior reports, and no new signals were identified.
-- In May 2026, Nuvation Bio announced new patient-reported outcomes data
from the pivotal TRUST-II study of IBTROZI in patients with advanced
ROS1+ NSCLC, presented at the 2026 ASCO Annual Meeting. Findings showed
that 88% of patients reported improved or stable global health
quality-of-life scores at first assessment, cognitive function scores
improved or remained stable throughout treatment, and patients
experienced rapid relief from burdensome symptoms including cough and
shortness of breath.
-- In May 2026, Nuvation Bio announced the successful completion of process
technology transfer and product introduction to Thermo Fisher Scientific
for U.S.-based manufacturing of drug product for IBTROZI, further
securing critical drug supply for ROS1+ NSCLC patients and providers.
-- In April 2026, Nuvation Bio presented updated pooled results from the
TRUST-I and TRUST-II studies of IBTROZI in both TKI-naïve and
TKI-pretreated patients at the American Association for Cancer Research
(AACR) Annual Meeting 2026. Notably, in the pooled TKI-naïve
population, IBTROZI demonstrated robust confirmed overall response rates
(cORR), mDOR and mPFS in TKI-naïve patients. Updated results from
the TRUST-I study were also simultaneously published in the Journal of
Clinical Oncology.
-- In April 2026, Nuvation Bio announced that taletrectinib (IBTROZI) has
been added to the latest National Comprehensive Cancer Network(R)
Clinical Practice Guidelines (NCCN Guidelines(R)) in Oncology for Central
Nervous System $(CNS)$ Cancers. Specifically, the NCCN Guidelines(R) for
CNS Cancers now recommend taletrectinib (IBTROZI) as a systemic therapy
option for ROS1+ NSCLC patients with brain metastases.
Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma
-- In July 2026, Nuvation Bio 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.
Highlights of the findings, at a median of 38.8 months of follow-up,
include the following:
-- The centrally assessed ORR, per Response Assessment in
Neuro-Oncology (RANO) for low grade gliomas (LGG) criteria, was
51.9%.
-- Median PFS was not reached, and the 36-month PFS rate was 79.1%.
-- Responses were durable, with only one patient who had previously
responded experiencing subsequent disease progression.
-- No new safety signals were identified.
-- In July 2026, Nuvation Bio also announced a significant expansion of the
clinical development program for safusidenib supported by the updated
long-term follow-up data from the Phase 2 (J201) study. The company
initiated two new studies to evaluate safusidenib across the broader
landscape of IDH1-mutant glioma: a pivotal Phase 3 study in patients with
grade 2 IDH1-mutant glioma outside the U.S. (G307; NCT07712757) and a
Phase 2 study in patients with IDH1-mutant glioma that has progressed
after prior treatment with vorasidenib in the U.S. (G209; NCT07703436).
-- In April 2026, Nuvation Bio announced that it has acquired the Japan
rights to safusidenib from Daiichi Sankyo, giving Nuvation Bio full
global development and commercialization rights. The agreement also
transfers ownership of the global clinical development program to
Nuvation Bio, inclusive of clinical trials, past and current data
generation, and future publications.
Drug-drug conjugate $(DDC)$ platform: Solid tumors
-- Nuvation Bio continues to explore new preclinical candidates for this
novel modality and aims to provide further updates by year-end 2026.
Corporate Update:
-- In July 2026, Nuvation Bio successfully completed a public offering of
0.75% Convertible Senior Notes with estimated net proceeds of
approximately $279.1 million, net of fees and related reimbursements. In
order to reduce dilution, the Company concurrently entered into capped
call transactions at a cap price of $10.4580 per share, representing an
80.0% premium over the last reported sale price of $5.81 per share.
Second Quarter 2026 Financial Results
As of June 30, 2026, Nuvation Bio had cash, cash equivalents, and marketable securities of $661.0 million. This does not reflect net proceeds of $36.5 million from exercise of the overallotment option in the Company's recent convertible senior notes offering, which occurred in July 2026.
Product Revenue, Net
To date, Nuvation Bio's only source of product revenue remains from the U.S. sales of IBTROZI, which Nuvation Bio began distributing to its U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $23.2 million for the three months ended June 30, 2026.
Collaboration and License Agreements Revenue
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