Achieved $18.5 million in first quarter of 2026 net product revenues for IBTROZI$(R)$ (taletrectinib); majority of the approximately 200 patients started on IBTROZI in the first quarter of 2026 were TKI-naïve, highlighting continued momentum in the first-line setting
Presented newly updated clinical data demonstrating IBTROZI's impressive durability of response and progression-free survival in TKI-naïve and TKI-pretreated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) at AACR 2026
Announced acquisition of Japan rights to safusidenib from Daiichi Sankyo, enabling global development and commercialization of promising investigational medicine
Strong balance sheet with cash, cash equivalents, and marketable securities of $533.7 million as of March 31, 2026
Company to host a conference call today at 4:30 pm ET
NEW YORK, May 4, 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 first quarter ended March 31, 2026, and provided a business update.
"We are pleased with IBTROZI's ongoing launch trends in the first quarter of 2026, as we continue to deepen its adoption across lines of therapy and make significant progress in becoming the standard of care for people living with advanced ROS1-positive NSCLC. The newly updated long-term follow-up data from our pivotal studies presented at AACR demonstrated an unprecedented durability for IBTROZI of now more than four years in TKI-naïve patients, further supporting healthcare providers and their patients' confidence in selecting IBTROZI. With our partners, we are well on our way to bringing this important medicine to patients in need around the world," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are also thrilled to have secured exclusive global development and commercialization rights to safusidenib. We look forward to advancing the pivotal Phase 3 SIGMA study for patients with high-risk IDH1-mutant glioma, where targeted treatment options are incredibly limited. Additionally, we are well on track to provide updates on our drug-drug conjugate platform later this year as we further our mission to tackle some of the toughest challenges in cancer treatment."
First Quarter 2026 and Recent Corporate Highlights:
IBTROZI(R) (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC
-- In the first quarter of 2026, Nuvation Bio reported $18.5 million in net
product revenues for IBTROZI.
-- In the first quarter of 2026, more than half of the approximately 200 new
patients who started treatment with IBTROZI for advanced ROS1+ NSCLC were
TKI-naïve, reflecting a sustained high rate of adoption and
confidence in IBTROZI among healthcare professionals and patients. Since
launch in late June 2025, over 600 patients have started IBTROZI.
-- 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), median duration of response (mDOR) and median progression-free
survival (mPFS) in TKI-naïve patients. Updated results from the
TRUST-I study were also simultaneously published in the Journal of
Clinical Oncology.
-- For TKI-naïve patients (n=157): the analysis showed a cORR of
89.8%, a mDOR of 49.7 months, a mPFS of 46.1 months and an
intracranial response rate of 76.5% in patients with brain
metastases (n=17). Median overall survival (OS) was not yet
reached.
-- For TKI-pretreated patients (n=113): the analysis showed a cORR of
55.8%, a mDOR of 16.6 months, a mPFS of 9.7 months and an
intracranial response rate of 65.6% in patients with brain
metastases (n=32). Median OS was 29.8 months. Notably, 98% of
TKI-pretreated patients (111/113) enrolled following progressive
disease on entrectinib or crizotinib rather than intolerance, a
higher bar for efficacy. The remaining two patients were enrolled
following intolerance to a prior TKI.
-- A pooled safety analysis demonstrated a favorable and generally
manageable safety profile for IBTROZI, consistent with its
prescribing information and no new safety signals were identified
with longer follow-up.
-- 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.
-- In March 2026, Nuvation Bio announced with Eisai Co., Ltd. that the
European Medicines Agency $(EMA)$ had validated the Marketing Authorisation
Application $(MAA)$ for taletrectinib for the treatment of advanced ROS1+
NSCLC. The filing is being considered for full approval and will follow a
standard review timeline.
-- On January 11, 2026, Nuvation Bio entered an exclusive license and
collaboration agreement with Eisai Co., Ltd. to develop, register and
commercialize taletrectinib for the treatment of ROS1+ NSCLC in Europe
and certain other territories outside of the U.S., China and Japan.
Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma
-- 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.
-- Nuvation Bio plans to present longer-term data from the Phase 2
study at a future medical meeting. As of February 2026, 12 of the
27 patients in the study remain on treatment with safusidenib with
a median follow-up of over 5 years.
-- In January 2026, Nuvation Bio announced the finalization of the protocol
amendment for the ongoing global Phase 3 SIGMA study for the maintenance
treatment of patients with IDH1-mutant astrocytoma who have high-risk
features following standard-of-care (G203). At that time, Nuvation Bio
also announced that the trial would enroll a non-pivotal single-arm
cohort to examine the efficacy and safety of safusidenib in chemotherapy-
and radiotherapy-naïve patients with grade 3 IDH1-mutant
oligodendroglioma with the primary endpoint of this arm being objective
response rate.
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 March 2026, Nuvation Bio appointed Stephen Dang, Ph.D., as Chief Legal
Officer. Dr. Dang originally joined Nuvation Bio in 2021 and has over 18
years of experience in the biopharmaceutical industry across all stages
of the drug product life cycle.
First Quarter 2026 Financial Results
As of March 31, 2026, Nuvation Bio had cash, cash equivalents, and marketable securities of $533.7 million.
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 $18.5 million for the three months ended March 31, 2026.
Collaboration and License Agreements Revenue
For the three months ended March 31, 2026, collaboration and license agreements revenue was $64.7 million, compared to $3.1 million for the three months ended March 31, 2025. The increase is primarily due to a $58.7 million increase in license revenue because of the upfront payment received under the Eisai agreement, a $2.4 million increase in product supply, a $1.5 million increase in royalty revenue, and was offset by a $1.0 million decrease in research and development service revenue.
Taletrectinib was included in China's National Reimbursement Drug List effective January 1, 2026. Royalty revenue for the quarter from collaboration agreements for China and Japan was $1.7 million.
Research and Development Expenses
For the three months ended March 31, 2026, research and development expenses were $35.0 million, compared to $24.6 million for the three months ended March 31, 2025. The increase was primarily due to a $1.5 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $8.9 million increase in third-party costs related to clinical trials.
Selling, General and Administrative Expenses
For the three months ended March 31, 2026, selling, general, and administrative expenses were $38.3 million, compared to $35.4 million for the three months ended March 31, 2025. The increase was due to a $5.7 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $0.1 million increase in taxes, offset by a $1.7 million decrease in sales and marketing expenses and $1.2 million decrease in professional fees.
Net income
(MORE TO FOLLOW) Dow Jones Newswires
May 04, 2026 16:10 ET (20:10 GMT)
Comments