Nuvation Bio Reports First Quarter 2026 Financial Results and Provides Business Update
Rhea-AI Summary
Nuvation Bio (NYSE: NUVB) reported Q1 2026 results and corporate updates on May 4, 2026. Key points: IBTROZI net product revenue $18.5M, collaboration and license revenue $64.7M, and cash, cash equivalents, and marketable securities of $533.7M as of March 31, 2026. Clinical updates include pooled TRUST-I/II data showing a TKI-naïve cORR 89.8%, mDOR 49.7 months and mPFS 46.1 months; EMA MAA validation in Europe; acquisition of global safusidenib rights; SIGMA Phase 3 ongoing.
AI-generated analysis. Not financial advice.
Positive
- IBTROZI net product revenue of $18.5 million in Q1 2026
- Collaboration and license revenue of $64.7 million in Q1 2026
- Cash and marketable securities of $533.7 million as of March 31, 2026
- TKI-naïve pooled data: cORR 89.8%, mDOR 49.7 months, mPFS 46.1 months
- Acquired global development and commercialization rights to safusidenib
Negative
- Revenue concentrated in a single marketed product, IBTROZI, to date
- Collaboration revenue increase driven largely by one-time Eisai upfront payment
- R&D expenses increased to $35.0 million, up $10.4 million year-over-year
News Market Reaction – NUVB
On the day this news was published, NUVB gained 9.52%, reflecting a notable positive market reaction. Argus tracked a peak move of +3.6% during that session. Argus tracked a trough of -13.1% from its starting point during tracking. Our momentum scanner triggered 27 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $146M to the company's valuation, bringing the market cap to $1.68B at that time. Trading volume was elevated at 2.8x the daily average, suggesting notable buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
NUVB was up 0.9% ahead of earnings while scanner activity showed only one peer (WVE) moving, down about 2.01%. Other close peers like ELVN, ORIC, GPCR, RCUS, and ZYME showed mixed, mostly modest moves, pointing to stock-specific rather than sector-driven dynamics.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 02 | Q4/FY 2025 earnings | Positive | -25.3% | Reported Q4 and full-year 2025 results with IBTROZI launch metrics and strong cash. |
| Jan 12 | Preliminary FY 2025 | Positive | -19.6% | Issued preliminary Q4/FY 2025 metrics and 2026 outlook ahead of JPM conference. |
| Nov 03 | Q3 2025 earnings | Positive | -6.6% | Reported Q3 2025 results with IBTROZI uptake, TRUST data, and strong cash. |
| Aug 07 | Q2 2025 earnings | Positive | -0.4% | Announced Q2 2025 results featuring FDA approval of IBTROZI and financing. |
| May 07 | Q1 2025 earnings | Positive | +2.9% | Q1 2025 results with taletrectinib under FDA Priority Review and strong funding. |
Earnings and financial updates have frequently been followed by negative price reactions despite generally constructive operational updates.
Over the past year, Nuvation Bio’s earnings-related news has focused on the commercial rollout of IBTROZI, expanding partnerships, and maintaining a large cash balance. Events on May 7, 2025, August 7, 2025, November 3, 2025, January 12, 2026, and March 2, 2026 highlighted FDA approval, patient starts, revenue growth, and sizable cash reserves, yet four of these five earnings-linked announcements were followed by single-day share price declines.
Historical Comparison
In the past year, NUVB issued 5 earnings-related updates, with an average next-day move of -9.81%, showing a tendency for pressured reactions even to constructive financial news.
Earnings updates have tracked IBTROZI’s path from pre-approval to commercial launch, growing patient starts and revenues, alongside expanding safusidenib development and maintaining a substantial cash position.
Market Pulse Summary
The stock moved +9.5% in the session following this news. A strong positive reaction aligns with a quarter that shifted from a prior-year loss to net income of $5.4M and highlighted $18.5M in IBTROZI product revenue and $64.7M in collaboration and license revenue. Historically, earnings updates saw an average one-day move of -9.81%, so a sizable gain would contrast with past patterns and could be sensitive to profit-taking or position cover by traders.
Key Terms
progression-free survival medical
overall response rate medical
median duration of response medical
median progression-free survival medical
median overall survival medical
Phase 3 medical
Marketing Authorisation Application regulatory
Rule 10b5-1 trading plan financial
AI-generated analysis. Not financial advice.
Achieved
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
Strong balance sheet with cash, cash equivalents, and marketable securities of
Company to host a conference call today at 4:30 pm ET
"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® (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC
- In the first quarter of 2026, Nuvation Bio reported
$18.5 million - 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 of76.5% 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 of65.6% 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.
- For TKI-naïve patients (n=157): the analysis showed a cORR of
- In April 2026, Nuvation Bio announced that taletrectinib (IBTROZI) has been added to the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for Central Nervous System (CNS) cancers. Specifically, the NCCN Guidelines® 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 theU.S. ,China andJapan .
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
Product Revenue, Net
To date, Nuvation Bio's only source of product revenue remains from the
Collaboration and License Agreements Revenue
For the three months ended March 31, 2026, collaboration and license agreements revenue was
Taletrectinib was included in
Research and Development Expenses
For the three months ended March 31, 2026, research and development expenses were
Selling, General and Administrative Expenses
For the three months ended March 31, 2026, selling, general, and administrative expenses were
Net income
For the three months ended March 31, 2026, Nuvation Bio reported a net income of
Conference Call and Webcast
Nuvation Bio will host a conference call and webcast today, May 4, 2026, at 4:30 pm ET to discuss its financial results for the first quarter of 2026 and provide business updates.
Investors and the general public are invited to listen to the live webcast and may register on the Investor Relations section of the Nuvation Bio website. To access the live conference call, participants can dial +1 833-461-5787 (
About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately
About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the
About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in
Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).
IMPORTANT SAFETY INFORMATION FOR IBTROZI® (taletrectinib)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur.
Increased AST or ALT each led to dose interruption in
Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in
ILD/pneumonitis led to dose interruption in
QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.
In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in
Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.
Hyperuricemia: Hyperuricemia can occur and was reported in
Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in
Concurrent myalgia with increased CPK within a 7-day time period occurred in
Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures.
Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.
ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥
The most frequently reported Grade 3/4 laboratory abnormalities (≥
DRUG INTERACTIONS
- Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
- Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS
- Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
- Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
- Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
- Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
- Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.
Please see accompanying full Prescribing Information.
About IDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the
About Safusidenib
Safusidenib is an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. In Phase 1 and Phase 2 clinical studies, safusidenib demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile that supports the currently enrolling Phase 3 SIGMA study.
About the SIGMA (G203) Study
SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029.
A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027.
About Nuvation Bio
Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program.
Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements about IBTROZI and safusidenib's therapeutic and commercial potential, IBTROZI becoming the new standard of care in advanced ROS1+ NSCLC, Nuvation Bio's expectations that the MAA filing for taletrectinib will follow a standard review timeline and be considered for full approval, the need for new therapeutic options in IDH1-mutant gliomas, Nuvation Bio's plans for safusidenib development and future data presentations, and Nuvation Bio's evaluation of additional preclinical candidates. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to whether Nuvation Bio is successful in commercializing IBTROZI; the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; whether Nuvation Bio meets its post-marketing requirements and commitments for IBTROZI; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 4, 2026 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
Media and Investor Contacts
Nuvation Bio Investor Contact
JR DeVita
ir@nuvationbio.com
Nuvation Bio Media Contact
Kaitlyn Nealy
media@nuvationbio.com
NUVATION BIO INC. and Subsidiaries | |||
Consolidated Balance Sheets | |||
(In thousands, except share and per share data) | |||
March 31, | December 31, | ||
2026 | 2025 | ||
(unaudited) | |||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 125,391 | $ 164,086 | |
Accounts receivable, net of allowance for credit loss of $nil and nil, respectively | 22,723 | 16,076 | |
Inventory | 15,844 | 11,411 | |
Prepaid expenses and other current assets | 15,972 | 11,536 | |
Marketable securities | 408,338 | 365,125 | |
Interest receivable on marketable securities | 3,261 | 3,285 | |
Total current assets | 591,529 | 571,519 | |
Property and equipment, net of accumulated depreciation of | 535 | 564 | |
Intangible assets, net of accumulated amortization of | 10,755 | 11,214 | |
Operating lease right-of-use assets | 3,598 | 3,918 | |
Other non-current assets | 3,824 | 7,607 | |
Total assets | $ 610,241 | $ 594,822 | |
Liabilities and stockholders' equity | |||
Current liabilities: | |||
Accounts payable | $ 22,435 | $ 9,479 | |
Current operating lease liabilities | 1,838 | 1,880 | |
Contract liabilities, current portion | 8,651 | 7,515 | |
Liability related to revenue interest financing agreement, current portion | 7,944 | 9,585 | |
Short-term borrowings | 5,790 | 5,724 | |
Warrant liability | - | 2,865 | |
Accrued expenses | 32,864 | 45,183 | |
Total current liabilities | 79,522 | 82,231 | |
Contract liabilities, net of current portion | 9,743 | 11,305 | |
Non-current operating lease liabilities | 2,199 | 2,543 | |
Non-current liability related to revenue interest financing agreement, net of deferred financing costs of | 151,886 | 145,819 | |
Long-term borrowings, net of deferred financing costs of | 47,327 | 47,208 | |
Total liabilities | 290,677 | 289,106 | |
Stockholders' equity | |||
Class A and Class B common stock and additional paid in capital, | |||
(Class A 1,000,000,000, Class B 60,000,000) shares authorized as of March 31, 2026 and December 31, 2025, | |||
347,693,331 (Class A 346,693,331, Class B 1,000,000) and 346,503,675 (Class A 345,503,675, Class B 1,000,000) | |||
shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively | 1,431,214 | 1,421,273 | |
Accumulated deficit | (1,109,973) | (1,115,370) | |
Accumulated other comprehensive income | (1,677) | (187) | |
Total stockholders' equity | 319,564 | 305,716 | |
Total liabilities and stockholders' equity | $ 610,241 | $ 594,822 |
NUVATION BIO INC. and Subsidiaries | |||
Consolidated Statements of Operations and Comprehensive Loss | |||
(In thousands, except per share data) | |||
Three Months Ended March 31, | |||
2026 | 2025 | ||
Revenues: | |||
Product revenue, net | $ 18,510 | $ - | |
Collaboration and license agreements revenue | 64,718 | 3,084 | |
Total revenues | 83,228 | 3,084 | |
Costs and expenses: | |||
Cost of sales | 375 | - | |
Cost of collaboration and license agreements revenue | 5,616 | 2,094 | |
Research and development | 35,047 | 24,601 | |
Selling, general and administrative | 38,309 | 35,393 | |
Total costs and expenses | 79,347 | 62,088 | |
Income (loss) from operations | 3,881 | (59,004) | |
Other income (expense): | |||
Interest income | 5,108 | 5,321 | |
Interest expense | (6,708) | (54) | |
Investment advisory fees | (195) | (203) | |
Change in fair value of warrant liability | 2,865 | (751) | |
Realized gain (loss) on marketable securities | 8 | 3 | |
Other income (expense) | 438 | 1,452 | |
Total other income, net | 1,516 | 5,768 | |
Income (loss) before income taxes | 5,397 | (53,236) | |
Provision for income taxes | - | - | |
Net income (loss) | $ 5,397 | $ (53,236) | |
Basic earnings (loss) per share attributable to common stockholders | $ 0.02 | $ (0.16) | |
Diluted earnings (loss) per share attributable to common stockholders | $ 0.01 | $ (0.16) | |
Basic weighted average common shares outstanding | 347,332 | 338,612 | |
Diluted weighted average common shares outstanding | 377,521 | 338,612 | |
Comprehensive income (loss): | |||
Net income (loss) | $ 5,397 | $ (53,236) | |
Other comprehensive (loss) income, net of taxes: | |||
Currency translation adjustment | (268) | 465 | |
Change in unrealized loss on available-for-sale securities | (1,222) | (493) | |
Comprehensive income (loss) | $ 3,907 | $ (53,264) | |
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SOURCE Nuvation Bio Inc.