Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in Advanced ROS1-Positive Non-Small Cell Lung Cancer

Rhea-AI Summary

Nuvation Bio (NYSE: NUVB) announced FDA acceptance of a supplemental NDA for IBTROZI (taletrectinib) in advanced ROS1-positive NSCLC, with a target action date of January 4, 2027. The submission adds 10 months of follow-up (August 2025 cutoff) from TRUST-I and TRUST-II.

Key efficacy updates: TRUST-I TKI-naïve mDOR 49.7 months and mPFS 49.6 months; TRUST-II TKI-pretreated mDOR 19.4 months. Safety remained consistent with prior reports.

Positive

• FDA accepted sNDA with Jan 4, 2027 target action date
• TRUST-I TKI‑naïve mDOR 49.7 months
• TRUST-I TKI‑naïve mPFS 49.6 months
• TRUST-II TKI‑pretreated mDOR 19.4 months
• Safety profile consistent; no new signals
• Existing full approval (US June 2025) and Japan/China approvals

Negative

• sNDA outcome pending until Jan 4, 2027
• TRUST-II mDOR in TKI‑naïve patients not reached and may change

News Market Reaction – NUVB

+4.35%

4 alerts

+4.35% Session close to close

$1.80B Market Cap

0.1x Rel. Volume

In the May 6 session, NUVB gained 4.35%, reflecting a moderate positive market reaction. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details FDA acceptance of an sNDA for IBTROZI with updated TRUST-I/II data showing...

Analysis

This announcement details FDA acceptance of an sNDA for IBTROZI with updated TRUST-I/II data showing mDOR and mPFS near 50 months in TKI-naïve ROS1+ NSCLC and 19.4 months mDOR in TKI-pretreated patients. The filing fulfills a post‑marketing commitment and targets a January 4, 2027 action date. In context of prior pivotal results and global approvals, investors may track future regulatory milestones and additional maturity of TRUST-II TKI‑naïve outcomes, which remain unreached.

Key Figures

TRUST-I mDOR (TKI-naïve): 49.7 months TRUST-I mPFS (TKI-naïve): 49.6 months TRUST-II mDOR (TKI-pretreated): 19.4 months +3 more

6 metrics

TRUST-I mDOR (TKI-naïve) 49.7 months Advanced ROS1+ NSCLC, IBTROZI pivotal TRUST-I study

TRUST-I mPFS (TKI-naïve) 49.6 months Advanced ROS1+ NSCLC, IBTROZI pivotal TRUST-I study

TRUST-II mDOR (TKI-pretreated) 19.4 months Advanced ROS1+ NSCLC, IBTROZI pivotal TRUST-II study

Additional follow-up 10 months Extra data included vs prior TRUST-I/II cutoff

FDA target action date January 4, 2027 sNDA for IBTROZI label update in ROS1+ NSCLC

TRUST-II mDOR (TKI-naïve) Not yet reached Advanced ROS1+ NSCLC, IBTROZI pivotal TRUST-II study

Previous Clinical trial Reports

5 past events · Latest: Feb 09 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Feb 09	Trial upgrade	Positive	-1.1%	Safusidenib SIGMA study converted to pivotal Phase 3 with larger enrollment.
Dec 03	Phase 2 results	Positive	+12.1%	Positive Phase 2 safusidenib data in IDH1-mutant glioma with strong PFS signals.
Sep 30	Phase 3 enrollment	Positive	+14.9%	First patient enrolled in TRUST-IV Phase 3 adjuvant IBTROZI NSCLC study.
Sep 07	Pivotal data update	Positive	-10.5%	New TRUST-I/II IBTROZI data with high cORR and strong intracranial responses.
Jun 02	ASCO/JCO data	Positive	-12.3%	Updated TRUST-I taletrectinib data with high cORR and durable responses in NSCLC.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial announcements have generally been positive but produced mixed price reactions, with more instances of downside than upside moves.

Recent Company History

Over recent clinical updates, Nuvation Bio has advanced both IBTROZI and safusidenib. IBTROZI data have shown high response rates and long PFS in ROS1+ NSCLC, while safusidenib progressed from positive Phase 2 results toward a pivotal Phase 3 SIGMA trial expanding to 300 patients. Price reactions around these clinical milestones have been volatile, with several positive data releases followed by negative single‑day moves, underscoring event-driven but inconsistent trading around trial news.

Key Terms

supplemental new drug application (sNDA), median duration of response (mDOR), median progression-free survival (mPFS), tki-naïve, +4 more

8 terms

supplemental new drug application (sNDA) regulatory

"FDA has accepted a supplemental New Drug Application (sNDA) with updated data"

A supplemental new drug application (snda) is a formal request made to regulatory authorities to make changes to an already approved medication, such as adding new uses, adjusting dosages, or improving manufacturing processes. It’s similar to updating a product’s packaging or instructions after it has been approved for sale. For investors, an snda signals ongoing development or improvements that could impact a company’s future sales or regulatory approval prospects.

median duration of response (mDOR) medical

"demonstrated median duration of response (mDOR) of 49.7 months"

Median duration of response (mDOR) measures how long the middle patient — half respond for longer, half for shorter — keeps a positive treatment effect before the disease returns or worsens. For investors, mDOR indicates how durable a drug’s benefit is: longer mDOR can mean stronger clinical value, higher chances of regulatory approval and broader market uptake, similar to preferring a phone with a longer-lasting battery.

median progression-free survival (mPFS) medical

"and median progression-free survival (mPFS) of 49.6 months"

Median progression-free survival is the middle value of time, in a group of patients in a clinical trial, during which their disease does not get worse after starting a treatment — half the patients went longer without progression and half progressed sooner. Investors use it as an early measure of a drug’s effectiveness and commercial promise, because longer progression-free times can signal stronger clinical benefit, higher chances of regulatory approval, and greater market value, even though it is not the same as overall survival.

tki-naïve medical

"in both TKI-naïve and TKI-pretreated advanced ROS1-positive"

TKI‑naïve describes a patient who has never received treatment with a tyrosine kinase inhibitor, a class of targeted drugs that block specific enzymes involved in cancer cell growth. For investors, this matters because therapies and trial results in TKI‑naïve populations can signal a larger potential market and clearer measure of a new drug’s effectiveness, similar to testing a product on first-time users rather than people already using competitors’ products.

tki-pretreated medical

"in both TKI-naïve and TKI-pretreated advanced ROS1-positive"

Patients described as “tki-pretreated” have already received one or more tyrosine kinase inhibitors, a class of targeted cancer drugs, before entering a new treatment or trial. For investors, this signals the study population is more experienced with prior therapy and may respond differently than untreated patients, much like a car that’s had previous repairs behaving differently under a new mechanic’s approach; it affects how to interpret efficacy, safety and market opportunity for the new therapy.

non-small cell lung cancer (nsclc) medical

"advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)"

A common group of lung cancers that arise from the lungs’ cell lining and grow in ways different from the faster-spreading “small cell” form; think of it as several related varieties of the same illness rather than one single disease. It matters to investors because diagnosis rates, new drugs, diagnostic tests, and clinical trial results for these cancers can drive large, sustained revenue opportunities and regulatory decisions that materially affect healthcare and biotech company valuations.

post-marketing commitment regulatory

"submission, which fulfills an FDA post-marketing commitment"

Post-marketing commitment is an agreement a drug or medical device maker makes with regulators to carry out additional studies, safety monitoring, or other actions after a product is approved and sold. Like promising to keep checking a car model after it hits the road, these commitments matter to investors because they can create future costs, lead to label changes or usage restrictions, delay broader launches, or uncover safety findings that affect sales and a company’s stock value.

marketing authorisation application (maa) regulatory

"Marketing Authorisation Application (MAA) for taletrectinib was validated"

An marketing authorisation application is a formal request submitted to a health regulator asking for permission to sell a new medicine or medical product in a given market. For investors it matters because approval is the regulatory ‘green light’ that allows commercial sales and revenue, while delays, additional requirements, or rejection create uncertainty about timing, costs and a product’s market potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Application includes updated TRUST-I TKI-naïve median duration of response (mDOR) and median progression-free survival (mPFS) of more than 4 years, as well as TRUST-II TKI-pretreated mDOR of nearly 20 months

FDA has assigned a target action date of January 4, 2027

NEW YORK, May 6, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI^® (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) with a target action date of January 4, 2027.

The submission, which fulfills an FDA post-marketing commitment and is intended to update the efficacy information provided in the IBTROZI label, includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, further validating the overall clinical profile with long-term follow-up. As of this data cutoff, IBTROZI demonstrated 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, reflecting more than four years of sustained clinical benefit, 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. Many patients remained on therapy for extended periods and without disease progression—some for multiple years—highlighting the long-term tolerability of IBTROZI and reinforcing its importance as a treatment option. These data were recently presented at the American Association for Cancer Research (AACR) Annual Meeting 2026.

"These longer-term data for IBTROZI—which show an impressive median duration of response of more than four years in TKI-naïve patients, mirrored by the progression-free survival results and supported by a consistent safety profile—reinforce our belief that IBTROZI is becoming the new standard of care in advanced ROS1+ NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "The breadth and maturity of these data give both patients and providers even greater confidence when selecting IBTROZI."

The U.S. FDA granted full approval to IBTROZI in June 2025 for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, followed by a successful launch. IBTROZI is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON^®. Additionally, the Company, along with its partner, Eisai, announced in March 2026 that the Marketing Authorisation Application (MAA) for taletrectinib was validated by the European Medicines Agency for full approval consideration with a standard review timeline.

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 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, following Priority Review and Breakthrough Therapy Designations for both first- and second-line or later, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com.

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 China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. 

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. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

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 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

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 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

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 (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

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 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 New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc).

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 regarding IBTROZI'S long-term therapeutic potential, our belief that IBTROZI is becoming the new standard of care in advanced ROS1+ NSCLC, and regulatory review timelines and outcomes. 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 the challenges associated with conducting drug discovery and commercialization, 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; physician and patient behavior; 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

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SOURCE Nuvation Bio Inc.

FAQ

What did NUVB announce about the IBTROZI sNDA and FDA timeline?

The sNDA for IBTROZI was accepted by FDA with a target action date of January 4, 2027. According to the company, the filing adds 10 months of follow-up (August 2025 cutoff) from TRUST-I and TRUST-II.

What are the updated TRUST-I results for IBTROZI in TKI-naïve ROS1+ NSCLC (NUVB)?

TRUST-I TKI‑naïve patients showed mDOR 49.7 months and mPFS 49.6 months. According to the company, these figures reflect more than four years of follow-up as of the August 2025 cutoff.

What is the TRUST-II mDOR update for TKI‑pretreated patients for IBTROZI (NUVB)?

TRUST-II reported a TKI‑pretreated mDOR of 19.4 months as of the August 2025 cutoff. According to the company, TKI‑naïve mDOR in TRUST‑II had not yet been reached and remains immature.

Does the IBTROZI safety profile change with the new data (NUVB)?

No new safety signals were identified and the safety profile remained consistent with prior reports. According to the company, many patients remained on therapy for multiple years without progression.

Has IBTROZI received regulatory approvals outside this sNDA (NUVB)?

Yes. According to the company, IBTROZI received full U.S. approval in June 2025 and is approved in Japan and China (marketed partners noted); an EMA MAA validation occurred in March 2026.

How does the sNDA relate to previous IBTROZI approvals for NUVB?

The sNDA fulfills an FDA post‑marketing commitment to update label efficacy with longer follow-up. According to the company, it supplements the existing full U.S. approval granted in June 2025.