Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer
Rhea-AI Summary
Nuvation Bio (NYSE: NUVB) announced a collaboration with Thermo Fisher Scientific for U.S.-based manufacturing of IBTROZI (taletrectinib), for advanced or metastatic ROS1-positive non-small cell lung cancer. Process tech transfer, product introduction, and an NDA supplement for the manufacturing transition have been completed to help secure drug supply.
Positive
- Thermo Fisher to manufacture IBTROZI final drug product in the United States
- Process tech transfer and product introduction for IBTROZI manufacturing completed
- Supplement to the IBTROZI New Drug Application for the manufacturing transition completed
Negative
- None.
News Market Reaction – NUVB
In the May 14 session, NUVB declined 1.26%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| 2026-05-06 | Regulatory update | Positive | +4.3% | FDA accepted supplemental NDA for IBTROZI with updated duration of response. |
| 2026-05-05 | Investor conferences | Positive | +4.3% | Management participation in several May 2026 investor conferences announced. |
| 2026-05-04 | Earnings and update | Positive | +9.5% | Q1 2026 results with IBTROZI revenue, strong cash, and pipeline updates. |
| 2026-04-27 | Guideline inclusion | Positive | -6.8% | IBTROZI added to NCCN CNS cancer guidelines for ROS1+ NSCLC with brain mets. |
| 2026-04-21 | Clinical data | Positive | -0.5% | Pooled TRUST data showed durable responses and manageable safety for IBTROZI. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent fundamentally positive events (earnings, sNDA acceptance, conferences) often saw positive price reactions, while some strong clinical/NCCN guideline updates drew negative or muted responses.
Over the past month, Nuvation Bio has reported several IBTROZI milestones. On Apr 21, durable AACR 2026 data drew a slight -0.49% move, and on Apr 27 an NCCN CNS guideline addition coincided with a larger -6.75% reaction. In contrast, Q1 2026 earnings on May 4 and subsequent conference participation on May 5 each saw +9.52% and +4.35% moves. FDA acceptance of a supplemental NDA on May 6 also aligned with a +4.35% gain, underscoring stronger reactions to financial and regulatory catalysts.
Key Terms
new drug application regulatory
non-small cell lung cancer medical
nsclc medical
ros1-positive medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Thermo Fisher Scientific, the world leader in serving science, will now manufacture drug product for Nuvation Bio in
Move by Nuvation Bio further ensures critical drug supply for patients and providers
"Our commitment to unencumbered access to IBTROZI for appropriate patients with ROS1+ NSCLC starts at the manufacturing stage, where we work to ensure that our collaborators and processes deliver critical medicine with high quality," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We are pleased to collaborate with Thermo Fisher, a leading contract manufacturer of pharmaceuticals, to bring IBTROZI manufacturing closer to the patients we serve."
Jennifer Cannon, President, Commercial Operations, Pharma Services at Thermo Fisher added, "We are pleased that Nuvation Bio has selected us for their final drug product manufacturing of IBTROZI in
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
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 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 ensuring drug supply and access to IBTROZI. 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 manufacturing or acquiring necessary products. 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.