Nuvation Bio Reports TRUST-II Study Outcomes for IBTROZI in ROS1+ NSCLC
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Source: PRnewswire
- Quality of Life Improvement: In the TRUST-II study, 88% of patients reported improved or stable quality of life, indicating IBTROZI's effectiveness in alleviating symptoms, which enhances patient confidence and adherence to treatment.
- Cognitive Function Preservation: The study demonstrated that cognitive function scores remained stable throughout treatment, suggesting that IBTROZI can effectively manage the disease without neurological impairment, aligning with patient expectations for quality of life.
- Rapid Symptom Relief: IBTROZI provides rapid relief from burdensome symptoms such as cough and shortness of breath, enabling patients to maintain normal daily activities during treatment, thereby enhancing their overall life experience.
- FDA Approval and Market Outlook: IBTROZI has received FDA approval for the treatment of ROS1+ NSCLC, and a supplemental New Drug Application is underway, which is expected to further drive market acceptance and sales growth.
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Analyst Views on NUVB
Wall Street analysts forecast NUVB stock price to rise
10 Analyst Rating
9 Buy
1 Hold
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Strong Buy
Current: 4.740
Low
8.00
Averages
11.38
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18.00
Current: 4.740
Low
8.00
Averages
11.38
High
18.00
About NUVB
Nuvation Bio Inc. is a global oncology company. The Company is focused on tackling cancer treatment. Its diverse pipeline includes taletrectinib (IBTROZI), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor, and a drug-drug conjugate (DDC) program. IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor. Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1), which is detected in various tumors, including gliomas. Its platform leverages its drug discovery and chemistry expertise to find the minimum target binding sites of drug X and drug Y and fuse them together, while maintaining activity. Its DDCs are designed to selectively bind to intracellular as well as surface cell membrane targets that are expressed more highly in specific target tissues and to potently deliver anti-cancer warheads to these target tissues.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Nuvation Bio Reports TRUST-II Study Outcomes for IBTROZI in ROS1+ NSCLC
- Quality of Life Improvement: In the TRUST-II study, 88% of patients reported improved or stable quality of life, indicating IBTROZI's effectiveness in alleviating symptoms, which enhances patient confidence and adherence to treatment.
- Cognitive Function Preservation: The study demonstrated that cognitive function scores remained stable throughout treatment, suggesting that IBTROZI can effectively manage the disease without neurological impairment, aligning with patient expectations for quality of life.
- Rapid Symptom Relief: IBTROZI provides rapid relief from burdensome symptoms such as cough and shortness of breath, enabling patients to maintain normal daily activities during treatment, thereby enhancing their overall life experience.
- FDA Approval and Market Outlook: IBTROZI has received FDA approval for the treatment of ROS1+ NSCLC, and a supplemental New Drug Application is underway, which is expected to further drive market acceptance and sales growth.
See More
Nuvation Bio to Speak at Jefferies Global Healthcare Conference
- Executive Participation: Nuvation Bio's Founder and CEO, Dr. David Hung, along with CFO Philippe Sauvage, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 3, 2026, in New York, where they are expected to discuss the company's latest advancements and strategies in cancer treatment.
- Live Webcast: The fireside chat will be available via live webcast on Nuvation Bio's Investor Relations page, and an archived recording will be accessible for 90 days post-event, ensuring that investors who cannot attend live can still access critical information.
- Company Overview: Founded in 2018, Nuvation Bio focuses on developing therapies that create a profound positive impact on patients' lives, with a diverse pipeline that includes the next-generation ROS1 inhibitor taletrectinib (IBTROZI®) and the brain-penetrant IDH1 inhibitor safusidenib.
- Experienced Leadership: Dr. David Hung, the founder of Nuvation Bio, previously established Medivation, Inc., which successfully launched one of the world's leading prostate cancer medications, highlighting his extensive background and expertise in the biopharmaceutical industry.
See More
Investigation Launched into Nuvation Bio's Corporate Governance
- Investigation Initiated: Purcell & Lefkowitz LLP is investigating Nuvation Bio Inc. to determine if the company's directors breached their fiduciary duties in recent corporate actions, potentially impacting shareholder rights.
- Shareholder Rights Focus: The investigation is aimed at Nuvation Bio's shareholders, and those interested in learning more about their rights and options can visit the law firm's website for detailed information.
- Commitment to Legal Services: Purcell & Lefkowitz LLP is dedicated to representing shareholders nationwide who are victims of securities fraud, breaches of fiduciary duty, and other corporate misconduct, demonstrating its expertise in protecting shareholder interests.
- No-Cost Consultation: The law firm offers no-cost consultations, allowing shareholders to directly contact attorneys via phone or email to discuss case details, thereby enhancing shareholder confidence in legal support.
See More
Nuvation Bio's Lung Cancer Therapy Application Accepted by FDA
- FDA Application Acceptance: Nuvation Bio (NUVB) announced on Wednesday that its marketing application for the lung cancer therapy Ibtrozi has been accepted by the U.S. FDA, marking a significant advancement in the company's efforts to expand the drug's indications.
- Indication Expansion: The application aims to provide treatment options for both TKI-naive and TKI-pretreated advanced ROS1-positive non-small cell lung cancer patients, demonstrating the company's commitment to addressing diverse patient needs.
- Key Data Support: This supplemental New Drug Application (sNDA) is backed by 10 months of additional data from the company's TRUST-I and TRUST-II studies, further enhancing the validity and compliance of its market application.
- Target Action Date: The FDA has set a target action date of January 4, 2027, and Nuvation Bio expects to continue advancing its market strategy ahead of this date to ensure a successful launch.
See More
Nuvation Bio Updates Efficacy Data for IBTROZI in ROS1+ NSCLC
- Efficacy Data Update: Nuvation Bio reported that IBTROZI shows a median duration of response (mDOR) exceeding 49.7 months in TKI-naïve patients, indicating over four years of sustained clinical benefit, thereby reinforcing its position in advanced ROS1+ non-small cell lung cancer (NSCLC) treatment.
- FDA Review Timeline: The U.S. FDA has accepted the supplemental New Drug Application (sNDA) for IBTROZI, setting a target action date of January 4, 2027, reflecting the company's proactive approach in meeting regulatory commitments.
- Safety Profile Consistency: The latest data indicates that IBTROZI's safety profile remains consistent with prior reports, with no new safety signals identified, enhancing confidence among patients and providers regarding long-term tolerability.
- International Market Expansion: IBTROZI has received approvals in the U.S., Japan, and China, with a validated marketing authorization application in Europe, indicating Nuvation Bio's potential for global market expansion.
See More
Nuvation Bio Q1 2026 Earnings Call Highlights
- Sustained Patient Starts: Nuvation Bio successfully treated approximately 200 new patients in Q1, bringing the total to over 600 since launch, indicating steady market demand and a shift towards earlier-line use, which is expected to drive future revenue growth.
- Significant Revenue and Collaboration Gains: The company reported total revenue of $83.2 million in Q1, with IBTROZI net U.S. product revenue of $18.5 million, reflecting an 18% increase from the prior quarter, driven by a growing population of active patients and stable frontline usage.
- Guideline Inclusion Enhances Market Recognition: IBTROZI's inclusion in the latest CNS NCCN guidelines as a systemic therapy option for ROS1-positive NSCLC patients boosts product recognition and may facilitate broader clinical adoption, enhancing its competitive positioning.
- Cash Flow and Future Outlook: The company ended the quarter with $533.7 million in cash and equivalents, expecting to receive approximately $30 million in milestone payments upon IBTROZI's approval in Europe in H1 2027, with management indicating potential for future revenue and EPS guidance, reflecting confidence in long-term growth.
See More
Nuvation Bio Reports TRUST-II Study Outcomes for IBTROZI in ROS1+ NSCLC
- Quality of Life Improvement: In the TRUST-II study, 88% of patients reported improved or stable quality of life, indicating IBTROZI's effectiveness in alleviating symptoms, which enhances patient confidence and adherence to treatment.
- Cognitive Function Preservation: The study demonstrated that cognitive function scores remained stable throughout treatment, suggesting that IBTROZI can effectively manage the disease without neurological impairment, aligning with patient expectations for quality of life.
- Rapid Symptom Relief: IBTROZI provides rapid relief from burdensome symptoms such as cough and shortness of breath, enabling patients to maintain normal daily activities during treatment, thereby enhancing their overall life experience.
- FDA Approval and Market Outlook: IBTROZI has received FDA approval for the treatment of ROS1+ NSCLC, and a supplemental New Drug Application is underway, which is expected to further drive market acceptance and sales growth.
See More
Nuvation Bio to Speak at Jefferies Global Healthcare Conference
- Executive Participation: Nuvation Bio's Founder and CEO, Dr. David Hung, along with CFO Philippe Sauvage, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 3, 2026, in New York, where they are expected to discuss the company's latest advancements and strategies in cancer treatment.
- Live Webcast: The fireside chat will be available via live webcast on Nuvation Bio's Investor Relations page, and an archived recording will be accessible for 90 days post-event, ensuring that investors who cannot attend live can still access critical information.
- Company Overview: Founded in 2018, Nuvation Bio focuses on developing therapies that create a profound positive impact on patients' lives, with a diverse pipeline that includes the next-generation ROS1 inhibitor taletrectinib (IBTROZI®) and the brain-penetrant IDH1 inhibitor safusidenib.
- Experienced Leadership: Dr. David Hung, the founder of Nuvation Bio, previously established Medivation, Inc., which successfully launched one of the world's leading prostate cancer medications, highlighting his extensive background and expertise in the biopharmaceutical industry.
See More
Investigation Launched into Nuvation Bio's Corporate Governance
- Investigation Initiated: Purcell & Lefkowitz LLP is investigating Nuvation Bio Inc. to determine if the company's directors breached their fiduciary duties in recent corporate actions, potentially impacting shareholder rights.
- Shareholder Rights Focus: The investigation is aimed at Nuvation Bio's shareholders, and those interested in learning more about their rights and options can visit the law firm's website for detailed information.
- Commitment to Legal Services: Purcell & Lefkowitz LLP is dedicated to representing shareholders nationwide who are victims of securities fraud, breaches of fiduciary duty, and other corporate misconduct, demonstrating its expertise in protecting shareholder interests.
- No-Cost Consultation: The law firm offers no-cost consultations, allowing shareholders to directly contact attorneys via phone or email to discuss case details, thereby enhancing shareholder confidence in legal support.
See More
Nuvation Bio's Lung Cancer Therapy Application Accepted by FDA
- FDA Application Acceptance: Nuvation Bio (NUVB) announced on Wednesday that its marketing application for the lung cancer therapy Ibtrozi has been accepted by the U.S. FDA, marking a significant advancement in the company's efforts to expand the drug's indications.
- Indication Expansion: The application aims to provide treatment options for both TKI-naive and TKI-pretreated advanced ROS1-positive non-small cell lung cancer patients, demonstrating the company's commitment to addressing diverse patient needs.
- Key Data Support: This supplemental New Drug Application (sNDA) is backed by 10 months of additional data from the company's TRUST-I and TRUST-II studies, further enhancing the validity and compliance of its market application.
- Target Action Date: The FDA has set a target action date of January 4, 2027, and Nuvation Bio expects to continue advancing its market strategy ahead of this date to ensure a successful launch.
See More
Nuvation Bio Updates Efficacy Data for IBTROZI in ROS1+ NSCLC
- Efficacy Data Update: Nuvation Bio reported that IBTROZI shows a median duration of response (mDOR) exceeding 49.7 months in TKI-naïve patients, indicating over four years of sustained clinical benefit, thereby reinforcing its position in advanced ROS1+ non-small cell lung cancer (NSCLC) treatment.
- FDA Review Timeline: The U.S. FDA has accepted the supplemental New Drug Application (sNDA) for IBTROZI, setting a target action date of January 4, 2027, reflecting the company's proactive approach in meeting regulatory commitments.
- Safety Profile Consistency: The latest data indicates that IBTROZI's safety profile remains consistent with prior reports, with no new safety signals identified, enhancing confidence among patients and providers regarding long-term tolerability.
- International Market Expansion: IBTROZI has received approvals in the U.S., Japan, and China, with a validated marketing authorization application in Europe, indicating Nuvation Bio's potential for global market expansion.
See More
Nuvation Bio Q1 2026 Earnings Call Highlights
- Sustained Patient Starts: Nuvation Bio successfully treated approximately 200 new patients in Q1, bringing the total to over 600 since launch, indicating steady market demand and a shift towards earlier-line use, which is expected to drive future revenue growth.
- Significant Revenue and Collaboration Gains: The company reported total revenue of $83.2 million in Q1, with IBTROZI net U.S. product revenue of $18.5 million, reflecting an 18% increase from the prior quarter, driven by a growing population of active patients and stable frontline usage.
- Guideline Inclusion Enhances Market Recognition: IBTROZI's inclusion in the latest CNS NCCN guidelines as a systemic therapy option for ROS1-positive NSCLC patients boosts product recognition and may facilitate broader clinical adoption, enhancing its competitive positioning.
- Cash Flow and Future Outlook: The company ended the quarter with $533.7 million in cash and equivalents, expecting to receive approximately $30 million in milestone payments upon IBTROZI's approval in Europe in H1 2027, with management indicating potential for future revenue and EPS guidance, reflecting confidence in long-term growth.
See More
