Nuvalent Files NDA for Zidesamtinib, Targeting FDA Approval by September 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
0mins
Should l Buy NUVL?
Source: Newsfilter
- NDA Submission: Nuvalent, Inc. has filed a New Drug Application (NDA) for zidesamtinib, targeting adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received at least one prior ROS1 tyrosine kinase inhibitor. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026, for this application.
- Clinical Trial Basis: The NDA submission is based on results from the global ARROS-1 Phase 1/2 clinical trial involving TKI-pretreated patients with advanced ROS1-positive NSCLC. These data were presented at the Presidential Symposium during the IASLC 2025 World Conference on Lung Cancer, indicating the drug's potential efficacy.
- Drug Characteristics: Zidesamtinib is a novel ROS1-selective inhibitor designed to overcome limitations of existing ROS1 inhibitors, particularly for tumors that have developed resistance. It also features CNS penetrance, potentially improving treatment options for patients with brain metastases.
- Market Potential: Zidesamtinib has received breakthrough therapy designation for patients previously treated with two or more ROS1 TKIs. This advancement may provide Nuvalent with significant market opportunities in the competitive lung cancer treatment landscape, further solidifying its position in the biopharmaceutical sector.
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Analyst Views on NUVL
Wall Street analysts forecast NUVL stock price to rise
16 Analyst Rating
16 Buy
0 Hold
0 Sell
Strong Buy
Current: 101.330
Low
125.00
Averages
140.86
High
158.00
Current: 101.330
Low
125.00
Averages
140.86
High
158.00
About NUVL
Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. It develops small molecules that have the potential to overcome resistance, minimize adverse events, and address brain metastases. It is advancing a robust pipeline with investigational candidates for ROS proto-oncogene 1 (ROS1)-positive, anaplastic lymphoma kinase (ALK)-positive, and human epidermal growth factor receptor 2 (HER2)-positive non-small cell lung cancer, and multiple discovery-stage research programs. Its product candidate, Zidesamtinib (NVL-520), is being developed for patients with ROS1-positive non-small cell lung cancer (NSCLC). NVL-520 is a novel ROS1-selective inhibitor. Its product candidate, Neladalkib (NVL-655), is being developed for patients with ALK-positive NSCLC. NVL-655 is a brain-penetrant ALK-selective inhibitor. Its product candidate, NVL-330, is a brain-penetrant HER2-selective inhibitor.
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.
Nuvalent to Speak at Biotech Summit 2026
- Executive Participation: Nuvalent's CEO Dr. James Porter and CFO Alexandra Balcom will participate in the Guggenheim Emerging Outlook: Biotech Summit on February 12, 2026, in New York City, showcasing the company's latest advancements in cancer treatment.
- Live Webcast Arrangement: The summit will feature a live webcast available in the Investors section of Nuvalent's website, with an archived version accessible for 30 days post-event, aimed at enhancing investor awareness and understanding of the company's R&D progress.
- Focus on Precision Therapy: Nuvalent is dedicated to developing precisely targeted therapies for cancer, leveraging deep expertise in chemistry and structure-based drug design to overcome the limitations of existing treatments, particularly for ROS1, ALK, and HER2-altered non-small cell lung cancer.
- Robust Pipeline Development: The company is advancing a rich pipeline of investigational candidates addressing cancer resistance, minimizing adverse events, and improving long-term patient outcomes, demonstrating its strong potential in the biopharmaceutical sector.
See More
Nuvalent to Speak at Biotech Summit 2026
- Executive Participation: Nuvalent's CEO James Porter, Ph.D., and CFO Alexandra Balcom will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 12, 2026, in NYC, showcasing the company's latest advancements in cancer treatment.
- Live Webcast Available: The summit will feature a live webcast accessible in the Investors section of Nuvalent's website, archived for 30 days post-presentation, ensuring investors can obtain critical information promptly.
- Focus on Precision Therapy: Nuvalent is dedicated to developing precisely targeted therapies for cancer, leveraging deep expertise in chemistry and structure-based drug design to overcome the limitations of existing treatments and drive innovation in small molecules.
- Robust R&D Pipeline: The company is advancing investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, demonstrating its potential and competitive edge in the cancer treatment market.
See More
Nuvalent Submits NDA for Zidesamtinib, Targeting Approval by September 2026
- FDA Acceptance: The FDA has accepted Nuvalent's NDA for zidesamtinib targeting TKI-pretreated patients with ROS1-positive NSCLC, with a PDUFA date set for September 18, 2026, potentially opening significant market opportunities for the company.
- Strong Financial Position: Nuvalent ended 2025 with approximately $1.4 billion in cash and equivalents, expected to fund operations into 2029, providing robust financial backing for product launches and ongoing R&D efforts.
- Future Submissions: The company plans to submit an NDA for neladalkib in the first half of 2026, targeting ALK-positive NSCLC patients, thereby expanding its product portfolio and enhancing competitive positioning in the market.
- Key Presentation: Nuvalent will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, showcasing its latest advancements in cancer treatment and increasing visibility among investors.
See More
Nuvalent Submits NDA for Zidesamtinib, Targeting 2026 U.S. Launch
- FDA Acceptance: The FDA has accepted Nuvalent's NDA for zidesamtinib, aimed at treating advanced ROS1-positive NSCLC patients who have received at least one prior ROS1 TKI, with a target action date of September 18, 2026, marking a potential first commercial success for the company.
- NDA Submission Plans: Nuvalent plans to submit an NDA for neladalkib in the first half of 2026 for TKI-pretreated advanced ALK-positive NSCLC patients, further expanding its product line and enhancing market competitiveness.
- Strong Financial Position: As of the end of 2025, Nuvalent reported approximately $1.4 billion in cash and cash equivalents, expected to fund operations into 2029, ensuring financial stability as the company advances its product launches and development projects.
- Key Conference Presentation: Nuvalent will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, enhancing the company's visibility among investors and preparing for upcoming product launches.
See More
Royalty Pharma Acquires Evrysdi Royalty for $240 Million Upfront
- Stock Performance: Royalty Pharma's stock has surged approximately 53% year-to-date, reflecting strong market confidence in its acquisition strategy and enhancing investor sentiment.
- Acquisition Details: Royalty Pharma acquired the remaining Evrysdi royalty from PTC Therapeutics for $240 million upfront, with potential sales-based milestones of up to $60 million, further solidifying its position in the SMA treatment market.
- Sales Growth Potential: Evrysdi generated approximately 1.6 billion Swiss francs ($1.9 billion) in sales in 2024, representing an 18% year-over-year growth, and is projected to reach 2.3 billion Swiss francs ($2.9 billion) by 2030, promising substantial long-term revenue for Royalty Pharma.
- Competitive Landscape: With Biogen and Novartis also advancing their products in the SMA treatment space, Royalty Pharma's acquisition positions it favorably in the competitive landscape, enhancing its market share.
See More
Nuvalent CEO James Porter to Present at 2026 J.P. Morgan Healthcare Conference
- Conference Presentation: Nuvalent's CEO James Porter, Ph.D., is scheduled to present at the 2026 J.P. Morgan Healthcare Conference on January 13, 2026, in San Francisco, showcasing the company's advancements in targeted cancer therapies, which is expected to attract investor interest.
- Live Webcast Availability: The presentation will be available via live webcast on the company's investor section of its website, with an archived version accessible for 30 days post-event, aimed at enhancing transparency and increasing investor engagement.
- Company Background: Nuvalent focuses on developing precisely targeted therapies for cancer, leveraging deep expertise in chemistry and structure-based drug design to overcome the limitations of existing therapies and drive the development of innovative small molecules.
- Pipeline Progress: The company is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, demonstrating its potential and competitiveness in the cancer treatment market.
See More
Nuvalent to Speak at Biotech Summit 2026
- Executive Participation: Nuvalent's CEO Dr. James Porter and CFO Alexandra Balcom will participate in the Guggenheim Emerging Outlook: Biotech Summit on February 12, 2026, in New York City, showcasing the company's latest advancements in cancer treatment.
- Live Webcast Arrangement: The summit will feature a live webcast available in the Investors section of Nuvalent's website, with an archived version accessible for 30 days post-event, aimed at enhancing investor awareness and understanding of the company's R&D progress.
- Focus on Precision Therapy: Nuvalent is dedicated to developing precisely targeted therapies for cancer, leveraging deep expertise in chemistry and structure-based drug design to overcome the limitations of existing treatments, particularly for ROS1, ALK, and HER2-altered non-small cell lung cancer.
- Robust Pipeline Development: The company is advancing a rich pipeline of investigational candidates addressing cancer resistance, minimizing adverse events, and improving long-term patient outcomes, demonstrating its strong potential in the biopharmaceutical sector.
See More
Nuvalent to Speak at Biotech Summit 2026
- Executive Participation: Nuvalent's CEO James Porter, Ph.D., and CFO Alexandra Balcom will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 12, 2026, in NYC, showcasing the company's latest advancements in cancer treatment.
- Live Webcast Available: The summit will feature a live webcast accessible in the Investors section of Nuvalent's website, archived for 30 days post-presentation, ensuring investors can obtain critical information promptly.
- Focus on Precision Therapy: Nuvalent is dedicated to developing precisely targeted therapies for cancer, leveraging deep expertise in chemistry and structure-based drug design to overcome the limitations of existing treatments and drive innovation in small molecules.
- Robust R&D Pipeline: The company is advancing investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, demonstrating its potential and competitive edge in the cancer treatment market.
See More
Nuvalent Submits NDA for Zidesamtinib, Targeting Approval by September 2026
- FDA Acceptance: The FDA has accepted Nuvalent's NDA for zidesamtinib targeting TKI-pretreated patients with ROS1-positive NSCLC, with a PDUFA date set for September 18, 2026, potentially opening significant market opportunities for the company.
- Strong Financial Position: Nuvalent ended 2025 with approximately $1.4 billion in cash and equivalents, expected to fund operations into 2029, providing robust financial backing for product launches and ongoing R&D efforts.
- Future Submissions: The company plans to submit an NDA for neladalkib in the first half of 2026, targeting ALK-positive NSCLC patients, thereby expanding its product portfolio and enhancing competitive positioning in the market.
- Key Presentation: Nuvalent will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, showcasing its latest advancements in cancer treatment and increasing visibility among investors.
See More
Nuvalent Submits NDA for Zidesamtinib, Targeting 2026 U.S. Launch
- FDA Acceptance: The FDA has accepted Nuvalent's NDA for zidesamtinib, aimed at treating advanced ROS1-positive NSCLC patients who have received at least one prior ROS1 TKI, with a target action date of September 18, 2026, marking a potential first commercial success for the company.
- NDA Submission Plans: Nuvalent plans to submit an NDA for neladalkib in the first half of 2026 for TKI-pretreated advanced ALK-positive NSCLC patients, further expanding its product line and enhancing market competitiveness.
- Strong Financial Position: As of the end of 2025, Nuvalent reported approximately $1.4 billion in cash and cash equivalents, expected to fund operations into 2029, ensuring financial stability as the company advances its product launches and development projects.
- Key Conference Presentation: Nuvalent will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, enhancing the company's visibility among investors and preparing for upcoming product launches.
See More
Royalty Pharma Acquires Evrysdi Royalty for $240 Million Upfront
- Stock Performance: Royalty Pharma's stock has surged approximately 53% year-to-date, reflecting strong market confidence in its acquisition strategy and enhancing investor sentiment.
- Acquisition Details: Royalty Pharma acquired the remaining Evrysdi royalty from PTC Therapeutics for $240 million upfront, with potential sales-based milestones of up to $60 million, further solidifying its position in the SMA treatment market.
- Sales Growth Potential: Evrysdi generated approximately 1.6 billion Swiss francs ($1.9 billion) in sales in 2024, representing an 18% year-over-year growth, and is projected to reach 2.3 billion Swiss francs ($2.9 billion) by 2030, promising substantial long-term revenue for Royalty Pharma.
- Competitive Landscape: With Biogen and Novartis also advancing their products in the SMA treatment space, Royalty Pharma's acquisition positions it favorably in the competitive landscape, enhancing its market share.
See More
Nuvalent CEO James Porter to Present at 2026 J.P. Morgan Healthcare Conference
- Conference Presentation: Nuvalent's CEO James Porter, Ph.D., is scheduled to present at the 2026 J.P. Morgan Healthcare Conference on January 13, 2026, in San Francisco, showcasing the company's advancements in targeted cancer therapies, which is expected to attract investor interest.
- Live Webcast Availability: The presentation will be available via live webcast on the company's investor section of its website, with an archived version accessible for 30 days post-event, aimed at enhancing transparency and increasing investor engagement.
- Company Background: Nuvalent focuses on developing precisely targeted therapies for cancer, leveraging deep expertise in chemistry and structure-based drug design to overcome the limitations of existing therapies and drive the development of innovative small molecules.
- Pipeline Progress: The company is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, demonstrating its potential and competitiveness in the cancer treatment market.
See More
