Nuvalent
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2017-01-01
- Employees
- 92
- Market Cap
- $5.4B
- Website
- http://www.nuvalent.com
- Introduction
Nuvalent, Inc. is a clinical stage biopharmaceutical company, which focuses on creating precisely targeted therapies for patients with cancer. Its pipeline includes ROS1 NSCLC, ALK NSCLC and HER2 NSCLC. The company was founded by Matthew D. Shair in January 2017 and is headquartered in Cambridge, MA.
Nuvalent's Lung Cancer Drug Shows Promise Amid Risks
Nuvalent, Inc., a clinical-stage biotechnology company, is making significant strides in the development of brain-penetrant tyrosine kinase inhibitors for non-small cell lung cancer (NSCLC). With promising early-stage clinical trial results for its lead candidates, zidesamtinib and NVL-655, and a strong financial foundation, Nuvalent is poised for potential commercialization. However, the company faces challenges in a competitive NSCLC treatment market and risks associated with clinical trial setbacks.
Nuvalent Fast-Tracks First Approval for Zidesamtinib in ROS1-Positive NSCLC by 2026
• Nuvalent aims for its first FDA approval by 2026, prioritizing zidesamtinib for TKI pre-treated ROS1-positive NSCLC patients.
• NDA submission for zidesamtinib is expected by mid-2025, with topline pivotal data from the ARROS-1 trial anticipated in H1 2025.
• Pivotal data for neladalkib (NVL-655) in TKI pre-treated ALK-positive NSCLC from the ALKOVE-1 trial is expected by the end of 2025.
• The company plans to initiate the ALKAZAR Phase 3 trial of neladalkib for TKI-naïve ALK-positive NSCLC patients in H1 2025.
Focused Ultrasound Shows Promise in Alzheimer's Treatment
• A clinical trial using focused ultrasound to treat Alzheimer’s disease has shown promising results, marking a potential new direction in treating this debilitating condition.
• The study, published in the Journal of Neurosurgery, highlights the noninvasive nature of focused ultrasound as a key advantage in Alzheimer's treatment.
• Researchers are optimistic about the potential of this approach to offer a new therapeutic avenue for patients suffering from Alzheimer's disease.
• Further research is needed to fully understand the long-term effects and optimal use of focused ultrasound in Alzheimer's treatment.
ESMO 2024: AbbVie and Nuvalent Present Promising Data on Novel Cancer Therapies
• AbbVie presented data on mirvetuximab soravtansine for platinum-sensitive ovarian cancer, showing a 51.9% objective response rate in pre-treated patients.
• Nuvalent's NVL-655 and zidesamtinib demonstrated durable responses in heavily pre-treated NSCLC patients, targeting ALK and ROS1, respectively.
• AbbVie's telisotuzumab vedotin (Teliso-V) is under FDA review for accelerated approval in c-Met overexpressing non-small cell lung cancer.
• Nuvalent plans to initiate a Phase 3 trial (ALKAZAR) of NVL-655 in TKI-naïve ALK-positive NSCLC patients in the first half of 2025.
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