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Nuvalent (NUVL)
NASDAQ:NUVL
Alectinib, Neladalkib (Nvl-655)
Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-Positive
Phase III
Recruiting
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Nov 08, 2024
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Nvl-330
Metastatic Solid Tumor, Locally Advanced Solid Tumor
Phase I
Recruiting
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Jul 22, 2024
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Neladalkib (Nvl-655)
Metastatic Solid Tumor, Locally Advanced Solid Tumor
Phase I/II
Recruiting
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
May 17, 2022
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Zidesamtinib (Nvl-520)
Metastatic Solid Tumor, Locally Advanced Solid Tumor
Phase I/II
Recruiting
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Oct 19, 2021
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Nuvalent (NUVL) have in its pipeline
NUVL is currently developing the following drugs: Alectinib, Neladalkib (Nvl-655), Nvl-330, Neladalkib (Nvl-655). These drug candidates are in various stages of clinical development as the company works toward FDA approval.