This section highlights FDA-related milestones and regulatory updates for drugs developed by Nuvalent (NUVL).
Over the past two years, Nuvalent has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NVL-330, NVL-520, NVL-655, and zidesamtinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NVL-330 - FDA Regulatory Timeline and Events
NVL-330 is a drug developed by Nuvalent for the following indication: For pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NVL-330
- Announced Date:
- July 22, 2024
- Indication:
- For pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC).
Announcement
Nuvalent, Inc. announced the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC).
AI Summary
Nuvalent, Inc. announced the start of its HEROEX-1 Phase 1a/1b trial to test a new drug called NVL-330. This novel HER2-selective inhibitor is aimed at treating patients with advanced, HER2-altered non-small cell lung cancer (NSCLC) who have already received previous treatments. The study focuses on patients with HER2 abnormalities, including those with HER2 exon 20 mutations, as this mutation is a common driver in NSCLC. The trial will assess the safety and tolerability of NVL-330, determine the best dose for future studies, study how the drug is processed in the body, and look for early signs that it can shrink tumors. Nuvalent hopes that NVL-330 will offer a more targeted treatment option that reduces side effects and effectively addresses cancer in this high-need patient group.
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NVL-520 - FDA Regulatory Timeline and Events
NVL-520 is a drug developed by Nuvalent for the following indication: Advanced ROS1-positive Non-small cell lung cancer (NSCLC) and other advanced solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NVL-520
- Announced Date:
- April 8, 2024
- Indication:
- Advanced ROS1-positive Non-small cell lung cancer (NSCLC) and other advanced solid tumors
Announcement
Nuvalent, Inc announced the presentation of new preclinical data for its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib (NVL-520).
AI Summary
Nuvalent, Inc. recently announced new preclinical data for two promising drug candidates at the AACR Annual Meeting. The first, NVL-330, is a HER2-selective inhibitor that has demonstrated broad activity against various HER2 oncogenic alterations. It shows strong efficacy while sparing wild-type EGFR and achieving enhanced central nervous system (CNS) penetration, which is crucial for treating brain metastases. The second candidate, zidesamtinib (NVL-520), is a ROS1-selective inhibitor designed to overcome resistance mutations, including those seen with earlier generations of ROS1 inhibitors. Preclinical mutagenesis screens indicated that zidesamtinib could effectively suppress on-target ROS1 resistance mutations, predicting a lower chance of resistance at clinical concentrations. These findings support the potential for both NVL-330 and zidesamtinib to offer deep and durable responses for patients with cancers driven by HER2 and ROS1 alterations.
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NVL-655 - FDA Regulatory Timeline and Events
NVL-655 is a drug developed by Nuvalent for the following indication: ALK inhibitors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NVL-655
- Announced Date:
- January 13, 2025
- Indication:
- ALK inhibitors
Announcement
Nuvalent, Inc. today highlighted pipeline progress and outlined key anticipated milestones towards its first potential U.S. Food and Drug Administration (FDA) approval under its "OnTarget 2026" operating plan.
AI Summary
Nuvalent, Inc. has outlined key milestones in its "OnTarget 2026" operating plan, aimed at achieving its first potential FDA approval. The company plans to report pivotal data from its ARROS-1 Phase 1/2 trial of zidesamtinib in TKI pre-treated, ROS1-positive NSCLC patients during the first half of 2025. An initial NDA submission for zidesamtinib, targeting these patients, is expected by mid-2025. Additionally, Nuvalent expects to present topline pivotal data from its ALKOVE-1 Phase 1/2 trial of neladalkib in TKI pre-treated, ALK-positive NSCLC patients by the end of 2025, along with initiating its ALKAZAR Phase 3 trial for TKI-naïve patients in the first half of 2025. These steps are critical as the company aims for its first FDA approval in 2026, offering a promising new treatment option for patients with NSCLC.Read Announcement
- Drug:
- NVL-655
- Announced Date:
- September 14, 2024
- Indication:
- ALK inhibitors
Announcement
Nuvalent today highlighted the presentation of updated data from the fully enrolled Phase 1 dose-escalation portions of the ongoing ARROS-1 Phase 1/2 clinical trial of zidesamtinib, a novel ROS1-selective inhibitor, and ALKOVE-1 Phase 1/2 clinical trial of NVL-655, a novel ALK-selective inhibitor, during two oral presentations at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain
AI Summary
Nuvalent recently presented updated data from the fully enrolled Phase 1 dose-escalation portions of its ongoing ARROS-1 and ALKOVE-1 clinical trials at the ESMO Congress 2024 in Barcelona, Spain. The ARROS-1 trial is studying zidesamtinib, a novel ROS1-selective inhibitor, while the ALKOVE-1 trial is evaluating NVL-655, a new ALK-selective inhibitor. Both trials showed promising early results, with data supporting favorable tolerability and potential best‐in‐class profiles. The presentations highlighted the clinical proof-of-concept for these compounds, especially their ability to provide durable responses in heavily pre-treated patient populations. Nuvalent’s findings are a key step in advancing these therapies into later-stage trials, with pivotal datasets for both programs anticipated in 2025. This update underscores Nuvalent’s commitment to addressing unmet needs in the treatment of advanced NSCLC by developing tailored and brain-penetrant targeted therapies.
Read Announcement- Drug:
- NVL-655
- Announced Date:
- September 9, 2024
- Indication:
- ALK inhibitors
Announcement
Nuvalent, Inc. announced data from abstracts to be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, including updates from the Phase 1 portions of the ongoing ALKOVE-1 Phase 1/2 clinical trial of ALK-selective inhibitor NVL-655 and ARROS-1 Phase 1/2 clinical trial of ROS1-selective inhibitor zidesamtinib, and new preclinical data further characterizing the intracranial activity of zidesamtinib accepted for a poster session.
AI Summary
Nuvalent, Inc. announced that it will present updated Phase 1 study data at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. The company will share findings from the ongoing ALKOVE-1 Phase 1/2 clinical trial of its ALK-selective inhibitor, NVL-655, and the ARROS-1 Phase 1/2 trial for the ROS1-selective inhibitor, zidesamtinib. These updates highlight the durable responses achieved in heavily pre-treated patients, reinforcing the potential of both drugs to improve treatment outcomes in ALK- and ROS1-positive non-small cell lung cancer.
In addition to the clinical data, Nuvalent will present new preclinical results in a poster session that further detail the intracranial activity of zidesamtinib. This data suggests that zidesamtinib may offer more lasting effects in the brain compared to other inhibitors, addressing challenges such as brain metastases and treatment resistance.
Read Announcement- Drug:
- NVL-655
- Announced Date:
- July 16, 2024
- Indication:
- ALK inhibitors
Announcement
Nuvalent, Inc announced that updated data from the ARROS-1 Phase 1/2 clinical trial of zidesamtinib and ALKOVE-1 Phase 1/2 clinical trial of NVL-655, will be presented during two oral presentations at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain.
AI Summary
Nuvalent, Inc. announced that updated data from two key Phase 1/2 clinical trials will be shared at the upcoming European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13-17, 2024. The company will present oral presentations on the ARROS-1 trial, which evaluates zidesamtinib in ROS1 fusion-positive solid tumors, and the ALKOVE-1 trial, focused on NVL-655 in ALK-positive solid tumors. These presentations, scheduled for September 14, 2024, aim to highlight new insights into the performance of these novel, brain-penetrant inhibitors. Both drugs are designed to overcome resistance seen with current treatments and to improve outcomes for patients with challenging tumor profiles, including those with brain metastases. Nuvalent’s participation in ESMO 2024 underscores its progress in developing targeted therapies for cancer patients.
Read Announcement- Drug:
- NVL-655
- Announced Date:
- May 16, 2024
- Indication:
- ALK inhibitors
Announcement
Nuvalent, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).
AI Summary
Nuvalent, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for its drug NVL-655. This designation is aimed at treating patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC). The treatment is intended for patients who have already tried two or more ALK tyrosine kinase inhibitors (TKIs) without sufficient success. The breakthrough therapy designation is a significant step in speeding up the development and review process for drugs that may show substantial improvement over existing therapies. With NVL-655, the company is hoping to offer a new option for patients who have exhausted current targeted treatments and face a challenging prognosis. This development reflects ongoing efforts to improve treatment options for advanced lung cancer through innovative therapies.
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zidesamtinib - FDA Regulatory Timeline and Events
zidesamtinib is a drug developed by Nuvalent for the following indication: ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- zidesamtinib
- Announced Date:
- June 24, 2025
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial.
AI Summary
Nuvalent announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer from its global ARROS-1 Phase 1/2 trial. In a group of 117 patients, the treatment reached an overall response rate (ORR) of 44%, with durability of response reaching 78% at 12 months and 62% at 18 months. In a subset of 55 patients who had received only one prior TKI, the ORR was even higher at 51% with 93% durability at the 12-month mark. Zidesamtinib also demonstrated promising intracranial activity, showing responses in patients with brain metastases and activity against the challenging ROS1 G2032R resistance mutation.
The FDA has accepted Nuvalent’s NDA submission plan under the Real-Time Oncology Review pilot program, with a rolling NDA set to begin in July 2025 and target completion in the third quarter of 2025.
Read Announcement- Drug:
- zidesamtinib
- Announced Date:
- June 23, 2025
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, announced that the company will host a webcast and conference call on Tuesday, June 24, 2025 at 8:00 a.m. ET, to discuss pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer from the global ARROS-1 Phase 1/2 clinical trial.
AI Summary
Nuvalent, Inc. announced that it will host a webcast and conference call on Tuesday, June 24, 2025, at 8:00 a.m. ET. During the call, the company will discuss pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, from the global ARROS-1 Phase 1/2 clinical trial. This trial focuses on TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer. The presentation will cover important details about zidesamtinib’s safety, efficacy, and its potential to overcome resistance seen with available ROS1 inhibitors, including its design to treat brain metastases effectively. Investors and interested parties are encouraged to join the live webcast for insights directly from Nuvalent’s team, with the call details and related presentation slides available on the company’s investor website for further review.
Read Announcement- Drug:
- zidesamtinib
- Announced Date:
- April 29, 2025
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, Inc. announced the publication of a manuscript in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research, which supports the rational molecular design of zidesamtinib, its novel and selective ROS1 inhibitor.
AI Summary
Nuvalent, Inc. recently published a manuscript in Molecular Cancer Therapeutics—the journal of the American Association for Cancer Research—that supports the rational molecular design of its innovative drug, zidesamtinib. This novel ROS1 inhibitor is designed to treat advanced cancers by targeting tumors that have become resistant to other treatments.
The study highlights the first crystal structure of a common ROS1 mutation (G2032R) in complex with zidesamtinib. This research shows how the drug specifically interacts with and inhibits the mutation found in ROS1-positive lung cancer and other tumors. The findings add strong preclinical evidence of zidesamtinib’s ability to control tumor growth both in the brain and elsewhere, while minimizing side effects. These promising results may guide further clinical studies and help improve treatment outcomes for patients.
Read Announcement- Drug:
- zidesamtinib
- Announced Date:
- March 25, 2025
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, Inc. announced upcoming poster presentations further characterizing the preclinical profiles of its novel ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib, at the American Association for Cancer Research (AACR) Annual Meeting 2025 from April 25-30, 2025, in Chicago.
AI Summary
Nuvalent, Inc. announced that it will present posters at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago from April 25-30. The company’s presentations will showcase new preclinical data on two targeted cancer therapies: neladalkib, a novel ALK-selective inhibitor, and zidesamtinib, a novel ROS1-selective inhibitor. Both compounds are designed to penetrate the brain, aiming to improve treatment options for patients with brain metastases, and to avoid side effects related to TRK inhibition.
Neladalkib is developed to treat ALK-positive non-small cell lung cancer, particularly in cases resistant to existing ALK inhibitors. Meanwhile, zidesamtinib aims to overcome limitations seen with current ROS1 inhibitors and maintain activity against tumors with drug-resistant mutations. These detailed poster studies underline Nuvalent’s commitment to advancing precise, targeted therapies for cancer treatment.
Read Announcement
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