Nuvalent (NUVL) has upcoming FDA regulatory milestones for zidesamtinib. The table below outlines estimated target dates and event types for these pending regulatory actions.
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
neladalkib, zidesamtinib, NVL-330, and NVL-655. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Neladalkib FDA Regulatory Timeline and Events
Neladalkib is a drug developed by Nuvalent for the following indication: advanced ALK-positive solid tumors outside of 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:
- neladalkib
- Announced Date:
- April 21, 2026
- Indication:
- advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC).
Announcement
Nuvalent, Inc. announced that pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago.
AI Summary
Nuvalent, Inc. said it will present pivotal data for neladalkib, an investigational ALK-selective inhibitor, from the global ALKOVE-1 Phase 1/2 trial at the 2026 ASCO Annual Meeting in Chicago (May 29–June 2). The data include results in patients with advanced ALK-positive non‑small cell lung cancer who were previously treated with ALK TKIs, and the company will also share preliminary findings in TKI‑naïve patients. The neladalkib findings will be delivered during an oral presentation, highlighting its development path and potential benefits for ALK-positive NSCLC after prior therapy.
Nuvalent will also present preliminary data for zidesamtinib, an investigational ROS1-selective inhibitor, in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 Phase 1/2 trial during a poster session. Investigators include teams from Mass General Brigham Cancer Institute (Boston) and Peter MacCallum Cancer Centre (Melbourne).
Read Announcement- Drug:
- neladalkib
- Announced Date:
- April 7, 2026
- Indication:
- advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC).
Announcement
Nuvalent, Inc announced the submission to the U.S. Food and Drug Administration (FDA) of the Company's NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC.
AI Summary
Nuvalent, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for neladalkib, an investigational ALK-selective inhibitor. The filing seeks approval to treat patients with advanced ALK-positive non–small cell lung cancer (NSCLC) who have already been treated with ALK tyrosine kinase inhibitors (TKIs).
The NDA is supported by data from the global ALKOVE-1 Phase 1/2 trial, which evaluated neladalkib in TKI pre-treated patients. Nuvalent cites the trial data as the basis for the submission and will await the FDA’s review and decision. If the application is accepted and approved, neladalkib could become a treatment option for people with ALK-positive NSCLC after prior TKI therapy. Nuvalent is expected to provide updates on regulatory timing and next steps during the review process.
Read Announcement- Drug:
- neladalkib
- Announced Date:
- November 17, 2025
- Indication:
- advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC).
Announcement
Nuvalent, announced positive topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 clinical trial.
AI Summary
Nuvalent reported positive topline pivotal results for neladalkib, an investigational ALK-selective inhibitor, from the global ALKOVE-1 Phase 1/2 trial in TKI pre-treated advanced ALK-positive non‑small cell lung cancer. The primary analysis included 253 TKI pre-treated patients treated at the recommended Phase 2 dose (150 mg once daily). These patients were heavily pre-treated (median three prior lines), and many had prior lorlatinib or resistance mutations like G1202R.
Efficacy by blinded independent central review showed an objective response rate (ORR) of 31% (95% CI 26–37) in the 253-patient group, with estimated durability of response of 64% at 12 months and 53% at 18 months. In 63 lorlatinib‑naïve TKI pre-treated patients, ORR was 46% (95% CI 33–59) with 12‑ and 18‑month durability of 80% and 60%, respectively. Intracranial responses were also observed.
Neladalkib was generally well tolerated, with dose reductions in 17% and treatment discontinuation for adverse events in 5% of patients. Nuvalent plans to discuss the pivotal data with regulators and present detailed results at a future medical meeting.
Read Announcement- Drug:
- neladalkib
- Announced Date:
- November 14, 2025
- Indication:
- advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC).
Announcement
Nuvalent, announced that the company will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET, to discuss topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer from the global ALKOVE-1 Phase 1/2 clinical trial.
AI Summary
Nuvalent said it will host a live webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET to review topline pivotal data for neladalkib, its investigational ALK-selective inhibitor, from the global ALKOVE-1 Phase 1/2 trial in TKI pre-treated patients with advanced ALK‑positive non‑small cell lung cancer. Management will summarize efficacy, safety and next steps for potential registration; slides and a replay will be made available on the company’s investor site.
Topline results in 253 TKI pre-treated patients showed an objective response rate (ORR) by blinded independent central review (BICR) of 31% (95% CI: 26–37), with estimated durability of response of 64% at 12 months and 53% at 18 months. In 63 lorlatinib‑naïve patients, ORR was 46% (95% CI: 33–59) with 12‑ and 18‑month durability of 80% and 60%. Neladalkib showed intracranial activity and a generally well‑tolerated safety profile (5% discontinued, 17% dose reductions). Nuvalent plans a pre‑NDA meeting with the FDA and will present detailed results at a future medical meeting.
Read Announcement- Drug:
- neladalkib
- Announced Date:
- October 18, 2025
- Indication:
- advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC).
Announcement
Nuvalent, announced preliminary data from the ongoing ALKOVE-1 Phase 1/2 clinical trial of neladalkib, an investigational ALK-selective inhibitor, in patients with advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC).
AI Summary
Nuvalent, Inc. announced preliminary results from its ALKOVE-1 Phase 1/2 trial of neladalkib, a next-generation ALK-selective inhibitor, in 34 patients with advanced ALK-positive solid tumors outside of non-small cell lung cancer. Patients represented 14 rare tumor types, and most (32/34) received the 150 mg once-daily dose. Nearly half (44%) achieved an objective response: 9 of 13 ALK TKI-naïve and 6 of 21 TKI-pre-treated patients responded. At data cut-off, 80% of responders remained on treatment without progression, with responses lasting up to 16 months.
Neladalkib was generally well-tolerated, with an 8.8% dose-reduction rate and no discontinuations for treatment-related adverse events. The agent’s brain penetrance and sparing of off-target TRK inhibition may support deep, durable responses. Global enrollment continues in the Phase 2 cohort for adult and adolescent patients beyond NSCLC, with further data updates expected as the trial matures.
Read Announcement
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:
- March 17, 2026
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, Inc. announced the presentation of new data for zidesamtinib, an investigational ROS1-selective inhibitor, during two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026, being held April 17-22 in San Diego.
AI Summary
Nuvalent, Inc. announced it presented new clinical and preclinical data for zidesamtinib, an investigational ROS1‑selective inhibitor, during two poster sessions at the American Association for Cancer Research (AACR) Annual Meeting 2026. The meeting took place April 17–22 in San Diego. Nuvalent described zidesamtinib as a targeted therapy designed to inhibit ROS1, a driver of certain cancers, and said the posters highlighted recent findings that advance understanding of the compound’s activity and potential clinical use.
The poster presentations listed author affiliations including Princess Margaret Hospital in Toronto and Nuvalent, Inc. in Cambridge, Massachusetts. The announcement noted that it contained forward‑looking statements about ongoing research and development, and identified Nuvalent as the source. Market distribution of the news was handled via Benzinga’s news and data services.
Read Announcement- Drug:
- zidesamtinib
- Announced Date:
- November 19, 2025
- Target Action Date:
- September 18, 2026
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, Inc. announced that FDA assigns PDUFA target action date of September 18, 2026
AI Summary
Nuvalent announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for zidesamtinib, an investigational ROS1-selective inhibitor for adults 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, which is the goal date for the agency to complete its review and issue a decision.
The NDA submission is based on data from the global ARROS-1 Phase 1/2 clinical trial, specifically results from patients who were previously treated with ROS1 TKIs. Acceptance of the filing means the application is considered sufficiently complete to begin a substantive review by the FDA.
The PDUFA date will be an important milestone for patients and clinicians waiting for potential new treatment options for ROS1-positive NSCLC after prior TKI therapy.
Read Announcement- Drug:
- zidesamtinib
- Announced Date:
- November 19, 2025
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI).
AI Summary
Nuvalent announced the U.S. Food and Drug Administration has accepted for filing its New Drug Application for zidesamtinib, an investigational ROS1-selective inhibitor to treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received at least one prior ROS1 tyrosine kinase inhibitor. The application has a PDUFA target action date of September 18, 2026.
The NDA is based on data from the global ARROS-1 Phase 1/2 clinical trial in patients who had previously been treated with ROS1 TKIs. The trial's Phase 1 evaluated safety, tolerability, and dose, and the Phase 2 cohort is run for registration.
Zidesamtinib is designed to be selective for ROS1, penetrate the central nervous system, and remain active against resistance mutations such as G2032R. These features aim to improve control of brain metastases and provide lasting responses for patients who progressed on prior ROS1 therapy.
Read Announcement- Drug:
- zidesamtinib
- Announced Date:
- September 7, 2025
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, today presented pivotal data for zidesamtinib, a novel investigational ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from its global ARROS-1 Phase 1/2 clinical trial as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC 2025), being held in Barcelona, Spain.
AI Summary
Nuvalent presented pivotal data for zidesamtinib, a new ROS1‐selective inhibitor, at the Presidential Symposium during the IASLC 2025 World Conference on Lung Cancer in Barcelona. These results come from the global ARROS-1 Phase 1/2 trial in patients with advanced ROS1-positive non-small cell lung cancer who had already received at least one tyrosine kinase inhibitor (TKI).
The data, first shared in June 2025, form the basis of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration under its Real-Time Oncology Review (RTOR) program. By submitting topline efficacy and safety results early, Nuvalent aims to speed the review. The company expects to complete the rolling NDA by the third quarter of 2025 and is discussing broader uses beyond TKI-pretreated patients.
Zidesamtinib is designed to overcome resistance mutations like G2032R and to penetrate the central nervous system, offering hope for patients with brain metastases or intolerance to current therapies. The drug showed promising responses with a generally safe, well-tolerated profile, supporting its potential as a new treatment standard in ROS1-positive NSCLC.
Read Announcement- Drug:
- zidesamtinib
- Announced Date:
- August 13, 2025
- Indication:
- ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
Announcement
Nuvalent, Inc. announced that 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, in addition to preliminary data for TKI-naïve patients, will be presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC 2025). The conference is hosted by the International Association for the Study of Lung Cancer and is being held September 6-9, 2025, in Barcelona, Spain.
AI Summary
Nuvalent, Inc. announced that pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial, along with preliminary data for TKI-naïve patients, will be presented at the Presidential Symposium of the IASLC 2025 World Conference on Lung Cancer in Barcelona, Spain, from September 6–9, 2025.
Zidesamtinib is a brain-penetrant ROS1-selective inhibitor designed to overcome resistance to prior ROS1 therapies, including G2032R mutations, while avoiding TRK-related side effects. Phase 1 data defined safety and dose, and the ongoing Phase 2 trial is evaluating efficacy in both TKI pre-treated and TKI-naïve advanced ROS1-positive NSCLC patients. Nuvalent’s Chief Medical Officer, Dr. Christopher Turner, said collaboration with physician-scientists guided the program and that the company is encouraged by these results ahead of discussions at WCLC 2025.
Read Announcement- 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
NVL-330 FDA Regulatory 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:
- October 13, 2025
- Indication:
- For pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC).
Announcement
Nuvalent, Inc. announced an upcoming poster presentation further characterizing the preclinical intracranial activity of its novel HER2-selective inhibitor, NVL-330, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston.
AI Summary
Nuvalent, Inc., a clinical-stage biopharma company, announced it will present new data on NVL-330, its HER2-selective tyrosine kinase inhibitor, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. The poster will focus on preclinical intracranial activity, exploring NVL-330’s potential to treat brain metastases in HER2-positive cancers.
The poster, titled “Preclinical intracranial activity of NVL-330, a selective HER2 tyrosine kinase inhibitor” (Abstract B057), is scheduled for Poster Session B on Friday, October 24, 2025, from 12:30 to 4:00 p.m. ET in Exhibit Hall D. The research team includes Yuting Sun*, Kristin L. Andrews, Anupong Tangpeerachaikul, Michael J. Walsh, Nancy E. Kohl, Joshua C. Horan, and Henry E. Pelish, with Yuting Sun serving as presenter and corresponding author.
This work highlights NVL-330’s brain activity and its promise for targeted cancer treatment.
Read Announcement- 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.
Read Announcement
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.
Read Announcement
