Nuvalent, Inc., a preclinical stage biopharmaceutical company, develops therapies for patients with cancer. Its lead product candidates are NVL-520, a brain-penetrant ROS1-selective inhibitor, designed to inhibit ROS1 fusions that express the normal ROS1 kinase domain without any drug-resistant mutations and also remain active in the presence of mutations conferring resistance to approved and investigational ROS1 inhibitors; and NVL-655, a brain-penetrant ALK-selective inhibitor, designed to inhibit ALK fusions that express the normal ALK kinase domain without any drug-resistant mutations and also remain active in the presence of mutations conferring resistance to first, second, and third generation ALK inhibitors. The company was incorporated in 2017 and is headquartered in Cambridge, Massachusetts.
IPO Year: 2021
Exchange: NASDAQ
Website: nuvalent.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 5/22/2026 | $189.00 | Outperform | Bernstein |
| 3/30/2026 | $116.00 | Overweight | Wells Fargo |
| 11/24/2025 | Buy | Truist | |
| 11/12/2025 | $126.00 | Buy | Canaccord Genuity |
| 10/16/2025 | $115.00 | Buy | Stifel |
| 10/15/2025 | $135.00 | Overweight | Cantor Fitzgerald |
| 9/4/2025 | $122.00 | Buy | Guggenheim |
| 9/3/2025 | $105.00 | Outperform | Raymond James |
| 8/19/2025 | $112.00 | Overweight | Piper Sandler |
| 3/14/2025 | $100.00 | Neutral → Buy | UBS |
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New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026Veteran biopharmaceutical executive, Georg Pirmin Meyer, M.D., joins as Chief International Officer to lead Nuvalent's global expansion strategyCAMBRIDGE, Mass., May 27, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has gra
Presentation of pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from ALKOVE-1 trialTKI pre-treated data from ALKOVE-1 trial of neladalkib support recent NDA submission and ongoing investigation in Phase 3 ALKAZAR trial for TKI-naïve patients with advanced ALK-positive NSCLCFirst presentation of encouraging preliminary data for zidesamtinib in patients with advanced ROS1-positive solid tumors other than NSCLC from ARROS-1 trialCAMBRIDGE, Mass., May 21, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highli
NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18, 2026Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC planned for the second half of 2026Strengthened leadership team with key internal promotionsCAMBRIDGE, Mass., May 7, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and rep
Multi-year global collaboration will leverage Guardant's tissue and liquid biopsy portfolio to support clinical development and companion diagnostic strategies Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced a multi-year strategic collaboration with Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, to support the development and potential commercialization of Nuvalent's oncology pipeline using the tissue and liquid offerings of the Guardant Infinity™ platform. The collaboration reflects the growing importance of precision diag
Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial CAMBRIDGE, Mass., April 21, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today 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
Zidesamtinib demonstrated meaningful clinical activity in subset of TKI pre-treated ROS1-positive NSCLC patients from ARROS-1 trial previously treated with repotrectinib or taletrectinib, including in those with CNS disease or ROS1 resistance mutationsPreclinical data support differentiated brain penetrance and intracranial activity as compared to repotrectinib and taletrectinibCAMBRIDGE, Mass., April 17, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced new clinical and preclinical data for zidesamtinib, an investigational ROS1-selectiv
New Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trialCAMBRIDGE, Mass., April 7, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today 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. "The advancement of neladalkib from first
CAMBRIDGE, Mass., March 17, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today 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. The posters will highlight clinical data from a subset of TKI pre-treated patients with ROS1-positive NSCLC treated in the ARROS-1 Phase 1/2 clinical trial and preclinical data further characterizing zidesamtinib's brain penetra
Commercial preparations well underway to support potential U.S. launch of zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC population, pending FDA review; PDUFA target action date of September 18, 2026NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC population planned for the first half of 2026Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC population planned for the second half of 2026Strong financial position with operating runway anticipated into 2029CAMBRIDGE, Mass., Feb. 26, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely
CAMBRIDGE, Mass., Feb. 5, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026, at 1:30 p.m. ET in NYC. A live webcast will be available in the Investors section of Nuvalent's website at www.nuvalent.com,
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Bernstein initiated coverage of Nuvalent with a rating of Outperform and set a new price target of $189.00
Wells Fargo initiated coverage of Nuvalent with a rating of Overweight and set a new price target of $116.00
Truist initiated coverage of Nuvalent with a rating of Buy
Canaccord Genuity initiated coverage of Nuvalent with a rating of Buy and set a new price target of $126.00
Stifel resumed coverage of Nuvalent with a rating of Buy and set a new price target of $115.00
Cantor Fitzgerald initiated coverage of Nuvalent with a rating of Overweight and set a new price target of $135.00
Guggenheim resumed coverage of Nuvalent with a rating of Buy and set a new price target of $122.00
Raymond James initiated coverage of Nuvalent with a rating of Outperform and set a new price target of $105.00
Piper Sandler initiated coverage of Nuvalent with a rating of Overweight and set a new price target of $112.00
UBS upgraded Nuvalent from Neutral to Buy and set a new price target of $100.00
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Live Leadership Updates
New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026Veteran biopharmaceutical executive, Georg Pirmin Meyer, M.D., joins as Chief International Officer to lead Nuvalent's global expansion strategyCAMBRIDGE, Mass., May 27, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has gra
CAMBRIDGE, Mass., Dec. 10, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Ron Squarer to its Board of Directors. "We welcome Ron to our Board of Directors, where his personal dedication to advancing oncology therapeutics, demonstrated success in evolving research and development organizations to fully integrated businesses, and proven global commercial acumen will strengthen and sharpen our pre-launch
Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with target completion in the third quarter of 2025 Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025 Preliminary data for neladalkib in patients with ALK-positive solid tumors beyond NSCLC to be presented at the ESMO Congress 2025 Jason Waters, MBA, promoted to Senior Vice President, Commercial CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical
CAMBRIDGE, Mass., June 18, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Christy Oliger to its Board of Directors. "Christy's proven success in delivering new therapies to patients living with cancer strengthens our Board as we evolve from a development-stage company toward potential commercialization," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We welcome her deep expertise and
CAMBRIDGE, Mass., Dec. 9, 2024 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Grant Bogle to its Board of Directors. "Grant's demonstrated success in leading the growth and evolution of oncology biotechnology companies augments our Board as we work towards a potential first approval from our pipeline of novel kinase inhibitors in 2026," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We wel
CAMBRIDGE, Mass., Oct. 6, 2022 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Michael L. Meyers, M.D., Ph.D., to its Board of Directors. An experienced drug developer and medical oncologist who has contributed to the successful development and commercialization of multiple new therapies for patients with cancer, Dr. Meyers has served as a Senior Clinical Advisor to Nuvalent since 2020. "We look forward to
Veteran Biotech Executive with Broad Oncology Perspective to Lead Nuvalent Board as Company Advances its Pipeline of Precisely Targeted Therapies CAMBRIDGE, Mass., March 31, 2022 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical stage biopharmaceutical company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics, as Chair of its Board of Directors. "I am excited to join the Nuvalent Board of Directors and have been impressed
NVL-655 IND cleared by FDA, supporting planned initiation of ALKOVE-1 Phase 1/2 clinical trial in patients with ALK-positive NSCLC and other solid tumors in second quarter of 2022 Enrollment ongoing in ARROS-1 trial of NVL-520 for advanced ROS1-positive NSCLC and other solid tumors Discovery pipeline continues to advance toward two development candidate nominations in 2022 CAMBRIDGE, Mass., March 29, 2022 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported pipeline and business progress and fourth quarter and full year 2021 financial results.
CAMBRIDGE, Mass., Feb. 3, 2022 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Emily Drabant Conley, Ph.D., Chief Executive Officer of Federation Bio, to its Board of Directors. "I'm impressed by Nuvalent's focus on compelling science and only advancing opportunities with best-in-class potential, both of which I believe position the company to deliver on their goal of new therapies that may help physicians and their patients stay one st
Live finance-specific insights
In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectivelyIn the subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectivelyNeladalkib demonstrated intracranial responses, ability to address key drivers of disease progression, and a generally well-tolerated safety profile with low rates of dose discontinuation (5%) and dose reduction (17%) due to TEAEs, consistent with its ALK-selective, TRK-sparing designCompany p
Company to host webcast and conference call on November 17, 2025 at 8:00am ET CAMBRIDGE, Mass., Nov. 14, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today 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.
Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 prior ROS1 TKIs ± chemotherapy, ORR by BICR was 44% (95% CI: 34, 53) with initial estimated durability of response of 78% at the 12-month landmark and 62% at the 18-month landmarkIn the subset of 55 patients treated with 1 prior ROS1 TKI (crizotinib or entrectinib) ± chemotherapy, ORR was 51% (95% CI: 37, 65) with initial estimated durability of respo
Company to host webcast and conference call on June 24, 2025 at 8:00am ET CAMBRIDGE, Mass., June 23, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today 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.
Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials continue to support potential best-in-class profiles for zidesamtinib and NVL-655 Rapid enrollment in Phase 2 portions of the ARROS-1 and ALKOVE-1 clinical trials; Pivotal data from both ROS1 and ALK programs now anticipated in 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of NVL-655 for treatment-naïve patients with advanced ALK-positive NSCLC anticipated in the first half of 2025 Company to host a conference call today at 8:30 a.m. ET/2:30 p.m. CEST CAMBRIDGE, Mass., Sept. 14, 2024 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating pre
Updated Phase 1 data from ALKOVE-1 and ARROS-1 clinical trials to be presented at the ESMO Congress 2024 Durable activity of NVL-655 and zidesamtinib in heavily pre-treated patient populations supports ongoing Phase 2 investigation in earlier lines of treatment Company plans to host a conference call on September 14, 2024 at 8:30 a.m. ET/2:30 p.m. CEST following oral presentations at ESMO CAMBRIDGE, Mass., Sept. 9, 2024 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced data from abstracts to be presented at the European Society for Medical O
Company plans to host a conference call in conjunction with oral presentations at ESMO on September 14, 2024, at 8:30 a.m. ET/2:30 p.m. CEST $658.0 million in cash, cash equivalents and marketable securities expected to support operating runway into 2027 CAMBRIDGE, Mass., Aug. 8, 2024 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted pipeline progress, reiterated key anticipated milestones, and reported second quarter 2024 financial results.
Encouraging preliminary signs of activity observed in heavily pre-treated patients with ALK-positive NSCLC, including in subgroups of patients who have previously received a 2nd generation ALK TKI and lorlatinib, have brain metastases, or have single or compound ALK resistance mutations Favorable preliminary safety profile is consistent with an ALK-selective, TRK sparing design Company to host a conference call today, October 13, at 8:00am EDT CAMBRIDGE, Mass., Oct. 13, 2023 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced updated preliminar
Updated preliminary data to be presented at the 35th AACR-NCI-EORTC Symposium Company plans to host a conference call on October 13, 2023 at 8:00am EDT CAMBRIDGE, Mass., Oct. 4, 2023 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced preliminary data from the Phase 1 dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors as reported in an abstract accepted for presentation at the 35th AACR-NCI-EORTC (ANE) Symposium in
Company plans to host a conference call on October 13, 2023 CAMBRIDGE, Mass., Sept. 18, 2023 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced it will present preliminary dose-escalation data from its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 at the 35th AACR-NCI-EORTC (ANE) Symposium taking place October 11-15, 2023, in Boston, Massachusetts. The presentation marks the first disclosure of data characterizing the saf