Rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC initiated under FDA's RTOR program, with completion on track for the third quarter of 2025 CAMBRIDGE, Mass. , Sept. 7, 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 presented pivotal data... Read More

CAMBRIDGE, Mass. , Aug. 28, 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 James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the Cantor Global Healthcare Conference 2025 on... Read More

CAMBRIDGE, Mass. , Aug. 13, 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 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)... Read More

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... Read More

CAMBRIDGE, Mass. , July 21, 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 first patient has been dosed in ALKAZAR, the company's global Phase 3 randomized, controlled trial evaluating neladalkib for TKI-naïve patients with advanced ALK-positive non-small... Read More

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 2025 In 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... Read More

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... Read More

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... Read More

Topline pivotal data expected for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population in the first half of 2025 in support of anticipated first NDA submission by mid-year 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC planned for first half of 2025 Pivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC population anticipated by year-end... Read More

CAMBRIDGE, Mass. , April 29, 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 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... Read More

CAMBRIDGE, Mass. , April 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 two "Trial in Progress" poster presentations for its novel ALK-selective inhibitor, neladalkib, and novel HER2-selective inhibitor, NVL-330, at the 2025 American Society of Clinical Oncology... Read More

CAMBRIDGE, Mass. , April 1, 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 James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the Stifel 2025 Virtual Targeted Oncology Forum... Read More

CAMBRIDGE, Mass. , March 25, 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 upcoming poster presentations further characterizing the preclinical profiles of its novel ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib, at the... Read More

CAMBRIDGE, Mass. , Feb. 28, 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 James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in fireside chats during the following March investor conferences: TD Cowen... Read More

Topline pivotal data expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populations First NDA submission planned for mid-year 2025 towards potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population Development strategies in place for TKI-naïve populations, including planned initiation of ALKAZAR Phase 3 randomized, controlled trial of... Read More

Strategy prioritizes most accelerated path to first potential approval Initial NDA submission expected by mid-year for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population, with topline pivotal data anticipated in the first half of 2025 Topline pivotal data for neladalkib (NVL-655) in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025 Company to present at 43 rd Annual J.P. Morgan Healthcare... Read More

CAMBRIDGE, Mass. , Dec. 19, 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 that James Porter , Ph.D., Chief Executive Officer, will present at the 43 rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025 , at 9:00 a.m. PT in San Francisco. A live... Read More

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... Read More

CAMBRIDGE, Mass , Nov. 26, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the Piper Sandler 36 th Annual Healthcare... Read More

Achievement of all anticipated 2024 milestones and accelerated development timelines reinforce progress on OnTarget 2026 operating plan towards first approved product in 2026 Leading medical oncologist Alice Shaw , M.D., Ph.D. appointed to Scientific Advisory Board Strong cash position of $1.2 billion , including proceeds from upsized $575 million public offering, expected to extend operating runway into 2028 CAMBRIDGE,... Read More

CAMBRIDGE, Mass. , Sept. 18, 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 closing of its previously announced upsized underwritten public offering of 5,750,000 shares of Class A common stock, which includes 750,000 shares of Class A common stock sold pursuant... Read More

CAMBRIDGE, Mass. , Sept. 16, 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 pricing of an upsized underwritten public offering of 5,000,000 shares of Class A common stock at a price to the public of $100.00 per share. All shares are being offered by Nuvalent. The... Read More

CAMBRIDGE, Mass. , Sept. 16, 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 that it has commenced an underwritten public offering of $350.0 million of its shares of Class A common stock. All shares are being offered by Nuvalent. The offering is subject to market and... Read More

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... Read More

Publication provides comprehensive assessment of NVL-655's preclinical activity and includes preliminary clinical case studies CAMBRIDGE, Mass. , Sept. 13, 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 publication of a manuscript in Cancer Discovery , a journal... Read More

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... Read More

CAMBRIDGE, Mass. , Aug. 29, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the Morgan Stanley 22 nd Annual Global Healthcare... Read More

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... Read More

CAMBRIDGE, Mass. , July 22, 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 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... Read More

CAMBRIDGE, Mass. , July 16, 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 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... Read More

CAMBRIDGE, Mass. , July 11, 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 that Henry Pelish , Ph.D., has been promoted to Chief Scientific Officer. In this role, Dr. Pelish will continue to oversee discovery and early-stage development activities. "This promotion... Read More

CAMBRIDGE, Mass. , May 29, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the 2024 Jefferies Global Healthcare Conference on... Read More

CAMBRIDGE, Mass. , May 16, 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 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... Read More

Updates from the ongoing Phase 1/2 ARROS-1 and ALKOVE-1 clinical trials expected at a medical meeting in the second half of 2024 Strong financial position with operating runway anticipated into 2027 CAMBRIDGE, Mass. , May 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... Read More

Preclinical data continue to support NVL-330's broad activity against HER2 oncogenic alterations, selectivity over wild-type EGFR, and differentiated brain-penetrant profile Zidesamtinib shown to be effective at suppressing on-target ROS1 resistance mutations in preclinical mutagenesis screens CAMBRIDGE, Mass. , April 8, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on... Read More

CAMBRIDGE, Mass. , March 5, 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 upcoming preclinical data poster presentations further characterizing the preclinical profiles of its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib... Read More

Well-capitalized with operating runway anticipated into 2027 CAMBRIDGE, Mass. , Feb. 27, 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 fourth quarter and full year 2023 financial results. "With... Read More

CAMBRIDGE, Mass. , Feb. 27, 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 that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-520 for the treatment of patients with ROS1-positive metastatic non-small cell lung... Read More

Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-655 of 150 mg once daily Phase 2 Designed with Registrational Intent for TKI Pre-Treated Patients with ALK-Positive NSCLC and Enables Preliminary Evaluation in the TKI-naïve Setting CAMBRIDGE, Mass. , Feb. 12, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted... Read More

CAMBRIDGE, Mass. , Feb. 1, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the Guggenheim Healthcare Talks 6 th Annual... Read More

Targeting first approved product in 2026 towards realizing mission of bringing new, potential best-in-class treatments to patients with cancer Well-capitalized to support OnTarget 2026 initiatives with operating runway anticipated into 2027 Company to present at 42 nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9 th at 7:30 a.m. PT CAMBRIDGE, Mass. , Jan. 8, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq:... Read More

CAMBRIDGE, Mass. , Dec. 21, 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 that James Porter , Ph.D., Chief Executive Officer, will present at the 42 nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024 , at 7:30 a.m. PT in San Francisco. A live... Read More

Presented preliminary Phase 1 clinical data from ALKOVE-1 trial of NVL-655, initiated Phase 2 portion of ARROS-1 trial of NVL-520, and continued advancement of NVL-330 toward clinical development Appointed industry veteran Perrin Wilson Ph.D. as Senior Vice President of Business Development and Strategy Net proceeds from $300 million public offering, along with cash, cash equivalents, and marketable securities as of... Read More

CAMBRIDGE, Mass. , Nov. 1, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the BMO Virtual BioPharma Spotlight Series:... Read More

CAMBRIDGE, Mass. , Oct. 16, 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 that it has commenced an underwritten public offering of $300.0 million of its shares of Class A common stock. All shares are being offered by Nuvalent. The offering is subject to market and... Read More

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 2 nd 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,... Read More

Updated preliminary data to be presented at the 35 th 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... Read More

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 35 th... Read More

Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-520 of 100 mg daily CAMBRIDGE, Mass. , Sept. 5, 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 the initiation of the Phase 2 portion of ARROS-1, its Phase 1/2 clinical trial of... Read More

CAMBRIDGE, Mass. , Aug. 31, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in fireside chats during the following September investor conferences: 2023... Read More

Continued execution across pipeline with clinical trials ongoing for NVL-520 and NVL-655, and advancement of NVL-330 toward clinical development Preliminary dose-escalation data anticipated from ongoing ALKOVE-1 study of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors at a medical meeting in the fourth quarter of 2023 $431.2 million in cash, cash equivalents and marketable securities expected to... Read More

CAMBRIDGE, Mass. , Aug. 1, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in the following August investor conferences: 2023 Wedbush PacGrow... Read More

CAMBRIDGE, Mass. , May 24, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the TD Cowen 4th Annual Oncology Innovation Summit... Read More

Preliminary dose-escalation data anticipated in second half of 2023 from ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors Strong financial position with expected operating runway into the second half of 2025 CAMBRIDGE, Mass. , May 11, 2023 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating... Read More

CAMBRIDGE, Mass. , April 19, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the Stifel 2023 Virtual Targeted Oncology Days... Read More

CAMBRIDGE, Mass. , April 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 the presentation of new preclinical data supporting the intracranial activity NVL-655. NVL-655 is a brain-penetrant, ALK-selective tyrosine kinase inhibitor (TKI) designed to maintain... Read More

CAMBRIDGE, Mass. , March 23, 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 an upcoming poster presentation for the ongoing Phase 1/2 ALKOVE-1 study of its ALK-selective inhibitor, NVL-655. The poster will be presented at the European Lung Cancer Congress (ELCC... Read More

Significant progress made across pipeline of novel kinase inhibitors with parallel-lead programs in ongoing Phase 1 clinical trials and a third program advancing toward clinical development Strengthened leadership team with key internal promotions Strong financial position with $472 million in cash, cash equivalents and marketable securities to support operating runway into the second half of 2025 CAMBRIDGE, Mass. , March... Read More

CAMBRIDGE, Mass. , March 14, 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 an upcoming preclinical data poster presentation supporting the ongoing clinical development of its ALK-selective inhibitor, NVL-655. The data, resulting from a collaboration with the Yonsei... Read More

CAMBRIDGE, Mass. , March 1, 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 that James Porter , Ph.D., Chief Executive Officer, and Alexandra Balcom , Chief Financial Officer, will participate in a fireside chat during the 43 rd Annual Cowen Healthcare Conference on... Read More

CAMBRIDGE, Mass. , Jan. 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 that James Porter , Ph.D., Chief Executive Officer, will present at the 41 st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023 , at 7:30 a.m. PT in San Francisco . A live... Read More

Publication provides comprehensive assessment of NVL-520's activity spanning preclinical characterization and preliminary clinical case studies CAMBRIDGE, Mass. , Dec. 13, 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 publication of a manuscript in Cancer... Read More

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 pricing of its previously announced underwritten public offering of 6,865,672 shares of Class A common stock at a price to the public of $33.50 per share. All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the... Read More

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 it has commenced an underwritten public offering of $200.0 million of its shares of Class A common stock. All shares are being offered by Nuvalent. The offering is subject to market and other conditions, and there can be no assurance as... Read More

Favorable preliminary safety profile of NVL-520 suggests potential for a highly ROS1-selective, TRK sparing design, with no dose-limiting toxicities, treatment-related serious adverse events, treatment- related dizziness, or adverse events leading to treatment reductions or discontinuations as of the data cut-off date Encouraging preliminary signs of activity observed across all dose levels in heavily pre-treated patients... Read More

Preclinical data demonstrated that NVL-330 inhibits HER2 exon 20 insertion mutations, is selective for HER2 versus wild-type EGFR, and is brain-penetrant NVL-655 preclinical data further support its best-in-class potential for patients with advanced ALK-positive NSCLC and other solid tumors Data Presented at the 34 th EORTC-NCI-AACR (ENA) Symposium Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company... Read More

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 management will host a live webcast and conference call in conjunction with its data presentations at the 34th EORTC-NCI-AACR (ENA) Symposium in Barcelona, Spain on Friday, October 28, 2022 at 8:30 a.m. EDT . The event will be... Read More

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... Read More

Preliminary Dose Escalation Data on ROS1-selective Inhibitor NVL-520 to be Presented in the "New Drugs on the Horizon" Oral Plenary Session New Preclinical Data to be Presented on Parallel-lead, Clinical-stage Candidate NVL-655, an ALK-selective Inhibitor Selection of Third Development Candidate NVL-330, a Potential Best-in-Class HER2-selective Inhibitor for Patients with HER2 Exon 20 Insertion-Positive Cancers, and... Read More

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, will participate in a fireside chat at the Wells Fargo 2022 Healthcare Conference on Thursday, September 8, 2022 , at 2:35 p.m. ET in Boston . A live webcast will be available in the... Read More

Preliminary dose escalation data expected in second half of 2022 from the ARROS-1 study of NVL-520 for advanced ROS1 positive NSCLC and other solid tumors Rapid advancement of pipeline with clinical trials ongoing for NVL-520 and NVL-655 and two additional development candidates on-track for selection in 2022 Nuvalent, Inc . (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted... Read More

Trial in progress poster also to be presented for Phase 1/2 ARROS-1 study of ROS1-selective inhibitor NVL-520 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 preclinical data supporting the potential best-in-class profile of NVL-655 – an ALK-selective inhibitor, and a "Trial in... Read More

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, will present at the Canaccord Genuity 42 nd Annual Growth Conference on Wednesday, August 10, 2022 , at 4:00 p.m. ET in Boston . A live webcast will be available in the Investors section of... Read More

Darlene Noci , A.L.M. promoted to Chief Development Officer Benjamin Lane , Ph.D. promoted to Senior Vice President, Technical Operations Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced two leadership team promotions. Darlene Noci , A.L.M. has been promoted to Chief Development Officer... Read More

Preclinical activity of ALK-selective inhibitor NVL-655 in a lorlatinib-resistant model of NSCLC with a compound resistance mutation continues to support potential for best-in-class profile 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 two posters for its parallel lead... Read More

Preliminary dose-escalation data anticipated in second half of 2022 for ongoing ARROS-1 Phase 1/2 clinical trial of NVL-520 for patients with advanced ROS1-positive NSCLC and other solid tumors First patient dosed in ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating... Read More

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, will present at the 2022 Jefferies Healthcare Conference on Thursday, June 9, 2022 , at 1:00 p.m. ET in New York City . A live webcast will be available in the Investors section of the... Read More

Two clinical-stage programs ongoing for potential best-in-class ROS1 and ALK-selective inhibitors On-track for selection of two additional development candidates in 2022 Ended the first quarter of 2022 with $272.7 million in cash, cash equivalents, and marketable securities to support planned operations into 2024 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted... Read More

NVL-520 showed strong preclinical activity against diverse ROS1 fusion partners and kinase-domain resistance mutations, as well as in a ROS1-driven model of glioblastoma NVL-655 demonstrated differentiation through broad preclinical activity across diverse ALK oncoproteins, resistance mutations, and tumor types while... Read More

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, will participate in a virtual fireside chat during the 2022 Canaccord Genuity Horizons in... Read More

Veteran Biotech Executive with Broad Oncology Perspective to Lead Nuvalent Board as Company Advances its Pipeline of Precisely Targeted Therapies Nuvalent, Inc. (Nasdaq: NUVL), a clinical stage biopharmaceutical company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the... Read More

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... Read More

Nuvalent, Inc. , (Nasdaq: NUVL) a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced multiple preclinical data presentations supporting advancement of its parallel lead programs including NVL-520 – a ROS1-selective inhibitor – and NVL-655 – an... Read More

Nuvalent, Inc. (Nasdaq: NUVL), a 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, will participate in a virtual panel titled, "Lung Cancer Panel," during the Cowen 42 nd Annual... Read More

Nuvalent, Inc. (Nasdaq: NUVL), a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the first patient has been dosed in ARROS-1, its Phase 1/2 clinical trial evaluating NVL-520 in patients with advanced ROS1-positive non-small cell lung cancer... Read More

Nuvalent, Inc. (Nasdaq: NUVL), a 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, will present at the 40 th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 , at... Read More

Nuvalent, Inc. , (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported recent pipeline progress and third quarter 2021 financial results. "Throughout the third quarter of 2021, we continued to progress our novel portfolio of... Read More

Nuvalent, Inc. , (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, provided new preclinical data on Thursday supporting advancement of its parallel lead programs in non-small cell lung cancer (NSCLC). NVL-520, a ROS1-selective inhibitor,... Read More

Nuvalent, Inc. , (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported recent pipeline and business highlights and second quarter 2021 financial results. "At Nuvalent, we are leveraging our team's deep expertise in chemistry... Read More

Nuvalent, Inc. , a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the closing of its upsized initial public offering of 11,212,500 shares of common stock, consisting of 10,612,500 shares of Class A common stock and 600,000 shares of... Read More