| Nuvalent Outlines Recent Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2025 Financial Results |
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 2025 Strengthened leadership team with key internal promotions CAMBRIDGE, Mass. , May 8, 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 outlined pipeline and business progress, reiterated key anticipated milestones, and reported first quarter 2025 financial results. |
prnewswire.com |
2025-05-08 11:31:00 |
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| Nuvalent Announces Publication in Molecular Cancer Therapeutics Reinforcing Rational Molecular Design of Zidesamtinib as a Novel ROS1-Selective Inhibitor |
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 novel and selective ROS1 inhibitor. |
prnewswire.com |
2025-04-29 17:09:00 |
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| Nuvalent to Present Trial in Progress Posters for the ALKAZAR Trial of Neladalkib and HEROEX-1 Trial of NVL-330 at the 2025 American Society of Clinical Oncology Annual Meeting |
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 (ASCO) Annual Meeting from May 30 – June 5, 2025, in Chicago. |
prnewswire.com |
2025-04-23 14:28:00 |
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| Nuvalent to Participate in the Stifel 2025 Virtual Targeted Oncology Forum |
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. |
prnewswire.com |
2025-04-01 10:30:00 |
Czytaj oryginał (ang.) |
| Nuvalent to Present New Preclinical Data on ALK-Selective Inhibitor, Neladalkib, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2025 |
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 American Association for Cancer Research (AACR) Annual Meeting 2025 from April 25-30, 2025, in Chicago. |
prnewswire.com |
2025-03-25 19:24:00 |
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| Nuvalent to Participate in Upcoming March Investor Conferences |
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. |
prnewswire.com |
2025-02-28 08:30:00 |
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| Nuvalent Outlines Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2024 Financial Results |
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 neladalkib for front-line ALK-positive NSCLC in first half of 2025 Implemented global Expanded Access Programs for zidesamtinib and neladalkib, in line with goal of prioritizing patient access CAMBRIDGE, Mass. , Feb. 27, 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 outlined pipeline and business progress, reiterated key anticipated milestones, and reported fourth quarter and full year 2024 financial results. |
prnewswire.com |
2025-02-27 08:30:00 |
Czytaj oryginał (ang.) |
| Nuvalent Details Strategy to Seek First Potential Approval in 2026 and Outlines Key Anticipated 2025 Milestones |
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 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14 th at 9:00 a.m. |
prnewswire.com |
2025-01-13 08:30:00 |
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| Nuvalent: A Logical Acquisition Target |
Nuvalent's NVL-655 and Zidesamtinib show strong potential as first-line therapies for NSCLC, with impressive Phase I/II trial results and FDA designations. Nuvalent's robust financial position and pipeline make it a prime M&A target, with potential suitors like Pfizer, AstraZeneca, and Novartis. Downside risks include regulatory setbacks, commercialization challenges, strong competition, and financial management, but Nuvalent's cash runway is healthy until 2028. |
seekingalpha.com |
2025-01-10 15:22:03 |
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| Nuvalent to Present at the 43rd Annual J.P. Morgan Healthcare Conference |
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. |
prnewswire.com |
2024-12-19 08:30:00 |
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| Nuvalent Appoints Grant Bogle to Board of Directors |
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. |
prnewswire.com |
2024-12-09 08:30:00 |
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| Nuvalent to Participate in the Piper Sandler 36th Annual Healthcare Conference |
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 36th Annual Healthcare Conference on Tuesday, December 3, 2024, at 3:30 p.m. |
prnewswire.com |
2024-11-26 08:52:00 |
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| Nuvalent Highlights Corporate and Pipeline Achievements, Reiterates Key Anticipated Milestones, and Reports Third Quarter 2024 Financial Results |
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, Mass. |
prnewswire.com |
2024-11-12 08:30:00 |
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| Nuvalent: Promising Data Keeps Validating Pipeline And Platform |
Nuvalent's lead candidates, NVL-520 and NVL-655, show promising efficacy and safety in Phase 1/2 trials. Both drugs have received FDA Breakthrough Therapy and orphan drug designations, with pivotal Phase 2 data expected in 2025 and potential approvals by 2026. The company completed a $500 million secondary offering, reflecting strong investor interest and providing the cash runway through Phase 3. |
seekingalpha.com |
2024-09-23 16:34:31 |
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| Nuvalent Announces Closing of Upsized Public Offering of Common Stock |
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 to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $100.00 per share. |
prnewswire.com |
2024-09-18 20:05:00 |
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| Nuvalent Stock Moves Up 20% in a Week: What's Driving the Rally? |
The upside comes after NUVL reported encouraging data on two experimental lung cancer therapies. |
zacks.com |
2024-09-18 19:31:16 |
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| Nuvalent: NSCLC Program Now Lends Credibility Towards 2025 Pivotal Data Releases |
Nuvalent, Inc. achieved positive data from the phase 1/2 ALKOVE-1 study, using NVL-655 for the treatment of patients with ALK-mutant NSCLC. Positive data achieved from phase 1/2 ARROS-1 study, using zidesamtinib for the treatment of patients with ROS-1 mutant NSCLC. The global non-small cell lung cancer market size is projected to reach $36.9 billion by 2031; 3% to 5% are ALK-positive and then 1% to 3% are ROS-1 positive. |
seekingalpha.com |
2024-09-17 17:20:49 |
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| Nuvalent Announces Pricing of Upsized Public Offering of Common Stock |
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. |
prnewswire.com |
2024-09-17 02:23:00 |
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| Nuvalent Stock Jumps On ESMO Data Presentation, Seeks To Raise $350M Via Equity |
Over the weekend, Nuvalent, Inc. NUVL highlighted the presentation of updated data from Phase 1 dose-escalation portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib and ALKOVE-1 Phase 1/2 trial of NVL-655, at the European Society for Medical Oncology (ESMO) Congress 2024. |
benzinga.com |
2024-09-16 17:44:01 |
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| Nuvalent Flies On 'Multibillion-Dollar' Potential, While Iteos Crashes On Patient Deaths |
Biotech stocks Nuvalent and Iteos diverged Monday on updates for their lung cancer treatments at the ESMO meeting in Madrid. |
investors.com |
2024-09-16 17:05:24 |
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| Cancer Biotech Nuvalent's Stock Jumps on Positive Data |
Biotech Nuvalent unveiled updates on two experimental cancer medicines over the weekend. Analysts say each could be the best in their category. |
barrons.com |
2024-09-16 15:18:00 |
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| Nuvalent Announces Public Offering of Common Stock |
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. |
prnewswire.com |
2024-09-16 11:00:00 |
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| Nuvalent Highlights Presentation of Clinical Data at ESMO 2024 for Parallel Lead Programs for ROS1 and ALK-positive NSCLC and Accelerated Development Timelines |
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. |
prnewswire.com |
2024-09-14 09:00:00 |
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| Nuvalent Announces Publication in Cancer Discovery Detailing Design and Characterization of ALK-selective inhibitor NVL-655 |
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 of the American Association for Cancer Research, which describes the design and characterization of NVL-655 and details Nuvalent's approach to rationally targeting ALK. |
prnewswire.com |
2024-09-13 13:53:00 |
Czytaj oryginał (ang.) |
| Updated Data for Nuvalent's ALK-Selective Inhibitor, NVL-655, and ROS1-Selective Inhibitor, Zidesamtinib, Continue to Support Potential Best-in-Class Profiles |
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. |
prnewswire.com |
2024-09-09 10:30:00 |
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| Nuvalent to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference |
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. |
prnewswire.com |
2024-08-29 10:30:00 |
Czytaj oryginał (ang.) |
| Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Second Quarter 2024 Financial Results |
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. |
prnewswire.com |
2024-08-08 10:30:00 |
Czytaj oryginał (ang.) |
| Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor |
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 (NSCLC). |
prnewswire.com |
2024-07-22 10:30:00 |
Czytaj oryginał (ang.) |
| Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024 |
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 Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain. |
prnewswire.com |
2024-07-16 10:30:00 |
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