NASDAQ Framework: Nuvalent Inc.

Clinical-stage biopharmaceutical company targeting kinase inhibitors 1 2 3.

Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. Leveraging deep expertise in chemistry and structure-based drug design, Nuvalent develops innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. The company is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs 4 5 6.

4: About NuvalentNuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. View Source5: Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. It develops small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases and drive more durable responses. It is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-positive non-small cell lung cancer, and multiple... View Source6: Nuvalent, Inc., a clinical stage biopharmaceutical company, engages in the development of therapies for patients with cancer. Its lead product candidates are NVL-520, a novel ROS1-selective inhibitor to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of ROS1 tyrosine kinase inhibitors (TKIs) for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC) which is under the phase 2 portion of the ARROS-1 Phase 1/2 clinical trial; NVL-655, a brain-penetrant ALK-selective inhibitor, to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that might limit the use of first-, second-, and third-generation ALK inhibitors that is under the phase 2 portion of the ALKOVE-1 Phase 1/2 clinical trial; and NVL-330, a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor designed to treat tumors driven by HER2ex20, brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type EGFR, which is expected to initiate phase 1 trial. The company was incorporated in 2017 and is headquartered in Cambridge, Massachusetts. View Source

UNKNOWN

The provided facts do not specify whether Nuvalent Inc. is still led by its founders or if the founders are heavily involved. The information available details the current leadership and recent promotions but does not clarify the involvement of the founders 7 8 9 10 11.

7: Jul 22, 2024 Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor 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... Jul 16, 2024 Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024 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... Jul 11, 2024 Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer 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... May 29, 2024 Nuvalent to Participate in the 2024 Jefferies Global Healthcare Conference 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... May 16, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655 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... May 9, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results 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 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... Apr 8, 2024 Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024 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... Mar 5, 2024 Nuvalent to Present New Preclinical Data on HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, zidesamtinib, at AACR Annual Meeting 2024 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... Feb 27, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones and Reports Fourth Quarter and Full Year 2023 Financial Results Well-capitalized with operating runway anticipated into 2027 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted... Feb 27, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for 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 that the... View Source8: “The initiation of this trial represents a significant milestone for Nuvalent, marking the third program from our novel pipeline to enter clinical development in under three years,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent. “This rapid execution serves as a testament to our team’s dedication to rapid progress and growth across our pipeline, and our unwavering commitment to our goal of bringing precisely targeted therapies to patients with cancer.” View Source9: Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven... View Source10: Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven... View Source11: Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer View Source

LOW RISK

Nuvalent Inc. has a strong financial position with cash, cash equivalents, and marketable securities amounting to $691.8 million as of March 31, 2024, which is expected to fund its current operating plan into 2027 12. Additionally, the company has received breakthrough therapy designations from the FDA for its lead candidates, which could expedite their path to market and potentially enhance financial stability 13 14. Despite the inherent risks associated with drug development, the company's robust pipeline and significant financial runway suggest a low-risk financial situation.

12: Cash Position: Cash, cash equivalents and marketable securities were $691.8 million as of March 31, 2024. Nuvalent believes these existing cash, cash equivalents and marketable securities to be sufficient to fund its current operating plan into 2027. R&D Expenses: Research and development (R&D) expenses were $38.6 million for the first quarter of 2024. G&A Expenses: General and administrative (G&A) expenses were $14.0 million for the first quarter of 2024. Net Loss: Net loss was $44.5 million for the first quarter of 2024. View Source13: 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 non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs). View Source14: "Today's announcement of FDA breakthrough therapy designation for NVL-655 marks another important milestone for our ALK program and the second breakthrough designation granted to our pipeline of novel kinase inhibitors this year," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "Our team is committed to expeditiously advancing NVL-655 in recognition of the continued need for innovation for patients with ALK-positive NSCLC who have exhausted available therapies. We expect to provide an update from the ALKOVE-1 trial of NVL-655 at a medical meeting in the second half of this year." View Source

YES

Nuvalent Inc. is launching new product offerings, as evidenced by the initiation of the HEROEX-1 Phase 1a/1b clinical trial of NVL-330, its novel HER2-selective inhibitor 15 16 17 18 19.

15: Jul 22, 2024 Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor 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... Jul 16, 2024 Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024 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... Jul 11, 2024 Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer 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... May 29, 2024 Nuvalent to Participate in the 2024 Jefferies Global Healthcare Conference 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... May 16, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655 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... May 9, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results 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 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... Apr 8, 2024 Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024 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... Mar 5, 2024 Nuvalent to Present New Preclinical Data on HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, zidesamtinib, at AACR Annual Meeting 2024 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... Feb 27, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones and Reports Fourth Quarter and Full Year 2023 Financial Results Well-capitalized with operating runway anticipated into 2027 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted... Feb 27, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for 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 that the... View Source16: PR Newswire•2 days agoNuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective InhibitorNuvalent, 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).PR Newswire•8 days agoNuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024Nuvalent, 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.PR Newswire•13 days agoNuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific OfficerNuvalent, 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.PR Newswire•2 months agoNuvalent to Participate in the 2024 Jefferies Global Healthcare ConferenceNuvalent, 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 Wednesday, June 5, 2024, at 4:30 p.m. ET in NYC.PR Newswire•2 months agoNuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655Nuvalent, 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 non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).PR Newswire•2 months agoNuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial ResultsNuvalent, 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 first quarter 2024 financial results.Zacks•3 months agoWhy Earnings Season Could Be Great for Nuvalent (NUVL)Nuvalent (NUVL) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.PR Newswire•4 months agoNuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024Nuvalent, 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 for its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib (NVL-520). The two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5 – 10 in San Diego. The posters wiGuruFocus.com•4 months agoChief Legal Officer Deborah Miller Sells 3,000 Shares of Nuvalent Inc (NUVL)Nuvalent Inc (NASDAQ:NUVL), a company specializing in the development of precisely targeted therapies for patients with cancer, has reported an insider sale according to a recent SEC filing.GuruFocus.com•4 months agoChief Legal Officer Deborah Miller Sells 22,000 Shares of Nuvalent Inc (NUVL)Nuvalent Inc (NASDAQ:NUVL), a company specializing in the development of precisely targeted therapies for patients with cancer, has reported an insider sale according to a recent SEC filing. View Source17: Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven... View Source18: Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor View Source19: CAMBRIDGE, MA, USA I July 22, 2024 I 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). View Source

Nuvalent Inc.'s product roadmap for 2024 through to 2026 is guided by its OnTarget 2026 operating plan, which delineates a strategic path towards bringing new, potential best-in-class medicines to patients with cancer. The company anticipates sharing clinical updates from its parallel lead programs for ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC) at medical meetings in the second half of 2024. Additionally, Nuvalent has initiated the HEROEX-1 Phase 1a/1b clinical trial for its novel HER2-selective inhibitor, NVL-330, and expects to dose the first patient in this program within the year. The plan aims for the first potential pivotal data in 2025 and the first potential approved product in 2026, reflecting Nuvalent's commitment to efficiently advancing its pipeline and bringing precisely targeted therapies to patients 20 21 22 23.

20: "Guided by our OnTarget 2026 operating plan, 2024 is a year of focused execution on our path towards a potential first approval in 2026 from our pipeline of novel kinase inhibitors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We expect to share clinical updates from our parallel lead programs for ROS1-positive and ALK-positive NSCLC at a medical meeting in the second half of the year and are on-track to dose the first patient in our HER2 program this year. This is an important time for Nuvalent, and we are excited to carry this momentum forward in hopes of bringing our therapies to patients as efficiently as possible." View Source21: About OnTarget 2026OnTarget 2026 delineates Nuvalent's 3-year operating plan towards bringing new, potential best-in-class medicines to patients with cancer. As part of this plan announced in January 2024, Nuvalent outlined the following anticipated milestones throughout 2024, leading to the company's first potential pivotal data in 2025 and first potential approved product in 2026: View Source22: Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven... View Source23: Enrollment is ongoing in the global Phase 2 portion of the ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors. The Phase 2 cohorts are designed with registrational intent for TKI pre-treated patients with ALK-positive NSCLC and to enable preliminary evaluation in patients with ALK-positive NSCLC who are TKI naïve. The company expects to share updated data from the ALKOVE-1 trial at a medical meeting in the second half of 2024. Additionally, Nuvalent plans to outline its broader front-line development strategy for its ALK program in 2024. View Source

Sources

1: Jul 22, 2024 Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor 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... Jul 16, 2024 Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024 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... Jul 11, 2024 Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer 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... May 29, 2024 Nuvalent to Participate in the 2024 Jefferies Global Healthcare Conference 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... May 16, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655 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... May 9, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results 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 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... Apr 8, 2024 Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024 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... Mar 5, 2024 Nuvalent to Present New Preclinical Data on HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, zidesamtinib, at AACR Annual Meeting 2024 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... Feb 27, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones and Reports Fourth Quarter and Full Year 2023 Financial Results Well-capitalized with operating runway anticipated into 2027 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted... Feb 27, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for 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 that the... View Source2: About NuvalentNuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. View Source3: Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. It develops small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases and drive more durable responses. It is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-positive non-small cell lung cancer, and multiple... View Source4: About NuvalentNuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. View Source5: Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. It develops small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases and drive more durable responses. It is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-positive non-small cell lung cancer, and multiple... View Source6: Nuvalent, Inc., a clinical stage biopharmaceutical company, engages in the development of therapies for patients with cancer. Its lead product candidates are NVL-520, a novel ROS1-selective inhibitor to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of ROS1 tyrosine kinase inhibitors (TKIs) for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC) which is under the phase 2 portion of the ARROS-1 Phase 1/2 clinical trial; NVL-655, a brain-penetrant ALK-selective inhibitor, to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that might limit the use of first-, second-, and third-generation ALK inhibitors that is under the phase 2 portion of the ALKOVE-1 Phase 1/2 clinical trial; and NVL-330, a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor designed to treat tumors driven by HER2ex20, brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type EGFR, which is expected to initiate phase 1 trial. The company was incorporated in 2017 and is headquartered in Cambridge, Massachusetts. View Source7: Jul 22, 2024 Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor 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... Jul 16, 2024 Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024 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... Jul 11, 2024 Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer 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... May 29, 2024 Nuvalent to Participate in the 2024 Jefferies Global Healthcare Conference 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... May 16, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655 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... May 9, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results 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 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... Apr 8, 2024 Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024 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... Mar 5, 2024 Nuvalent to Present New Preclinical Data on HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, zidesamtinib, at AACR Annual Meeting 2024 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... Feb 27, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones and Reports Fourth Quarter and Full Year 2023 Financial Results Well-capitalized with operating runway anticipated into 2027 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted... Feb 27, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for 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 that the... View Source8: “The initiation of this trial represents a significant milestone for Nuvalent, marking the third program from our novel pipeline to enter clinical development in under three years,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent. “This rapid execution serves as a testament to our team’s dedication to rapid progress and growth across our pipeline, and our unwavering commitment to our goal of bringing precisely targeted therapies to patients with cancer.” View Source9: Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven... View Source10: Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven... View Source11: Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer View Source12: Cash Position: Cash, cash equivalents and marketable securities were $691.8 million as of March 31, 2024. Nuvalent believes these existing cash, cash equivalents and marketable securities to be sufficient to fund its current operating plan into 2027. R&D Expenses: Research and development (R&D) expenses were $38.6 million for the first quarter of 2024. G&A Expenses: General and administrative (G&A) expenses were $14.0 million for the first quarter of 2024. Net Loss: Net loss was $44.5 million for the first quarter of 2024. View Source13: 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 non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs). View Source14: "Today's announcement of FDA breakthrough therapy designation for NVL-655 marks another important milestone for our ALK program and the second breakthrough designation granted to our pipeline of novel kinase inhibitors this year," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "Our team is committed to expeditiously advancing NVL-655 in recognition of the continued need for innovation for patients with ALK-positive NSCLC who have exhausted available therapies. We expect to provide an update from the ALKOVE-1 trial of NVL-655 at a medical meeting in the second half of this year." View Source15: Jul 22, 2024 Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor 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... Jul 16, 2024 Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024 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... Jul 11, 2024 Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer 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... May 29, 2024 Nuvalent to Participate in the 2024 Jefferies Global Healthcare Conference 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... May 16, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655 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... May 9, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results 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 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... Apr 8, 2024 Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024 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... Mar 5, 2024 Nuvalent to Present New Preclinical Data on HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, zidesamtinib, at AACR Annual Meeting 2024 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... Feb 27, 2024 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones and Reports Fourth Quarter and Full Year 2023 Financial Results Well-capitalized with operating runway anticipated into 2027 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted... Feb 27, 2024 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for 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 that the... View Source16: PR Newswire•2 days agoNuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective InhibitorNuvalent, 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).PR Newswire•8 days agoNuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024Nuvalent, 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.PR Newswire•13 days agoNuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific OfficerNuvalent, 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.PR Newswire•2 months agoNuvalent to Participate in the 2024 Jefferies Global Healthcare ConferenceNuvalent, 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 Wednesday, June 5, 2024, at 4:30 p.m. ET in NYC.PR Newswire•2 months agoNuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655Nuvalent, 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 non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).PR Newswire•2 months agoNuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial ResultsNuvalent, 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 first quarter 2024 financial results.Zacks•3 months agoWhy Earnings Season Could Be Great for Nuvalent (NUVL)Nuvalent (NUVL) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.PR Newswire•4 months agoNuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024Nuvalent, 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 for its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib (NVL-520). The two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5 – 10 in San Diego. The posters wiGuruFocus.com•4 months agoChief Legal Officer Deborah Miller Sells 3,000 Shares of Nuvalent Inc (NUVL)Nuvalent Inc (NASDAQ:NUVL), a company specializing in the development of precisely targeted therapies for patients with cancer, has reported an insider sale according to a recent SEC filing.GuruFocus.com•4 months agoChief Legal Officer Deborah Miller Sells 22,000 Shares of Nuvalent Inc (NUVL)Nuvalent Inc (NASDAQ:NUVL), a company specializing in the development of precisely targeted therapies for patients with cancer, has reported an insider sale according to a recent SEC filing. View Source17: Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven... View Source18: Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor View Source19: CAMBRIDGE, MA, USA I July 22, 2024 I 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). View Source20: "Guided by our OnTarget 2026 operating plan, 2024 is a year of focused execution on our path towards a potential first approval in 2026 from our pipeline of novel kinase inhibitors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We expect to share clinical updates from our parallel lead programs for ROS1-positive and ALK-positive NSCLC at a medical meeting in the second half of the year and are on-track to dose the first patient in our HER2 program this year. This is an important time for Nuvalent, and we are excited to carry this momentum forward in hopes of bringing our therapies to patients as efficiently as possible." View Source21: About OnTarget 2026OnTarget 2026 delineates Nuvalent's 3-year operating plan towards bringing new, potential best-in-class medicines to patients with cancer. As part of this plan announced in January 2024, Nuvalent outlined the following anticipated milestones throughout 2024, leading to the company's first potential pivotal data in 2025 and first potential approved product in 2026: View Source22: Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven... View Source23: Enrollment is ongoing in the global Phase 2 portion of the ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors. The Phase 2 cohorts are designed with registrational intent for TKI pre-treated patients with ALK-positive NSCLC and to enable preliminary evaluation in patients with ALK-positive NSCLC who are TKI naïve. The company expects to share updated data from the ALKOVE-1 trial at a medical meeting in the second half of 2024. Additionally, Nuvalent plans to outline its broader front-line development strategy for its ALK program in 2024. View Source