SEC Form SC 13G/A filed by Nuvalent Inc. (Amendment)
$NUVL
Biotechnology: Pharmaceutical Preparations
Health Care
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 5/22/2026 | $189.00 | Outperform | Bernstein |
| 3/30/2026 | $116.00 | Overweight | Wells Fargo |
| 11/24/2025 | Buy | Truist | |
| 11/12/2025 | $126.00 | Buy | Canaccord Genuity |
| 10/16/2025 | $115.00 | Buy | Stifel |
| 10/15/2025 | $135.00 | Overweight | Cantor Fitzgerald |
| 9/4/2025 | $122.00 | Buy | Guggenheim |
| 9/3/2025 | $105.00 | Outperform | Raymond James |
4 - Nuvalent, Inc. (0001861560) (Issuer)
4 - Nuvalent, Inc. (0001861560) (Issuer)
4 - Nuvalent, Inc. (0001861560) (Issuer)
New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026Veteran biopharmaceutical executive, Georg Pirmin Meyer, M.D., joins as Chief International Officer to lead Nuvalent's global expansion strategyCAMBRIDGE, Mass., May 27, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has gra
Presentation of pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from ALKOVE-1 trialTKI pre-treated data from ALKOVE-1 trial of neladalkib support recent NDA submission and ongoing investigation in Phase 3 ALKAZAR trial for TKI-naïve patients with advanced ALK-positive NSCLCFirst presentation of encouraging preliminary data for zidesamtinib in patients with advanced ROS1-positive solid tumors other than NSCLC from ARROS-1 trialCAMBRIDGE, Mass., May 21, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highli
NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18, 2026Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC planned for the second half of 2026Strengthened leadership team with key internal promotionsCAMBRIDGE, Mass., May 7, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and rep
Bernstein initiated coverage of Nuvalent with a rating of Outperform and set a new price target of $189.00
Wells Fargo initiated coverage of Nuvalent with a rating of Overweight and set a new price target of $116.00
Truist initiated coverage of Nuvalent with a rating of Buy
10-Q - Nuvalent, Inc. (0001861560) (Filer)
8-K - Nuvalent, Inc. (0001861560) (Filer)
SCHEDULE 13G/A - Nuvalent, Inc. (0001861560) (Subject)
New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026Veteran biopharmaceutical executive, Georg Pirmin Meyer, M.D., joins as Chief International Officer to lead Nuvalent's global expansion strategyCAMBRIDGE, Mass., May 27, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has gra
CAMBRIDGE, Mass., Dec. 10, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Ron Squarer to its Board of Directors. "We welcome Ron to our Board of Directors, where his personal dedication to advancing oncology therapeutics, demonstrated success in evolving research and development organizations to fully integrated businesses, and proven global commercial acumen will strengthen and sharpen our pre-launch
Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with target completion in the third quarter of 2025 Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025 Preliminary data for neladalkib in patients with ALK-positive solid tumors beyond NSCLC to be presented at the ESMO Congress 2025 Jason Waters, MBA, promoted to Senior Vice President, Commercial CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical
In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectivelyIn the subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectivelyNeladalkib demonstrated intracranial responses, ability to address key drivers of disease progression, and a generally well-tolerated safety profile with low rates of dose discontinuation (5%) and dose reduction (17%) due to TEAEs, consistent with its ALK-selective, TRK-sparing designCompany p
Company to host webcast and conference call on November 17, 2025 at 8:00am ET CAMBRIDGE, Mass., Nov. 14, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the company will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET, to discuss topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer from the global ALKOVE-1 Phase 1/2 clinical trial.
Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 prior ROS1 TKIs ± chemotherapy, ORR by BICR was 44% (95% CI: 34, 53) with initial estimated durability of response of 78% at the 12-month landmark and 62% at the 18-month landmarkIn the subset of 55 patients treated with 1 prior ROS1 TKI (crizotinib or entrectinib) ± chemotherapy, ORR was 51% (95% CI: 37, 65) with initial estimated durability of respo
SC 13G/A - Nuvalent, Inc. (0001861560) (Subject)
SC 13G/A - Nuvalent, Inc. (0001861560) (Subject)
SC 13G/A - Nuvalent, Inc. (0001861560) (Subject)