Welcome to our dedicated page for Nuvalent news (Ticker: NUVL), a resource for investors and traders seeking the latest updates and insights on Nuvalent stock.
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company developing precisely targeted kinase inhibitors for oncogene-driven cancers, with a focus on non-small cell lung cancer (NSCLC). The NUVL news feed on Stock Titan aggregates company announcements, press releases, and related coverage so readers can follow how its pipeline and regulatory interactions progress over time.
According to Nuvalent’s disclosures, its lead investigational programs include zidesamtinib, a ROS1-selective inhibitor for ROS1-positive NSCLC, and neladalkib, an ALK-selective inhibitor for ALK-positive NSCLC. News items often highlight pivotal and preliminary data from the ARROS-1 and ALKOVE-1 Phase 1/2 trials, updates on the ALKAZAR Phase 3 trial in TKI-naïve ALK-positive NSCLC, and information about design features such as brain penetrance and activity against resistance mutations.
Investors and observers can also find coverage of Nuvalent’s regulatory milestones, including FDA breakthrough therapy and orphan drug designations, New Drug Application (NDA) submissions and acceptances, and PDUFA target action dates. Corporate developments such as public equity offerings, cash runway guidance, royalty arrangements on future net sales of zidesamtinib and neladalkib, and board appointments are regularly disclosed through press releases and Form 8-K filings and are reflected in the news flow.
For those tracking NUVL, this news stream provides a centralized view of clinical trial readouts, conference presentations, financing activities, and strategic updates that shape the company’s outlook in targeted oncology. Bookmarking the NUVL news page on Stock Titan can help readers quickly review new disclosures and place them in the context of Nuvalent’s broader development strategy.
Nuvalent, Inc. (NUVL) reported promising preliminary Phase 1 data for NVL-520 in ROS1-positive NSCLC at the EORTC-NCI-AACR Symposium, supporting its best-in-class potential. The company is progressing in the ALKOVE-1 trial for NVL-655 targeting ALK-positive NSCLC, while NVL-330 shows selectivity for HER2 Exon 20 mutations. A successful upsized public offering raised $264.5 million, extending the cash runway to late 2025. Q3 financials show a net loss of $19.7 million, with R&D expenses at $14.6 million, as the company advances its innovative oncology pipeline.
Nuvalent, Inc. (Nasdaq: NUVL) announced the closing of an upsized underwritten public offering of 7,895,522 shares of Class A common stock at $33.50 per share, generating gross proceeds of approximately $264.5 million. This includes 1,029,850 shares from the full exercise of underwriters' options. The shares were offered under a shelf registration statement effective since August 16, 2022. Notably, J.P. Morgan, Cowen, Piper Sandler, and BMO Capital Markets acted as joint book-running managers for this transaction.
Nuvalent, Inc. (Nasdaq: NUVL) has priced its underwritten public offering of 6,865,672 shares of Class A common stock at $33.50 per share, aiming for gross proceeds of approximately $230 million before expenses. The offering is expected to close on November 3, 2022, pending customary conditions. There is also a 30-day option for underwriters to buy an additional 1,029,850 shares. This offering is part of a shelf registration statement effective since August 16, 2022.
Nuvalent, Inc. (Nasdaq: NUVL) has launched an underwritten public offering of $200 million of Class A common stock, all offered by the company. A 30-day underwriters' option for an additional 15% of shares is also expected. The offering is subject to market conditions, and completion is uncertain. The offering is conducted under a shelf registration statement effective since August 16, 2022. Nuvalent specializes in targeted cancer therapies, focusing on kinase targets. J.P. Morgan and others are managing the offering.
Nuvalent reported preliminary Phase 1 data for NVL-520, a novel ROS1-selective inhibitor, at the EORTC-NCI-AACR Symposium. The treatment showed a favorable safety profile, with no dose-limiting toxicities or serious adverse events observed among 35 enrolled patients. Encouraging signs of efficacy were noted, with 48% of heavily pre-treated ROS1-positive NSCLC patients achieving partial responses. Notable response rates were 78% in patients with G2032R mutations and 73% in those with CNS metastases. NVL-520 aims to address challenges associated with existing treatments, including resistance mutations and CNS adverse effects.
Nuvalent, Inc. (Nasdaq: NUVL) announced new preclinical data for its selective kinase inhibitors NVL-330 and NVL-655 at the 34th EORTC-NCI-AACR symposium. NVL-330 targets HER2 exon 20 insertion mutations and demonstrates selectivity over wild-type EGFR, along with potential for treating brain metastases. Preclinical results indicate NVL-655's activity in ALK-positive tumors, overcoming resistance mutations. Nuvalent continues to advance its pipeline, showcasing significant therapeutic potential against hard-to-treat cancers.
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, will host a live webcast and conference call on October 28, 2022, at 8:30 a.m. EDT, to discuss preliminary Phase 1 data from the ARROS-1 clinical trial of NVL-520, alongside additional preclinical updates. This event coincides with the 34th EORTC-NCI-AACR Symposium in Barcelona, Spain. Interested parties can access the webcast via Nuvalent’s investor page or by phone using the provided dial-in details.
On October 6, 2022, Nuvalent, Inc. (Nasdaq: NUVL) appointed Dr. Michael L. Meyers, an experienced oncologist and drug developer, to its Board of Directors. Dr. Meyers has been a Senior Clinical Advisor to Nuvalent since 2020 and brings a wealth of experience from his roles at Syndax Pharmaceuticals and Johnson & Johnson. His expertise is expected to enhance Nuvalent's capabilities as it advances its clinical programs, including NVL-520 and NVL-655, which target advanced ROS1-positive and ALK-positive non-small cell lung cancer. The company continues to position itself as a leader in oncology therapies.
Nuvalent, Inc. (Nasdaq: NUVL) announced it will present preliminary results from the ARROS-1 Phase 1/2 trial of NVL-520, aimed at treating advanced ROS1-positive non-small cell lung cancer (NSCLC), during the EORTC-NCI-AACR Symposium from October 26-28, 2022. Additional presentations will feature new preclinical data on NVL-655, an ALK-selective inhibitor, and the selection of NVL-330, targeting HER2 exon 20 insertion-positive tumors. The conference call is scheduled for October 28, 2022, to discuss these developments further.
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, announced CEO James Porter will participate in a fireside chat at the Wells Fargo 2022 Healthcare Conference on September 8, 2022, at 2:35 p.m. ET in Boston. Nuvalent focuses on developing targeted therapies for cancer, leveraging expertise in chemistry and drug design to combat resistance and minimize adverse effects. A live webcast of the event will be accessible on their website, with an archive available for 30 days.