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 dedicated to improving human health by developing innovative small molecule therapeutics. The company uses advanced chemical insights to target biological mechanisms in new ways, focusing particularly on 'undruggable' targets. Nuvalent’s research aims to produce first-in-class and best-in-class small molecule therapies that significantly enhance patient outcomes.
Nuvalent is primarily engaged in creating precisely targeted therapies for cancer patients. Its novel approach seeks to surmount the limitations of existing treatments for clinically validated kinase targets. All of Nuvalent’s operations are based in the United States.
Key product candidates include:
- NVL-520: A brain-penetrant ROS1-selective inhibitor aimed at overcoming resistance to current ROS1 inhibitors and treating brain metastases in patients with ROS1-positive non-small cell lung cancer (NSCLC).
- NVL-655: An ALK-selective inhibitor designed to combat resistance and brain metastases in ALK-positive NSCLC.
- NVL-330: An HER2-selective inhibitor for treating HER2-mutant tumors, including those with HER2 exon 20 insertion mutations and brain metastases.
Nuvalent has made significant progress in its pipeline. Recently, the company presented preliminary proof-of-concept data for its ROS1 and ALK programs and advanced NVL-330 towards clinical development. Their latest financial results indicate a strong balance sheet, providing a cash runway into 2027.
On the partnership front, Nuvalent continues to attract support from both new and long-standing stockholders, as demonstrated by a successful $300 million public offering. The company is also expanding its team to support its global development plans and aims to submit new drug applications (NDAs) by 2026.
Recent significant milestones include:
- Initiation of the Phase 2 portion of the ALKOVE-1 study for NVL-655.
- FDA breakthrough therapy designation for NVL-520 and NVL-655 for specific NSCLC indications.
- Pipeline progress updates at major medical meetings.
In 2024, Nuvalent revealed its “OnTarget 2026” operating plan, aiming for its first potential product approval by 2026. This plan underscores Nuvalent’s commitment to delivering new treatments to patients as swiftly as possible.
Nuvalent, Inc. (NASDAQ: NUVL), a clinical-stage biopharmaceutical company, announced a preclinical data poster presentation for its ALK-selective inhibitor, NVL-655, at the AACR Annual Meeting 2023 in Orlando, Florida, from April 14-19. The data demonstrates NVL-655's intracranial antitumor activity in a specific lung cancer model with the EML4-ALK v3 G1202R mutation. This inhibitor aims to address limitations of existing ALK inhibitors. NVL-655 is currently being explored in the ALKOVE-1 Phase 1/2 clinical trial for advanced ALK-positive non-small cell lung cancer. Full poster details will be available on Nuvalent's website post-presentation.
Nuvalent, Inc. (Nasdaq: NUVL), a biopharmaceutical company, announced participation in the 43rd Annual Cowen Healthcare Conference on March 8, 2023, at 9:10 a.m. ET in Boston. CEO James Porter, Ph.D., and CFO Alexandra Balcom will engage in a fireside chat.
A live webcast will be available in the Investors section of Nuvalent's website, with an archive accessible for 30 days post-event. Nuvalent focuses on developing targeted cancer therapies aimed at kinase targets, with ongoing programs for ROS1-positive and ALK-positive non-small cell lung cancer.
Nuvalent, Inc. (Nasdaq: NUVL) announced that CEO James Porter will present at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 7:30 a.m. PT in San Francisco. The company, focused on developing targeted therapies for cancer, aims to address the limitations of current treatments. A live webcast of the presentation will be available on the company's website and archived for 30 days. Nuvalent is advancing a pipeline targeting ROS1-positive and ALK-positive lung cancers, HER2 Exon 20 insertion-positive cancers, and other discovery-stage programs.
Nuvalent, Inc. (Nasdaq: NUVL) announced a manuscript publication detailing NVL-520’s design and characterization in Cancer Discovery. Currently in the ARROS-1 Phase 1/2 trial for ROS1-positive non-small cell lung cancer, NVL-520 aims to address limitations of existing ROS1 inhibitors. The publication presents extensive preclinical data and case studies showing NVL-520’s efficacy against ROS1 fusions, including the prevalent G2032R mutation, with no observed neurological toxicities. This underscores NVL-520's potential as a best-in-class ROS1 inhibitor.
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.
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