Nuvalent, Inc. - NUVL STOCK NEWS

Nuvalent, Inc. (Nasdaq: NUVL) presented new preclinical data at the AACR Annual Meeting 2023, highlighting the intracranial activity of NVL-655, a brain-penetrant ALK-selective tyrosine kinase inhibitor (TKI). The study, in collaboration with Yonsei University, demonstrates NVL-655's efficacy against treatment-resistant ALK mutations, particularly the G1202R resistance mutation. Preclinical results from a patient-derived model showed potent activity, and NVL-655 maintained selectivity over TRK to avoid adverse neurological effects. Currently under investigation in the ALKOVE-1 phase 1/2 clinical trial, NVL-655 aims to offer innovative treatment options for patients with advanced ALK-positive non-small cell lung cancer and other solid tumors.

Nuvalent, Inc. (Nasdaq: NUVL) has announced a poster presentation for its ongoing Phase 1/2 ALKOVE-1 study focusing on the ALK-selective inhibitor NVL-655. The presentation will occur at the European Lung Cancer Congress (ELCC 2023) in Copenhagen, Denmark, from March 29 to April 1, 2023. The poster details the safety and preliminary activity of NVL-655 in patients with solid tumors possessing oncogenic ALK alterations, including those with resistance mutations and CNS metastases. This first-in-human study aims to evaluate NVL-655 as an oral monotherapy, showcasing its potential to overcome limitations of current ALK inhibitors.

Nuvalent, Inc. (Nasdaq: NUVL) reported significant advancements in its pipeline of kinase inhibitors and strong financial results for 2022. The company has initiated clinical trials for NVL-520 and NVL-655 and presented preliminary data supporting NVL-520's potential best-in-class profile. Cash and equivalents stood at $472 million, anticipated to sustain operations through mid-2025. R&D expenses were $63.7 million for 2022, while the net loss increased to $81.9 million. Leadership was strengthened with promotions of Dr. Henry Pelish and Dr. John Soglia to senior vice president roles, demonstrating commitment to advancing targeted cancer therapies.

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.