Nuvalent

Nuvalent, Inc. operates as a preclinical stage biopharmaceutical company. The company creates precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets. Its focus its discovery efforts on small molecule inhibitors of kinases, a class of cellular targets that can play a central role in cancer growth and proliferation. The company was founded in January 2017 and is headquartered Cambridge, MA.

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Nuvalent, Inc. is a clinical stage biopharmaceutical company, which focuses on creating precisely targeted therapies for patients with cancer. Its pipeline includes ROS1 NSCLC, ALK NSCLC and HER2 NSCLC. The company was founded by Matthew D. Shair in January 2017 and is headquartered in Cambridge, MA.

Nuvalent's lead candidates, NVL-520 and NVL-655, show promising efficacy and safety in Phase 1/2 trials. Both drugs have received FDA Breakthrough Therapy and orphan drug designations, with pivotal Phase 2 data expected in 2025 and potential approvals by 2026. The company completed a $500 million secondary offering, reflecting strong investor interest and providing the cash runway through Phase 3.

Nuvalent: Promising Data Keeps Validating Pipeline And Platform

CAMBRIDGE, Mass. , Sept. 18, 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 the closing of its previously announced upsized underwritten public offering of 5,750,000 shares of Class A common stock, which includes 750,000 shares of Class A common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $100.00 per share.

Nuvalent Announces Closing of Upsized Public Offering of Common Stock

The upside comes after NUVL reported encouraging data on two experimental lung cancer therapies.

Nuvalent Stock Moves Up 20% in a Week: What's Driving the Rally?

Nuvalent, Inc. achieved positive data from the phase 1/2 ALKOVE-1 study, using NVL-655 for the treatment of patients with ALK-mutant NSCLC. Positive data achieved from phase 1/2 ARROS-1 study, using zidesamtinib for the treatment of patients with ROS-1 mutant NSCLC. The global non-small cell lung cancer market size is projected to reach $36.9 billion by 2031; 3% to 5% are ALK-positive and then 1% to 3% are ROS-1 positive.

Nuvalent: NSCLC Program Now Lends Credibility Towards 2025 Pivotal Data Releases

CAMBRIDGE, Mass. , Sept. 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 the pricing of an upsized underwritten public offering of 5,000,000 shares of Class A common stock at a price to the public of $100.00 per share.

Nuvalent Announces Pricing of Upsized Public Offering of Common Stock

Over the weekend, Nuvalent, Inc. NUVL highlighted the presentation of updated data from Phase 1 dose-escalation portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib and ALKOVE-1 Phase 1/2 trial of NVL-655, at the European Society for Medical Oncology (ESMO) Congress 2024.

Nuvalent Stock Jumps On ESMO Data Presentation, Seeks To Raise $350M Via Equity

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Biotech stocks Nuvalent and Iteos diverged Monday on updates for their lung cancer treatments at the ESMO meeting in Madrid.

Nuvalent Flies On 'Multibillion-Dollar' Potential, While Iteos Crashes On Patient Deaths

Biotech Nuvalent unveiled updates on two experimental cancer medicines over the weekend. Analysts say each could be the best in their category.

Cancer Biotech Nuvalent's Stock Jumps on Positive Data

CAMBRIDGE, Mass. , Sept. 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 it has commenced an underwritten public offering of $350.0 million of its shares of Class A common stock.

Nuvalent Announces Public Offering of Common Stock

Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials continue to support potential best-in-class profiles for zidesamtinib and NVL-655 Rapid enrollment in Phase 2 portions of the ARROS-1 and ALKOVE-1 clinical trials; Pivotal data from both ROS1 and ALK programs now anticipated in 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of NVL-655 for treatment-naïve patients with advanced ALK-positive NSCLC anticipated in the first half of 2025 Company to host a conference call today at 8:30 a.m. ET/2:30 p.m.

Nuvalent Highlights Presentation of Clinical Data at ESMO 2024 for Parallel Lead Programs for ROS1 and ALK-positive NSCLC and Accelerated Development Timelines

Publication provides comprehensive assessment of NVL-655's preclinical activity and includes preliminary clinical case studies CAMBRIDGE, Mass. , Sept. 13, 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 the publication of a manuscript in Cancer Discovery, a journal of the American Association for Cancer Research, which describes the design and characterization of NVL-655 and details Nuvalent's approach to rationally targeting ALK.

Nuvalent Announces Publication in Cancer Discovery Detailing Design and Characterization of ALK-selective inhibitor NVL-655

Updated Phase 1 data from ALKOVE-1 and ARROS-1 clinical trials to be presented at the ESMO Congress 2024 Durable activity of NVL-655 and zidesamtinib in heavily pre-treated patient populations supports ongoing Phase 2 investigation in earlier lines of treatment Company plans to host a conference call on September 14, 2024 at 8:30 a.m. ET/2:30 p.m.

Updated Data for Nuvalent's ALK-Selective Inhibitor, NVL-655, and ROS1-Selective Inhibitor, Zidesamtinib, Continue to Support Potential Best-in-Class Profiles

CAMBRIDGE, Mass. , Aug. 29, 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 James Porter, Ph.D.

Nuvalent to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference

Company plans to host a conference call in conjunction with oral presentations at ESMO on September 14, 2024, at 8:30 a.m. ET/2:30 p.m.

Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Second Quarter 2024 Financial Results

CAMBRIDGE, Mass., July 22, 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 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).

Nuvalent Announces First Patient Dosed in HEROEX-1 Phase 1a/1b Clinical Trial of NVL-330, its Novel HER2-selective Inhibitor

CAMBRIDGE, Mass. , July 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 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.

Nuvalent to Present Updated Data for ROS1-Selective Inhibitor, Zidesamtinib, and ALK-Selective Inhibitor, NVL-655, at the ESMO Congress 2024

CAMBRIDGE, Mass. , July 11, 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 Henry Pelish, Ph.D.

Nuvalent Announces Promotion of Henry Pelish, Ph.D. to Chief Scientific Officer

Nuvalent, Inc. is a biotechnology company with precision-targeted treatments using kinase inhibitors for non-small cell lung cancer. NVL-520 targets ROS1-positive cancer and addresses treatment resistance, kinase mutations, and CNS-related adverse events, which limit existing treatments for NSCLC. NVL-655 is an ALK-selective inhibitor to overcome treatment resistance and CNS-related adverse events in ALK-driven NSCLC.

Nuvalent: Making Precise Progress In Its Oncology Pipeline

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Nuvalent's NVL-655 received FDA Breakthrough Therapy Designation for ALK+ NSCLC, showing potential as a vital therapy. Nuvalent's pipeline includes innovative kinase therapies for NSCLC, with NVL-655 and Zidesamtinib showing promise in clinical trials. NVL-655 has the potential to become a blockbuster drug, with peak sales estimates supporting a higher share price for Nuvalent in the future.

Nuvalent: NVL-655 Could Bring Blockbuster Potential

CAMBRIDGE, Mass. , May 29, 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 James Porter, Ph.D.

Nuvalent to Participate in the 2024 Jefferies Global Healthcare Conference

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).

Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655

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 2027 CAMBRIDGE, Mass. , May 9, 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 highlighted pipeline progress, reiterated key anticipated milestones, and reported first quarter 2024 financial results.

Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results

Nuvalent (NUVL) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Why Earnings Season Could Be Great for Nuvalent (NUVL)

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 be effective at suppressing on-target ROS1 resistance mutations in preclinical mutagenesis screens CAMBRIDGE, Mass. , April 8, 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 the presentation of new preclinical data for its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib (NVL-520).

Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024

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