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.

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

CAMBRIDGE, Mass., March 5, 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 upcoming preclinical data poster presentations further characterizing the preclinical profiles of its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib (NVL-520), at the American Association for Cancer Research (AACR) Annual Meeting 2024 from April 5 – 10 in San Diego.

Nuvalent to Present New Preclinical Data on HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, zidesamtinib, at AACR Annual Meeting 2024

Well-capitalized with operating runway anticipated into 2027 CAMBRIDGE, Mass. , Feb. 27, 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 fourth quarter and full year 2023 financial results.

Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones and Reports Fourth Quarter and Full Year 2023 Financial Results

CAMBRIDGE, Mass. , Feb. 27, 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-520 for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with two or more  ROS1 tyrosine kinase inhibitors (TKIs).

Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520

Nuvalent, Inc. expects final results from the phase 1 ARROS-1 study, using NVL-520 for the treatment of patients with ROS-1 positive non-small cell lung cancer, in 2024 at a medical meeting. Final results from the phase 1 ALKOVE-1, using NVL-655 for the treatment of patients with ALK-positive non-small cell lung cancer, expected in 2024 at a medical meeting. The global non-small cell lung cancer market size is projected to reach $36.9 billion by 2031; About 1% to 3% have ROS-1 mutation and 3% to 5% have ALK mutation.

Nuvalent: Pivotal NSCLC Programs Progressing With Additional Data In 2024

Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-655 of 150 mg once daily Phase 2 Designed with Registrational Intent for TKI Pre-Treated Patients with ALK-Positive NSCLC and Enables Preliminary Evaluation in the TKI-naïve Setting CAMBRIDGE, Mass. , Feb. 12, 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 the Phase 2 portion of ALKOVE-1, its Phase 1/2 clinical trial of NVL-655 for patients with ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors, following alignment with the US Food and Drug Administration (FDA) on a recommended Phase 2 dose (RP2D) of 150 mg once daily (QD).

Nuvalent Initiates the Phase 2 Portion of ALKOVE-1 Clinical Trial for Patients with ALK-Positive NSCLC and other Solid Tumors

CAMBRIDGE, Mass. , Feb. 1, 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 Guggenheim Healthcare Talks 6th Annual Biotechnology Conference

Targeting first approved product in 2026 towards realizing mission of bringing new, potential best-in-class treatments to patients with cancer Well-capitalized to support OnTarget 2026 initiatives with operating runway anticipated into 2027 Company to present at 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9 th at 7:30 a.m.

Nuvalent Announces "OnTarget 2026" Operating Plan and Key Anticipated Milestones

CAMBRIDGE, Mass. , Dec. 21, 2023 /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 Present at the 42nd Annual J.P. Morgan Healthcare Conference

Presented preliminary Phase 1 clinical data from ALKOVE-1 trial of NVL-655, initiated Phase 2 portion of ARROS-1 trial of NVL-520, and continued advancement of NVL-330 toward clinical development Appointed industry veteran Perrin Wilson Ph.D. as Senior Vice President of Business Development and Strategy Net proceeds from $300 million public offering, along with cash, cash equivalents, and marketable securities as of September 30, 2023, expected to extend operating runway into 2027 CAMBRIDGE, Mass.

Nuvalent Highlights Corporate and Pipeline Achievements and Reports Third Quarter 2023 Financial Results

CAMBRIDGE, Mass. , Nov. 1, 2023 /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 BMO Virtual BioPharma Spotlight Series: Oncology Day

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The biotech announced a secondary share flotation. It will sell over 5 million shares of its common stock in a public offering.

Why Nuvalent Stock Tanked on Tuesday

CAMBRIDGE, Mass., Oct. 16, 2023 /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 its previously announced underwritten public offering of 5,357,143 shares of Class A common stock at a price to the public of $56.00 per share.

Nuvalent Announces Pricing of Public Offering of Common Stock

Encouraging preliminary signs of activity observed in heavily pre-treated patients with ALK-positive NSCLC, including in subgroups of patients who have previously received a 2nd generation ALK TKI and lorlatinib, have brain metastases, or have single or compound ALK resistance mutations Favorable preliminary safety profile is consistent with an ALK-selective, TRK sparing design Company to host a conference call today, October 13, at 8:00am EDT CAMBRIDGE, Mass. , Oct. 13, 2023 /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 updated preliminary data from the Phase 1 dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.

Nuvalent Reports Preliminary Phase 1 Clinical Data from ALKOVE-1 Trial that Support Best-In-Class Potential of NVL-655 for Patients with ALK-Positive NSCLC

Nuvalent announced favorable preliminary data from a phase 1 trial indicating its drug NVL-655 was well tolerated with mild adverse events. It's still early, but management is encouraged by the data.

Why Nuvalent Stock Skyrocketed 35% This Week

Nuvalent (NUVL) surges 36% on encouraging preliminary results from the phase I dose-escalation portion of its early-mid-stage development program for NVL-655 to treat advanced ALK-positive NSCLC.

Nuvalent (NUVL) Soars 36% on Upbeat Initial NSCLC Study Data

Nuvalent, Inc. stock gained 36% and reached an all-time high of $58 per share yesterday, with a market cap valuation of $3.3bn. The biotech company is focused on developing targeted therapies for cancer patients, with its lead drug candidates showing promising results in treating lung cancer. Data released yesterday from candidate NVL-655 in NSCLC, showing a 65% ORR in patients with ALK+NSCLC, impressed the market.

Nuvalent Stock Gains On Lung Cancer Data, But I'd Only Buy On Dip

Nuvalent is a clinical-stage biotech. The company said its therapy showed effectiveness and a strong safety profile in its phase 1/2 trial to treat ALK-positive non-small cell lung cancer.

Why Nuvalent Stock Was Soaring Wednesday

Updated preliminary data to be presented at the 35th AACR-NCI-EORTC Symposium Company plans to host a conference call on October 13, 2023 at 8:00am EDT CAMBRIDGE, Mass. , Oct. 4, 2023 /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 preliminary data from the Phase 1 dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors as reported in an abstract accepted for presentation at the 35th AACR-NCI-EORTC (ANE) Symposium in Boston, Massachusetts.

Preliminary Phase 1 Dose-Escalation Data from ALKOVE-1 Trial of NVL-655 Demonstrated Activity in Heavily Pre-Treated Patients with ALK-Positive NSCLC and an ALK-Selective, TRK-Sparing Safety Profile

Company plans to host a conference call on October 13, 2023 CAMBRIDGE, Mass. , Sept. 18, 2023 /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 it will present preliminary dose-escalation data from its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 at the 35th AACR-NCI-EORTC (ANE) Symposium taking place October 11-15, 2023, in Boston, Massachusetts.

Nuvalent to Present Preliminary Data from ALKOVE-1 Phase 1/2 Clinical Trial of NVL-655 at 35th AACR-NCI-EORTC Symposium

Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-520 of 100 mg daily CAMBRIDGE, Mass. , Sept. 5, 2023 /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 the Phase 2 portion of ARROS-1, its Phase 1/2 clinical trial of NVL-520 for patients with ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors, following alignment with the US Food and Drug Administration (FDA) on a recommended Phase 2 dose (RP2D) of 100 mg daily.

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