Nuvalent, Inc.

Equities

NUVL

US6707031075

Biotechnology & Medical Research

Market Closed - Nasdaq Other stock markets 04:00:00 2024-05-31 pm EDT			5-day change	1st Jan Change
65.62 ^USD	-1.29%		-3.43%	-10.83%

May. 17	Nuvalent Insider Sold Shares Worth $345,450, According to a Recent SEC Filing	MT
May. 16	Nuvalent Gets FDA Breakthrough Therapy Designation for Lung-Cancer Treatment	DJ

Nuvalent Gets FDA Breakthrough Therapy Designation for Lung-Cancer Treatment

May 16, 2024 at 04:32 pm EDT

By Paul Ziobro

Nuvalent said federal regulators have granted breakthrough therapy designation for NVL-655 to treat patients with a certain type of lung cancer.

The clinical-stage biopharmaceutical company on Thursday said that the Food and Drug Administration granted the status for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer who have been previously treated with two or more ALK tyrosine kinase inhibitors, or TKIs.

The company said there remains no clear standard of care for patients who have been previously been treated with two or more ALK TKIs.

The breakthrough therapy designation is designed by the FDA to expedite the development and evaluation of treatments for serious or life-threatening conditions if they have preliminary clinical evidence showing substantial improvement at certain endpoints over currently available therapies.

Write to Paul Ziobro at paul.ziobro@wsj.com

(END) Dow Jones Newswires

05-16-24 1631ET

Latest news about Nuvalent, Inc.

Nuvalent Insider Sold Shares Worth $345,450, According to a Recent SEC Filing	May. 17	MT
Nuvalent Gets FDA Breakthrough Therapy Designation for Lung-Cancer Treatment	May. 16	DJ
Nuvalent Gets Breakthrough Therapy Designation for Lung Cancer Treatment Candidate	May. 16	MT
Nuvalent, Inc. Receives U.S. FDA Breakthrough Therapy Designation for NVL-655	May. 16	CI
Nuvalent Q1 Net Loss Widens	May. 09	MT
Nuvalent, Inc. Reports Earnings Results for the First Quarter Ended March 31, 2024	May. 09	CI
Nuvalent Insider Sold Shares Worth $2,605,525, According to a Recent SEC Filing	May. 08	MT
Nuvalent Insider Sold Shares Worth $2,666,555, According to a Recent SEC Filing	May. 01	MT
Nuvalent Insider Sold Shares Worth $2,458,335, According to a Recent SEC Filing	Apr. 17	MT
Jefferies Initiates Nuvalent With Buy Rating, $97 Price Target	Apr. 17	MT
Nuvalent Insider Sold Shares Worth $2,566,479, According to a Recent SEC Filing	Apr. 10	MT
North American Morning Briefing : Stocks Seen -2-	Apr. 02	DJ
Nuvalent Insider Sold Shares Worth $1,654,311, According to a Recent SEC Filing	Apr. 01	MT
Leerink Partners Upgrades Nuvalent to Outperform From Market Perform, Raises Price Target to $110 From $69	Apr. 01	MT
Nuvalent Insider Sold Shares Worth $3,032,528, According to a Recent SEC Filing	Mar. 27	MT
Nuvalent Insider Sold Shares Worth $1,550,229, According to a Recent SEC Filing	Mar. 25	MT
BMO Capital Raises Price Target on Nuvalent to $102 From $93, Maintains Outperform Rating	Feb. 28	MT
Nuvalent's Non-Small Cell Lung Cancer Drug Candidate Gets FDA Breakthrough Therapy Designation	Feb. 27	MT
Nuvalent, Inc. Reports Earnings Results for the Fourth Quarter Ended December 31, 2023	Feb. 27	CI
Nuvalent, Inc. Reports Earnings Results for the Full Year Ended December 31, 2023	Feb. 27	CI
Baird Initiates Nuvalent With Outperform Rating, Price Target is $105	Feb. 23	MT
Nuvalent Starts Phase 2 Part of Clinical Trial of Potential Lung Cancer Treatment	Feb. 12	MT
Wedbush Raises Nuvalent's Price Target to $99 From $82, Maintains Outperform Rating	Feb. 12	MT
Nuvalent, Inc. Initiates the Phase 2 Portion of Alkove-1 Clinical Trial for Patients with Alk-Positive Nsclc and Other Solid Tumors	Feb. 12	CI
Nuvalent Outlines Three-Year Product Plan	Jan. 08	MT

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Company Profile

Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. It develops small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases and drive more durable responses. It is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-positive non-small cell lung cancer, and multiple discovery-stage research programs. Its product candidate, NVL-520, is being developed for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC). NVL-520 is a novel ROS1-selective inhibitor. Its product candidate, NVL-655, is being developed for patients with anaplastic lymphoma kinase (ALK)-positive NSCLC. LC. NVL-655 is a brain-penetrant ALK-selective inhibitor. Its product candidate, NVL-330, is a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor.

Sector

Biotechnology & Medical Research

Calendar

2024-06-05 - Jefferies Global Healthcare Conference - Fireside Chat

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BUY

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Last Close Price

65.62 USD

Average target price

99.67 USD

Spread / Average Target

+51.88%

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