Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520 [Yahoo! Finance]
Nuvalent, Inc. - Class A (NUVL)
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Source: Yahoo! Finance
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). ROS1 rearrangements occur in up to approximately 3% of metastatic NSCLCs. At the time of diagnosis, up to 40% of these patients present with accompanying brain metastases, and approximately 40% of patients develop resistance mutations following current front-line treatment. There remains no clear standard of care for patients who have been previously treated with two or more ROS1 TKIs. NVL-520 is a novel brain-penetrant ROS1-selective tyrosine kinase inhibitor (TKI) created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, brain metastases, and off-target centra
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News
- Jefferies starts Nuvalent at buy, cites lung cancer drug candidates [Seeking Alpha]Seeking Alpha
- Nuvalent, Inc. (NASDAQ: NUVL) is now covered by analysts at Jefferies Financial Group Inc.. They set a "buy" rating and a $97.00 price target on the stock.MarketBeat
- Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024PR Newswire
- Nuvalent, Inc. (NASDAQ: NUVL) was upgraded by analysts at Leerink Partnrs from a "market perform" rating to an "outperform" rating.MarketBeat
- Nuvalent, Inc. (NASDAQ: NUVL) was upgraded by analysts at SVB Leerink LLC from a "market perform" rating to an "outperform" rating. They now have a $110.00 price target on the stock, up previously from $69.00.MarketBeat
NUVL
Earnings
- 11/14/23 - In-Line
NUVL
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- NUVL's page on the SEC website