企業プロフィール
Nuvalent 株価・ニュース・カタリスト
- ティッカー:
- NUVL
- 取引所:
- NASDAQ
- セクター:
- Biopharma
- 所在地:
- United States
株価変動の要因
NUVL の終値変動に関する情報は現在取得できません。
企業概要
Precision Oncology Company
Nuvalent develops highly selective small-molecule kinase inhibitors for cancers with established oncogenic drivers. Its design strategy aims to overcome resistance mutations, penetrate the central nervous system, avoid off-target toxicities, and produce durable responses in patients with advanced solid tumors.
ROS1 Program
Zidesamtinib is a ROS1-selective inhibitor developed for ROS1-positive non-small cell lung cancer, including tumors with resistance mutations and brain metastases. The program includes an initial application for previously treated patients and a label-expansion strategy for patients who have not received a prior ROS1 inhibitor.
ALK Program
Neladalkib is an ALK-selective, TRK-sparing inhibitor designed for advanced ALK-positive non-small cell lung cancer. Development spans previously treated patients and the Phase 3 ALKAZAR study comparing neladalkib with alectinib in the first-line setting.
HER2 and Discovery Pipeline
NVL-330 targets HER2 alterations and is being evaluated in the HEROEX-1 Phase 1 study. Earlier discovery programs apply Nuvalent's structure-based chemistry approach to additional validated kinase targets where existing therapies are limited by resistance, brain penetration, or tolerability.
Acquisition by GSK
GSK subsequently agreed to acquire Nuvalent, adding the company's precision-oncology portfolio and kinase-design capabilities to a larger global oncology organization. The transaction links Nuvalent's late-stage assets with GSK's regulatory, manufacturing, and commercial infrastructure.
今後のカタリスト
- FDA PDUFA decision for zidesamtinib in previously treated ROS1-positive non-small cell lung cancer on September 18, 2026.
- Submission of data supporting a zidesamtinib label expansion in TKI-naive ROS1-positive non-small cell lung cancer in the second half of 2026.
- FDA review of the submitted NDA for neladalkib in previously treated ALK-positive non-small cell lung cancer.
- Disclosure of a new development candidate by year-end 2026.
最近のニュース
ニュースタイトルは機械翻訳です。詳細は英語の原文をご覧ください。
類似銘柄
事業成熟度、治療領域、カタリスト傾向が近い同業銘柄です。