Nuvalent, Inc.
NASDAQ•NUVL
CEO: Dr. James R. Porter Ph.D.
セクター: Healthcare
業種: Biotechnology
上場日: 2021-07-29
Nuvalent, Inc., a clinical stage biopharmaceutical company, engages in the development of therapies for patients with cancer. Its lead product candidates are NVL-520, a novel ROS1-selective inhibitor to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of ROS1 tyrosine kinase inhibitors (TKIs) for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC) which is under the phase 2 portion of the ARROS-1 Phase 1/2 clinical trial; NVL-655, a brain-penetrant ALK-selective inhibitor, to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that might limit the use of first-, second-, and third-generation ALK inhibitors that is under the phase 2 portion of the ALKOVE-1 Phase 1/2 clinical trial; and NVL-330, a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor designed to treat tumors driven by HER2ex20, brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type EGFR, which is expected to initiate phase 1 trial. The company was incorporated in 2017 and is headquartered in Cambridge, Massachusetts.
連絡先情報
時価総額
$7.48B
PER (TTM)
-18.1
17.5
配当利回り
--
52週高値
$113.02
52週安値
$55.54
52週レンジ
順位54Top 78.1%
2.7
F-Score
改良版 Piotroski 分析
6年ファンダメンタル
弱い • 2.7 / 9 ポイント
スコアレンジ (0-9)
8-9: 価値が優れている
6-7: 基礎体質が強い
4-5: 全体的に堅調
0-3: パフォーマンスが弱い
データ期間: 2020-2025
財務ダッシュボード
Q4 2025 データ
売上高
$0.00+0.00%
直近4四半期の推移
EPS
-$1.58+0.00%
直近4四半期の推移
フリーCF
-$73.33M+0.00%
直近4四半期の推移
2025 Annual 決算ハイライト
主なハイライト
Net Loss Increased Significantly Net loss reached $425.4M USD in 2025, up $164.8M from $260.8M loss in 2024 due to R&D expansion.
R&D Spending Ramped Up Research and development expenses totaled $307.0M USD in 2025, marking an $89.2M increase over 2024 spending levels.
Zidesamtinib NDA Accepted FDA accepted NDA for zidesamtinib (TKI pre-treated) with PDUFA target action date set for September 18, 2026.
Strong Cash Position Maintained Cash and cash equivalents stood at $261.7M USD as of December 31, 2025, funding operations into 2029.
リスク要因
Continued Substantial Net Losses Incurred accumulated deficit of $972.4M USD; expects significant net losses for foreseeable future operations.
Product Candidate Development Dependence Business materially harmed if zidesamtinib, neladalkib, or NVL-330 fail development, approval, or commercialization efforts.
Regulatory Approval Uncertainty Remains Cannot assure FDA approval for zidesamtinib NDA by September 2026 PDUFA date, or any future product approvals.
Reliance on Third-Party Manufacturing Heavy reliance on third parties for manufacturing and clinical trials introduces risks of delays, quality issues, and supply disruptions.
見通し
2026 First Approved Product Goal Anticipates 2026 commercial launch for zidesamtinib (TKI pre-treated) pending FDA review and approval outcome.
Neladalkib NDA Submission Planned Plan to submit NDA for neladalkib (TKI pre-treated) in the first half of 2026, following positive pivotal data.
Advance TKI-Naïve Label Expansion Plan to submit data for zidesamtinib TKI-naïve label expansion to FDA in the second half of 2026.
Continue Pipeline Discovery Efforts Prioritizing research programs, planning to disclose a new development candidate by year-end 2026 timeline.
同業比較
売上高 (TTM)
$4.27B
$1.09B
$638.50M
粗利益率 (最新四半期)
100.0%
97.9%
94.7%
主要指標
銘柄コード | 時価総額 | PER (TTM) | ROE (TTM) | 負債比率 |
|---|---|---|---|---|
| JAZZ | $11.45B | -31.8 | -8.8% | 46.4% |
| AXSM | $8.51B | -46.0 | -254.1% | 35.0% |
| PCVX | $8.38B | -10.3 | -25.9% | 7.5% |
長期トレンド
直近4四半期
売上高
純利益
営業キャッシュフロー
4四半期売上高CAGR
N/M
売上高の変動が大きい
4四半期純利益CAGR
N/M
収益構造の変化
キャッシュフロー安定性
0%
キャッシュフローに注意が必要
深度リサーチ
次回決算:2026年5月7日
EPS:-$1.33
|売上高:-
財務データ
決算説明会
財務レポート
ニュース
損益計算書
バランスシート
キャッシュフロー計算書
財務比率
変化率
損益計算書 | 直近12ヶ月 |
|---|
データなし