お知らせ • Aug 04

Nuvation Bio Presents New Subgroup Analyses Of Pivotal Data For IBTROZI (Taletrectinib) In Advanced ROS1-Positive Non-Small Cell Lung Cancer

Nuvation Bio Inc. announced that new analyses of long-term Phase 2 TRUST-I and TRUST-II data will be presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) taking place September 12–15, 2026, in Seoul, South Korea, and at the European Society of Medical Oncology Congress (ESMO) October 23–27, 2026, in Madrid, Spain. These findings from the pivotal Phase 2 studies will feature the efficacy and safety of IBTROZI (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) across key patient subgroups. Presentations Overview: WCLC Title: Taletrectinib Across Key Subgroups in Patients With ROS1+ Non-Small Cell Lung Cancer: Results From TRUST-I and TRUST-II Presenter: Hidetoshi Hayashi, Kindai University Faculty of Medicine, Osaka, Japan Date: Tuesday, September 15, 2026 Session Time: 9:30-11:00 a.m. KST ESMO Title: Updated Efficacy and Safety of Taletrectinib in Patients with Advanced ROS1+ Non-Small Cell Lung Cancer (NSCLC) After Prior Entrectinib Exposure: Results from the Global TRUST-II Study Presenter: Maurice Pérol, Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France Date: Monday, October 26, 2026 Session Time: 12:00-12:45 p.m. CEST The materials will be made available in the Publications section of Nuvation Bio's website after the presentations. IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib) WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months). Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients. Concurrent elevations in AST or ALT =3 times the ULN and total bilirubin =2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months). ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients. QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner. In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade =3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients. Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc. Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade =3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients. Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months). Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation. Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients. Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

Pharmaceuticals 業界の成長	7.33%
収益成長率	95.76%
株主資本利益率	-59.02%
ネット・マージン	-88.19%
前回の決算情報	30 Jun 2026

日付	収益	収益	G+A経費	研究開発費
30 Jun 26	170	-150	159	129
31 Mar 26	143	-146	154	126
31 Dec 25	63	-205	152	115
30 Sep 25	27	-217	137	110
30 Jun 25	14	-203	120	109
31 Mar 25	11	-606	97	111
31 Dec 24	8	-568	69	99
30 Sep 24	2	-532	49	85
30 Jun 24	1	-511	37	76
31 Mar 24	0	-69	28	65
31 Dec 23	0	-76	29	71
30 Sep 23	0	-83	31	73
30 Jun 23	0	-90	31	76
31 Mar 23	0	-105	32	86
31 Dec 22	0	-104	32	88
30 Sep 22	0	-108	32	89
30 Jun 22	0	-103	30	85
31 Mar 22	0	-88	27	70
31 Dec 21	0	-87	24	65
30 Sep 21	0	-75	21	56
30 Jun 21	0	-64	18	48
31 Mar 21	0	-53	14	41
31 Dec 20	0	-42	11	33
30 Sep 20	0	-38	8	32
30 Jun 20	0	-32	7	27
31 Mar 20	0	-33	7	26
31 Dec 19	0	-34	7	25

データ	最終更新日（UTC時間）
企業分析	2026/09/09 09:33
終値	2026/09/09 00:00
収益	2026/06/30
年間収益	2025/12/31

パッケージ	データ	タイムフレーム	米国ソース例
会社財務	10年	損益計算書キャッシュ・フロー計算書貸借対照表	SECフォーム10-K SECフォーム10-Q
アナリストのコンセンサス予想	+プラス3年	予想財務アナリストの目標株価	アナリストリサーチレポート Blue Matrix
市場価格	30年	株価配当、分割、措置	ICEマーケットデータ SECフォームS-1
所有権	10年	トップ株主インサイダー取引	SECフォーム4 SECフォーム13D
マネジメント	10年	リーダーシップ・チーム取締役会	SECフォーム10-K SECフォームDEF 14A
主な進展	10年	会社からのお知らせ	SECフォーム8-K

アナリスト	機関
Clarence Powell	BMO Capital Markets Equity Research
Mayank Mamtani	B. Riley Securities, Inc.
Li Wang Watsek	Cantor Fitzgerald & Co.

Nuvation Bio 過去の業績

過去基準チェック /06

主要情報

最近の業績更新

Nuvation Bio Inc. to Report Q2, 2026 Results on Aug 06, 2026

Recent updates

Nuvation Bio Receives FDA Fast Track Designation For Safusidenib For Treatment Of IDH1-Mutant Glioma

Forecast to breakeven in 2028

New minor risk - Profitability

Forecast to breakeven in 2028

Nuvation Bio Presents New Subgroup Analyses Of Pivotal Data For IBTROZI (Taletrectinib) In Advanced ROS1-Positive Non-Small Cell Lung Cancer

Nuvation Bio Inc. to Report Q2, 2026 Results on Aug 06, 2026

収支内訳

収益と収入の歴史

フリー・キャッシュフローと収益の比較

過去の収益成長分析

株主資本利益率

総資産利益率

使用総資本利益率

過去の好業績企業の発掘

企業分析と財務データの現状

データソース

分析モデルとスノーフレーク

業界およびセクターの指標

アナリスト筋

Nuvation Bio 過去の業績

過去 基準チェック /06

主要情報

最近の業績更新

Nuvation Bio Inc. to Report Q2, 2026 Results on Aug 06, 2026

Recent updates

Nuvation Bio Receives FDA Fast Track Designation For Safusidenib For Treatment Of IDH1-Mutant Glioma

Forecast to breakeven in 2028

New minor risk - Profitability

Forecast to breakeven in 2028

Nuvation Bio Presents New Subgroup Analyses Of Pivotal Data For IBTROZI (Taletrectinib) In Advanced ROS1-Positive Non-Small Cell Lung Cancer

Nuvation Bio Inc. to Report Q2, 2026 Results on Aug 06, 2026

収支内訳

収益と収入の歴史

フリー・キャッシュフローと収益の比較

過去の収益成長分析

株主資本利益率

総資産利益率

使用総資本利益率

過去の好業績企業の発掘

企業分析と財務データの現状

データソース

分析モデルとスノーフレーク

業界およびセクターの指標

アナリスト筋

過去基準チェック /06