U.S. Food and Drug Administration Accepts for Priority Review Nuvation Bio’s New Drug Application for Taletrectinib for the Treatment of Advanced ROS1-positive Non-Small Cell Lung Cancer
Nuvation Bio Inc. Class A (NUVB)
Company Research
Source: Business Wire
New Drug Application (NDA) is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+ NSCLCU.S. Food and Drug Administration (FDA) has assigned a target action date of June 23, 2025 NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that the U.S. FDA has accepted the company’s NDA for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of advanced ROS1+ NSCLC (line agnostic). The U.S. FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. Pr
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News
- Nuvation Bio Inc. (NYSE: NUVB) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $5.00 price target on the stock.MarketBeat
- FDA accepts Nuvation Bio's application for taletrectinib [Seeking Alpha]Seeking Alpha
- U.S. Food and Drug Administration Accepts for Priority Review Nuvation Bio's New Drug Application for Taletrectinib for the Treatment of Advanced ROS1-positive Non-Small Cell Lung Cancer [Yahoo! Finance]Yahoo! Finance
- Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China's National Medical Products AdministrationPR Newswire
- Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China's National Medical Products AdministrationPR Newswire
NUVB
Earnings
- 11/6/24 - Miss
NUVB
Sec Filings
- 12/6/24 - Form SCHEDULE
- 11/13/24 - Form 4
- 11/12/24 - Form SC
- NUVB's page on the SEC website