Nuvation Bio Secures $250M Financing Package to Launch Novel Lung Cancer Drug Taletrectinib
• Nuvation Bio has secured a $250 million non-dilutive financing deal with Sagard Healthcare Partners, including $150 million in royalty financing and up to $100 million in term loans.
• The financing package is contingent on FDA approval of taletrectinib, a targeted therapy for ROS1-positive non-small cell lung cancer, expected in mid-2025.
• The funding will fully support taletrectinib's U.S. commercial launch and ongoing clinical pipeline development without requiring additional capital raises.
Nuvation Bio's Taletrectinib Gains FDA Priority Review and Expanded Access Program for ROS1+ NSCLC
• The FDA granted priority review to Nuvation Bio's NDA for taletrectinib, a next-generation ROS1 inhibitor, for advanced ROS1+ non-small cell lung cancer, setting a PDUFA date of June 23, 2025.
• Taletrectinib demonstrated promising efficacy and tolerability in the TRUST-I and TRUST-II trials, showing durable responses and prolonged progression-free survival in ROS1+ NSCLC patients.
• Nuvation Bio has initiated an Expanded Access Program (EAP) in the U.S. for taletrectinib, offering access to eligible patients with advanced ROS1+ NSCLC outside of clinical trials.
• The NDA is based on pooled data from the TRUST-I and TRUST-II studies, which included over 300 patients, representing the largest ROS1-positive NSCLC dataset supporting an NDA.
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