Nuvation Bio Inc. - NUVB STOCK NEWS

Nuvation Bio (NYSE: NUVB) reported Q3 2024 financial results and business updates. Key highlights include the submission of a New Drug Application for taletrectinib to the FDA for ROS1-positive NSCLC treatment, with potential commercialization by mid-2025. The company presented positive pooled data showing 89% response rate in TKI-naïve patients. Financial results show cash position of $549.1 million, with increased R&D expenses of $27.7 million and G&A expenses of $19.6 million. The quarter ended with a net loss of $41.2 million, or ($0.15) per share, compared to $19.6 million loss in Q3 2023.

Nuvation Bio Inc. (NYSE: NUVB) has appointed Philippe Sauvage as Chief Financial Officer. With over 20 years of global leadership experience in finance, operations, and commercialization within healthcare and biopharmaceutical organizations, Sauvage joins Nuvation Bio as the company prepares to transition into a commercial-stage organization.

Sauvage's most recent role was Global Head of Operations and Access at Sanofi, where he oversaw strategic segments including commercial systems, multichannel strategy, and market access. He previously served as CFO for Sanofi-Genzyme and Sanofi North America, managing a $14 billion region. His experience also includes roles as CFO in Sanofi's JPAC region and Japan, as well as leadership positions in the French public health sector and Ministry of Health.

David Hung, M.D., Founder, President, and CEO of Nuvation Bio, expressed excitement about Sauvage joining the company, highlighting his broad skillset and strategic vision as invaluable for Nuvation Bio's transition to a commercial-stage organization in 2025.

Nuvation Bio (NYSE: NUVB) announced positive pooled data from TRUST-I and TRUST-II studies evaluating taletrectinib, a next-generation ROS1 TKI for advanced ROS1-positive NSCLC. Key findings include:

- 89% tumor shrinkage in TKI-naïve patients
- 56% tumor shrinkage in TKI-pretreated patients
- Median DOR of 44 months and PFS of 46 months in TKI-naïve patients
- Favorable safety profile with low neurologic TEAEs

Nuvation Bio plans to submit an NDA to the FDA in Q4 2024, aiming for a U.S. launch in 2025. The data support taletrectinib's potential as a best-in-class treatment for ROS1-positive NSCLC.

Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage biopharmaceutical company focusing on oncology, has announced its participation in the Cantor Global Healthcare Conference. The event is scheduled for Thursday, September 19, 2024, at 9:45 a.m. E.T. in New York, NY.

Dr. David Hung, the Founder, President, and Chief Executive Officer of Nuvation Bio, will be presenting at the conference. Interested parties can access a live webcast of the presentation through the company's investor relations website. For those unable to attend live, an archived recording will be available for 90 days following the event.

Nuvation Bio (NYSE: NUVB) reported Q2 2024 financial results and provided a business update. Key highlights include:

• Efficacy and safety data from the Phase 2 TRUST-I study of taletrectinib published in the Journal of Clinical Oncology and presented at ASCO 2024
• Pooled data from TRUST-I and TRUST-II studies to be presented at ESMO 2024, supporting planned NDA filing
• Taletrectinib granted Orphan Drug Designation by FDA for ROS1-positive NSCLC
• Strong balance sheet with $577.2 million in cash and equivalents as of June 30, 2024
• Q2 2024 net loss of $462.5 million, or $(1.89) per share, compared to $20.6 million in Q2 2023
• R&D expenses increased to $29.2 million, up from $18.6 million in Q2 2023

Nuvation Bio (NYSE: NUVB) announced updates for its taletrectinib program, a ROS1 inhibitor for non-small cell lung cancer (NSCLC). Key highlights include:

• Presentation of pooled data from pivotal Phase 2 TRUST-I and TRUST-II studies at ESMO Congress 2024, supporting the New Drug Application (NDA) in the US
• Presentation of global Phase 2 TRUST-II study data at WCLC 2024
• FDA granted Orphan Drug Designation for taletrectinib in ROS1-positive NSCLC and other NSCLC indications

The company aims to commercialize taletrectinib in 2025. The Orphan Drug Designation provides development incentives, including tax credits and potential market exclusivity. Taletrectinib is being evaluated in two pivotal Phase 2 studies for ROS1-positive NSCLC patients.

Innovent Biologics announced updated data from its pivotal Phase 2 TRUST-I study of taletrectinib, a next-generation ROS1 inhibitor, published in the Journal of Clinical Oncology and presented at the 2024 ASCO Annual Meeting. The study involved 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) in China. Results showed a 91% confirmed objective response rate (cORR) in ROS1 TKI-naïve patients and a 52% cORR in those previously treated with crizotinib. Taletrectinib demonstrated favorable outcomes in patients with brain metastases and resistance mutations. The median duration of response and progression-free survival were not reached in TKI-naïve patients after a median follow-up of 23.5 months, while TKI-pretreated patients had a median duration of response of 10.6 months and median progression-free survival of 7.6 months. The safety profile was consistent with previous reports. Two new drug applications have been accepted for priority review by China's NMPA.

Innovent Biologics announced publication of Phase 2 TRUST-I study results in the Journal of Clinical Oncology and at the 2024 ASCO Annual Meeting. The study evaluated taletrectinib in 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). Tumor shrinkage was observed in 91% of ROS1 TKI-naïve and 52% of TKI-pretreated patients. Taletrectinib showed efficacy in treating brain metastases and resistance mutations. Median follow-up was 23.5 months for TKI-naïve and 9.7 months for TKI-pretreated patients. Median duration of response was not reached for TKI-naïve and was 10.6 months for TKI-pretreated. Two new drug applications have been accepted by China's NMPA with priority review. The safety profile showed low incidence of neurologic adverse events.

Nuvation Bio has published data from its Phase 2 TRUST-I study of taletrectinib, a ROS1 inhibitor, in the Journal of Clinical Oncology and presented at the 2024 ASCO Annual Meeting.

This study involved 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) in China. Results showed that tumors shrank in 91% of ROS1 TKI-naïve and 52% of ROS1 TKI-pretreated patients.

Long-term follow-up indicated 71% of TKI-naïve patients remained progression-free at two years. The study highlighted taletrectinib's effectiveness in patients with brain metastases and resistance mutations.

Safety profile was consistent with previous reports, showing low incidence of neurologic treatment-emergent adverse events.