Nuvation Bio Inc Stock Price, News & Analysis

Nuvation Bio (NYSE:NUVB) announced that its drug taletrectinib (IBTROZI™) has been added as a Preferred Agent in the National Comprehensive Cancer Network® Clinical Practice Guidelines for Non-Small Cell Lung Cancers. The drug, which received FDA approval on June 11, is specifically recommended for ROS1-positive NSCLC patients across all treatment lines.

IBTROZI is designed as a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor targeting a rare form of lung cancer that affects approximately 2% of NSCLC cases, representing about 3,000 new diagnoses annually in the U.S. The guidelines particularly recognize the drug's benefits for patients with brain metastases and those with acquired resistance after first-line therapy.

The FDA has approved Nuvation Bio's IBTROZI (taletrectinib) for treating adult patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). IBTROZI, a next-generation oral ROS1 tyrosine kinase inhibitor, demonstrated impressive efficacy in the TRUST clinical trials with confirmed overall response rates of 90% and 85% in TKI-naïve patients in TRUST-I and TRUST-II respectively. The drug showed strong brain-penetrant efficacy with intracranial response rates of 73% in TKI-naive patients and 63% in TKI-pretreated patients. The safety profile was favorable, with most adverse events being low grade and manageable. ROS1+ NSCLC affects approximately 3,000 new patients annually in the U.S., primarily younger individuals around age 50. The approval follows Priority Review and is supported by one of the largest clinical trial programs in ROS1+ NSCLC, involving over 300 patients.

Nuvation Bio (NYSE: NUVB) will present new data from its pivotal Phase 2 clinical studies TRUST-I and TRUST-II at the ASCO 2025 Annual Meeting (May 30-June 3, 2025). The presentation will showcase the efficacy and safety results of taletrectinib, their next-generation oral tyrosine kinase inhibitor for treating advanced ROS1-positive non-small cell lung cancer (NSCLC). The drug is currently under Priority Review by the FDA with a PDUFA date of June 23, 2025. Dr. Maurice Perol from Léon Bérard Cancer Center will present findings demonstrating comparable results across different ethnicities and world regions. The presentation is scheduled for May 31, 2025, at 1:30-4:30 p.m. CT.

Nuvation Bio (NYSE: NUVB) has announced that it will present new comparative data for its drug taletrectinib versus entrectinib in treating ROS1-positive non-small cell lung cancer (NSCLC) at the upcoming ISPOR 2025 conference. The presentation will feature a matching-adjusted indirect comparison (MAIC) study between the two treatments.

The poster presentation will be delivered by Dr. Misako Nagasaka from UCI School of Medicine on May 14, 2025, during the 10:30 a.m. - 1:30 p.m. ET session at ISPOR 2025 in Montreal. The presentation materials will be made available on Nuvation Bio's website following the event.

Nuvation Bio (NYSE: NUVB), a global oncology company, announced its leadership team's participation in three upcoming investor conferences in May 2025. David Hung, M.D., Founder, President, and CEO, along with Philippe Sauvage, CFO, will engage in fireside chats at:

• H.C. Wainwright BioConnect Conference (May 20, 3:00 PM ET)
• RBC Capital Markets Healthcare Conference (May 21, 1:35 PM ET)
• TD Cowen Oncology Innovation Summit (May 28, 3:30 PM ET, virtual)

Live webcasts will be available on Nuvation Bio's investor website, with recordings accessible for 90 days after each event.

Nuvation Bio (NYSE: NUVB) reported its Q1 2025 financial results and provided key business updates. The company's lead drug taletrectinib for ROS1-positive non-small cell lung cancer is under FDA Priority Review with a PDUFA date of June 23, 2025. The drug received approval in China in January 2025 and is pending review in Japan.

Financial highlights include $461.7 million in cash and equivalents, and the company secured up to $250 million in non-dilutive financing from Sagard Healthcare Partners. Q1 2025 showed a net loss of $53.2 million ($0.16 per share), compared to $14.8 million in Q1 2024. R&D expenses increased to $24.6 million, while SG&A expenses rose to $35.4 million.

Nuvation Bio (NYSE: NUVB), a global oncology company, announced that its Chief Financial Officer, Philippe Sauvage, will participate in a fireside chat at The Citizens Life Sciences Conference. The presentation is scheduled for Thursday, May 8, 2025, at 10:00 a.m. ET in New York. Investors can access a live webcast of the presentation through Nuvation Bio's investor relations website, with the recording remaining available for 90 days after the event.

Nuvation Bio (NYSE: NUVB), a global oncology company, has scheduled its first quarter 2025 earnings release and business update for May 7, 2025. The company will host a conference call at 4:30 p.m. ET, where executives will discuss their programs, financial results, and outline the commercial strategy for taletrectinib.

Notably, the FDA has assigned a PDUFA date of June 23, 2025 for taletrectinib's New Drug Application. The presentation will be accessible via webcast at the company's investor relations website, with related materials available before the call and a replay option afterward.

Nuvation Bio (NYSE: NUVB), a global biopharmaceutical company focused on oncology, has announced its upcoming participation in the Jones Healthcare and Technology Innovation Conference.

The company's leadership, including Founder, President, and CEO David Hung, M.D., and CFO Philippe Sauvage, will engage in a fireside chat scheduled for April 9, 2025, at 10:00 a.m. PT/1:00 p.m. ET in Las Vegas.

An audio recording of the presentation will be accessible on the company's investor relations website at investors.nuvationbio.com/investors/ and will remain available for 90 days after the event.