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NEW YORK - The U.S. Food and Drug Administration has approved Nuvation Bio Inc.’s (NYSE: NUVB) IBTROZI (taletrectinib) for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), the company announced Wednesday. The news comes as Nuvation Bio, currently valued at $806 million, trades at $2.37 per share. According to InvestingPro analysis, analysts have set price targets ranging from $5 to $10, suggesting significant upside potential.
IBTROZI is an oral tyrosine kinase inhibitor designed to target ROS1+ NSCLC, a rare form of lung cancer affecting approximately 2% of NSCLC cases, or about 3,000 new diagnoses annually in the U.S. InvestingPro data shows the company maintains a strong financial position with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn as it commercializes this breakthrough treatment.
The approval is supported by data from the TRUST clinical program, which enrolled over 300 patients. In the TRUST-I study, IBTROZI achieved a confirmed overall response rate of 90% in treatment-naïve patients, while TRUST-II showed an 85% response rate in similar patients. The drug also demonstrated effectiveness against brain metastases, with intracranial responses in 73% of treatment-naïve patients and 63% of previously treated patients.
"IBTROZI delivered high response rates with sustained durability—truly meaningful benefits for patients," said David Hung, Founder, President and CEO of Nuvation Bio, according to the press release.
The most common adverse reactions included diarrhea (64%), nausea (47%), and vomiting (43%). Only 7% of patients discontinued treatment due to adverse events.
ROS1+ NSCLC typically affects younger patients with a median age of 50, and is more common in non-smokers. Brain metastases are frequent in this population and represent a leading cause of mortality.
Nuvation Bio has launched NuvationConnect, a program offering financial assistance and support for eligible patients prescribed IBTROZI.
The company will host a conference call on June 12 to discuss the approval and commercialization plans. With a current ratio of 9.01 and an Altman Z-Score of 3.97, InvestingPro analysis indicates strong short-term financial stability. Investors seeking deeper insights into Nuvation Bio’s financial health and growth prospects can access comprehensive Pro Research Reports, available exclusively to InvestingPro subscribers.
In other recent news, Nuvation Bio Inc. reported its Q1 2025 earnings, revealing an earnings per share (EPS) of -0.16, slightly missing the forecasted -0.15. The company’s revenue was reported at $3.08 billion, significantly below the expected $800 million, highlighting a substantial shortfall. Meanwhile, JMP Securities has maintained its Market Outperform rating on Nuvation Bio with a price target of $6.00, following a promising subgroup analysis from the company’s TRUST I/II studies. This analysis demonstrated consistent efficacy in treating both Asian and non-Asian patients, which is considered significant ahead of the critical Prescription Drug User Fee Act (PDUFA) date set for June 23, 2025. Additionally, Nuvation Bio’s stockholders recently approved the election of board members and executive compensation, alongside the ratification of KPMG LLP as the independent registered public accounting firm for 2025. The company also secured a $250 million non-dilutive financing deal, which bolsters its cash position as it prepares for the potential FDA approval of its lead asset, talotrectinib. Finally, Nuvation Bio is set to participate in the 2025 American Society of Clinical Oncology (ASCO) annual meeting, where its presentations are anticipated to influence investor perceptions in the biopharmaceutical industry.
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