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The U.S. Food and Drug Administration granted full approval to Nuvation Bio Inc’s (NYSE:NUVB) lung cancer drug IBTROZI this week. The announcement comes as the company’s stock trades at $1.81, having declined over 27% in the past week. According to InvestingPro data, the stock currently appears undervalued based on its Fair Value analysis. The medication treats advanced ROS1-positive non-small cell lung cancer on a line-agnostic basis, following results from the Phase 2 TRUST-I and TRUST-II studies.
In ROS1 TKI-naive patients, IBTROZI achieved confirmed objective response rates of 90% and 85% in the TRUST-I and TRUST-II trials, respectively. The drug also demonstrated 52% and 62% response rates in TKI-pretreated populations across the two studies. Notably, the median duration of response and median progression-free survival have not yet been reached in either trial.
IBTROZI’s safety profile showed 29% of treated subjects required dose reduction and 7% discontinued treatment due to adverse events. By comparison, Bristol-Myers Squibb (NYSE:BMY)’s competing drug Augtyro saw 38% of patients requiring dose reduction and 7% discontinuing treatment in its TRIDENT-1 trial.
Following the approval, IBTROZI is now available for order in the United States through specialty distribution channels. Nuvation Bio has set the gross price at $29,488 per month, which the company positions as competitive in the market. The company maintains a strong liquidity position with a current ratio of 9.01 and more cash than debt on its balance sheet, though InvestingPro analysis indicates rapid cash burn rates that investors should monitor.
H.C. Wainwright maintained its Buy rating on Nuvation Bio with a 12-month price target of $10 per share. The investment firm noted that IBTROZI’s response rates compare favorably to competitor agents in the same treatment space. This aligns with the broader analyst consensus, which remains strongly bullish with targets ranging from $5 to $10 per share. Discover more insights about NUVB and access detailed analysis in the Pro Research Report, available exclusively on InvestingPro.
In other recent news, Nuvation Bio Inc. has received FDA approval for its lung cancer drug, IBTROZI (taletrectinib), marking a significant milestone as the company transitions to a commercial-stage entity. The drug is approved for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The approval is based on data from the TRUST clinical program, which demonstrated high response rates in patients, including those with brain metastases. Despite the FDA approval, analysts from JMP Securities noted a decline in the stock, attributing it to concerns over the drug’s side effect profile. JMP Securities maintained its Market Outperform rating and a $6 price target, viewing the stock dip as a potential buying opportunity. Citizens JMP also reiterated a Market Outperform rating, with a $6 price target, following Nuvation Bio’s presentation on the launch plans for IBTROZI. The drug is priced at $29,844 per month, and the company has launched a support program, NuvationConnect, to assist eligible patients. Investors are closely monitoring these developments as Nuvation Bio prepares for its upcoming conference call to discuss the drug’s commercialization plans.
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