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NEW YORK - Nuvation Bio Inc. (NYSE:NUVB), a biopharmaceutical company focused on oncology with a market capitalization of $777 million, has launched an Expanded Access Program (EAP) in the United States for its drug taletrectinib, aimed at treating patients with a specific type of lung cancer. According to InvestingPro data, the company’s stock has seen a 46% gain over the past year, despite recent market volatility. The program targets individuals with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have exhausted other treatment options.
The EAP, authorized by the U.S. Food and Drug Administration (FDA), is designed to provide access to taletrectinib for patients with serious or life-threatening ROS1+ NSCLC outside of ongoing clinical trials. The initiative reflects Nuvation Bio’s commitment to addressing the needs of patients with this rare form of lung cancer, which accounts for approximately 2% of NSCLC diagnoses annually. InvestingPro analysis shows the company maintains a strong financial position with a current ratio of 9.57, indicating robust liquidity to support its clinical programs.
David Hung, M.D., Founder, President, and CEO of Nuvation Bio, expressed the company’s dedication to collaborating with the ROS1-positive NSCLC community and healthcare providers to facilitate efficient access to taletrectinib.
Taletrectinib is an oral, potent, and selective next-generation ROS1 inhibitor currently undergoing evaluation in two Phase 2 pivotal studies, TRUST-I in China and the global TRUST-II. The FDA has accepted the New Drug Application (NDA) for taletrectinib, granting it Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. The application is supported by pooled results from the TRUST-I and TRUST-II studies presented at the European Society of Medical (TASE:PMCN) Oncology Congress in September 2024.
Janet Freeman-Daily, Co-Founder and President of The ROS1ders, a patient advocacy group, highlighted the importance of EAPs in offering investigational drugs to patients who have not benefited from approved therapies or are ineligible for clinical trials.
In January 2025, China’s National Medical Products Administration approved taletrectinib for adult patients with locally advanced or metastatic ROS1+ NSCLC. The drug has also received Breakthrough Therapy and Orphan Drug designations from the U.S. FDA for the treatment of ROS1+ NSCLC.
This news is based on a press release statement from Nuvation Bio Inc. While the company currently shows negative earnings with an EPS of -$2.23, analysts following the stock maintain optimistic price targets, with estimates ranging from $5 to $11 per share. For deeper insights into Nuvation Bio’s financial health and growth prospects, including 8 additional ProTips and comprehensive valuation metrics, visit InvestingPro for exclusive access to the detailed Pro Research Report.
In other recent news, Nuvation Bio has been making significant strides with their drug, taletrectinib, which is under review by the U.S. Food and Drug Administration (FDA) for the treatment of advanced ROS1-positive non-small cell lung cancer (NSCLC). The FDA has scheduled a decision for June 23, 2025, under the Prescription Drug User Fee Act (PDUFA). This follows impressive results from pivotal Phase 2 TRUST-I and TRUST-II studies, which reported promising response rates in patients.
Analysts from H.C. Wainwright and Clear Street have both reaffirmed a Buy rating on Nuvation Bio, with price targets of $7.00 and $5.00 respectively, reflecting their confidence in the company’s prospects. The company also reported better than projected net loss of $0.07 per share for the first quarter of 2024, and maintains a robust cash position of $597 million.
In other developments, Nuvation Bio has announced the appointment of Philippe Sauvage as its new Chief Financial Officer, bringing over two decades of experience in the healthcare sector to the role. These recent developments highlight Nuvation Bio’s ongoing progress and the potential of its drug, taletrectinib.
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