Nuvation Bio Inc (NYSE: NUVB), a biopharma company with offices in the United States and China, has secured a major financing deal to propel commercialization of its flagship drug “taletrectinib.” It is used to treat ROS1-positive non-small cell lung cancer (NSCLC) — a rare variation of the disease.
This funding arrangement with the investment firm Sagard Healthcare Partners will be comprised of a mix of debt and royalty financing. But, Nuvation may receive US$150 million upfront in cash if the FDA gives its approval to the oral medication by Q3 this year following review of the company’s new drug application.
Chinese regulators have already fully approved this therapeutic. It has demonstrated admirable efficacy in clinical studies.
“We believe taletrectinib has the potential to redefine the treatment landscape for patients with ROS1-positive NSCLC,” Sagard Healthcare Partners representative, Raja Manchanda, stated in a news release.
Nuvation Bio currently has a market capitalization of US$663 million. Certain financial analysts, such as H.C. Wainwright and Clear Street, have set high share targets ranging between US$5.00 and US$7.00 for the drug developer. The company completed its IPO on the New York Stock Exchange in 2021.
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Taletrectinib was acquired from AnHeart Therapeutics
This company, now a subsidiary of Nuvation, paved the way with the drug’s development after obtaining rights to it from Daiichi Sankyo Co Ltd – ADR (OTCMKTS: DSNKY) (FRA: D4S) in 2018.
Crizotinib from Pfizer Inc (NYSE: PFE) (ETR: PFE); entrectinib from Roche Holdings AG Basel ADR Common Stock (OTCMKTS: RHHBY); and repotrectinib from Bristol-Myers Squibb Co (NYSE: BMY) (FRA: BRM) are currently the only three other drugs approved in the United States to treat this rare type of lung cancer. Nuvation claims that taletrectinib is superior.
“Taletrectinib has the highest overall response rate and median progression-free survival of any ROS1 inhibitor in the first line [TKI-naïve] setting,” Nuvation says. “TKI naïve” refers to those who have never received a tyrosine kinase inhibitor drug like this.
In the U.S., about 3,000 people will be diagnosed per annum, while in China, more than 16,000 will contract the condition.
In September, Nuvation presented data on taletrectinib to the European Society for Medical Oncology.
rowan@mugglehead.com
