Pliant Therapeutics

The FDA has granted fast-track status to Pliant Therapeutics' oral dual-selective integrin inhibitor PLN-101095. PLN-101095 is being tested in combination with pembrolizumab in patients with solid tumors and is in the Phase 1a/1b FORTIFY study. The news triggered a pre-market share rise of about 6%, while the company has roughly $159.6 million in cash, expected to fund operations through the second half of 2028. Fast-track status speeds interaction with the FDA and reduces regulatory risk but does not guarantee approval; clinical results are expected in 2027. » More on de.investing.com

The FDA has granted Fast Track designation to Pliant Therapeutics' oral integrin inhibitor PLN-101095. PLN-101095 is being tested in combination with pembrolizumab to treat solid tumors that are resistant to immune checkpoint inhibitors. The drug is being evaluated in the phase 1a/1b FORTIFY study, with data analysis planned for 2027 (enrollment: non-small cell lung cancer, tumors with high tumor mutational burden, clear cell renal cell carcinoma). The Fast Track status facilitates development discussions with the FDA, allows rolling submissions, and can qualify the drug for priority review. » More on de.investing.com

Pliant Therapeutics has appointed Dr. Flavia Borellini and Dr. Robert Iannone to its board of directors; both have long-standing experience in oncology development and leading large pharmaceutical projects. Borellini has been involved in the development and approval of Calquence and in the commercialization of Tagrisso and Zelboraf; Iannone brings experience from Jazz Pharmaceuticals, AstraZeneca and Merck and has contributed to the development of Keytruda and Imfinzi. Pliant is developing integrin-based therapeutics; its lead program, PLN-101095, targets solid tumors. The stock is trading near its 52-week low; InvestingPro estimates a fair value of $1.63 with a current market capitalization of about $68.8 million and assesses the company’s financial position as moderate. » More on de.investing.com