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Shares of GRI Bio (NASDAQ:GRI) were down 9% in mid-morning trading Monday despite the company announcing it had received FDA clearance to begin clinical testing of its therapy candidate GRI-0621in the treatment of idiopathic pulmonary fibrosis.
GRI said it plans to begin a Phase 2a biomarker study of the product before the end of the year. Interim data is expected during the first half of 2024, with topline results during the second half of the year.
The company added that it plans to pursue a 505(b)(2) regulatory pathway for the drug.