GRI Bio Inc（GRI）资讯与事件GRIGRI Bio Inc

GRI Bio Receives FDA Orphan Drug Designation for GRI-0621

GRI Bio announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, to GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis, a progressive, irreversible and ultimately fatal lung disease affecting tens of thousands of patients in the United States. "Receiving FDA Orphan Drug Designation for GRI-0621 in IPF is an important validation of our development strategy and highlights the urgent need for innovative therapies capable of altering the course of this devastating disease," said Marc Hertz, Ph.D., Chief Executive Officer of GRI Bio. "We believe GRI-0621's differentiated mechanism of action has the potential to address key drivers of inflammation and fibrosis, and this designation strengthens our ability to advance the program efficiently while creating significant long-term value for patients and shareholders."

GRI Bio Cash and Cash Equivalents Reach $8.2M

As of December 31, 2025, the Company had cash and cash equivalents of approximately $8.2M. Following the close of the quarter, the Company raised an additional $6.5M in gross proceeds through the use of its At The Market offering. Based on the Company's current operating plan, GRI Bio believes that its existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into the first quarter of 2027. Net loss was $12M for the year ended December 31, 2025. "In 2025, we prioritized disciplined clinical execution and balance sheet strength, delivering compelling clinical data from our lead IPF program which underscores the therapeutic differentiation of GRI-0621," commented Marc Hertz, CEO. "Entering 2026 with a strong cash position, we are focused on advancing GRI-0621 in IPF, progressing GRI-0803 toward the clinic and executing our clinical strategy with capital discipline to drive long-term value creation."