Faron Pharmaceuticals Ltd. announces that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) Application for Traumakine, the Company's wholly-owned product for the treatment of Acute Respiratory Distress Syndrome (ARDS), which is part of the regulatory process towards BLA submission. The FDA has already proposed that Faron can proceed directly to Biologics License Application (BLA) pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) and the IND forms part of this process towards BLA submission. Faron also continues to consider providing access to Traumakine in the US to ARDS patients under an expanded access program, which requires an IND. Top-line data from the INTERST study is due in the first half of 2018. Faron is also planning to conduct a small open label study in the US for pharmacological purposes and the IND will allow opening of clinical activities in the US. This first US study will target Traumakine (drug product FP-1201-lyo) in moderate and severe ARDS patients, especially with end organ (kidney and liver) failures.