November 07, 2017 | Company developing NRL-1, a proprietary intranasal formulation of diazepam, for epilepsy patients who experience acute repetitive or cluster seizures
January 05, 2017 | Funds to be utilized to complete development work and begin commercialization preparations for NRL-1. Program has received Orphan Drug and Fast Track Designation from FDA.
January 04, 2017 | Neurelis Intranasal Diazepam Treatment For Epilepsy Granted Fast Track Designation By FDA
February 22, 2016 | The investment, led by LYZZ Capital, is intended to advance the company's lead program, NRL-1 (intranasal diazepam), through the remaining clinical work in preparation for FDA submission of a New Drug Application (NDA) in the US.
January 19, 2016 | Following the receipt of Orphan Drug Designation for their lead product, NRL-1 (intranasal diazepam), Neurelis, Inc. ("Neurelis") today announced the receipt of guidance from the FDA for the final clinical trial requirements necessary for approval of NRL-1.
December 21, 2015 | The FDA's Orphan Drug Designation program provides orphan status to drugs intended for the safe and effective treatment of rare disorders that affect fewer than 200,000 people in the United States.
