Princeton, New Jersey-based Grace Therapeutics, Inc. (Nasdaq: GRCE) announced a USD 10 million private placement to fund manufacturing and regulatory work supporting resubmission of the New Drug Application (NDA) for GTx-104, an injectable formulation of nimodipine for aneurysmal subarachnoid hemorrhage (aSAH). The company said the proceeds, together with existing cash, are expected to fund operations through the end of 2028.
The financing follows an April 2026 US FDA Complete Response Letter (CRL) that cited chemistry, manufacturing, and controls (CMC) deficiencies at Grace's contract manufacturing organization and outstanding non-clinical requirements, but raised no concerns regarding the drug's clinical safety or efficacy. Following a Type A meeting in July, the company said it is pursuing two parallel manufacturing pathways: remediation of its existing manufacturer while simultaneously transferring production to a second US-based contract manufacturer. NDA resubmission timing will depend on which manufacturing pathway reaches readiness first.
GTx-104 is a nanoparticle-based intravenous formulation of nimodipine designed for intensive care patients with aSAH. Unlike the current oral formulation, which often requires nasogastric administration and has variable absorption, GTx-104 is intended to provide more reliable drug delivery while reducing hypotension. In the Phase III STRIVE-ON trial, GTx-104 met the primary endpoint, with 28% of patients experiencing at least one clinically significant, drug-related hypotension episode compared with 35% receiving oral nimodipine.