Grace Therapeutics received a Complete Response Letter from the FDA regarding its GTx-104 application for treating aSAH, citing concerns about chemistry, manufacturing, and non-clinical data. The company is confident that they can address these issues, which could lead to a pivotal approval, marking a significant advancement in aSAH treatment after decades.
GTx-104 trial met primary endpoint, showing clinical benefit over nimodipine. GTx-104 reduced hypotension incidents by 19% in hospitalized aSAH patients. 54% dose intensity for GTx-104 patients was significantly higher than for nimodipine. Grace Therapeutics plans $30 million private placement to fund GTx-104 development. Current GRCE stock price is $3.38, reflecting positive investor sentiment.