Company: GRCE
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001140361-25-041804
Chunk: 24

Company: Grace Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Item 8
Chunk 24
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 receiving GTx-104 were observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored or were comparable to GTx-104, including:

     •

     54% of patients who received GTx-104 had a relative dose intensity of 95% or higher of the prescribed dose compared to only 8% on oral nimodipine.

     •

     29% relative increase in the number of patients receiving GTx-104 compared to oral nimodipine with favorable outcomes at 90 days follow up on the modified Rankin scale. Quality of life as measured by EQ-5D-3L also favored patients receiving GTx-104 versus oral nimodipine.

     •

     Fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral nimodipine.

     •

     Adverse events were comparable between the two arms and no new safety issues were identified with patients receiving GTx-104. All deaths in both arms of the trial were due to severity of the patient’s underlying disease. There were eight deaths on the GTx-104 arm compared to four deaths on the oral nimodipine arm. The survival status of one patient on the oral nimodipine arm was unknown. No deaths were determined to be related to GTx-104 or oral nimodipine.

     •

     Pharmacoeconomic measures favored the use of GTx-104 for patients with aSAH.

On June 25, 2025, we announced the submission of our NDA
to the FDA for GTx-104. On August 22, 2025, the FDA accepted our NDA for review
and established April 23, 2026 as the PDUFA target date for completing its
review of our submission.

In
September 2025, results from our STRIVE-ON trial were presented by Dr. H. Alex Choi
(Professor of Neurosurgery and Neurology at UT Health Houston McGovern Medical
School, member of the Grace Scientific Advisory Board) at the 2025 Neurocritical
Care annual meeting, held in Montreal, Quebec, Canada.  

   We believe these data validate the GTx-104 value proposition. If approved, GTx-104 has the potential to address significant challenges with oral nimodipine