On Monday, Grace Therapeutics, Inc. ( GRCE ) , formerly b, announced topline data from its Phase 3 STRIVE-ON safety trial of GTx-104 compared with oral nimodipine in patients hospitalized with aneurysmal Subarachnoid Hemorrhage (aSAH).

aSAH is bleeding over the brain’s surface in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain.

The study met its primary endpoint and provides evidence of clinical benefit compared to orally administered nimodipine.

The trial met its primary endpoint, with patients receiving GTx-104 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 (RDI) 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.

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 the severity of the patient’s underlying disease.

US new drug application submission is expected in the first half of 2025.

Concurrently, Grace Therapeutics ( GRCE ) announced a private placement of approximately $30 million consisting of initial upfront funding of approximately $15.0 million and the potential to receive up to an additional approximately $15.0 million upon cash exercise of accompanying warrants at the election of the investors.

Grace Therapeutics ( GRCE ) will issue an aggregate of 4.42 million common shares and accompanying common warrants to purchase up to 4.42 million at a combined purchase price of $3.395.

Grace Therapeutics ( GRCE ) will use the net proceeds to fund the development of GTx-104.

Price Action: GRCE stock is up 4.32% at $3.38 at last check Monday.

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