GRCE Stock In Spotlight Ahead Of FDA Verdict On Brain Bleed Drug This Week

• Grace Therapeutics’ NDA for GTx-104 was accepted by FDA last August
• GTx-104 already received Orphan Drug Designation, which could grant seven years of market exclusivity in the U.S. if approved.
• Patients on GTx-104 also recorded fewer ICU readmissions and shorter hospital stays, the company said.

Shares of Grace Therapeutics (GRCE) are gaining investor attention ahead of a key decision from the U.S. Food and Drug Administration on its treatment for the highly fatal aneurysmal subarachnoid hemorrhage, with a verdict expected on April 23.

GRCE shares traded 1.7% higher in pre-market trading on Wednesday.

Data Shows Fewer ICU Admissions

Last August, Grace Therapeutics announced that the FDA accepted its New Drug Application (NDA) for GTx-104, a potential treatment for patients with aneurysmal subarachnoid hemorrhage (aSAH), setting a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2026

A PDUFA date is the FDA’s target date for making a decision on a drug application, which allows the drug to be marketed in the U.S.

The submission was backed by positive results from the Phase 3 STRIVE-ON safety trial, which compared GTx-104, an injectable form of nimodipine, with its oral version. The study met its primary endpoint, showing a 19% reduction in clinically significant hypotension among patients treated with GTx-104.

Patients on GTx-104 also recorded fewer ICU readmissions and shorter hospital stays. Safety outcomes were comparable between the two groups, with no new concerns identified.

GTx-104 has also received Orphan Drug Designation, which could grant seven years of market exclusivity in the U.S. if approved. The designation could also result in the waiver of FDA application user fees.

How Did Retail Traders React?

Retail sentiment on Stocktwits turned ‘neutral’ from ‘bearish’ a day earlier, amid ‘high’ message volumes.

One bullish user highlighted a potential rally given the “super low float.”

Another user weighed in on trading in the stock if the approval was granted.

Year-to-date, the stock has gained around 37%.

For updates and corrections, email newsroom[at]stocktwits[dot]com.