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PRINCETON, N.J. - Grace Therapeutics, Inc. (NASDAQ:GRCE), a small-cap biotech company currently valued at $41.49 million, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for GTx-104, an injectable formulation of nimodipine designed to treat aneurysmal subarachnoid hemorrhage (aSAH), the company announced today. According to InvestingPro analysis, the company appears undervalued at its current price of $3.00 per share.
The NDA submission includes data from the Phase 3 STRIVE-ON safety trial, which met its primary endpoint with patients receiving GTx-104 showing a 19% reduction in clinically significant hypotension compared to those receiving oral nimodipine (28% versus 35%). While the company is currently not profitable, InvestingPro data shows analysts expect profitability this year, with consensus price targets ranging from $11.23 to $12.45.
According to the company, the trial demonstrated that 54% of patients on GTx-104 achieved a relative dose intensity of 95% or higher compared to only 8% on oral nimodipine, and 29% more patients had favorable functional outcomes at 90 days.
"The standard of care for aSAH has not seen meaningful innovation in nearly 40 years," said Prashant Kohli, Chief Executive Officer of Grace Therapeutics, in the press release statement.
The FDA typically has 60 days to determine if the NDA is complete and acceptable for filing. If accepted, the submission could trigger the exercise of up to $7.6 million in warrants issued during a September 2023 private placement.
GTx-104 has received Orphan Drug Designation from the FDA, which generally provides seven years of marketing exclusivity in the United States upon approval.
aSAH is a type of stroke caused by bleeding between the brain and skull, typically from a ruptured aneurysm. It accounts for approximately 5% of all strokes and affects an estimated 42,500 hospital-treated patients in the U.S. Despite rapid cash burn, Grace maintains strong liquidity with a current ratio of 11.77, indicating robust short-term financial stability. Get access to 6 more key financial insights and real-time analysis with InvestingPro.
In other recent news, Grace Therapeutics has made significant strides with its investigational treatment, GTx-104, designed for intravenous infusion in patients with aneurysmal subarachnoid hemorrhage (aSAH). The company recently held a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the New Drug Application (NDA) for GTx-104, with plans to file in the second quarter of 2025. The Phase 3 STRIVE-ON safety trial data indicated that GTx-104 reduced the incidence of clinically significant hypotension by 19% compared to the oral form of nimodipine, the current standard of care. Additionally, the trial showed better functional outcomes and fewer ICU readmissions for patients treated with GTx-104.
In another development, TD Cowen initiated coverage on Grace Therapeutics with a Buy rating and set a price target of $12.00. This decision was influenced by the positive results from the Phase III clinical trial of GTx-104. TD Cowen highlighted the potential of GTx-104 to meet a significant unmet medical need for an IV formulation of nimodipine, offering improved dosing and tolerability. The firm’s optimistic outlook reflects confidence in Grace Therapeutics’ innovative approach to treating diseases with considerable unmet needs.
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