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Grace Therapeutics ( (GRCE) ) has issued an update.
On August 22, 2025, the FDA accepted Grace Therapeutics‘ New Drug Application for GTx-104, a novel injectable formulation of nimodipine for IV infusion, for formal review. This development marks a significant milestone for the company, potentially impacting its market position and stakeholder interests. The NDA is supported by positive results from the Phase 3 STRIVE-ON safety trial, indicating improved clinical outcomes for aSAH patients. The FDA has set a Prescription Drug User Fee Act target date of April 23, 2026, for the review. The acceptance of the NDA also triggers the potential exercise of up to $7.6 million in warrants issued in a previous private placement.
The most recent analyst rating on (GRCE) stock is a Buy with a $12.00 price target. To see the full list of analyst forecasts on Grace Therapeutics stock, see the GRCE Stock Forecast page.
Spark’s Take on GRCE Stock
According to Spark, TipRanks’ AI Analyst, GRCE is a Neutral.
Grace Therapeutics is navigating a challenging financial landscape, marked by no revenue and persistent operational losses, which are somewhat mitigated by a strong equity base and absence of debt. The stock shows positive technical momentum but is at risk of being overbought. The negative P/E ratio highlights the risk associated with the company’s current financial performance and lack of earnings. Strategic management is required to improve operational viability and financial sustainability.
To see Spark’s full report on GRCE stock, click here.
More about Grace Therapeutics
Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing drug candidates for rare and orphan diseases. The company utilizes novel drug delivery technologies to enhance the performance of existing drugs, aiming for faster onset of action, improved efficacy, reduced side effects, and more convenient delivery. Their lead clinical asset, GTx-104, targets aneurysmal Subarachnoid Hemorrhage (aSAH) and has been granted Orphan Drug Designation by the FDA, providing seven years of marketing exclusivity in the United States.
Average Trading Volume: 67,005
Technical Sentiment Signal: Hold
Current Market Cap: $44.46M
For a thorough assessment of GRCE stock, go to TipRanks’ Stock Analysis page.