tiprankstipranks
Trending News
More News >

Grace Therapeutics Submits New Drug Application to FDA

Story Highlights
Grace Therapeutics Submits New Drug Application to FDA

Don’t Miss TipRanks’ Half-Year Sale

The latest announcement is out from Grace Therapeutics ( (GRCE) ).

On June 25, 2025, Grace Therapeutics announced the submission of a New Drug Application to the FDA for GTx-104, an injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH). The submission includes positive results from the Phase 3 STRIVE-ON safety trial, demonstrating clinical benefits over oral nimodipine. This milestone could trigger the exercise of up to $7.6 million in warrants and potentially secure seven years of marketing exclusivity in the U.S. upon approval, strengthening Grace Therapeutics’ market position.

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: 32,891

Technical Sentiment Signal: Hold

Current Market Cap: $40.19M

Find detailed analytics on GRCE stock on TipRanks’ Stock Analysis page.

Disclaimer & DisclosureReport an Issue

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App
1