Grace Therapeutics Receives FDA Complete Response for GTx-104

An announcement from Grace Therapeutics ( (GRCE) ) is now available.

On April 23, 2026, Grace Therapeutics reported that the U.S. Food and Drug Administration issued a Complete Response Letter for its New Drug Application for GTx-104, an IV formulation of nimodipine for aneurysmal subarachnoid hemorrhage. The FDA cited outstanding chemistry, manufacturing and controls and non-clinical issues, including leachables data, toxicology risk assessments and deficiencies at a contract manufacturer, but did not request additional clinical data.

Grace said it plans to seek a Type A meeting and resubmit the application after addressing the cited items, a process that could delay potential approval of what it views as the first major advance in aSAH care in more than four decades. The update follows positive Phase 3 STRIVE-ON trial results, where GTx-104 reduced clinically significant hypotension versus oral nimodipine and showed favorable dosing intensity, functional outcomes and ICU resource use with comparable overall safety, underscoring the drug’s clinical rationale despite the regulatory setback.

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.

The score is primarily held down by weak financial performance driven by pre-revenue status, ongoing losses, and persistent cash burn, despite a low-debt balance sheet. Technicals are also soft with the price below key moving averages and weak momentum. Valuation contributes little support because earnings are negative and no dividend yield is provided.

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 drug candidates for rare and orphan diseases, using novel drug delivery technologies to improve the performance of existing therapies. Its lead asset, GTx-104, is an intravenous nimodipine formulation targeting aneurysmal subarachnoid hemorrhage, and its programs benefit from Orphan Drug Designation and a broad patent estate.

Average Trading Volume: 510,011

Technical Sentiment Signal: Buy

Current Market Cap: $72.11M

See more insights into GRCE stock on TipRanks’ Stock Analysis page.