Grace Therapeutics Inc. (NASDAQ:GRCE) shares are down during Friday’s premarket session following a regulatory update regarding its New Drug Application (NDA) for GTx-104.
The stock’s decline comes as the FDA issued a Complete Response Letter citing outstanding items related to Chemistry, Manufacturing, and Controls, and non-clinical sections of the application.
FDA Strikes Off Grace Therapeutics Drug
The FDA’s Complete Response Letter indicates that Grace Therapeutics must address specific Chemistry, Manufacturing, and Controls issues before resubmitting its NDA for GTx-104, a treatment for aneurysmal subarachnoid hemorrhage (aSAH).
The cited items are related to leachables data for product packaging, non-clinical product toxicology risk assessments, and product manufacturing deficiencies at the contract manufacturing organization.
The late-stage biopharma company plans to request a Type A meeting with the FDA to clarify the next steps.
The FDA did not request additional clinical data.
“We are confident in the robust data package supporting our NDA submission, and that the CMC issues identified by the FDA can be successfully addressed in our resubmission,” said Prashant Kohli, CEO of Grace Therapeutics.
GRCE Technical Analysis: Bearish Trend And Key Support Levels
Grace Therapeutics is currently trading 44.6% below its 20-day simple moving average (SMA) and 43.5% below its 50-day SMA, suggesting a bearish trend in the short term. The stock is also 39% below its 100-day SMA, indicating continued selling pressure and a lack of upward momentum.
The relative strength index (RSI) is at 28.81, which is considered oversold, suggesting that the stock may be under pressure but could also be due for a rebound if buying interest returns.
This low RSI indicates that the stock has been heavily sold off, which might attract buyers looking for a potential turnaround.
- Key Resistance: $4.20 — This level has historically been a point where selling pressure has emerged.
- Key Support: $1.79 — This is the 52-week low, a critical level for potential buying interest.
The stock has experienced a 12-month return of -1.26%, reflecting a generally weak performance over the past year. Currently, it is trading near its 52-week low, suggesting that the stock is struggling to find support and may continue to face challenges unless there is a significant change in market sentiment or company performance.
GRCE Stock Price Activity: Grace Therapeutics shares were down 3.19% at $2.27 during premarket trading on Friday, and the stock closed around 46% lower on Thursday, according to Benzinga Pro data.
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