Grace Therapeutics Inc (GRCE)
NASDAQHealth CareBiotechnologySnapshot 2026-09-04
$2.10-1.87%
Close 2026-09-04 · 1-day change
NASDAQHealth CareBiotechnologySnapshot 2026-09-04
QuarterlyIQ Insights · GRCE
What must go right, what could break, what the price assumes, and what evidence comes next.
The current health of the standing investment case.
Recent financial performance sits well below its industry cohort — worth keeping an eye on, though it has not freshly broken.
One-year growth currently built into the price, compared with our model's estimate.
A comparable price-assumption read is not available for this company.
For each item: what to watch, what would become a concern, and what would make it less concerning.
A reporting-risk estimate, not a forecast of the stock-price response.
Historical relationships that met the evidence threshold. They do not prove cause or forecast a move.
Usually moved in the same direction.
Price observations: 365 days
Most sensitive to the broad stock market.
Based on historical daily prices through 2026-09-04.
Past price behavior in dollars on a $10,000 position. This does not measure permanent business risk.
How much price usually moves either way.
A larger daily loss that occurred about once in every 20 trading days.
Use the underlying financial and sector pages to investigate the cause.
Not investment advice. Scores describe historical and current data; they are not forecasts of future returns. Consult a licensed advisor before making investment decisions.
Elevated risk of a next-quarter earnings miss: this name has erratic recent earnings surprises and is a smaller-cap name (higher miss base rate). A fundamental tilt, not a price call.
Model as of 2026-09-04 · Compared with 398 industry peers · Company calendar date is not available
GRCE — earnings miss
Dated 2026-08-13
Results of Operations and Financial Condition. The following information is furnished pursuant to Item 2.02 “Results of Operations and Financial Condition.” On August 13, 2026, Grace Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K. The information in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for…
Why it matters: The meeting will clarify the path for resubmitting the NDA for GTx-104. Positive feedback could speed up the approval process.
Supportive ifFDA provides clear guidance on the necessary steps to address the CRL items.
Worry ifThe FDA has serious concerns. They need more data or studies.
Why it matters: The FDA reinspection results will affect when the NDA can be resubmitted.
Watch forThe FDA reinspection goes well, allowing the company to resubmit the NDA.
Also watch forThe FDA reinspection finds more compliance issues, delaying the NDA resubmission.
Why it matters: This transfer is essential for the dual-source strategy. It provides an alternative path for NDA resubmission.
Supportive ifThe technology transfer to the second U.S. contract manufacturer is done.
Worry ifTechnology transfer is delayed beyond Q4 2026.
Why it matters: Less losses mean better cash management. This is important for staying in business.
Supportive ifOperating losses drop to less than negative $2.5M next quarter.
Worry ifOperating losses go back up to more than negative $4M.
We watch for confirming and disproving signals on each item. Resolutions are found automatically where possible and checked by hand for unclear cases. Last 90 days shown.
Deepest peak-to-trough drop in the last year.
| Measure | Value | Meaning |
|---|---|---|
| Typical day | ±$140 on $10,000 · ±1.4% | How much price usually moves either way. |
| Bad day | $481 loss on $10,000 · 4.8% | A larger daily loss that occurred about once in every 20 trading days. |
| Largest peak-to-trough drop in the past year | $5,965 loss on $10,000 · 59.7% | Deepest peak-to-trough drop in the last year. |
Past year. 1.00 means similar movement; 1.20 means about 20% more.
Past year. 1.00 means similar movement to the sector. This is secondary context.
Latest 30 trading days, shown as an annual percentage.
Latest 252 trading days, shown as an annual percentage.
20-trading-day average in US dollars.
Trading days used by the source risk snapshot.
Past results, not a forecast. Not investment advice.
Why it matters: A timely FDA response could indicate progress on GTx-104 approval. This is crucial for the company's future.
Supportive ifFDA approval for GTx-104 is granted after resubmission.
Worry ifAnother Complete Response Letter is issued for GTx-104.
Why it matters: Fixing the issues in the Complete Response Letter is key for NDA resubmission.
Supportive ifManagement says all required non-clinical studies will be done in the next 6 months.
Worry ifManagement fails to report progress on addressing CRL items within the next 6 months.
Why it matters: Reinspection is key to resolving the compliance issues noted in the CRL. It impacts NDA timing.
Supportive ifThe FDA inspects the current contract manufacturer again. The inspection goes well.
Worry ifFDA finds ongoing compliance issues during the reinspection.
Why it matters: How well the company addresses the FDA's concerns will impact the success of GTx-104's NDA resubmission.
Watch forManagement reports that all items from the CRL are on track to be addressed by the next update.
Also watch forManagement reports delays or problems in fixing the CRL items.
Why it matters: Watching cash burn shows how well the company manages its money. This is important for the NDA resubmission.
Worry ifCash burn goes down a lot compared to past quarters. This shows better money management.
Less concerning ifCash burn goes up or stays high. This raises worries about financial stability.
Why it matters: The timing of the NDA resubmission is crucial for GTx-104's approval. It indicates progress in addressing FDA concerns.
Supportive ifThe company will resubmit the NDA in 6 months. This is after fixing FDA issues.
Worry ifNo NDA resubmission happens in 6 months. This shows there are still manufacturing problems.
Why it matters: Closing this financing will extend Grace Therapeutics' cash runway to the end of 2028. This is crucial for funding their operations and advancing GTx-104.
Supportive ifThe private placement will close on or before August 6, 2026. All usual conditions must be met.
Worry ifIf the private placement does not close, there will be uncertainty about cash and operations.
Why it matters: Updates on cash are important as the company deals with losses and plans for resubmission.
Worry ifThe company reports cash and cash equivalents over $17 million. This shows they have enough runway.
Less concerning ifCash and cash equivalents drop below $15 million. This raises worries about staying in business.
Why it matters: Moving forward with the dual-source plan helps reduce risks. It also helps with NDA resubmission.
Supportive ifThe company will finish transferring technology to the second U.S. manufacturer in 3 months.
Worry ifThere are delays in technology transfer or fixes at the current manufacturer. These delays are longer than 3 months.