Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
GRCE Catalyst Timeline
Dated clinical, regulatory and corporate events for Grace Therapeutics, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Grace Therapeutics, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How GRCE actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-04-23 | GTx-104 (injectable formulation of nimodipine) | PDUFA Date CRL | PDUFA |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| GTX-104 Small moleculeNCT05995405 | Aneurysmal Subarachnoid Hemorrhage | Phase 3 | ACTIVE NOT_RECRUITING | 158 | Dec 1, 2024 |
Clinical Trial Results
Readouts, endpoints and source filings for every GRCE program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| GTx-104 Orphan | aneurysmal subarachnoid hemorrhage (aSAH) | Phase 3 | 2026-04-14 | reduction in hypotension: 19%; hypotension GTx 104: 28%; hypotension nimodipine: 35%; RDI 95 percent or higher GTx 104: 54%; RDI 95 percent or higher nimodipine: 8%; favorable outcomes increase: 29%Read More | Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026Read More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Opaleye Management Inc.10% Owner | Buy | 1,694 2,858,657 held | $2.06 | 10/05/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in GRCE
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in GRCE for Q2 2026. | ||||
GRCE Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2027-02-19 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How GRCE ranks across every disease it competes in
GRCE News
Grace Therapeutics to Participate in the H.C. Wainright 28th Annual Global Investment Conference
Grace Therapeutics will participate in the H.C. Wainwright 28th Annual Global Investment Conference from September 14-16, 2026. CEO Prashant Kohli will present the company's clinical-stage drug GTx-104, which targets aSAH, and will be available for one-on-one meetings with investors. The conference aims to showcase investment opportunities in the biopharma sector.
Read more →Grace Therapeutics Announces First Quarter 2027 Financial Results, Provides Business Update
Grace Therapeutics reported its first quarter 2027 financial results, highlighting progress towards resubmitting its New Drug Application (NDA) for GTx-104. The FDA's Complete Response Letter did not identify clinical deficiencies, focusing instead on manufacturing and non-clinical data. The company secured $10 million in financing to support its efforts and is implementing a dual-source manufacturing strategy to mitigate risks.
Read more →Grace Therapeutics Announces $10 Million Private Placement
Grace Therapeutics has announced a $10 million private placement financing to support the development of GTx-104, a novel injectable formulation for treating aSAH. The financing will close on August 6, 2026, and the proceeds will extend the company's cash runway until the end of 2028. The company is also implementing a dual-source manufacturing strategy to address compliance issues with its current manufacturer.
Read more →Grace Therapeutics Announces Receipt of Type A Meeting Minutes from U.S. Food and Drug Administration
Grace Therapeutics has received Type A meeting minutes from the FDA regarding their drug GTx-104, which did not reveal any clinical safety or efficacy issues. The company is addressing manufacturing compliance concerns and plans to resubmit their NDA. They are also implementing a dual-source manufacturing strategy to enhance compliance and reduce risks.
Read more →Grace Therapeutics Announces 2026 Fiscal Year-End Financial Results, Provides Business Update
Grace Therapeutics reported its fiscal year-end results for 2026, focusing on GTx-104, an injectable formulation of nimodipine for aSAH. The company is preparing to resubmit its NDA following a Complete Response Letter from the FDA. Positive Phase 3 trial results were shared at major conferences, and the company holds multiple patents for GTx-104. Despite a decrease in net loss, financial challenges remain as cash reserves have diminished.
Read more →Corporate Presentation June 2026 Summary 2 Forward Looking Statements Statements in this presentation that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of th
Grace Therapeutics, Inc. presented findings related to its GTx-104 drug candidate, a novel intravenous formulation aimed at treating patients with aneurysmal subarachnoid hemorrhage (aSAH). A pivotal Phase 3 safety trial demonstrated its effectiveness compared to current oral nimodipine treatments. However, the company received an FDA Complete Response Letter citing deficiencies in its chemistry, manufacturing, and controls data. A Type A meeting with the FDA is scheduled to seek clarity on the next steps for the drug's regulatory submission.
Read more →Corporate Presentation April 2026 Summary 2 Forward Looking Statements Statements in this presentation that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of t
Grace Therapeutics, Inc. presented forward-looking statements regarding their drug candidate GTx-104, aimed at treating acute brain injury due to aneurysmal subarachnoid hemorrhage (aSAH). The FDA issued a Complete Response Letter citing issues with the chemistry, manufacturing, and controls (CMC) data package. Despite these challenges, the company plans to resubmit its New Drug Application (NDA) after meetings with the FDA for clarification on the path forward. The drug is noted for its potential benefits compared to the oral formulation of nimodipine, particularly in addressing significant unmet medical needs.
Read more →Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104
Grace Therapeutics received a Complete Response Letter from the FDA regarding its New Drug Application for GTx-104, intended for treating aneurysmal subarachnoid hemorrhage. The letter cited issues related to Chemistry, Manufacturing, and Controls, but did not request additional clinical data. The company plans to address these issues and resubmit the application after a Type A meeting with the FDA.
Read more →GTx-104 FDA Approval
Grace Therapeutics announced that the FDA issued a Complete Response Letter for GTx-104, citing issues in Chemistry, Manufacturing, and Controls. The company plans to address these items and resubmit its application. The trial showed promising results, including a reduction in hypotension incidents compared to oral nimodipine.
Read more →Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026
Grace Therapeutics announced that an abstract detailing the results of the STRIVE-ON Phase 3 trial of GTx-104 has been accepted for presentation at the AAN 2026 meeting. The trial showed that GTx-104 significantly reduced episodes of clinically significant hypotension compared to oral nimodipine. Additionally, GTx-104 demonstrated better relative dose intensity and favorable functional outcomes at 90 days.
Read more →Grace Therapeutics to Present Data on the Unmet Medical Needs and Potential Benefits of GTx-104 in the Treatment of aSAH at Upcoming Medical Conferences
Grace Therapeutics is set to present data on GTx-104, an injectable formulation of nimodipine, at two major medical conferences in March 2026. The presentations will focus on the unmet medical needs in treating aneurysmal subarachnoid hemorrhage (aSAH) and the advantages of GTx-104 over oral nimodipine. Data from the Phase 3 STRIVE-ON Trial indicates that GTx-104 may improve patient outcomes and tolerability.
Read more →Grace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference
Grace Therapeutics will participate in the TD Cowen 46th Annual Health Care Conference, with CEO Prashant Kohli presenting on March 4, 2026. The company is advancing GTx-104, an injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH). GTx-104 aims to address significant unmet medical needs in this patient population.
Read more →Grace Therapeutics Announces Third Quarter 2026 Financial Results, Provides Business Update
Grace Therapeutics reported its third quarter 2026 financial results, highlighting progress on its GTx-104 drug candidate for aneurysmal Subarachnoid Hemorrhage (aSAH). The FDA has set a PDUFA target date of April 23, 2026, for the review of GTx-104's NDA submission. The company also presented positive data from the Phase 3 STRIVE-ON trial, which demonstrated improved clinical outcomes for patients treated with GTx-104.
Read more →Grace Therapeutics to Participate in 16th Annual Craig-Hallum Alpha Select Conference
Grace Therapeutics, Inc. (Nasdaq: GRCE) has announced its participation in the 16th Annual Craig-Hallum Alpha Select Conference, scheduled for November 18, 2025. CEO Prashant Kohli will present at this invitation-only event, which showcases smaller public companies believed to have significant growth potential. The company is developing GTx-104, a novel intravenous formulation of nimodipine targeting unmet medical needs in patients with aneurysmal subarachnoid hemorrhage (aSAH), an uncommon but serious condition. GTx-104 has shown to be well tolerated in clinical studies, potentially offering better management of hypotension in aSAH patients.
Read more →Grace Therapeutics Announces Second Quarter 2026 Financial Results, Provides Business Update
Grace Therapeutics announced the FDA's acceptance of their NDA for GTx-104, aimed at treating aneurysmal Subarachnoid Hemorrhage (aSAH), with a PDUFA target date set for April 23, 2026. The company highlighted positive outcomes from the Phase 3 STRIVE-ON trial, which demonstrated improved clinical results for patients. Additionally, a new patent for the IV dosing regimen of GTx-104 was granted, enhancing their intellectual property portfolio.
Read more →Grace Therapeutics Announces Abstract Accepted for Presentation at Society of Vascular and Interventional Neurology Annual Meeting
Grace Therapeutics announced that an abstract for its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 has been accepted for presentation at the Society of Vascular and Interventional Neurology annual meeting. The trial focuses on treating aneurysmal subarachnoid hemorrhage (aSAH) with an innovative injectable formulation of nimodipine. The presentation will occur on November 21, 2025, in Orlando, FL.
Read more →Grace Therapeutics Secures Approximately $4.0 Million through Common Warrant Exercises Following Acceptance of New Drug Application for GTx-104 for formal FDA Review
Grace Therapeutics has raised approximately $4.0 million through common warrant exercises following the FDA's acceptance of their New Drug Application for GTx-104. This drug aims to treat patients with aneurysmal subarachnoid hemorrhage (aSAH) and is supported by positive results from a Phase 3 trial. The FDA has set a PDUFA target date for review on April 23, 2026.
Read more →Grace Therapeutics Pivotal Phase 3 STRIVE-ON Safety Trial Presented at 2025 Neurocritical Care Annual Meeting
Grace Therapeutics presented positive results from its Phase 3 STRIVE-ON Safety Trial for GTx-104 at the Neurocritical Care Society annual meeting. The trial demonstrated that GTx-104, an injectable formulation of nimodipine, is safe and well-tolerated in patients with aneurysmal subarachnoid hemorrhage (aSAH). The findings suggest it may outperform oral nimodipine in managing hypotension and improving patient outcomes.
Read more →Grace Therapeutics Granted Sixth U.S. Patent Covering I.V. Dosing Regimen for GTx-104
Grace Therapeutics has been granted a new U.S. patent for the intravenous dosing regimen of GTx-104, extending its protection until 2043. This patent complements the existing five patents on the composition of nimodipine, enhancing the company's market exclusivity. The STRIVE-ON safety trial demonstrated GTx-104's potential benefits over oral nimodipine, particularly in managing hypotension in aSAH patients.
Read more →Grace Therapeutics Announces Presentation at The H.C. Wainwright 27th Annual Global Investment Conference
Grace Therapeutics, a late-stage biopharma company, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025. The company will showcase its lead clinical asset, GTx-104, aimed at treating aneurysmal Subarachnoid Hemorrhage (aSAH). CEO Prashant Kohli will be available for one-on-one meetings with investors during the event.
Read more →