Every 8-K that Grace Therapeutics, Inc. (GRCE) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow GRCE and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full GRCE filings page.
Grace Therapeutics, Inc. reported results for the three months ended June 30, 2026 and provided an update on its GTx-104 program. Net loss was $15.8 million, or $0.91 per share, compared with $3.4 million, or $0.21 per share, a year earlier, driven largely by a $13.5 million impairment of in-process R&D for GTx-101 and GTx-102 after these programs were deprioritized.
Research and development expense declined to $0.7 million and general and administrative expense to $1.7 million, reflecting reduced GTx-104 clinical and pre-commercial activities. The company reassessed GTx-104 following an FDA Complete Response Letter focused on CMC and non-clinical items and concluded no impairment was required. As of August 11, 2026, cash and cash equivalents were $22.2 million; management believes this will fund planned operations, including work to address the CRL and dual-source manufacturing strategy for GTx-104, through the end of calendar 2028.
Grace Therapeutics, Inc. completed a private placement of 4,761,904 shares of common stock at $2.10 per share, generating approximately $10 million in gross proceeds from institutional and accredited investors. Craig-Hallum Capital Group LLC acted as placement agent. The shares were issued under Section 4(a)(2) and Rule 506 exemptions, and the company will file a resale registration statement, using reasonable best efforts to have it declared effective within specified SEC review timelines and to keep it effective until the shares are sold or freely tradable under Rule 144. The company agreed to bear related registration expenses and accepted near-term restrictions on additional equity issuance, reverse stock splits and new registration statements, subject to exceptions.
Grace Therapeutics expects net proceeds, together with existing cash, to extend its cash runway to the end of calendar 2028 and intends to use the funds to support manufacturing and regulatory work for its lead asset, GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH). aSAH accounts for about 5% of strokes and an estimated 42,500 U.S. hospital-treated patients annually. GTx-104 has been administered to over 200 patients and volunteers, has Orphan Drug Designation with potential seven years of U.S. marketing exclusivity, and is supported by an intellectual property estate of 52 granted and pending patents as the company pursues an NDA resubmission and a dual-source manufacturing strategy.
Grace Therapeutics, Inc. reports receipt of official U.S. FDA Type A meeting minutes regarding the Complete Response Letter for its GTx-104 new drug application. The minutes confirm that the CRL raised only chemistry, manufacturing and controls issues, including contract-manufacturer cGMP compliance and additional leachables and excipient toxicology data, and did not cite clinical safety or efficacy deficiencies or request new clinical trials.
The company plans to resubmit the NDA after addressing all items through a dual-source manufacturing strategy and required non-clinical studies, with remediation at its existing contract manufacturer and parallel technology transfer to a second U.S. site. Supporting this plan, Phase 3 STRIVE-ON data in hospitalized aneurysmal subarachnoid hemorrhage patients showed a 19% relative reduction in clinically significant hypotension with GTx-104 versus oral nimodipine (28% vs 35%), higher dose intensity (54% vs 8% achieving ≥95% of planned dose), fewer ICU and ventilator days, and fewer ICU readmissions, with comparable overall safety. GTx-104 holds FDA Orphan Drug Designation, Grace cites an estimated 42,500 U.S. hospital-treated aSAH patients annually, and it reported $17.0 million of cash and 16,024,026 common shares outstanding as of March 31, 2026.
Grace Therapeutics, Inc. updated its corporate presentation, focusing on GTx-104, a novel intravenous nimodipine for aneurysmal subarachnoid hemorrhage. The FDA issued an April 2026 Complete Response Letter driven by chemistry, manufacturing and controls and contract manufacturer inspection issues, with no clinical deficiencies cited.
A Type A meeting is scheduled to clarify the path to resubmitting the GTx-104 New Drug Application. Phase 3 STRIVE-ON data showed 28% of GTx-104 patients had clinically significant hypotension versus 35% with oral nimodipine capsules, and 54% achieved at least 95% relative dose intensity versus 8% on capsules.
Patients on GTx-104 had 1.5 fewer intensive care unit days on average and 5 fewer days on mechanical ventilation compared with capsules, with overall safety appearing comparable. The company reports orphan drug status for GTx-104, patents extending to 2043, cash of $17.0 M, 16,024,026 common shares outstanding, and fully diluted shares of 23,033,731 as of March 31, 2026.
Grace Therapeutics reported fiscal year 2026 results and updated progress on its lead drug GTx-104. The company recorded a net loss of $7.8 million, or $0.47 per share, for the year ended March 31, 2026, improving from a $9.6 million loss, or $0.79 per share, a year earlier.
Research and development expenses fell to $2.4 million from $9.5 million as its pivotal Phase 3 STRIVE-ON safety trial for GTx-104 was closed out, while general and administrative expenses rose to $8.7 million from $7.2 million, mainly due to legal, due diligence and pre-commercial planning costs.
Grace ended March 31, 2026 with $17.0 million in cash and cash equivalents and expects this to fund operations for at least 12 months. Following an April 2026 Complete Response Letter from the FDA on the GTx-104 NDA, the company has a Type A meeting scheduled to clarify the path to resubmission and continues disciplined pre-commercial planning in anticipation of a potential approval for treating aneurysmal subarachnoid hemorrhage.
Grace Therapeutics, Inc. reported that Carrie D’Andrea will cease serving as Vice President of Clinical Operations and will no longer be employed by the company effective June 5, 2026, a change approved on June 1, 2026.
She is expected to receive severance benefits under a prior letter agreement, subject to a release of claims and continued compliance with non-competition, non-solicitation, and confidentiality obligations. In connection with her departure, D’Andrea entered into a 12‑month Consulting Agreement starting June 5, 2026, under which she will provide services at $250 per hour.
During the consulting term, her stock options granted under the company’s equity plans will continue to vest and remain exercisable while she provides, or is willing to provide, services. She will have 90 days after the consulting agreement ends to exercise any vested options.
Grace Therapeutics, Inc. updated its corporate presentation to highlight regulatory status, clinical data and capital position. The company received an FDA Complete Response Letter for its GTx-104 intravenous nimodipine NDA, driven by chemistry, manufacturing and controls and manufacturing facility issues, with no clinical deficiencies cited. Management plans a Type A FDA meeting and additional leachable and toxicology work, while evaluating manufacturing alternatives. Phase 3 STRIVE-ON data in aneurysmal subarachnoid hemorrhage showed fewer hypotension events, higher relative dose intensity and signals of better 90‑day outcomes and resource use versus oral nimodipine. The deck also notes orphan drug status and patents for GTx-104, additional programs GTx-102 and GTx-101, cash of $18.7 million and potential $15.0 million of gross proceeds from outstanding warrants.
Grace Therapeutics, Inc. reported that the U.S. Food and Drug Administration issued a Complete Response Letter for its New Drug Application for GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage. The letter cites outstanding Chemistry, Manufacturing, and Controls and non-clinical items, but does not request additional clinical data.
The cited items involve leachables data for product packaging, non-clinical toxicology risk assessments, and manufacturing deficiencies at the company’s contract manufacturer. Grace plans to request a Type A meeting with the FDA to clarify the path forward and intends to resubmit the application after resolving these issues.
Grace Therapeutics reported a net loss of about $2.3 million, or $0.14 per share, for the quarter ended December 31, 2025, improving from a $4.2 million loss a year earlier. The smaller loss mainly reflects a sharp drop in research and development spending after completing the pivotal Phase 3 STRIVE-ON trial of GTx-104.
Research and development expenses fell to $0.5 million from $2.2 million, while general and administrative costs rose to $2.0 million, driven by pre-commercial planning for GTx-104. Cash and cash equivalents were $18.7 million, and the company expects this to fund operations for at least 12 months. The FDA set a PDUFA target date of April 23, 2026 for the GTx-104 NDA in aneurysmal subarachnoid hemorrhage, supported by STRIVE-ON data showing fewer hypotension episodes, higher dose intensity, and better functional outcomes versus oral nimodipine.
Grace Therapeutics, Inc. updated its executive employment arrangements by entering into amendments to existing letter agreements with its CEO and four other executive officers. If an executive is terminated by the company without Cause, and there is no Change in Control, the executive will receive accrued obligations plus continued base salary and COBRA benefits for six months, or twelve months in the case of the CEO. Unvested equity awards are forfeited in this scenario.
If an executive is terminated without Cause or resigns for Good Reason in connection with or within twelve months after a Change in Control, the executive will receive accrued obligations plus a cash payment equal to six months (eighteen months for the CEO) of base salary and target bonus, as well as COBRA premiums for the same period. In this Change in Control context, all unvested equity awards held by the executive will fully vest and become exercisable.
Grace Therapeutics (GRCE) furnished an 8-K noting it issued a press release with financial results for the three months ended September 30, 2025. The company also updated its corporate presentation, which includes its updated cash position as of October 31, 2025.
The press release and presentation are furnished as Exhibits 99.1 and 99.2. The company states these materials are furnished, not “filed,” under the Exchange Act.
Grace Therapeutics reported securing approximately $4.0 million in cash proceeds from recent exercises of common warrants originally issued in a September 2023 private placement.
The Company also disclosed that 1,190,927 of those common warrants have expired, as the 60th day after the U.S. Food and Drug Administration’s acceptance for review of the Company’s New Drug Application for GTx-104 has passed. GTx-104 is a clinical-stage, injectable formulation of nimodipine being developed for I.V. infusion to address unmet needs in aneurysmal subarachnoid hemorrhage.
Grace Therapeutics announced that the U.S. Patent and Trademark Office issued Patent No. 12,414,943, titled "Nimodipine Parenteral Administration." The method-of-use patent, published on September 16, 2025 and issued on September 18, 2025, covers the dosing regimen for intravenous administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104 and extends patent protection for GTx-104 to 2043. GTx-104 is described as a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to treat aneurysmal subarachnoid hemorrhage patients. The company attached a press release as Exhibit 99.1 to this Current Report.
Grace Therapeutics reported that the U.S. Food and Drug Administration has accepted its New Drug Application for GTx-104 for formal review. GTx-104 is a novel, injectable formulation of nimodipine being developed for intravenous infusion to treat aneurysmal subarachnoid hemorrhage, a condition with significant unmet medical need.
The FDA has set a Prescription Drug User Fee Act, or PDUFA, target decision date of April 23, 2026 for the NDA. This step means the application passed the initial filing review and will now undergo a full regulatory assessment, but it does not represent an approval or guarantee of approval.
Grace Therapeutics, Inc. furnished a press release announcing its financial results for the three months ended June 30, 2025. The press release is attached to this report as Exhibit 99.1, and an Inline XBRL cover page is provided as Exhibit 104. The company states that the information in Item 2.02, including Exhibit 99.1, is furnished and not deemed "filed" for purposes of Section 18 of the Exchange Act, which limits the filing liabilities for this disclosure.
The Form 8-K identifies the issuer as Grace Therapeutics (trading as GRCE on The Nasdaq Stock Market) and is signed by Chief Executive Officer Prashant Kohli. The Form itself does not include the detailed financial line items in-line; those figures are conveyed in the attached press release exhibit.
Grace Therapeutics (NASDAQ:GRCE) filed an 8-K announcing the submission of a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine. The drug candidate is being developed as an IV infusion treatment for patients with aneurysmal subarachnoid hemorrhage. This represents a significant regulatory milestone in the company's drug development pipeline.
Grace Therapeutics, Inc. (NASDAQ: GRCE) filed a Form 8-K on 23 June 2025 under Item 2.02 to furnish – not file – its financial results for the fiscal year ended 31 March 2025.
The filing itself contains no numerical data; instead, it attaches a press release (Exhibit 99.1) that presumably holds the detailed results. Management explicitly states that the furnished information is exempt from Section 18 liability and will not be incorporated into other SEC filings unless specifically referenced.
No additional items (e.g., acquisitions, capital raises, leadership changes) were disclosed. Consequently, investors must review Exhibit 99.1 to evaluate revenue, earnings, cash position, or guidance. Until those figures are consulted, the market impact of this disclosure remains indeterminate.