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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.
Grace Therapeutics, Inc. (Nasdaq: GRCE) has filed its Form 10-K for the fiscal year ended 31 March 2025. The company remains a non-accelerated filer and smaller reporting company, indicating a market capitalization below SEC thresholds; non-affiliate market value was $24.0 million as of 30 September 2024. A total of 13,828,562 common shares were outstanding on 19 June 2025.
The filing reiterates management’s strategy to build a late-stage pharmaceutical business focused on rare and orphan diseases through its proprietary drug-delivery technologies. Development resources are being prioritized toward lead candidate GTx-104, an intravenous formulation of nimodipine intended to manage hypotension in aneurysmal subarachnoid hemorrhage patients via the FDA’s 505(b)(2) pathway, with potential orphan-drug exclusivity. GTx-102 (Ataxia Telangiectasia) and GTx-101 (post-herpetic neuralgia) have been de-prioritized; management will seek licensing or sale opportunities for these assets.
The forward-looking statements section outlines numerous operational and regulatory assumptions, including dependence on third-party CROs/CMOs, patent strategy, and the need for additional financing. Key risks cited are (i) single-asset dependency on GTx-104, (ii) clinical failure risks inherent in rare-disease drug development, (iii) reimbursement uncertainty, (iv) absence of internal manufacturing capabilities, and (v) intellectual-property challenges.
No income-statement, balance-sheet or cash-flow tables are provided in the excerpt, and the company has not yet secured commercial revenue. The report confirms ongoing SEC compliance (all reports filed, all XBRL data submitted) and that the auditor did not provide an attestation of internal control over financial reporting under SOX 404(b), consistent with its filer status.
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