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PRINCETON, N.J. – Grace Therapeutics Inc. (NASDAQ:GRCE), a $32.85 million market cap biotechnology company whose stock has gained over 37% in the past six months, has announced successful outcomes from its Phase 3 STRIVE-ON safety trial, which met its primary endpoint, indicating that GTx-104, its intravenous nimodipine formulation, could offer clinical benefits for patients with aneurysmal Subarachnoid Hemorrhage (aSAH) compared to the oral version of the drug.
The STRIVE-ON trial, which included 102 patients hospitalized with aSAH, aimed to evaluate the incidence of clinically significant hypotension, a potential side effect of nimodipine, which is used to treat aSAH. The findings revealed a 19% reduction in hypotension episodes in patients treated with GTx-104 compared to those receiving oral nimodipine. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $8.02 to $12.33, suggesting significant upside potential from current levels.
Additionally, the trial reported that 54% of the GTx-104 group achieved a relative dose intensity (RDI) of 95% or higher, significantly higher than the 8% in the oral nimodipine group. Patients treated with GTx-104 also demonstrated a 29% relative increase in favorable outcomes at a 90-day follow-up on the modified Rankin scale, a measure of disability.
Other benefits observed with GTx-104 included fewer intensive care unit (ICU) readmissions, less time spent in the ICU, and a reduced need for mechanical ventilation. The safety profile of GTx-104 was comparable to oral nimodipine, with no new safety issues identified.
Grace Therapeutics plans to submit a New Drug Application (NDA) for GTx-104 in the first half of 2025, following these promising results. The company’s CEO, Prashant Kohli, expressed optimism about the trial’s outcomes and the potential pharmacoeconomic advantages of GTx-104 for aSAH patients.
Dr. Loch MacDonald, Chief Medical (TASE:PMCN) Officer, emphasized the lack of significant innovation in aSAH treatment for nearly four decades, suggesting that GTx-104 could be a breakthrough for patient care.
GTx-104 is designed for IV infusion in aSAH patients to address unmet medical needs and potentially simplify administration in the ICU, especially for unconscious or dysphagic patients. The drug has been tested in over 150 healthy volunteers and has shown lower pharmacokinetic variability compared to oral nimodipine.
Grace Therapeutics, focusing on rare and orphan diseases, has secured Orphan Drug Designation for its lead clinical assets, including GTx-104, which grants seven years of marketing exclusivity post-launch in the United States.
This article is based on a press release statement from Grace Therapeutics, Inc.
In other recent news, Grace Therapeutics, a biopharmaceutical company, has announced agreements to secure up to $30 million in financing. The investment is spearheaded by Nantahala Capital and ADAR1 Partners, LP, with additional contributions from healthcare-focused institutional investors. The company has initially received $15 million and may receive an additional $15 million upon the exercise of warrants by the investors. Over 4.4 million shares of common stock or pre-funded warrants will be issued by Grace Therapeutics at a price of $3.395 per share. These warrants will become exercisable upon the U.S. Food and Drug Administration’s approval of the New Drug Application for GTx-104 or by September 25, 2028. The proceeds from this placement are intended to fund pre-commercial development of GTx-104, the company’s lead clinical asset, and for general corporate purposes. The securities offered in the financing are not yet registered under the Securities Act of 1933, but Grace Therapeutics has committed to filing a registration statement for the resale of the shares and warrants.
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