Grace Therapeutics Aktie

Grace Therapeutics announced the closing of a private placement to issue 4,761,904 common shares at $2.10 each, expected to raise about $10 million before costs. The company intends to use the proceeds to fund manufacturing and regulatory work for GTx-104, an injectable nimodipine formulation for aSAH. Grace expects the funds, together with existing cash, to extend its cash runway to the end of 2028; the transaction is expected to close on August 6, 2026. The company has initiated a technology transfer to a second U.S. contract manufacturer and is working to address outstanding CMC and FDA issues from the Complete Response Letter. » Altro su de.investing.com

Grace Therapeutics received an FDA Complete Response Letter for GTx-104 that raised no clinical safety or efficacy concerns but cited cGMP compliance issues at a contract manufacturer and requested additional data on extractables/leachables and toxicology assessments. The company is pursuing a two-source strategy and is transferring technology to a second US contract manufacturer while the existing partner addresses the deficiencies and aims for inspection readiness. Grace plans to complete the required nonclinical studies; a further FDA review will be needed once the deficiencies are remedied. GTx-104 is an injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage with orphan drug designation; the STRIVE-ON study met its primary endpoint but showed more deaths in the treatment arm versus oral nimodipine, with no link to the therapy. » Altro su de.investing.com

Grace Therapeutics published results for the quarter ended March 31, 2026: earnings per share were -$0.06, compared with $0.10 a year earlier. For the full year, loss per share was -$0.47, compared with -$0.79 in the prior year. » Altro su finanzen.net