Grace Therapeutics adds backup manufacturer as it works to refile brain-bleed drug after FDA rejection

Grace Therapeutics is hedging its manufacturing risk as it tries to get GTx-104, an intravenous nimodipine for aneurysmal subarachnoid hemorrhage, back before US regulators. The company said it has started transferring production to a second US contract manufacturer, while a corrective action plan continues at the one it already uses.

The disclosure came with fiscal second-quarter 2027 results, published on 12 November 2026 for the quarter ended 30 September. It follows the Complete Response Letter the FDA issued in April 2026. Grace says minutes from its later Type A meeting with the agency did not cite clinical safety or efficacy deficiencies. The outstanding work, it says, lies in chemistry, manufacturing and controls (CMC) and in non-clinical items.

Grace has not set a date for resubmitting its new drug application. It says timing will depend on which manufacturing site is ready first, so the two-track approach is meant to improve the odds of an earlier filing rather than commit the company to one route. The material provided does not say how long either track is expected to take.

On funding, Grace announced a $10m private placement, which it says extends its cash runway through 2028. No further detail on the terms of the placement was provided.

For context, a Complete Response Letter means the FDA has finished reviewing an application but cannot approve it as submitted. A Type A meeting is the type of sponsor-agency meeting used to unblock stalled development programmes, including after such a letter.