RegulatoryCompany release

Grace Therapeutics starts second US CMO transfer for GTx-104 after FDA complete response

🇺🇸 Grace Therapeutics, Inc. (GRCE) · Thu 12 Nov 2026

The company says Type A meeting minutes cited no clinical safety or efficacy deficiencies, and a $10M private placement extends its cash runway through 2028.

Grace Therapeutics reported fiscal second-quarter 2027 results on 12 November 2026, for the quarter ended 30 September, alongside an update on GTx-104. The product is an intravenous formulation of nimodipine for aneurysmal subarachnoid hemorrhage.

The update follows the US Food and Drug Administration's Complete Response Letter in April 2026. According to the company, minutes from its subsequent Type A meeting with the agency cited no clinical safety or efficacy deficiencies. Grace says it is now working through chemistry, manufacturing and controls (CMC) items and non-clinical items.

To address the manufacturing issues, the company has begun technology transfer to a second US contract manufacturing organisation (CMO). This runs in parallel with a corrective action plan at its current CMO. Timing of the NDA resubmission will depend on whichever site is ready first.

Grace also announced a $10M private placement, which it says extends its cash runway through 2028. The source material available does not give a resubmission date.

As general context, a Complete Response Letter signals that the FDA has completed its review of an application but cannot approve it in its present form. A Type A meeting is the category of sponsor-FDA meeting used to resolve stalled development programmes, including after such a letter.

What it means for your team

  • A dual-site manufacturing strategy can shorten the path to resubmission, but timing now depends on which CMO site is ready first.
  • Quality and CMC teams should note that the reported issues sit in manufacturing and non-clinical areas, not clinical safety or efficacy, according to the company's account of the Type A minutes.
  • Regulatory teams tracking GTx-104 should watch for a confirmed resubmission date and for how the FDA classifies the resubmission.
  • Companies facing manufacturing-related CRLs may find a parallel corrective action and second-site transfer a useful risk-mitigation model.

Company's press release (SEC filing): Grace Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Grace Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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