RegulatoryCompany release

Larimar completes rolling BLA for nomlabofusp in Friedreich's ataxia, seeks accelerated FDA approval

🇺🇸 Larimar Therapeutics, Inc. (LRMR) · Mon 09 Nov 2026

The filing rests on skin frataxin as a possible novel surrogate endpoint, with the Phase 3 FORWARD-FA confirmatory trial still enrolling.

Larimar Therapeutics said on 9 November 2026 that it has completed its rolling Biologics License Application (BLA) to the US Food and Drug Administration for nomlabofusp, seeking accelerated approval in Friedreich's ataxia.

The submission relies on skin frataxin as a potential novel surrogate endpoint. It is supported by data from open-label studies. The company's Phase 3 FORWARD-FA confirmatory trial is currently enrolling patients.

Larimar expects the FDA to accept the filing in early 2027. It is targeting approval in mid-2027 and a commercial launch in the third quarter of 2027.

For context, accelerated approval allows the FDA to authorise medicines for serious conditions on the basis of a surrogate endpoint considered reasonably likely to predict clinical benefit, with confirmatory trials required after approval.

What it means for your team

  • Regulatory teams should watch the FDA's filing decision, expected in early 2027, for how the agency views skin frataxin as a surrogate endpoint.
  • The open-label evidence base and the ongoing FORWARD-FA confirmatory trial will shape the accelerated approval pathway for this application.
  • Market-access teams in rare neurological disease can use the company's stated timeline of mid-2027 approval and a Q3 2027 launch for planning, noting that these are company targets, not FDA commitments.

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

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

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