Plano ng Larimar Therapeutics na maghain ng nomlabofusp BLA sa Q2 2026 para sa Friedreich’s Ataxia

In-update ng kumpanya ang corporate deck nito gamit ang bagong open-label data na nagpapakita ng patuloy na pagtaas ng FXN at directional clinical improvements, at muling pinagtibay ang plano nitong magsumite ng BLA sa Q2 2026 na naghahanap ng accelerated approval batay sa skin FXN levels. Sumang-ayon ang FDA sa revised dosing regimen matapos ang mga kaso ng anaphylaxis.

Mahahalagang fact

Na-file: Okt 14, 2025, 11:00 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: LRMRLarimar
Asset: nomlabofusp
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Pondo: $175.7 milyon
Taning ng pondo: hanggang Q4 2026
Pagkamit ng FXN: 100% ng mga kalahok sa Araw 180 ay may antas ng FXN sa balat na >50% ng malulusog na boluntaryo

Sipi mula sa source

EX-99.1 2 lrmr-ex99_1.htm EX-99.1 pro October 2025 Larimar Therapeutics Corporate Deck Forward-Looking Statements This presentation contains forward-looking statements that are based on the beliefs and assumptions of Larimar Therapeutics, Inc. ( “Company”) and on information currently available to management. All statements contained in this presentation other than statements of historical fact are forward-looking statements, including but not limited to Larimar’s ability to develop and commercialize nomlabofusp (CTI-1601) and any other planned product candidates, Larimar’s planned research and development efforts, including the timing of its nomlabofusp clinical trials and non-clinical investigations and overall development plan expectations with respect to the FDA START pilot program,

SEC 8-K