บันทึกจากแหล่งปฐมภูมิ
The company updated its corporate deck with new open-label data showing sustained FXN increases and directional clinical improvements, and reaffirmed its plan to submit a BLA in Q2 2026 seeking accelerated approval based on skin FXN levels. The FDA has agreed with the revised dosing regimen after anaphylaxis cases.
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,
Larimar ได้รับการกำหนด Breakthrough Therapy Designation สำหรับ nomlabofusp ใน FA
Larimar: FDA มอบสถานะ Breakthrough Therapy Designation ให้ nomlabofusp ใน FA
Larimar: คาดความคืบหน้าด้านกฎระเบียบของ nomlabofusp ในไตรมาส 1 ปี 2026; ยื่น BLA ไตรมาส 2 ปี 2026