DSGN - Larimar: Stronger Buy Now More Than Ever After Partial Clinical Hold Completely Removed

2024-05-31 16:11:42 ET

Summary

• Partial clinical hold from FDA, for use of nomlabofusp for the treatment of patients with Friedreich's Ataxia completely lifted; higher dosing of 50 mg of treatment now possible.
• It is expected that the global Friedreich's Ataxia market could reach $2.06 billion by 2030.
• Interim data from the ongoing phase 2 open-label study, using nomlabofusp for the treatment of patients with Friedreich's Ataxia, expected Q4 of 2024.
• Nomlabofusp for the treatment of patients with Friedreich's Ataxia selected as part of the FDA pilot program known as START, which is intended to accelerate the development of drugs that target rare unmet medical needs.

Larimar Therapeutics ( LRMR ) has had a few hiccups since I last wrote about this biotech. This was in a prior Seeking Alpha article I wrote entitled " Larimar: Friedreich's Ataxia Drug With Significant Potential ". In this article, I noted that its drug nomlabofusp had already proven itself in being able to raise frataxin levels in patients with FA. However, since then, there have been a few developments which have set this company on track to have a better shot at receiving approval of this specific drug. One key development, which I believe greatly frees up this biotech, is that the FDA had completely lifted the partial clinical hold on this program. More about this below, but it all started off with a full clinical hold back in 2021 and until now, had been riddled with a partial hold, only being able to dose patients with 25 mg of nomlabofusp for FA....

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