FDA Removed Partial Clinical Hold For Larimar Therapeutics' Nomlabofusp Program In Friedreich's Ataxia
Portfolio Pulse from Benzinga Newsdesk
The FDA has removed the partial clinical hold on Larimar Therapeutics' Nomlabofusp program for Friedreich's Ataxia. This decision follows a review of Phase 2 study data. Larimar plans to escalate the dose in their ongoing study and aims to submit a Biologics License Application by the second half of 2025.
May 20, 2024 | 8:07 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
The FDA has lifted the partial clinical hold on Larimar Therapeutics' Nomlabofusp program for Friedreich's Ataxia, allowing the company to proceed with dose escalation in their ongoing study. This regulatory milestone is a positive development for Larimar, potentially accelerating their path to market.
The removal of the partial clinical hold by the FDA is a significant regulatory milestone for Larimar Therapeutics. It allows the company to proceed with dose escalation in their ongoing study, which could accelerate the development timeline and improve investor sentiment.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100