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Larimar Therapeutics Receives FDA Guidance for BLA Submission

Story Highlights
  • Larimar Therapeutics focuses on developing treatments for rare diseases, with nomlabofusp for Friedreich’s ataxia.
  • The FDA provided recommendations for nomlabofusp’s BLA, with a submission planned for Q2 2026 and key data expected in September 2025.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Larimar Therapeutics Receives FDA Guidance for BLA Submission

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Larimar Therapeutics ( (LRMR) ) just unveiled an announcement.

On June 23, 2025, Larimar Therapeutics announced that the FDA has provided safety database recommendations and a refined timeline for the Biologics License Application (BLA) submission for nomlabofusp, aimed at treating Friedreich’s Ataxia. The FDA’s recommendations include evaluating safety in at least 30 participants with continuous exposure for six months, with a subset exposed for one year, primarily on a 50 mg dose. Larimar plans to submit the BLA for accelerated approval in the second quarter of 2026, with ongoing global Phase 3 study activities and expected data releases in September 2025. This development is part of Larimar’s participation in the START program, which has been instrumental in expediting their clinical and regulatory efforts.

The most recent analyst rating on (LRMR) stock is a Buy with a $15.00 price target. To see the full list of analyst forecasts on Larimar Therapeutics stock, see the LRMR Stock Forecast page.

Spark’s Take on LRMR Stock

According to Spark, TipRanks’ AI Analyst, LRMR is a Neutral.

Larimar Therapeutics’ stock score reflects its early-stage biotech status with high R&D costs, no consistent revenue, and reliance on equity financing. Despite positive short-term technical indicators suggesting upward momentum, the lack of profitability and a negative P/E ratio weigh heavily on the stock. Valuation concerns and the absence of earnings call insights further impact the score.

To see Spark’s full report on LRMR stock, click here.

More about Larimar Therapeutics

Larimar Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Their lead compound, nomlabofusp, is being developed as a potential treatment for Friedreich’s ataxia. The company also aims to use its intracellular delivery platform to create other fusion proteins targeting additional rare diseases characterized by deficiencies in intracellular bioactive compounds.

Average Trading Volume: 1,234,625

Technical Sentiment Signal: Sell

Current Market Cap: $165.8M

For detailed information about LRMR stock, go to TipRanks’ Stock Analysis page.

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