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Larimar Therapeutics files initial BLA module for Nomlabofusp therapy
The company says it filed the first module of its Biologics License Application on June 29 and plans to submit additional modules in the second half of 2026.
Larimar Therapeutics (NASDAQ: LRMR) has submitted the initial module of its Biologics License Application to the U.S. Food and Drug Administration for its Nomlabofusp therapy, seeking approval on an accelerated basis, according to Yahoo Finance.
The company said it plans to submit the remaining BLA modules during the second half of 2026. Larimar also disclosed that Nomlabofusp showed positive outcomes in an open-label study of adult patients receiving daily injections to treat Friedreich's ataxia.
Larimar Therapeutics President and CEO Carole Ben-Maimon said the new data is an important step in developing the therapy. Yahoo Finance also states the FDA confirmed existing data is sufficient for approval because the application is based on skin frataxin, described as a new surrogate endpoint.
The story also notes that on June 30, Baird analyst Christopher Chen reduced his target price for the stock from $7 to $5 while reiterating an Outperform rating, citing revisions to the firm’s model tied to recent Nomlabofusp updates.
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