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Larimar Therapeutics: FDA Guidance Boosts Buy Rating Amid Promising Regulatory Progress

Larimar Therapeutics: FDA Guidance Boosts Buy Rating Amid Promising Regulatory Progress

Analyst Cory Jubinville, PhD of LifeSci Capital maintained a Buy rating on Larimar Therapeutics (LRMRResearch Report), retaining the price target of $40.00.

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Cory Jubinville, PhD has given his Buy rating due to a combination of factors surrounding Larimar Therapeutics’ recent regulatory update. The company received favorable written guidance from the FDA regarding the safety database requirements for their lead asset, nomlabofusp, which is a frataxin replacement therapy for Friedreich’s ataxia. This guidance provides clarity on the path toward a Biologics License Application (BLA) submission, now anticipated for the second quarter of 2026. The FDA’s comfort with a smaller sample size for the safety database, despite previous anaphylaxis events, indicates a positive view of the therapy’s benefit-risk profile.
Additionally, the FDA’s acceptance of skin frataxin levels as a supportive endpoint for accelerated approval further underscores the potential of nomlabofusp in addressing a significant unmet need in a devastating rare disease. This regulatory progress positions Larimar as an attractive investment opportunity with asymmetric risk-reward potential over the next year. The favorable sentiment from the FDA, combined with the company’s strategic advancements, supports the Buy rating given by Cory Jubinville, PhD.

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