Citi maintains Buy on Larimar stock with $14 target following FDA nod

Published 25/03/2025, 10:14
Citi maintains Buy on Larimar stock with $14 target following FDA nod

On Tuesday, Citi reiterated its Buy rating on Larimar Therapeutics (NASDAQ:LRMR) shares with a price target of $14.00. According to InvestingPro data, this target represents significant upside potential from the current price of $2.28, which is trading near its 52-week low of $2.25, compared to its high of $11.20. Citi’s latest commentary follows Larimar’s announcement that the U.S. Food and Drug Administration (FDA) has provided guidance on an accelerated approval pathway for the company’s drug candidate, nomla, in treating Friedreich’s ataxia (FA). The company maintains a strong financial position, with InvestingPro analysis showing a healthy current ratio of 8.02 and minimal debt-to-capital ratio of 0.03.

The FDA has indicated that frataxin concentrations could be used as a reasonably likely surrogate endpoint (RLSE), which is a clinical trial measure that can predict therapeutic benefit. The agency has advised Larimar to focus on skin frataxin levels due to lower variability compared to buccal (mouth) measurements. The FDA also recognized the correlation between skin frataxin levels and those in other relevant tissues, as supported by Larimar’s non-clinical data.

Larimar is currently in ongoing discussions with the FDA to finalize the safety database required for a Biologics License Application (BLA) submission, which is expected by the end of 2025.

Citi’s endorsement comes despite a recent challenge for Larimar, as the company confirmed a drug-related anaphylaxis signal. Nonetheless, Citi believes this recent adversity has been overshadowed by the positive regulatory development, emphasizing the favorable risk/reward balance for Larimar’s shares. The firm suggests that the current trading price of Larimar’s stock, which is below the company’s cash level, presents a buying opportunity.

Citi’s assessment underscores the significance of the FDA’s feedback for Larimar Therapeutics as it progresses towards potential approval and commercialization of its FA treatment. For deeper insights into Larimar’s financial health and growth prospects, including 13 additional ProTips and comprehensive valuation metrics, explore the detailed Pro Research Report available on InvestingPro.

In other recent news, Larimar Therapeutics reported significant progress in its discussions with the FDA regarding its leading drug candidate, nomlabofusp, for Friedreich’s ataxia. The FDA has shown willingness to consider skin frataxin concentrations as a surrogate endpoint for accelerated approval, aiding Larimar’s planned Biologics License Application submission by the end of 2025. Financially, Larimar disclosed a robust position with $183.5 million in cash and equivalents as of December 31, 2024, despite a net loss of $28.8 million in the fourth quarter. The company has also initiated a pediatric pharmacokinetic study, with results expected in September 2025.

In company developments, Larimar awarded performance-based restricted stock units to key executives, aligning compensation with regulatory milestones. This strategic move aims to motivate management to achieve significant drug development and regulatory goals. Analyst firm JMP Securities maintained a Market Outperform rating on Larimar, with a price target of $21, citing confidence in the company’s progress towards its BLA submission. The firm also noted the initiation of pediatric dosing as a positive indicator of the drug’s safety profile.

JMP Securities highlighted upcoming data releases from Larimar’s ongoing trials as potential catalysts for the company’s stock. The analyst firm emphasized that nomlabofusp could stand out among Friedreich’s ataxia treatments due to its potential to address the disease’s root cause. These developments reflect Larimar’s continued focus on advancing nomlabofusp as a promising therapy for a broad patient population.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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