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On Tuesday, Jones Trading reaffirmed its Buy rating and a $14.00 price target for Larimar Therapeutics (NASDAQ:LRMR), following the company’s fourth-quarter earnings release. The stock, currently trading at $2.28, sits near its 52-week low of $2.25, having declined nearly 70% over the past year. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $10 to $40. The focal point of the report was the U.S. Food and Drug Administration’s (FDA) response concerning the use of frataxin (FXN) concentration in the skin as a surrogate endpoint for accelerated approval of treatments. With a market capitalization of $144 million, Larimar maintains a strong financial position, holding more cash than debt and maintaining a healthy current ratio of 8.02.
Larimar Therapeutics announced that the FDA has shown willingness to consider skin FXN concentration as a potential surrogate endpoint. The regulatory body has acknowledged that data submitted by Larimar demonstrates a sufficient correlation between skin FXN levels and those in critical tissues such as the heart and skeletal muscle. This development is seen as a positive step, although confirmation of skin FXN as a surrogate endpoint will likely remain uncertain until the Biologics License Application (BLA) acceptance.
Later in 2025, Larimar Therapeutics plans to begin a confirmatory Phase 3 study with an estimated 100-150 ambulatory patients with Friedreich’s ataxia (FA), who will undergo treatment for a period of 18 months. In the interim, September 2025 is set for the release of data from an ongoing open-label extension (OLE) study at a 50mg dosing level. This forthcoming data is anticipated to provide more substantial insights compared to the 25mg OLE data released in December, due to the higher dosage and extended duration of treatment.
Jones Trading’s analyst reiterated the firm’s positive stance on Larimar Therapeutics, emphasizing the significance of the upcoming clinical data and the potential for the FDA to recognize skin FXN as a surrogate endpoint for drug approval. The maintained price target reflects the analyst’s continued confidence in the company’s prospects. InvestingPro analysis indicates the stock is currently undervalued, with 13 additional key insights available to subscribers, including detailed financial health metrics and growth indicators. Access the comprehensive Pro Research Report for deeper analysis of LRMR’s investment potential.
In other recent news, Larimar Therapeutics has been making significant strides with its drug candidate, nomlabofusp, aimed at treating Friedreich’s ataxia (FA). Financially, Larimar reported a net loss of $28.8 million for the fourth quarter of 2024, with $183.5 million in cash and marketable securities as of December 31, 2024, indicating a solid financial position to support ongoing development. The company plans to submit a Biologics License Application (BLA) by the end of 2025, with the FDA open to using skin frataxin concentrations as a surrogate endpoint for accelerated approval. Analysts from H.C. Wainwright, Citi, and JMP Securities have maintained their Buy ratings on Larimar, with price targets of $16, $14, and $21, respectively, reflecting confidence in the company’s regulatory progress and market potential for nomlabofusp.
Citi highlighted the FDA’s guidance on an accelerated approval pathway, despite an identified anaphylaxis signal, while JMP Securities noted the commencement of pediatric dosing as an indicator of the FDA’s comfort with the drug’s safety profile. Larimar has amended its Open-Label Extension (OLE) study protocol to include premedication to reduce allergic reactions, and results from both adult and adolescent trials are expected to be pivotal for the company’s future. Additionally, Larimar has awarded performance-based restricted stock units to key executives, tying compensation to the achievement of specific regulatory milestones, as part of its 2020 Equity Incentive Plan. This strategic move aligns executive performance with the company’s objectives, aiming to enhance shareholder value through successful drug development and regulatory approvals.
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