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On Tuesday, H.C. Wainwright reaffirmed its Buy rating and $16.00 price target for Larimar Therapeutics (NASDAQ:LRMR), representing significant upside potential from the current price of $2.28. According to InvestingPro data, the stock is trading near its 52-week low of $2.25, far below its high of $11.20, while analyst targets range from $10 to $40. The firm’s analyst highlighted the potential of Larimar’s drug candidate, nomlabofusp, which is being developed to treat Friedreich’s ataxia (FA), a rare and progressive neurodegenerative movement disorder with no current cure. Nomlabofusp, a recombinant fusion protein, aims to deliver tissue frataxin directly to the mitochondria, addressing the fundamental cause of FA.
Nomlabofusp has garnered significant regulatory designations, including Rare Pediatric Disease Designation, Fast Track Designation, and Orphan Drug Designation from the FDA. Additionally, it has received Orphan Drug Designation from the European Commission and PRIME designation by the EMA. The START pilot program by the FDA has also selected nomlabofusp, indicating a strong regulatory interest in the drug’s development.
Larimar Therapeutics now anticipates submitting a Biologics License Application (BLA) for accelerated approval by the end of 2025, a more precise timeline compared to the previous expectation of the second half of 2025. The company is considering using skin frataxin concentration as a novel surrogate endpoint for accelerated approval and is in ongoing discussions with the FDA regarding the sufficiency of safety data for the BLA submission.
Following a press release on Monday and subsequent discussions with the company’s management, H.C. Wainwright expressed increased confidence in a potential BLA submission by the end of 2025. The firm anticipates a commercial launch of nomlabofusp in 2026, with initial sales projected at $7 million and increasing to $366 million by 2030. InvestingPro analysis indicates the company, currently valued at $145.5M, maintains strong liquidity with a current ratio of 8.02, though it faces challenges with negative EBITDA of -$90.57M. Get deeper insights into Larimar’s financial health and growth potential with InvestingPro’s comprehensive research report, available along with 13 additional ProTips for this stock. The analyst’s reiterated Buy rating and price target reflect optimism in the drug’s market potential and the company’s regulatory progress.
In other recent news, Larimar Therapeutics has made significant strides with its lead drug candidate, nomlabofusp, for treating Friedreich’s ataxia (FA). The U.S. Food and Drug Administration (FDA) has shown openness to using skin frataxin concentrations as a surrogate endpoint for accelerated approval, a development crucial for Larimar’s planned Biologics License Application (BLA) submission by the end of 2025. Financially, Larimar reported a strong cash position of $183.5 million as of December 31, 2024, although it incurred a net loss of $28.8 million in the fourth quarter, mainly due to increased research and development expenses. Citi has maintained its Buy rating on Larimar, with a price target of $14, following the FDA’s positive guidance, despite a recent anaphylaxis signal related to the drug. Meanwhile, JMP Securities has also expressed confidence in Larimar, maintaining a Market Outperform rating with a $21 price target, citing progress towards the BLA submission and ongoing pediatric trials. Larimar has begun dosing pediatric patients, which JMP views as a sign of the FDA’s comfort with the drug’s safety profile. Additionally, the company has awarded performance-based stock units to key executives, linking compensation to the achievement of specific regulatory milestones. This strategic move aligns executive incentives with shareholder interests, encouraging progress in drug development and regulatory approvals.
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