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On Tuesday, H.C. Wainwright reaffirmed its Buy rating and a price target of $15.00 for Larimar Therapeutics (NASDAQ:LRMR) following the company's presentation of data at the International Congress for Ataxia Research (ICAR). The data pertained to Larimar's lead product candidate, nomlabofusp, which is being developed as a potential treatment for Friedreich’s ataxia (FA), a rare and progressive neurodegenerative movement disorder currently without a cure.
Nomlabofusp, a subcutaneously administered recombinant fusion protein, aims to address frataxin deficiency, the fundamental cause of FA. The therapy has garnered significant designations from the FDA, including Rare Pediatric Disease Designation, Fast Track Designation, and Orphan Drug Designation. Additionally, the European Commission has granted it Orphan Drug Designation, and the EMA has given it PRIME designation.
Larimar presented findings from Phase 1 and Phase 2 dose exploration studies of nomlabofusp at ICAR, showcasing its administration in 61 adults with FA for short-term periods of up to 28 days. The results indicated that the drug was generally well tolerated and led to dose-dependent increases in frataxin levels. Moreover, improvements in gene expression and lipid profiles were observed in patients, aligning more closely with those of healthy individuals.
Looking forward, Larimar aims for a Biologics License Application (BLA) submission in the second half of 2025, with anticipation of commercial launch in 2026. Initial sales projections for nomlabofusp are estimated at $6 million for its launch year, with expectations of growth to $356 million by 2030. H.C. Wainwright's reaffirmation of its Buy rating and price target reflects these positive developments and projections for Larimar Therapeutics.
In other recent news, Larimar Therapeutics revealed promising results for its investigational treatment, nomlabofusp, in Phase 1 and Phase 2 studies for Friedreich’s ataxia (FA). The drug showed improved lipid profiles, modified gene expression, and increased frataxin levels in adults with FA. The company plans to provide a program update in mid-December 2024, with a Biologics License Application submission targeted for the second half of 2025.
In analyst news, Citi maintained its Buy rating on Larimar, focusing on the upcoming release of initial Open-Label Extension data for nomlabofusp. Leerink Partners also maintained an Outperform rating, anticipating key developments from the company's study data. Wedbush assigned an Outperform rating, predicting nomlabofusp could enter the market by FY27 and potentially generate $1,502M in revenue by FY31.
Jones Trading initiated coverage on Larimar with a Buy rating, forecasting that nomlabofusp could reach $1.3 billion in peak unadjusted sales by 2031. Baird initiated coverage with an Outperform rating, citing a 60% probability of nomlabofusp gaining approval, possibly with accelerated approval by 2026.
InvestingPro Insights
Recent InvestingPro data provides additional context to Larimar Therapeutics' (NASDAQ:LRMR) financial position and market performance. The company's market capitalization stands at $393.05 million, reflecting investor interest in its potential. Despite the positive outlook from H.C. Wainwright, it's important to note that Larimar is not currently profitable, with an adjusted operating income of -$73.76 million over the last twelve months.
InvestingPro Tips highlight that Larimar holds more cash than debt on its balance sheet, which could be crucial for funding its ongoing research and development efforts for nomlabofusp. Additionally, three analysts have revised their earnings upwards for the upcoming period, potentially indicating growing confidence in the company's prospects.
However, investors should be aware that the stock has taken a significant hit over the last week, with a 1-week price total return of -31.86%. This volatility may reflect the inherent risks associated with biotechnology companies in the development stage.
For those seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for Larimar Therapeutics, providing deeper insights into the company's financial health and market position.
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