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On Monday, Leerink Partners shifted its stance on Fulcrum Therapeutics (NASDAQ:FULC), upgrading the stock from Market Perform to Outperform and setting a new price target of $12.00. The decision comes as the company nears the release of its 12mg sickle-cell disease (SCD) data, with Leerink citing the promising results observed so far and the potential for improvement with longer or higher dosing. According to InvestingPro data, FULC has demonstrated remarkable momentum with a 98% surge over the past six months, though the stock remains below its 52-week high of $10.13.
Leerink highlighted the progress of Fulcrum’s leading drug candidate, pociredir (FTX-6058), in treating SCD. Despite previous challenges, including an FDA clinical hold, Fulcrum under CEO Alex Sapir’s leadership has successfully resumed its phase 1b PIONEER study, with enrollment now complete for the 12mg cohort. Leerink anticipates the data from this cohort to be available in early Q3 2025, with further results from the 20mg cohort expected by the end of the year. InvestingPro analysis reveals the company maintains a strong financial position with more cash than debt and a healthy current ratio, suggesting adequate resources to support its clinical programs.
The upgrade reflects Leerink’s optimism about Fulcrum’s potential in the SCD market, especially after the withdrawal of Pfizer (NYSE:PFE)’s Oxbryta (voxelotor) and the slow uptake of gene therapy alternatives. The firm’s analysts have also increased their gross peak sales estimates for Fulcrum to approximately $600 million, up from the previous $300 million, and doubled the probability-of-success rate to 50%. With a market capitalization of approximately $348 million and revenue of $80 million in the last twelve months, the company shows significant growth potential.
The market has already shown confidence in Fulcrum’s approach, with the company’s stock price rising by 30% year-to-date, outperforming the broader biotech index. Leerink believes that there is still significant upside potential, particularly if Fulcrum can expand its addressable patient population, an outcome that may become clearer in 2026. Based on InvestingPro’s Fair Value analysis, FULC appears undervalued at current levels. Subscribers can access 8 additional ProTips and a comprehensive Pro Research Report that provides deeper insights into Fulcrum’s financial health and growth prospects.
Leerink’s analysis suggests that the upcoming data could greatly impact the stock, with potential gains of up to 100% balanced against a 40% downside. Fulcrum’s focus on an oral small molecule approach to treat SCD appears to be gaining traction with investors, and the firm is positioning itself as a strong player in the space.
In other recent news, Fulcrum Therapeutics reported its Q1 2025 earnings, revealing a net loss of $17.7 million, an improvement compared to the $26.9 million loss in Q1 2024. Despite this progress, the company slightly missed earnings per share (EPS) forecasts, reporting an EPS of -$0.28 against the expected -$0.26. This EPS miss contributed to a 5.71% decline in premarket trading. Fulcrum’s strategic focus on cost management led to a decrease in Research and Development expenses, which fell to $13.4 million from $19.8 million in the previous year. The company also reduced General and Administrative expenses to $7.0 million from $10.1 million in Q1 2024. Fulcrum’s cash reserves, which stand at $226.6 million, are projected to support operations through at least 2027. The company continues to advance its lead program, Vociridere, with the completion of enrollment in the 12mg cohort of the PIONEER trial for sickle cell disease. Looking ahead, Fulcrum plans to report data from this cohort in early Q3 2025 and aims to initiate a 20mg cohort later this year.
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