Fiserv earnings missed by $0.61, revenue fell short of estimates
Investing.com - Truist Securities lowered its price target on Scholar Rock (NASDAQ:SRRK) to $44.00 from $54.00 on Monday, while maintaining a Buy rating on the stock. The adjustment comes as the stock has fallen nearly 18.5% in the past week, though analyst targets still range from $43 to $53, according to InvestingPro data.
The price target reduction follows a Complete Response Letter (CRL) for the company’s apitegromab drug candidate, which has prompted Truist to adjust its timeline expectations for the product’s commercial launch. Despite current challenges, InvestingPro data shows the company maintains strong liquidity with a current ratio of 6.33, indicating ample resources to navigate the extended timeline.
Truist analyst Srikripa Devarakonda now projects a first half 2027 launch for apitegromab, based on feedback from regulatory key opinion leaders, analysis of previous CRL resolution timelines, and discussions with Scholar Rock management.
Despite the delayed timeline, Truist remains positive on Scholar Rock, noting that apitegromab faces "limited regulatory risk, limited clinical trial risk (+ve Ph3 data), and limited/no competition."
The firm’s updated price target reflects the adjusted commercial timeline, with Truist indicating that earlier approval would represent upside to their current estimates.
In other recent news, Scholar Rock Holding Corp faced significant regulatory challenges after the FDA issued an Official Action Indicated (OAI) status for a Catalent manufacturing site involved in the production of its lead drug candidate, Apitegromab. This development was confirmed by Novo Nordisk, which owns the Catalent Indiana facility, following an FDA inspection that resulted in a Form FDA 483 being issued earlier. The OAI classification suggests that the FDA has identified conditions requiring regulatory or administrative action, potentially delaying Scholar Rock’s biologics license application resubmission. Scholar Rock acknowledged these issues, emphasizing that they pertain to procedural matters at the manufacturing site rather than the drug itself. Despite these setbacks, BofA Securities has initiated coverage on Scholar Rock with a Buy rating and a price target of $53.00, expressing optimism about the company’s development of Apitegromab. The company received a Complete Response Letter from the FDA due to these site issues, which contributed to a decline in its stock value. Scholar Rock continues to navigate these regulatory hurdles as it works toward resolving the manufacturing concerns.
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