tiprankstipranks
Trending News
More News >

Strategic Opportunity and Management Confidence Underpin Buy Rating for Cytokinetics Despite FDA Delay

Leerink Partners analyst Roanna Ruiz has maintained their bullish stance on CYTK stock, giving a Buy rating on May 2.

Roanna Ruiz’s rating is based on several key considerations regarding Cytokinetics’ stock. Despite the unexpected three-month delay in the PDUFA date for aficamten due to the FDA’s request for a Risk Evaluation and Mitigation Strategy (REMS), Ruiz views this as a procedural issue rather than a reflection of any problems with the drug’s data. This delay, while potentially disappointing to investors anticipating a quicker approval, could provide Cytokinetics with an opportunity to negotiate a differentiated REMS compared to existing treatments, potentially enhancing aficamten’s market position upon approval.
Furthermore, Ruiz remains optimistic about Cytokinetics’ management’s confidence in aficamten’s unique profile and the potential for a differentiated label and risk mitigation strategy. Although there are outstanding questions about the FDA’s motivations and the final REMS requirements, Ruiz believes that these factors do not fundamentally alter the drug’s approval prospects. This combination of strategic opportunity and management confidence underpins the Buy rating for Cytokinetics’ stock.

Ruiz covers the Healthcare sector, focusing on stocks such as Cytokinetics, Cormedix, and United Therapeutics. According to TipRanks, Ruiz has an average return of -12.6% and a 33.94% success rate on recommended stocks.

In another report released on May 2, H.C. Wainwright also reiterated a Buy rating on the stock with a $120.00 price target.

Disclaimer & DisclosureReport an Issue