Citi maintains Cytokinetics stock Buy rating, $86 target

On Monday, Cytokinetics (NASDAQ:CYTK), currently valued at $5.1 billion, received continued support from Citi, with analyst David Lebowitz reiterating a Buy rating and an $86.00 price target on the company’s shares. According to InvestingPro data, analyst price targets for the stock range from $60 to $120, reflecting strong institutional confidence in the company’s potential. Cytokinetics has recently completed a midcycle review with the FDA for its aficamten New Drug Application (NDA) in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The company announced through an SEC filing that the FDA does not plan to hold an advisory committee meeting for the review.

The management at Cytokinetics remains confident in the potential for a differentiated label and risk mitigation profile for aficamten upon FDA approval. This optimism comes despite recent label updates to Camzyos, a competing drug developed by Bristol Myers (NYSE:BMY) Squibb. The company’s strong financial position, with a current ratio of 6.17 and liquid assets exceeding short-term obligations according to InvestingPro, provides substantial runway for its development programs. Analysts are watching closely to see how aficamten’s label will compare, especially in terms of dose titration, as Cytokinetics’ treatment is believed to have an improved safety profile.

Cytokinetics is looking forward to a late-cycle meeting with the FDA scheduled for June. The outcome of this meeting could provide further insights into the FDA’s view on aficamten and its potential place in the market for oHCM treatments. The company’s progress and the FDA’s decision not to convene an advisory committee are significant steps toward the potential approval of aficamten.

The stock’s future performance hinges on the ongoing review process and the company’s ability to secure FDA approval for aficamten. Currently trading near its 52-week low of $40.53, the stock has seen significant volatility, with revenue growing 145% over the last twelve months despite ongoing losses. Investors and stakeholders in the biopharmaceutical sector are keeping a close eye on these developments, as they could have a considerable impact on Cytokinetics’ market position and financial outlook. For deeper insights into CYTK’s valuation and growth prospects, access the comprehensive Pro Research Report available on InvestingPro, which provides detailed analysis of the company’s financial health and market position.

Cytokinetics has not disclosed detailed updates on the substance of the midcycle review meeting, in line with their prior communication strategy. However, the company’s management has consistently expressed confidence in the drug’s profile and its prospects for approval. As the review process continues, market observers will be awaiting further announcements and regulatory milestones that could influence the stock’s trajectory.

In other recent news, Cytokinetics announced its fourth-quarter 2024 earnings, reporting a slight miss in earnings per share (EPS) with a figure of -$1.26, compared to the forecasted -$1.22. Despite this, the company demonstrated significant revenue growth, achieving $16.9 million in Q4 2024, a notable increase from $1.7 million in the same period last year. In terms of future expectations, the company is preparing for a potential U.S. commercial launch of its drug Afikamten in September 2025, pending FDA approval. Morgan Stanley (NYSE:MS) analysts have upgraded Cytokinetics to an Overweight rating, setting a price target of $67, citing anticipated developments such as the release of the MAPLE-HCM study data in 2025 and potential approval of Afikamten.

Cytokinetics has also provided financial guidance for 2025, projecting GAAP operating expenses to range between $670 million and $710 million, with stock-based compensation expenses estimated between $110 million and $120 million. The company maintains a strong cash position, with $1.2 billion in cash and investments, supporting its ongoing clinical trials and commercial preparations. Additionally, Cytokinetics is expecting a mid-cycle meeting with the FDA in March, following the submission of a 120-day safety update. The company is also expanding its commercial infrastructure in Europe and preparing for market entry in China through a partnership with Sanofi (NASDAQ:SNY).

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.