Cytokinetics’ heart disease drug shows improvement over standard of care in study

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(Reuters) – Cytokinetics said on Tuesday its experimental heart disease drug significantly improved patients’ ability to exercise compared to standard-of-care treatment in a late-stage study, sending shares of the company up more than 5% in premarket trading.

The keenly watched drug, aficamten, met the study’s main goal of significantly increasing oxygen uptake during exercise compared to metoprolol after 24 weeks of treatment, the company said.

The drug is being developed to treat obstructive hypertrophic cardiomyopathy (oCHM), a condition that makes heart muscles stiff and can cause cardiac arrest.

“We believe these data provide compelling evidence to support aficamten’s first-line opportunity in oHCM to drive further adoption,” Piper Sandler analyst Yasmeen Rahimi wrote in a client note.

The U.S. Food and Drug Administration is set to decide on aficamten by December 26.

The drug’s safety and tolerability were favorable in comparison to metoprolol, the company said, adding that it will present full results from the 175-patient study at an upcoming medical meeting.

The study “win can encourage physicians to use more aficamten, or switch patients earlier, even if payers will ultimately be the biggest hurdle to earlier line use,” according to RBC Capital analysts.

They estimate $900 million in peak sales for aficamten as a first-line treatment alone by 2034 and project a total revenue opportunity of $3.9 billion for the drug.

The drug in 2023 met the main goal in a separate late-stage study, improving patients’ exercise capacity compared to placebo after 24 weeks of treatment. Analysts had said the drug also showed favorable safety and efficacy compared to rival treatment Camzyos from Bristol Myers Squibb.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh Kuber and Shinjini Ganguli)