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Rhythm Pharmaceuticals is already worth more than six-times the market value it debuted at nearly a decade ago. Shares could continue their ascent if the Boston-based biotechnology company’s top drug, a once-daily shot called Imcivree, wins a key additional clearance by a March 20 decision deadline.
Rhythm already markets Imcivree for two rare, genetically driven forms of obesity. Since its initial 2020 approval, sales have steadily grown, topping $130 million in 2024 and reaching about $138 million over the first nine months of last year. But Rhythm is eyeing much broader use, starting with a type of obesity driven by injury to the hypothalamic region of the brain.
In clinical testing, Imcivree helped people with this “acquired hypothalamic obesity” lose about 20 percentage points more of their body weight than placebo recipients. Those results surpassed Wall Street expectations and opened up what analysts believe to be a more than $1 billion market opportunity.
On a conference call in September, executives said that, through market research, they’d already identified some 2,000 “diagnosed or suspected” U.S. patients and expect the total number to be north of there to be at least 10,000. Their condition is also distinct from general obesity, driven by a defect that causes “rapid, uncontrollable” weight gain and that can, in this case, be addressed by a targeted therapy, noted Leerink’s Faisal Khurshid, in a report following the discussion.
Rhythm’s path to approval hasn’t been clear-cut, however. The FDA in October called for additional analyses of the efficacy data in Rhythm’s trial. Those results were deemed a “major amendment” to the company’s application and delayed by three months the agency’s verdict. Multiple companies under current FDA leadership have seen surprise changes in guidance and slipping regulatory timelines, raising at least some concern about Rhythm’s application.
Still, the delay is “likely just a minor speedbump on the road to large success,” asserted Khurshid, in November, noting that the drug’s “efficacy profile remains strong.” — Ben Fidler
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