Rhythm compelled to attend for Imcivree growth as FDA delays resolution
The US Meals and Drug Administration (FDA) has prolonged the assessment interval for expanded approval of Rhythm Prescribed drugs’ Imcivree (setmelanotide) for a type of weight problems attributable to harm to the mind.
The corporate had been hoping to know whether or not its lead product would acquire a label extension to deal with acquired hypothalamic weight problems by 20 December 2025, however the FDA has pushed again the Prescription Drug Person Price Act (PDUFA) purpose date to twenty March 2025.
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Rhythm’s inventory dipped 6.2% to $98.43 per share at market open on 7 November following the PDUFA delay, in comparison with a $104.99 market shut on 6 November. The pharma firm has a market cap of $6.4bn.
The assessment extension comes because the FDA has requested the pharma firm for added sensitivity analyses of scientific efficacy knowledge from the Section III TRANSCEND trial (NCT05774756) that evaluated Imcivree in sufferers with acquired hypothalamic weight problems.
Hypothalamic weight problems is a uncommon dysfunction attributable to harm to the hypothalamus within the mind, resulting in uncontrollable weight acquire as a result of extreme starvation and a lowered metabolic charge.
TRANSCEND met its major endpoint of discount in physique mass index (BMI) in each grownup and paediatric sufferers versus placebo, based on an April 2025 readout.
Although the FDA has requested no new knowledge, the extra data displays a serious modification to Rhythm’s supplemental new drug software (sNDA), permitting the FDA extra time to go over the submission. There have been no security issues or manufacturing points, which means the additional analyses is all Rhythm is tasked with finishing.
Rhythm’s CEO David Meeker stated: “Imcivree has demonstrated a compelling product profile, and we have each confidence that these extra sensitivity analyses verify the energy of the information and Imcivree’s potential to learn sufferers with hypothalamic weight problems.”
Given as an injection, Imcivree is Rhythm’s sole FDA-approved product. The melanocortin 4 (MC4) receptor agonist is indicated for continual weight administration in adults and sure paediatric sufferers with monogenic or syndromic weight problems as a result of problems. These embody Bardet-Biedl syndrome (BBS) or deficiencies in pro-opiomelanocortin (POMC) or leptin receptor (LEPR) genes – each problems result in weight problems, amongst different signs. An growth into hypothalamic weight problems would mark the primary permitted remedy for the dysfunction.
Meeker added: “We recognize and proceed to collaborate with the FDA assessment staff and we are also persevering with to advance our preparations to ship Imcivree to a affected person group that at present has no remedy choices permitted for acquired hypothalamic weight problems.”
Imcivree’s gross sales and continued optimistic trial readouts have fuelled vital development for Rhythm over the previous 12 months. Imcivree generated gross sales of $51.3m in Q3 2025, up 6% from Q2 2025. This determine can be up a hefty 35% on the $33.3m from Q3 2024.
Web revenues for Imcivree totalled $137.5m for the 9 months of 2025, up the same 36% from the $88.3m throughout the identical interval final 12 months.
Development is anticipated to proceed for the drug, significantly if the FDA approves the hypothalamic weight problems indication. With gross sales predicted to achieve $1.2bn, Imcivree is forecast to achieve blockbuster standing by 2030, based on GlobalData’s Pharma Intelligence Heart.
GlobalData is the guardian firm of Pharmaceutical Expertise.
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