Rhythm Pharmaceuticals received a three‑month extension from the U.S. Food and Drug Administration to review its supplemental New Drug Application for setmelanotide in acquired hypothalamic obesity, moving the PDUFA goal date from December 20 2025 to March 20 2026.
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Rhythm Pharmaceuticals announced that it has secured product listing agreements in Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia, and the Federal Non‑Insured Health Benefits program, enabling public reimbursement for its rare‑obesity therapy IMCIVREE (setmelanotide) for patients with Bardet‑Biedl syndrome and obesity. The agreements cover adult and pediatric patients aged six and older who have clinically or genetically confirmed Bardet‑Biedl syndrome and obesity, removing a key barrier to access in Canada.
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Rhythm Pharmaceuticals reported third‑quarter 2025 net product revenue of $51.3 million, a 6 % sequential increase and a 54 % year‑over‑year rise from $33.3 million in Q3 2024. The company posted a net loss of $54.3 million, up from $45.0 million in the same quarter last year, and a net loss per share of $0.82.
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