Ipsen's shares experienced a significant decline on Monday, falling over 7% on the Paris stock exchange. This drop was triggered by the U.S. Food and Drug Administration (FDA) approval of a generic version of Ipsen's flagship drug, Somatuline, which was immediately launched by Amneal Pharmaceuticals. Somatuline accounted for 30% of Ipsen's total revenue in the first half of 2026, with annual U.S. sales reaching $983 million in the 12 months leading up to July 2026, according to IQVIA data.
Amneal Pharmaceuticals announced on Friday evening that its lanreotide injection, a competitive generic, had received FDA approval. This product is indicated for the treatment of acromegaly, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. Amneal stated it possesses dedicated, large-scale manufacturing capabilities for lanreotide, and RBC Capital noted that the generic competitor's dosage represents about 60% of Somatuline's volume.
Analysts had largely anticipated the entry of a generic competitor. Jefferies, for instance, had factored this into their 2026 forecasts for Ipsen but sees a risk to 2027 expectations, especially if the generic's weekly launch data proves strong. They also expressed longer-term concerns about Ipsen if Camurus's product, CAM-2029, proves superior to Somatuline, potentially leading to a 10% decline in consensus earnings estimates for 2028-2029. Jefferies maintains an "Underperform" rating on Ipsen with a price target of 135 EUR, while RBC Capital has an "Outperform" rating with a price target of 148 EUR.
