Recordati Achieves Phase 2 Primary Endpoint for Pasireotide in Post-Bariatric Hypoglycemia Ahead of FDA Meeting

An upcoming FDA meeting to discuss next steps for pasireotide (Signifor®) in post-bariatric hypoglycemia puts Recordati's CMC and supply chain teams on notice: a Phase 2 primary endpoint met in Q1 2026 moves the asset meaningfully closer to a scale-up decision. For manufacturing and regulatory leads tracking the program, the timeline compression between a positive readout and a regulatory conversation is worth noting.

Recordati reported consolidated net revenue of € 713.4 million for Q1 2026, up 4.9% year-on-year and 8.7% on a like-for-like basis at constant exchange rates. The Rare Diseases segment led growth, posting € 292.4 million, up 22.4% at CER, driven by volume gains across the Endocrinology and Hemo-Oncology franchises. Isturisa® (osilodrostat) contributed € 86.3 million, a 56.8% increase, reflecting new patient uptake in the U.S. across both overt and non-overt Cushing's syndrome populations. Enjaymo® (sutimlimab) reached € 43.9 million, up 37.6%, and will advance into a Phase 3 trial for chronic immune thrombocytopenia.

The Metabolic franchise was the one area of contraction, declining 18.3% to € 58.5 million, attributed to Carbaglu® phasing across geographies and softer Panhematin® demand in the U.S. against a strong prior-year comparative. Specialty and Primary Care revenue held broadly flat at € 404.4 million, down 1.0% reported but up 0.2% at CER on a like-for-like basis. An adverse FX impact of € 29.1 million, driven primarily by U.S. dollar and Turkish lira movements, weighed on reported figures across segments.

EBITDA reached € 283.6 million, up 5.0%, with a margin of 39.7% on net revenue. Adjusted net income rose 7.2% to € 188.1 million. Free cash flow of € 92.1 million represented a € 66.7 million decline versus the prior year. Net debt stood at € 1,985.2 million, just below 2.0x FY EBITDA, a leverage position that constrains but does not preclude further pipeline investment. Full-year 2026 financial targets were confirmed.

For QA and regulatory affairs leads, the pasireotide trajectory is the near-term operational signal: a scheduled FDA meeting following a Phase 2 readout typically initiates the process validation and CMC documentation cycle that precedes any Phase 3 manufacturing commitment. The parallel advancement of sutimlimab into Phase 3 for ITP adds a second program requiring concurrent supply readiness planning.

The FDA meeting outcome for pasireotide in post-bariatric hypoglycemia will be the next measurable checkpoint for teams assessing process development timelines and batch record requirements across both programs.

Source: Recordati S.p.A. via GlobeNewswire, 12 May 2026.