Recordati’s Isturisa Sales Boom, But Planned Phase 4 Study Signals Payer Evidence Gaps Persist

Recordati Reports Strong H1 2026 Financials Driven by Rare Diseases

Recordati reported strong financial results for the first half of 2026, with consolidated net revenue reaching €1,410.8 million, marking a 6.6% increase. EBITDA grew by 8.8% to €540.2 million, and adjusted net income rose by 6.7% to €349.9 million. The Rare Diseases business was a significant growth driver, with its revenue increasing by 17.1% to €603.9 million, notably boosted by Isturisa® which saw a 58.0% revenue surge. The company confirmed its full-year 2026 financial targets and provided pipeline updates, including a planned Phase 4 study for osilodrostat, positive Phase 2 results for pasireotide in post-bariatric hypoglycemia, and the advancement of sutimlimab to a pivotal Phase 3 trial for chronic ITP. Additionally, Recordati announced new collaborations, including a licensing agreement with Ionis for zilganersen for Alexander disease and a partnership with Moderna for mRNA-3927 for propionic acidemia.

• Robust Financial Performance in H1 2026: Recordati achieved significant financial growth in the first half of 2026, with consolidated net revenue increasing by 6.6% to €1,410.8 million. This strong performance was complemented by an 8.8% rise in EBITDA to €540.2 million, resulting in a 38.3% margin on net revenue. Adjusted net income also saw a healthy increase of 6.7%, reaching €349.9 million, demonstrating the company's disciplined execution and the strength of its diversified portfolio.
• Rare Diseases Business Drives Growth: The Rare Diseases segment emerged as the key growth engine, reporting €603.9 million in revenue, an impressive 17.1% increase (22.0% on a like-for-like basis at CER). This growth was primarily fueled by Isturisa® (osilodrostat), which experienced a substantial 58.0% increase in net revenue to €178.8 million, driven by expanded physician adoption and strong new patient uptake, particularly in the U.S. Other products like Enjaymo® and Qarziba® also contributed to the segment's strong momentum.
• Strategic Pipeline and Corporate Development: Recordati advanced its pipeline with several key updates, including the upcoming Phase 4 study for osilodrostat in Cushing’s syndrome and positive Phase 2 results for pasireotide in post-bariatric hypoglycemia, with Phase 3 development planned. The company also intends to initiate a pivotal Phase 3 trial for sutimlimab in chronic ITP. Furthermore, Recordati expanded its portfolio through a licensing agreement with Ionis for zilganersen (Alexander disease) and a collaboration with Moderna for mRNA-3927 (propionic acidemia), reinforcing its commitment to addressing rare diseases.

Isturisa's Impact on Cushing's Syndrome Outcomes

The treatment landscape for Cushing's syndrome encompasses surgical, medical, and radiotherapeutic options, all aimed at normalizing cortisol levels and managing associated comorbidities. Efficacy, safety, and long-term outcomes vary considerably across these interventions, often necessitating a multi-modal approach to achieve durable remission. The following table summarizes key response rates and survival outcomes reported in the literature for various approved therapies.

Addressing Unmet Needs in Cushing's Syndrome Management

Current management of Cushing's syndrome relies on a multi-modal approach, typically initiated with surgery. However, significant limitations persist across the treatment paradigm, from first-line surgical intervention to subsequent medical therapies, creating substantial unmet needs for patients with persistent or recurrent disease.

• Primary surgical intervention, the only potentially curative treatment, is not universally successful, with approximately 30% of patients experiencing persistent disease post-operatively. A smaller cohort of initial responders will develop recurrent hypercortisolism during long-term follow-up, necessitating second- or third-line therapeutic approaches.

• Pharmacotherapy, a cornerstone for patients with persistent disease or those ineligible for surgery, is frequently limited by poor treatment persistence. Mean duration of therapy can be brief and highly variable; for example, 30.0 days for mitotane, 157.1 days for ketoconazole, and 369.5 days for dopamine agonists. This is further complicated by significant safety concerns, such as the FDA warning on potentially fatal hepatotoxicity from ketoconazole.

• Management is particularly challenging in specific patient populations and disease subtypes. Severe hypercortisolism associated with ectopic Cushing's syndrome can be debilitating and is associated with increased mortality, with tumor aggressiveness and location often complicating treatment. Furthermore, patients with coexisting autoimmune disorders require careful management, as rapid cortisol fluctuations induced by treatment can trigger disease relapses, potentially requiring concurrent administration of exogenous steroids.