Recordati

The U.S. FDA has approved Ionis Pharmaceuticals' Zanvastro (zilganersen) as the first treatment for Alexander disease, a rare neurological disorder affecting fewer than 1,000 people in the U.S. The drug, designed to reduce abnormal GFAP protein production, showed statistically significant improvement in gait speed in a pivotal study and is approved for both pediatric and adult patients. Ionis plans to commercialize Zanvastro independently in the U.S., marking a key step in its strategy to launch wholly owned neurology medicines, while Recordati holds rights outside the U.S. Analysts at William Blair estimate peak annual sales of approximately $295 million, though the small patient population and complex administration may limit uptake. The approval validates Ionis' RNA-targeting platform and strengthens its neurology portfolio, which includes Spinraza, Wainua, and Qalsody.

Amarin expects positive cash flow for the full year 2026, driven by a completed restructuring and growing international demand. CEO Aaron Berg said the company's restructuring is now complete, resulting in a significantly lower cost base, and that VASCEPA's share of the U.S. icosapent ethyl market rose to 48% as of June 30, 2026, up from 43% a year earlier. In Europe, in-market demand for VAZKEPA under the Recordati partnership rose 69% in the second quarter of 2026 compared to the same period last year. CFO Peter Fishman reported second-quarter total net revenue of $42.2 million, with U.S. product revenue of $32.2 million and Europe product revenue of $5.4 million, while operating expenses fell 59% to $27 million. The company ended the quarter with $314.6 million in cash and investments and no debt, generating $7 million of positive cash flow from operations.

Recordati Industria Chimica e Farmaceutica posted higher net income for the first half of 2026 and confirmed its full-year guidance. Net income rose to 269.67 million euros from 216.12 million euros a year earlier, with earnings per share of 1.292 euros compared to 1.033 euros. Adjusted net income climbed to 349.85 million euros from 327.76 million euros, while EBITDA increased to 540.20 million euros from 496.35 million euros. Operating income advanced to 419.21 million euros from 331.03 million euros, and net revenue grew to 1.41 billion euros from 1.32 billion euros. The company still expects full-year 2026 net revenue between 2,730 million euros and 2,800 million euros, EBITDA between 995 million euros and 1,030 million euros, and adjusted net income between 655 million euros and 685 million euros.

Ionis Pharmaceuticals has signed an ex-U.S. licensing agreement with Recordati for zilganersen, an investigational RNA therapy for Alexander disease. The deal grants Recordati rights to commercialize zilganersen outside the United States, while Ionis retains U.S. rights and global development leadership. Ionis is set to receive upfront and milestone payments, plus potential royalties on ex-U.S. sales, as FDA review of zilganersen for Alexander disease continues.

This week brought a mix of FDA and EU approvals, layoffs, acquisitions, and clinical trial updates across the biotech sector. Ionis Pharmaceuticals secured FDA approval for TRYNGOLZA as an adjunct therapy for severe hypertriglyceridemia, while Merck received European Commission approval for Keytruda in combination with Padcev as a neoadjuvant treatment for muscle-invasive bladder cancer. Gilead's Trodelvy was cleared by the FDA for first-line metastatic triple-negative breast cancer, and Pfizer's IBRANCE won expanded approval for HR+/HER2+ metastatic breast cancer. Natera gained Japanese approval for its Signatera MRD test in colorectal cancer, and AbbVie's MAVIRET was approved in the EU for both acute and chronic Hepatitis C. Achieve Life Sciences received an FDA Complete Response Letter for its Cytisinicline NDA due to manufacturing deficiencies, though no efficacy or safety issues were raised. ADC Therapeutics announced a 17% workforce reduction as part of a strategic reorganization to focus on its ZYNLONTA lymphoma franchise. In dealmaking, Merck KGaA agreed to acquire Bio-Techne for $73 per share in cash, representing an enterprise value of $11.3 billion, while Ionis inked a licensing deal with Recordati for Zilganersen, an investigational therapy for Alexander disease. Passage Bio and Remix Therapeutics entered an all-stock merger agreement, and Boundless Bio and Serapha Bio also announced an all-stock merger. On the clinical front, IMUNON's Phase 3 OVATION 3 trial passed a safety review, Takeda's Zasocitinib showed superiority over Deucravacitinib in a Phase 3 psoriasis study, and Eledon reported positive long-term kidney transplant data for Tegoprubart. However, Pfizer's Sigvotatug vedotin missed its primary overall survival endpoint in a Phase 3 non-small cell lung cancer study, and MapLight's ML-004 failed to meet its primary endpoint in autism spectrum disorder, though it showed an irritability signal in adolescents. Definium Therapeutics reported positive Phase 3 results for DT120 ODT in major depressive disorder.