Peptide News Digest

#Familial-Chylomicronemia-Syndrome

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Industry · View digest

Ionis Pharmaceuticals Updates on TRYNGALZA (Olezarsen) Wells Fargo Launch Metrics: $32 Million H1 2026 U.S. Sales, $100-110 Million Full-Year 2026 Guidance, $2 Billion Peak Sales Guidance in Severe Hypertriglyceridemia

Ionis Pharmaceuticals (NASDAQ: IONS) CEO Brett Monia participated in a fireside chat Thursday September 10, 2026 at the Wells Fargo 21st Annual Healthcare Conference in Boston, disclosing TRYNGALZA (olezarsen, an antisense oligonucleotide that reduces apolipoprotein C-III production and lowers triglycerides) H1 2026 U.S. net product sales of $32 million (Q2 alone was $5 million) with full-year 2026 guidance of $100-110 million. The severe hypertriglyceridemia (sHTG) launch followed June 2026 FDA approval and represents the first indication expansion from the initial familial chylomicronemia syndrome (FCS) indication. Ionis raised peak sales guidance in the sHTG indication from $1 billion-plus to $2 billion-plus. The sHTG marketing application is under review in the European Union with potential launch in 2027. Ionis is also commercializing the September 3, 2026 FDA-approved ZANVASTRO (zilganersen, an antisense oligonucleotide) for Alexander disease, a first-in-class disease-modifying therapy for a rare progressive neurodegenerative disorder with no other approved therapies. The company acknowledged parallel setbacks in cardiovascular studies including the Novartis pelacarsen Phase 3 Lp(a)HORIZON miss reported September 4.

Regulatory · View digest

Arrowhead Pharmaceuticals (NASDAQ: ARWR) Confirmed on the Fiscal Q2 2026 Conference Call Tuesday August 4 That the Company Has Acquired a Priority Review Voucher (PRV) Providing the Option to Shorten a Future FDA New Drug Application Review From the Standard 10-Month Timeline to a 6-Month Timeline; Simultaneously REDEMPLO (Plozasiran, ApoC-III-Targeting siRNA Approved November 2025 for Familial Chylomicronemia Syndrome and Now Advanced to Phase 3 SHASTA-3 and SHASTA-4 Positive Win July 23, 2026 for Severe Hypertriglyceridemia) Prescription Volume Approximately Doubled Over Fiscal Q3 With Continued Momentum Into the Current Quarter

Arrowhead Pharmaceuticals (NASDAQ: ARWR) confirmed on the Fiscal Q2 2026 conference call Tuesday August 4, 2026 that the company has acquired a Priority Review Voucher (PRV), a transferable FDA-issued voucher that provides the option to shorten a future FDA new drug application review from the standard 10-month timeline to a 6-month timeline. PRVs are issued to sponsors that develop drugs for rare pediatric diseases, tropical diseases, or specific medical countermeasures under FDA statutory authority; they are transferable and can be sold on the secondary market where recent transactions have priced PRVs in the $100-200 million range. Arrowhead did not disclose the specific candidate to which the PRV will be applied but the timing (following the July 23, 2026 Phase 3 SHASTA-3 and SHASTA-4 positive readouts for plozasiran/Redemplo in severe hypertriglyceridemia) suggests the voucher may support the sNDA filing planned before end of 2026 for the severe hypertriglyceridemia indication. Separately, REDEMPLO (plozasiran) prescription volume has approximately doubled over fiscal Q3 following the November 2025 FDA approval for familial chylomicronemia syndrome, with continued momentum into the current quarter. Arrowhead management expressed continued satisfaction with the launch trajectory approximately 8.5 months after initial approval.