Sparsentan

Johnson & Johnson proposed changes to the 340B drug discount program, but backed down after HRSA deemed them inconsistent with the statute. The 340B program, established in 1992, aims to help underserved communities by allowing eligible hospitals and clinics to purchase outpatient prescription medications at discounts. Recent regulatory developments include FDA approvals for Exact Sciences' Cologuard Plus, Partners Fresenius Kabi and Formycon's Otulfi, Eli Lilly's Retevmo, Sanofi and Regeneron's Dupixent, Bristol Myers Squibb's Cobenfy, and others. Additionally, Pfizer withdrew Oxbryta from the market due to safety concerns.

Thrivent Financial reduced its stake in Ligand Pharmaceuticals by 1.6% in Q2. Other hedge funds also adjusted their positions, with Vanguard Group, Dimensional Fund Advisors, Chicago Capital, Rice Hall James, and William Blair Investment Management increasing their holdings. Wall Street analysts forecast growth, with a consensus 'Moderate Buy' rating and an average target price of $131.80. Ligand Pharmaceuticals' stock rose 2.5% to $104.78, with a market cap of $1.89 billion. The company reported quarterly earnings of $1.40 EPS, beating estimates by $0.34, and revenue of $41.50 million, up 57.2% YoY. Insiders sold 51,613 shares over the last 90 days, while CEO Todd C. Davis bought 2,500 shares at $97.39 each.

IgA nephropathy (IgAN) is a common autoimmune kidney disease characterized by IgA deposits, leading to progressive damage and chronic kidney disease (CKD). 40-53% of patients progress to end-stage renal disease (ESRD) within two decades, necessitating interventions like dialysis or transplantation. The treatment landscape for IgAN is evolving with ongoing phase 3 trials for 11 agents, including budesonide and sparsentan, which have received FDA approval. Early detection and intervention are crucial to delay progression, reduce healthcare costs, and improve patient outcomes.

FDA commissioner Robert Califf defends agency's standards amid criticism for granting full approval to Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys and Travere Therapeutics’ drug Filspari for IgAN, despite failed Phase 3 trials.

Canaccord Genuity raises Travere Therapeutics' price target to $23.00 following FDA's full approval of Filspari for IgAN, expanding its indication. Travere's FILSPARI sales grew 37% to $27.1 million in Q2 2024, with a projected market penetration of 13.8% by 2031. Citi and BofA Securities maintain Buy ratings, anticipating market expansion.

FDA approves Travere Therapeutics’ Filspari (sparsentan) for IgA nephropathy, the first non-immunosuppressive treatment to significantly slow kidney function decline. Based on the PROJECT study, Filspari outperformed irbesartan in preserving kidney function over two years. Common adverse events include hyperkalemia and hypotension.

FDA grants full approval to Travere Therapeutics’ Filspari (sparsentan) for slowing kidney function decline in adults with primary IgA nephropathy (IgAN), supported by phase 3 PROTECT study results showing significant kidney function preservation over two years compared to irbesartan.

Tra­vere Ther­a­peu­tics won full ap­proval for Filspari, treating a rare au­toim­mune dis­ease affecting the kid­neys.

The FDA has fully approved sparsentan (Filspari; Travere Therapeutics), an oral, non-immunosuppressive medication that significantly slows kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN). The approval is based on the PROTECT study, which showed a 1.2 mL/min/1.73m²/year treatment effect over 2 years compared to irbesartan. Sparsentan is well-tolerated and offers a superior option for preserving kidney function.