The HCPFive: Top News for Healthcare Providers from the Week of 09/07

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) removal of an advisory committee requirement for the supplemental New Drug Application (sNDA) for sparsentan (Filspari) in focal segmental glomerulosclerosis (FSGS), Intercept Pharmaceuticals’ voluntary withdrawal of obeticholic acid (Ocaliva) from the US market, the FDA’s acceptance of a Letter of Intent for the qualification of FibroScan as a reasonably likely surrogate endpoint in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH), the Agency’s clearance of a clinical trial evaluating a genetically engineered porcine-derived kidney in patients with end-stage kidney disease (ESKD), and positive data for Regeneron’s first-in-class investigational allergen-blocking antibodies in allergen-challenge phase 3 trials.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of September 7, 2025—let’s jump in!

FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA

On September 10, 2025, Travere Therapeutics announced that the FDA informed the Company that following further review of the sNDA for sparsentan (Filspari) in FSGS, an advisory committee is no longer needed. The sNDA remains under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026. If approved, sparsentan would be the first medication indicated for FSGS.

Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market

On September 11, 2025, Intercept Pharmaceuticals announced its decision to voluntarily withdraw obeticholic acid (Ocaliva) from the US market for the treatment of PBC following a request from the FDA.The Agency has placed a clinical hold on all Intercept clinical trials conducted under a US IND involving obeticholic acid.

FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials

On September 8, 2025, the FDA’s Center for Drug Evaluation and Research, Office of New Drugs accepted Echosense’ Letter of Intent for the qualification of Liver Stiffness Measurement (LSM) by Vibration-Controlled Transient Elastography (VCTE; FibroScan) as a reasonably likely surrogate endpoint in clinical trials for MASH. The Letter of Intent included official letters of support from Eli Lilly, Boehringer Ingelheim, and Novo Nordisk.

FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD

On September 8, 2025, eGenesis announced the FDA clearance of its IND application to initiate a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with ESKD. The IND supports a phase 1/2/3 study designed to assess the safety, tolerability, and efficacy of EGEN-2784 at 24 weeks post-transplant in patients with ESKD who are ≥ 50 years of age, dialysis-dependent, and on the kidney transplant waitlist.

First in Class Cat, Birch Allergen Blockers Succeed in Phase 3 Trials

On September 8, 2025, Regeneron Pharmaceuticals announced results evaluating its first-in-class investigational allergen-blocking antibodies in allergen-challenge phase 3 trials in adults with moderate-to-severe cat or birch allergies. Both trials met their respective primary and key secondary endpoints. Data from the phase 3 trials will be presented at an upcoming medical conference and will inform confirmatory phase 3 trials.