Vamorolone Demonstrates On-Target Glucocorticoid Activity Without the Immunosuppression Characteristic of Traditional Corticosteroids at Clinical Doses

About this update from Catalyst Pharmaceuticals, Inc.

Data Demonstrate Vamorolone's Balanced Corticosteroid Profile with On-Target Glucocorticoid Activity and Without Evidence of Significant Immunosuppressive Activity at Clinical Doses CORAL GABLES, Fla., June 30, 2026 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced topline results from a two-part Phase 1 clinical study of vamorolone in healthy adult volunteers. The study demonstrated balanced corticosteroid activity with expected cortisol suppression and no evidence of significant immunosuppressive activity at clinical doses. These findings suggest that vamorolone delivers glucocorticoid and anti-inflammatory activity, while avoiding significant immunosuppressant effects, supporting its potential use as a treatment across a broad range of chronic inflammatory rare diseases. Key Highlights and Readouts: Overall study design Part A: Vamorolone vs. deflazacort (equipotency assessment) "By demonstrating similar cortisol suppression at label-based clinical doses of vamorolone and deflazacort, these data support the currently labeled dosing of vamorolone in the treatment of DMD and do not suggest the need for other dosing considerations when switching patients from deflazacort to vamorolone," said William Andrews, MD, Chief Medical Officer of Catalyst Pharmaceuticals. "Moreover, vamorolone achieved robust glucocorticoid and anti-inflammatory activity without evidence of significant immunosuppression at clinical doses."

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