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8-KAccepted Jun 30, 4:57 PM ET

Catalyst Pharmaceuticals Announces Topline Phase 1 Results for AGAMREE

CPRXCATALYST PHARMACEUTICALS, INC.

Accepted (ET)

4:57 PM

Jun 30, 2026

Filed

Jun 30, 2026

Documents

12

Size

162.9 KB

Summary

Catalyst Pharmaceuticals Announces Topline Phase 1 Results for AGAMREE

Updated

What Happened Catalyst Pharmaceuticals, Inc. (CPRX) filed an Form 8-K (Item 8.01) on June 30, 2026 to announce topline results from a two-part Phase 1 clinical study of AGAMREE (vamorolone). The company issued a press release with the results; that press release is attached to the filing as Exhibit 99.1.

Key Details

  • Filing date: June 30, 2026 (Form 8-K, Item 8.01 — Other Events).
  • Program: AGAMREE (vamorolone), results from a two-part Phase 1 clinical study.
  • Disclosure: Topline results announced via company press release, included as Exhibit 99.1 to the 8-K.
  • Ticker: Catalyst Pharmaceuticals, Inc. (CPRX).

Why It Matters This 8-K signals clinical progress for AGAMREE and provides an early data update for investors. Topline Phase 1 results typically address safety, tolerability and initial pharmacology, which can influence development plans and upcoming regulatory or clinical milestones. Investors should review the attached press release for the specific data points and await any follow-up filings or presentations for full details.

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