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8-KAccepted Sep 21, 8:00 AM ET

Cue Biopharma Announces Positive Phase 2 Topline Results for CUE‑221

CUECue Biopharma, Inc.

Accepted (ET)

8:00 AM

Sep 21, 2026

Filed

Sep 21, 2026

Documents

37

Size

10.5 MB

Summary

Cue Biopharma Announces Positive Phase 2 Topline Results for CUE‑221

Updated

What Happened
Cue Biopharma, Inc. (CUE) filed a Current Report on Form 8‑K (Regulation FD disclosure) reporting positive topline results from its Phase 2 clinical trial of CUE‑221 in Chronic Spontaneous Urticaria (CSU). The company issued a press release on September 20, 2026 and furnished that release and a corporate slide presentation as exhibits to the 8‑K. Cue is hosting a conference call and live webcast to discuss the data on September 21, 2026 at 8:00 a.m. Eastern Time.

Key Details

  • Press release announcing topline Phase 2 results was issued September 20, 2026 and furnished as Exhibit 99.1 to the Form 8‑K.
  • Company slide presentation accompanying the call is furnished as Exhibit 99.2.
  • Conference call and live webcast scheduled for September 21, 2026 at 8:00 a.m. ET to review clinical data.
  • The 8‑K was filed September 21, 2026 under Items 7.01 (Regulation FD disclosure) and 8.01 (Other events).

Why It Matters
Positive topline Phase 2 results are an initial clinical milestone for CUE‑221 and may be a near‑term catalyst for the company by providing first public efficacy/safety data for investors to evaluate. Cue is providing a press release, slides and a live webcast so investors can review the topline findings and management commentary — attending or reviewing the furnished materials will be the best way to see the specific data and next steps disclosed by the company.

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