Denali Therapeutics Announces Topline Phase 2b LUMA Results for BIIB122

What Happened
Denali Therapeutics Inc. and Biogen Inc. on May 21, 2026 issued a press release announcing topline results from the Phase 2b LUMA study evaluating BIIB122 (DNL151) in individuals with early‑stage Parkinson’s disease. Denali filed a Form 8‑K (Regulation FD Disclosure, Item 7.01) to furnish that press release; the 8‑K was filed with the SEC on May 22, 2026 and the press release is attached as Exhibit 99.1.

Key Details

• Press release announcing topline Phase 2b LUMA results issued May 21, 2026 (co‑issued by Denali and Biogen).
• Study: Phase 2b LUMA evaluating BIIB122 (also called DNL151) in early‑stage Parkinson’s disease.
• Form 8‑K filed under Item 7.01 (Regulation FD Disclosure); press release furnished as Exhibit 99.1; Inline XBRL cover page filed as Exhibit 104.
• Report signed by Ryan J. Watts, Ph.D., President and CEO (signature dated May 21, 2026).

Why It Matters
Topline results from a Phase 2b study are a near‑term clinical milestone that can affect investor views of BIIB122’s development prospects and Denali’s pipeline value. The 8‑K itself furnishes the press release but does not replace a full clinical data release; investors should read the Exhibit 99.1 press release and watch for follow‑up disclosures with full data, regulatory guidance, or next‑step trial plans that could drive future company valuation.