ACTUATE THERAPEUTICS, INC. 8-K

What Happened Actuate Therapeutics, Inc. (ACTU) filed a Form 8-K on January 12, 2026 under Item 7.01 (Regulation FD Disclosure) to announce updated clinical data from its ongoing, fully enrolled randomized Phase 2 trial (Actuate-1801 Part 3B) of elraglusib in combination with gemcitabine/nab‑paclitaxel (GnP) for first‑line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The company furnished a press release as Exhibit 99.1 to the 8-K.

Key Details

• Filing date: January 12, 2026 (Form 8-K, Item 7.01).
• Trial: Actuate-1801 Part 3B — randomized, fully enrolled Phase 2 in first‑line mPDAC.
• Treatment regimen: elraglusib combined with gemcitabine/nab‑paclitaxel (GnP).
• Disclosure format: updated data announced via press release (Exhibit 99.1) included in the filing.

Why It Matters Updated clinical data from a fully enrolled randomized Phase 2 trial is a material development for investors because it relates directly to the company’s drug-development progress and potential next steps (e.g., additional analyses, regulatory discussions, or larger trials). The 8-K provides broad, public access to the information under Regulation FD, but the filing does not include financial results or corporate management changes. Investors should look for the full press release and any subsequent updates for specific efficacy, safety, and timeline details.