Summit Therapeutics Inc. 8-K

What Happened
Summit Therapeutics Inc. filed a Form 8‑K on January 29, 2026 to announce that the U.S. Food & Drug Administration has accepted for filing the company’s Biologics License Application (BLA) seeking approval of ivonescimab in combination with chemotherapy for patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non‑small cell lung cancer (NSCLC) after tyrosine kinase inhibitor therapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. A press release dated January 29, 2026 is attached as Exhibit 99.1 to the 8‑K.

Key Details

• Filing announced via Form 8‑K dated January 29, 2026.
• Product: ivonescimab in combination with chemotherapy for EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC post‑TKI therapy.
• FDA set a PDUFA goal action date of November 14, 2026.
• Press release attached as Exhibit 99.1; the 8‑K was signed by Manmeet S. Soni, Chief Operating Officer and Chief Financial Officer.

Why It Matters
FDA acceptance of the BLA and the assigned PDUFA date are formal regulatory milestones that establish a review timeline for ivonescimab’s potential approval in this indication. For investors, these filings provide a concrete date (Nov 14, 2026) by which the FDA aims to act, and they mark a transition from clinical development toward potential regulatory decision-making.