Summit Therapeutics (SMMT) has received a Prescription Drug User Fee Act (PDUFA) date of November 14, 2024, from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for ivonescimab. This significant milestone was highlighted by Co-CEO and Executive Chairman Robert Duggan during the company’s Q2 2026 earnings call.
Clinical Development and Commercialization Plans
Duggan stated, “we expand our clinical development plan and prepare for commercialization in anticipation of a decision from the FDA on our BLA towards the end of this year.” The company is actively preparing for potential approval and subsequent market entry.
HARMONi-3 PFS Trial Scheduled
In addition to the BLA submission, Summit Therapeutics is planning the HARMONi-3 PFS trial. This trial is slated to commence in the second half of 2026, indicating a continued commitment to advancing its pipeline and exploring further indications for its therapeutic candidates.
