Silexion Therapeutics Corp (NASDAQ:SLXN) slipped 4% in Tuesday’s premarket session after the biotech firm announced it received written Scientific Advice from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) concerning its planned Phase 2/3 study for SIL204.
The RNA interference drug developer characterized the guidance as both “positive” and “an important milestone,” signaling regulatory support for the overall direction of its proposed trial. Despite the encouraging language, the market appeared concerned about the timing, as Silexion expects to complete its regulatory filing in Israel by the end of Q4 2025 and submit to German authorities in Q1 2026.
Silexion reiterated that it remains on schedule to begin the Phase 2/3 trial of SIL204—its lead therapeutic candidate for locally advanced pancreatic cancer—in the first half of 2026, pending regulatory approval. BfArM’s written recommendations addressed key components of the program, including dosing, clinical design, patient selection criteria, nonclinical data support, and manufacturing readiness.
“This written Scientific Advice represents a meaningful step in our regulatory path and provides us with the supporting clarity needed to finalize our Phase 2/3 submission packages,” said Ilan Hadar, Chairman and Chief Executive Officer of Silexion.
In parallel, the company is continuing operational preparations for the trial, from manufacturing scale-up to the integration of toxicology data and establishing clinical sites.