Cessatech says KemSu pediatric pain study results align with EMA-endorsed model after refusal

• Cessatech issued an investor Q&A clarifying its strategy after the EMA refused marketing authorization for KemSu on July 23, 2026.
• It framed efficacy as consistent adult-to-pediatric bridging, citing aligned conclusions between adult data and pediatric validation in Study 0202.
• Study 0202 showed 88% of children hit pain score ≤4 within 30 minutes; median pain reduction was 75% at 30 minutes.
• It highlighted safety concerns for sufentanil alone, citing higher naloxone use and two serious adverse events limited to monotherapy in Study 0203.
• Proveca filed for re-examination; Cessatech expects a decision within 60 days of submission, with a possible oral hearing late 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cessatech A/S published the original content used to generate this news brief via Cision (Ref. ID: 202608031100BITN____UKPR__EN_20260803-BIT-3843-0) on August 03, 2026, and is solely responsible for the information contained therein.