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

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.
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