Business

Aelis Farma Receives a Positive Opinion From EMA Pediatric Committee on the Pediatric Investigation Plan for AEF0217 in Down Syndrome

BORDEAUX, France, January 12, 2026--Regulatory News: Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS, PEA-PME eligible), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain and peripheral diseases involving the CB1 receptor, announces today that the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has emitted a favorable opinion on the Paediatric Investigation Plan (PIP) for AEF0217 (EMA/PE/0000243385; IRIS: 0075800000532) in the t

articleAelis Farma SaJanuary 12, 20268/company/aelis-farma-sa-1/news/aelis-farma-receives-a-positive-opinion-from-ema-pediatric-committee-on-the-pediatric-investigation-plan-for-aef0217-in-down-syndrome-1
Aelis Farma Receives a Positive Opinion From EMA Pediatric Committee on the Pediatric Investigation Plan for AEF0217 in Down Syndrome

About this update from Aelis Farma Sa

[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":252,"url":"https://media.zenfs.com/en/business-wire.com/27110c61b3a3d7d2024fa3b18f8faee0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/EUfYitPoD.MmHE9UExsUAg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTUwNDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/27110c61b3a3d7d2024fa3b18f8faee0","width":480,"height":252}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"The EMA’s Pediatric Committee (PDCO) has delivered a favorable consensus opinion on the Pediatric Investigational Plan (PIP) of Aelis Farma’s first-in-class drug candidate AEF0217 for the treatment of adaptive behavior and cognitive impairments associated with Down syndrome.","length":275,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"The PDCO has agreed on a clinical program that will include children from birth to less than 18 years of age with a descending stepwise approach. It has also accepted the current formulation of AEF0217 for pediatric use and deemed appropriate and sufficient the preclinical toxicology already performed, as well as the population PK modelling approach to determine doses in children.","length":383,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"This major regulatory milestone, for a treatment that is likely to be destined to children, reinforces the program’s credibility, de-risks late-stage regulatory requirements, and strengthens visibility on the European path toward marketing authorization for AEF0217.","length":266,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":924,"olType":false},{"type":"text","content":"BORDEAUX, France, January 12, 2026--(BUSINESS WIRE)--Regulatory News:","length":69,"tagName":"p","attribs":{}},{"type":"text","content":"Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS, PEA-PME eligible), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain and peripheral diseases involving the CB1 receptor, announces today that the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has emitted a favorable opinion on the Paediatric Investigation Plan (PIP) for AEF0217 (EMA/PE/0000243385; IRIS: 0075800000532) in the treatment of Down syndrome.","l...

More updates from Aelis Farma Sa

Aelis FarmaCB1 receptorcognitive impairmentsEuropean Medicines Agencyadaptive behaviorDown syndromeclinical programEMA’s Pediatric Committeeclinical developmentcognitive disorders