Neuren Pharmaceuticals dives after EU regulation setback
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More news: Neuren Pharmaceuticals shares plunged after its licensee Arcadia Pharmaceuticals received a negative trend vote from European regulators for the commercialisation of Trofinetide to treat Rett syndrome.
Shares fell 10.28% lower to $14.58 at 11:31am AEDT.
Neuren's Rett syndrome therapy hits regulation block in EU
The news: Neuren Pharmaceuticals has received a setback in getting its Rett syndrome treatment, trofinetide, approved in Europe, after a European Medicines Agency (EMA) committee gave its marketing authorisation application a "negative trend vote".
The context: Neuren's global distribution partner Acadia Pharmaceuticals submitted a marketing authorisation application to the European Medicines Agency (EMA) last month.
Acadia said it intends to request a re-examination of the decision by the EMA's committee for medicinal products for human use (CHMP).
Applicants have the right to request a re-examination of a CHMP opinion within 15 calendar days of the decision.
Trofinetide, sold under the brand name Daybue, is already approved in the US, Canada and Israel for Rett syndrome.
What they said: "Given the totality of experience with trofinetide in clinical trials and real world use over many years, this negative trend vote is frustrating for us and the Rett syndrome community in the EU," said Neuren CEO Jon Pilcher.
Acadia CEO Catherine Owen Adams commented: "While the negative trend vote is disappointing and not what we hoped for, we believe the strong data that support the approval of trofinetide for the treatment of Rett syndrome in the United States, Canada, and Israel speak to the meaningful benefits that trofinetide can deliver," said Acadia's CEO Catherine Owen Adams.
"We look forward to working with the EMA and other stakeholders to advance trofinetide as an important potential treatment option in the EU. Our commitment to the Rett syndrome community in the EU remains steadfast, and we are fully dedicated to making trofinetide available to individuals and families who urgently need a new therapeutic option."
The source: ASX
