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Acadia Pharma (ACAD) Submits NDA U S FDA for Trofinetide for the Treatment of Rett Syndrome

Acadia Pharma (ACAD) Submits NDA U S FDA for Trofinetide for the Treatment of Rett Syndrome
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United statesSteve davisDrug administrationNeuren pharmaceuticals limitedAcadia pharmaceuticals incWall streetNew drug applicationChief executiveRett syndrome behaviour questionnaireClinical global impression improvementSymbolic behavior scales developmental profileInfant toddler checklistFast track statusOrphan drug designationRare pediatric diseasePriority review voucher

Stock Market | FinancialContent Business Page

Stock Market | FinancialContent Business Page
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United statesSteve davisNat genetDrug administrationNeuren pharmaceuticals limitedExchange commissionAcadia pharmaceuticalsAcadia pharmaceuticals incNew drug applicationChief executiveRett syndrome behaviour questionnaireClinical global impression improvementSymbolic behavior scales developmentalInfant toddler checklistFast track statusOrphan drug designation

Acadia Reports Positive Top-line Results from Pivotal Phase 3 Trial of Trofinetide in Rett Syndrome

Acadia Reports Positive Top-line Results from Pivotal Phase 3 Trial of Trofinetide in Rett Syndrome
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United statesKathie bishopJeffrey neulAnnette schaffer eskindVanderbilt university medical centerAcadia pharmaceuticalsDivision of neurologyDrug administrationVanderbilt kennedy centerNeuren pharmaceuticalsFast trackOrphan drugRare pediatric diseaseRett syndrome behavior questionnaireClinical global impressionToddler checklist

Positive FDA meetings enable Neuren to proceed with INDs for three Phase 2 trials

Neuren Pharmaceuticals Limited (ASX: NEU) has received clear and constructive guidance from the FDA Office of Neuroscience in pre-IND meetings for Phase 2 clinical trials of NNZ-2591 in Phelan-McDermid, Angelman and Pitt Hopkins syndromes. All three syndromes are serious neurological disorders that emerge in early childhood and have no approved medicines.

Angelman syndromeNeuren pharmaceuticals limitedPitt hopkins syndromePitt hopkinsAngelman syndromeNeurological disordersClinical trialsPhase 2 clinical trialதேவதை நோய்க்குறி