Acadia Pharmaceuticals Announces Trofinetide New Drug Submission for Treatment of Rett Syndrome Has Been Accepted for Filing and Priority Review by Health Canada
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that Nature Medicine published results from the pivotal Phase 3 LAVENDER™ trial, a 12-week randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of DAYBUE™ in patients with Rett syndrome five to 20 years of age.
Acadia Pharmaceuticals Announces DAYBUE™ (trofinetide) is Now Available for the Treatment of Rett Syndrome
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome. The FDA has granted a priority review and assigned a PDUFA (Prescription Drug User Fee Act) action date of March 12, 2023. The FDA has also informed the company that at this time they are not planning to hold an Advisory Committee meeting.
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the second quarter ended June 30, 2022.
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older.
Acadia’s trofinetide hit its co-primary endpoints in Phase III study in 187 girls and young women with the rare neurological disease Rett syndrome, which impacts between 6,000 and 9,000 US patients and is often misdiagnosed as autism, cerebral palsy or non-specific developmental delay, the company said Tuesday.
Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today that Knight's New Drug Submission (NDS) for Joyesta™ has been accepted for review by Health Canada. Joyesta, licensed from TherapeuticsMD, is an applicator-free estradiol softgel vaginal capsule for the treatment of postmenopausal symptoms of vulvar and vaginal atrophy due to estrogen deficiency. Joyesta is marketed as IMVEXXY® (estradiol vaginal inserts) by TherapeuticsMD in the U.S., for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that it has initiated the Phase 3 LAVENDER placebo-controlled study to evaluate the efficacy and safety of trofinetide for girls and young women with Rett syndrome. Rett syndrome is a serious and rare neurodevelopmental congenital CNS disorder with symptoms that typically present between six to 18 months of age, and lead to problems with cognitive, sensory, motor, and autonomic function.
SAN DIEGO & CINCINNATI & MELBOURNE, Australia--(BUSINESS WIRE)--ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), Neuren Pharmaceuticals Limited (ASX: NEU), and Rettsyndrome.org (RSO) announced today that the positive results from a Phase 2 study conducted by Neuren, which evaluated the safety and efficacy of trofinetide in females with Rett syndrome (RTT), have been published in Neurology®, the medical journal of the American Academy of Neurology.