Clinical Trials
Positive 12-month results reported in study of Becker muscular dystrophy therapeutic
Edgewise Therapeutics Inc. announced positive 12-month topline results from the ARCH study evaluating the safety, tolerability and pharmacokinetics of EDG-5506 in adults with Becker muscular dystrophy.
FDA approves Leqembi for Alzheimer’s disease
The FDA has granted Eisai full approval for Leqembi to treat adults with Alzheimer’s disease.
Monitoring board recommends Annovis Bio continue phase 3 trial of Parkinson’s drug
Annovis Bio announced it received a positive safety review from an independent Data and Safety Monitoring Board for its phase 3 trial of buntanetap, a drug for treatment of patients with early Parkinson’s disease.
FDA declines to approve Amneal’s novel carbidopa, levodopa formulation for Parkinson’s
The FDA has declined to approve Amneal Pharmaceuticals’ new drug application for IPX203, a novel, oral formulation of extended-release carbidopa/levodopa designed for the treatment of Parkinson’s disease.
Uplizna reduced formation, frequency of subclinical spinal cord lesions in NMOSD
Horizon Therapeutics announced positive results of MRI data from the phase 3 clinical trial of Uplizna, which showed reduction in formation of subclinical transverse myelitis lesions in patients with neuromyelitis optica spectrum disorder.
Long-term treatment with zavegepant nasal spray improves migraine-related quality of life
AUSTIN, Texas — Treatment with 10 mg zavegepant nasal spray resulted in better quality of life as early as 12 weeks and through 1 year in adult patients with migraine, according to research presented here.
FDA removes hold on investigational new drug application for ischemic stroke therapy
The FDA has removed the clinical hold on the investigational new drug application for the phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke, DiaMedica Therapeutics announced in a press release.
FDA approves Rystiggo for adults with generalized myasthenia gravis
The FDA has approved Rystiggo, a subcutaneous infusion therapy to treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
Alzamend identifies maximum tolerated dose of lithium treatment for neurological disorders
Topline data from a phase 2a, multiple ascending dose study identified a maximum tolerated dose for development of AL001, an investigational lithium-delivery system, according to a press release from manufacturer Alzamend Neuro.
Biotherapeutic firm to commence phase 2a trial of oral anxiety treatment
A Boston-based biotherapeutics company has announced initiation of a phase 2a proof-of-concept clinical trial of an oral prodrug of endogenous allopregnanolone in healthy volunteers using a validated clinical model of anxiety.