Praxis Precision Medicines announces FDA alignment for essential tremor drug and positive results for epilepsy treatment, marking major progress in neurological disorder therapies.
The FDA has lifted a study restriction on Vanda Pharmaceuticals' Tradipitant, potentially making it the first new motion sickness drug in decades.
Denali Therapeutics secures $275 million from Royalty Pharma for tividenofusp alfa, a promising therapy for Hunter syndrome awaiting FDA approval in April 2026.
FDA plans to require only one pivotal trial for drug approvals instead of two, potentially accelerating development timelines while raising safety and efficacy concerns.
Stifel initiates coverage of Tango Therapeutics with a Buy rating and $15 target, citing strong potential for its PRMT5 inhibitor vopimetostat and forecasting $1.2B in peak global revenue by 2035.
UniQure stock tumbles as FDA says AMT-130 gene therapy data insufficient for approval. Company seeks urgent Q1 2026 meeting to advance Huntington's disease treatment.
