AUVELITY

targets

all catalysts(0)

nothing on the calendar yet

News(7)

• Xenon tumbles on voluntary psychiatry hold, but analysts confident in $2B epilepsy opportunity
  As Xenon Pharmaceuticals announced that azetukalner has reached the FDA for focal seizures, the company also disclosed the emergence of psychosis adverse events in psychiatric trials of the drug, t…
  biospace · 15d ago
• Xenon pauses phase 3 depression trials after psychosis events
  The company has voluntarily stopped enrolling new patients in the studies in response to reports of mostly mild or moderate adverse events.
  fiercebiotech · 15d ago
• 5 biotechs braving the commercial waters with product launches
  A growing number of biotechs are entering the market with newly launched medicines, a pattern indicative of “improving capital markets,” according to Jefferies’ Andrew Tsai.
  biospace · 17d ago
• The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
  The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
  biospace · 2mo ago
• Opinion: RFK Jr.’s antidepressant deprescribing push gets one thing right — and others dangerously wrong
  “Deprescribing requires gradual tapering, psychological support, careful risk stratification, and accessible alternatives — none of which Kennedy’s initiative provides at scale.”
  stat · 4mo ago
• Summit’s ‘self-inflicted’ stumble; Esperion’s take-private deal
  Summit’s decision to conduct an interim analysis of a closely watched trial backfired. Elsewhere, Axsome got a much-needed label expansion and an FDA committee sided against an AstraZeneca breast c…
  biopharma_dive · 5mo ago
• FDA approval for Alzheimer's agitation drug; Esperion goes private in $1.1B deal
  🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness an…
  endpoints · 5mo ago