AUVELITY

targets

all catalysts(0)

nothing on the calendar yet

News(4)

• 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 · 1mo 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 · 3mo 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 · 3mo 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 · 3mo ago