- According to an SEC filing, the FDA action date for Eton Pharmaceuticals Inc's ETON antiepileptic topiramate oral solution has been delayed three months to November 6.
- An FDA decision was expected on Friday.
- However, Eton said that privately held Azurity Pharmaceuticals submitted a recent amendment to the drug application.
- Topiramate is one of three neurology candidates Azurity purchased from Eton in February.
- If approved, Eton is entitled to a $5M milestone payment and a royalty on sales.
- Eton suffered a setback in late May when FDA declined to approve the Company's dehydrated alcohol injection for methanol poisoning.
- Price Action: ETON stock is down 16.4% at $4.91 on the last check Monday.
- Related content: Benzinga's Full FDA Calendar.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
