Botanix Pharmaceuticals Passes FDA mid-cycle review for Sofpironium Bromide
- Botanix Pharmaceuticals’ (BOT) lead product, Sofpironium Bromide, passes an FDA mid-cycle review
- The FDA detected no safety issues and no risk management issues or board requirements in the review of the Botanix product
- BOT says it will now continue discussions with the FDA around labelling, clinical outcome assessments, patient instructions and a brand name for its product
- The planned approval date for Sofpironium Bromide remains on track for September 2023
- BOT has called a trading halt ahead of a planned capital raise, and shares last traded at 10 cents
