US and EU approval of vamorolone with peak sales of CHF 650+ mn in DMD alone will be transformational for Santhera. The equity upside should be a multiple of the likely share dilution to raise an estimated CHF 40 mn to build up a US and EU specialist sales force to commercialize vamorolone and maximize its long-term profitability.
Key catalysts include:
1. Vamorolone FDA “acceptance of filing” (January 2023)
2. Vamorolone US approval in DMD (Q2 2023)
3. Vamorolone EU approval in DMD (Q4 2023)