– Company planning for three potential New Drug Application (NDA) filings in three years with the first submission expected in Q3 2022 for lead program SB206 in molluscum contagiosum –
– Late-stage product candidate, SB204 for the treatment of acne vulgaris, selected to advance as second lead program toward pivotal Phase 3 study –
– SB019 SARS-CoV-2 development program advancing toward Phase 1 study in healthy volunteers, targeted for 1H 2022 –
– Company to host conference call and webcast today at 8:30 AM ET –
Upcoming Targeted Milestones:
- Full data readout from the B-SIMPLE4 study, including Week-24 safety, within the next several weeks.
- Pre-NDA meeting with the FDA, as well as conduct of stability testing, targeted for 1H 2022.
- Potential submission of an NDA targeted for Q3 2022.