MoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial Results
MoonLake Immunotherapeutics announced a positive outcome from its final pre-BLA meeting with the FDA for sonelokimab in hidradenitis suppurativa (HS). The FDA aligned with MoonLake on the submission plans and label strategy, including the acceptability of MIRA trial data and the inclusion of VELA-TEEN trial data for adolescent HS patients. The proposed label for HS is expected to include the MIRA trial’s ~43% HiSCR75 response rate and a ~29 percentage point delta-to-placebo, which are the highest values observed in any adequate and well-controlled clinical trial in HS to date.
Key figures
- Eps Beat
- 0
- Revenue
- 0
- Drug Name
- sonelokimab (SLK)
- Revenue Yoy
- 0
- Deal Value Usd
- 0
- Phase Of Trial
- Phase 3
- Offering Price
- 0
- Shares Offered
- 0
- Net loss
- 69707000
- Total assets
- 400374000
- Total liabilities
- 146350000
- Cash and cash equivalents
- 298490000
- Total shareholders equity
- 254024000
- Research and development expenses
- 54515000
- General and administrative expenses
- 15509000
- Short term marketable debt securities
- 59431000
AI analysis
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