regulatory
confidence high
sentiment positive
materiality 0.75
Lumos Pharma positive FDA End-of-Phase 2 meeting; Phase 3 trial plan with placebo control
LUMOS PHARMA, INC.
- FDA agreed placebo-controlled design for LUM-201 Phase 3 trial; 2:1 randomization, ~150 patients, 6-month placebo arm.
- Updated Phase 2 data show durable AHV: 12-month 8.2 cm/yr, 24-month 7.3 cm/yr (1.6 mg/kg) vs baseline 4.7 cm/yr.
- Cash $23.2M at March 31, 2024; expected to fund operations through Q3 2024; Q1 net loss $10.4M vs $7.3M year-ago.
- Full 12-month OraGrowtH212 data and additional analyses to be presented at ENDO in Q2 2024.