other material
confidence high
sentiment negative
materiality 0.85
SIGA's tecovirimat fails mpox lesion resolution endpoint; STOMP enrollment stopped
SIGA TECHNOLOGIES INC
- Tecovirimat did not improve time to lesion resolution vs placebo in mild to moderate clade II mpox; DSMB recommended stop enrollment.
- Enrollment halted in all study arms including open-label for severe patients; data analysis ongoing for secondary endpoints.
- Safety profile affirmed as comparable to placebo, consistent with prior studies over 15 years.
- CEO stated ~75% of randomized patients received drug >5 days after symptom onset; early treatment may offer benefit.
- Company expects three ongoing trials (UNITY, Platinum-CAN, EPOXI) to yield similar results given design parallels.