(RTTNews) - Wednesday, AEON Biopharma (AEON) said FDA feedback from a Type 2b meeting provided clarity on the development pathway for ABP-450 as a biosimilar to BOTOX. ABP-450 is a botulinum toxin being developed for therapeutic indications. AEON plans to submit an IND for a comparative pharmacodynamic study using Compound Muscle Action Potential (CMAP) measurements in the fourth quarter of 2026. The FDA indicated that previously completed comparative studies of ABP-450 versus BOTOX could be submitted as supportive evidence, subject to scientific bridging.
Chung toi hien cong khai y chinh. Tao tai khoan mien phi de doc toan bo bai viet, luu, thao luan va ket noi voi boi canh thi truong va OSINT.