Regulatory ApprovalThere is current uncertainty on the efficacy of Assembly's programs including ABI-5366, ABI-4334, and ABI-6250, at a level that could potentially support their advancement towards regulatory approvals.
Research And DevelopmentData readout for ABI-5366, originally expected in the first half of 2025, has been delayed to Fall 2025.
Trial RisksKey risks include failed or equivocal trial results, unforeseen safety or tolerability issues, meaningful delays to expected timelines, and inability to sufficiently fund operations.