ACER-001 (branded "Olpruva" in the US) received early US approval in UCDs with a US launch in early 2023. The US launches of PKU GOLIKE and Olpruva boost near-term revenues. Successful development of pipeline drugs, including RLF-100 in rare lung disease, RLF-OD032 in PKU, and RLF-TD011 in EB, boost long-term revenues.
Key catalysts include:
1. US launch Olpruva in UCDs (early 2023)
2. EU filing Olpruva/ACER-001 in UCDs (early 2023)
3. RLF-100 INHALED “Leuppi Study” topline results (Q1 2023)