Scholar Rock (SRRK) said Wednesday it aims to submit a biologics license application in the US and a marketing authorization application in Europe for apitegromab to treat spinal muscular atrophy.
Applications with the US Food and Drug Administration and European Medicines Agency are expected in Q1 2025, and a US launch in Q4.
Scholar Rock also plans to focus on three key priorities in 2025, including commercialization, expanded use of apitegromab, and advancing anti-myostatin program for cardiometabolic disorders.
Key milestones for the company include starting the phase 2 trial in SMA patients under two years old by mid-2025, phase 2 obesity trial data in Q2, and filing an investigational new drug application for SRK-439 to treat obesity in Q3, Scholar Rock said.
Scholar Rock said its current cash and equivalent funds are enough to cover operation through Q4 2026.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。