--- title: "SRRK: Apitegromab nears FDA approval with strong financials, dual manufacturing, and launch readiness" type: "News" locale: "en" url: "https://longbridge.com/en/news/295121147.md" description: "Apitegromab is on track for FDA approval by September 30, 2026, with robust commercial and financial readiness and two independent manufacturing paths mitigating regulatory risk. European launch preparations are advancing, and the anti-myostatin pipeline shows strong progress.Based on DisclaimerThis is an AI-generated summary and may contain inaccuracies. Please verify any important information with the original source." datetime: "2026-08-06T14:36:08.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/295121147.md) - [en](https://longbridge.com/en/news/295121147.md) - [zh-HK](https://longbridge.com/zh-HK/news/295121147.md) generator: "portal-rs" --- # SRRK: Apitegromab nears FDA approval with strong financials, dual manufacturing, and launch readiness Apitegromab is on track for FDA approval by September 30, 2026, with robust commercial and financial readiness and two independent manufacturing paths mitigating regulatory risk. European launch preparations are advancing, and the anti-myostatin pipeline shows strong progress. Based on **Disclaimer** This is an AI-generated summary and may contain inaccuracies. Please verify any important information with the original source. ### Related Stocks - [SRRK.US](https://longbridge.com/en/quote/SRRK.US.md) ## Related News & Research - [Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan | SRRK Stock News](https://longbridge.com/en/news/296622602.md) - [Scholar Rock withdraws Europe filing for muscle weakness drug, plans resubmission](https://longbridge.com/en/news/296631683.md) - [Walmart store workers have a new responsibility: correcting AI errors](https://longbridge.com/en/news/296213777.md) - [Scholar Rock Eyes Sept. 30 FDA Decision for SMA Drug Apitegromab](https://longbridge.com/en/news/296153267.md) - [Indra says FaRADAI R&D validates explainable AI to assess threats, plot safe routes in military operations](https://longbridge.com/en/news/296213236.md) --- > **Disclaimer: This article is for reference only and does not constitute any investment advice.**