Dyne Therapeutics' $4.3 Billion Peak Sales Potential? Analyst Highlights Key Strengths And Risks
Dyne Therapeutics' $4.3 Billion Peak Sales Potential? Analyst Highlights Key Strengths And Risks
In January, Dyne Therapeutics revealed new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101, the company's lead candidate, in patients with myotonic dystrophy type 1 (DM1).On Tuesday, BMO Capital Markets initiated coverage on Dyne Therapeutics, Inc. (NASDAQ:DYN), focused on developing therapies for genetically driven neuromuscular diseases.
週二，BMO 資本市場公司開始對戴納基（納斯達克：DYN）進行報道，該公司專注於研發基因驅動的神經肌肉疾病療法。
The company's FORCE platform is designed to overcome limitations in delivery to muscle tissue and the central nervous system (CNS).
該公司的FORCE平台旨在克服向肌肉組織和中樞神經系統（CNS）輸送的限制。
Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
戴納基在神經肌肉疾病方面擁有廣泛的管線，包括用於肌強直性肌病1型（DM1）和杜氏肌營養不良（DMD）的臨牀項目，以及用於面肩肱肌營養不良（FSHD）和龐貝病的前臨牀項目。
In January, Dyne Therapeutics revealed new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101, the company's lead candidate, in patients with myotonic dystrophy type 1 (DM1).
在一月，戴納基披露了來自其正在進行的DYNE-101的1/2期ACHIEVE試驗的新數據顯示，該候選藥物針對肌強直性肌病1型（DM1）患者。
Also Read: Muscle Disease Drug Developer Dyne Therapeutics Stock Plunges After Updated Data From Duchenne Muscular Dystrophy
另請閱讀：肌肉疾病藥物開發商戴納基的股票在從杜氏肌營養不良症更新數據後大幅下跌。
Dyne plans to begin a global Registrational Expansion Cohort with the potential to support a submission for U.S. Accelerated Approval based on biomarker and functional data in H1 2026.
戴納基計劃開始一個全球註冊擴展隊列，可能支持在2026年上半年基於生物標誌物和功能數據的美國加速批准申請。
Dyne leverages TfR1 Fab-conjugation for drug delivery to muscles. TfR1 is highly expressed in muscle cells. BMO analyst Kostas Biliouris acknowledges potential safety risks associated with TfR1-targeting (anemia, hemorrhage, kidney injury) but notes that the safety in Dyne's clinical data appears acceptable.
戴納基利用TfR1 Fab結合物進行藥物向肌肉的遞送。TfR1在肌肉細胞中高度表達。BMO 分析師Kostas Biliouris承認與TfR1靶標相關的潛在安全風險（貧血、出血、腎損傷），但注意到在戴納基的臨牀數據中安全性似乎是可以接受的。
Analyst Biliouris says Dyne's major catalyst and investor debate revolves around the FDA's decision on the DM1 regulatory pathway, as this dictates whether Dyne could enter the DM1 market concurrently or behind its competitor Avidity Biosciences, Inc (NASDAQ:RNA)
分析師Biliouris表示，戴納基的主要催化劑和投資者討論圍繞FDA對DM1監管路徑的決定，因爲這決定了戴納基是否能夠與競爭對手Avidity Biosciences, Inc（納斯達克：RNA）同時或稍後進入DM1市場。
BMO assumes a traditional approval pathway and sees the DM1 market as large enough to accommodate multiple players, and Dyne could differentiate via potential CNS benefits.
BMO假設採用傳統的審批路徑，並認爲DM1市場足夠大，可以容納多個參與者，而戴納基可以通過潛在的中樞神經系統益處來區分自己。
BMO has initiated with an Outperform rating and a price target of $50.
BMO已啓動覆蓋，給予優於大盤的評級，目標價爲50美元。
The analyst models around $4.3 billion DYNE-101 peak-risk unadjusted WW sales in 2035.
分析師預計到2035年DYNE-101的峰值風險未調整全球銷售額約爲43億美元。
Price Action: DYN stock is up 2.16% at $12.29 at the last check Wednesday.
價格動態：DYN股票在週三最後檢查時上漲2.16%，報12.29美元。
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Photo via Shutterstock.
圖片來源於Shutterstock。
譯文內容由第三人軟體翻譯。
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