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Biogen Inc. Receives Complete Response Letter from FDA for Nusinersen High Dose Regimen in Spinal Muscular Atrophy

Published on September 24, 2025
Biogen Inc. recently received a Complete Response Letter from the FDA regarding their Nusinersen High Dose Regimen for the treatment of Spinal Muscular Atrophy. Despite this setback, analysts believe that Biogen's innovative research and development pipeline will continue to drive growth for the company in the long term. Investors are advised to seek professional advice from Stocks Prognosis for insights into the potential movement of Biogen Inc. BIIB shares.

Investor opinions & comments

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R

RiskyRachel

September 26, 2025 at 06:28

¡Qué interesante! Estaré atenta a futuras noticias sobre el desarrollo de este tratamiento

S

SmartSteve

September 25, 2025 at 13:14

I'm not sure how Biogen will bounce back from this setback, they may face challenges in gaining FDA approval for their High Dose Regimen

S

StockSamantha

September 24, 2025 at 23:52

It's disappointing to hear about the Complete Response Letter, I wonder how this will impact Biogen's future plans and growth

R

RyanKing

September 24, 2025 at 23:44

I have confidence in Biogen's research capabilities and look forward to hearing more about their advancements in SMA treatment

A

AnthonyBennett

September 24, 2025 at 12:38

This news raises concerns about Biogen's ability to deliver on their promises, I'll be cautious before considering investing in their shares

M

MoneyMark

September 24, 2025 at 10:11

I believe Biogen has the potential to overcome this setback and make progress in finding a treatment for Spinal Muscular Atrophy