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FDA grants breakthrough therapy status to Biogen's salanersen for spinal muscular atrophy treatment

Market News
04 Jun 2026
GlobeNewsWire
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Bullish
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Biogen's investigational drug salanersen received FDA Breakthrough Therapy Designation for treating spinal muscular atrophy (SMA), based on Phase 1b study results showing improved motor function and slowed neurodegeneration in children with suboptimal response to prior gene therapy. Salanersen, administered once yearly, offers potential high efficacy and is currently in Phase 3 trials targeting various SMA patient groups. This designation accelerates development and review, highlighting the urgent unmet needs in SMA treatment and Biogen's commitment to advancing new therapies.

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Biogen names Michael J. Parini as new Chief Legal Officer starting August 3, 2026

Biogen names Michael J. Parini as new Chief Legal Officer starting August 3, 2026

Biogen Inc. announced the appointment of Michael J. Parini as its new Chief Legal Officer, effective August 3, 2026. Parini brings over 20 years of legal and strategic leadership in the biopharmaceutical industry, having held senior roles at Spur The...

Company Fundamentals
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20 hours ago
Real-world study shows 83% of early Alzheimer's patients stable or improved on LEQEMBI over 17 months

Real-world study shows 83% of early Alzheimer's patients stable or improved on LEQEMBI over 17 months

The LEADER study found that nearly 83% of early Alzheimer's patients remained stable or improved while on LEQEMBI treatment for an average of 17 months, consistent across demographics and genetic profiles. LEQEMBI targets amyloid beta to slow cogniti...

Market News
Bullish
1 day ago
Biogen's diranersen shows promising Phase 2 results slowing early Alzheimer's decline and reducing tau protein.

Biogen's diranersen shows promising Phase 2 results slowing early Alzheimer's decline and reducing tau protein.

Biogen announced positive Phase 2 results for diranersen, an antisense therapy targeting tau protein in early Alzheimer's disease. The study showed meaningful clinical benefits, including slowing cognitive decline by up to 50% on some measures, and r...

Company Fundamentals
Bullish
1 day ago
FDA approves LEQEMBI IQLIK, first at-home weekly injection for early Alzheimer's treatment

FDA approves LEQEMBI IQLIK, first at-home weekly injection for early Alzheimer's treatment

The FDA has approved LEQEMBI IQLIK, a once-weekly subcutaneous injection for initiating treatment of early Alzheimer's disease, allowing at-home dosing. This new form offers a convenient alternative to intravenous infusions, providing flexibility for...

Market News
Bullish
2 days ago
Biogen stock rises on upgrade ahead of key Alzheimer’s drug Phase 2 study data release

Biogen stock rises on upgrade ahead of key Alzheimer’s drug Phase 2 study data release

Biogen's stock received an upgrade as investors anticipate the company's upcoming announcement of detailed data from its Phase 2 study on an experimental Alzheimer's drug. This data release is significant because it could impact the future of Alzheim...

Analyst Insights
Bullish
2 days ago
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