Biogen Inc. (NASDAQ:BIIB) shares are up on Monday following the FDA’s approval of a new high-dose regimen for Spinraza (nusinersen), a treatment for spinal muscular atrophy (SMA).

• Biogen stock is moving in positive territory. Why is BIIB stock advancing?

High-Dose Spinraza Regimen Expands Treatment Approach

Spinraza is a prescription medicine that treats spinal muscular atrophy (SMA) in pediatric and adult patients.

The high dose regimen of Spinraza, which includes two 50 mg doses given 14 days apart, followed by maintenance doses every four months, is expected to enhance treatment options for patients.

The FDA’s approval is based on data from the Phase 2/3 DEVOTE study, which showed significant improvements in motor function for treatment-naïve infants compared to a matched sham group.

Results from the pivotal cohort of the study showed treatment-naïve, symptomatic infants who received high dose Spinraza experienced statistically significant improvements in motor function, when compared to a prespecified matched sham (untreated) group from the ENDEAR study.

In addition to the U.S. approval, the high-dose regimen has also received approval in the European Union, Switzerland and Japan, indicating a strong global market presence.

Biogen is actively working with regulatory authorities worldwide to advance this additional dosing option for SMA patients.

Biogen Litifilimab Data Signals Potential In Cutaneous Lupus

On Saturday, Biogen shared Phase 2 (Part A) results from the ongoing Phase 2/3 AMETHYST study of litifilimab in cutaneous lupus erythematosus (CLE), supporting its potential as a first targeted therapy for the disease in decades.

The Phase 3 portion remains blinded.

CLE is an autoimmune skin disease, either isolated or associated with systemic lupus erythematosus (SLE), characterized by inflammation, rashes, and photosensitivity.

Litifilimab met the primary endpoint, showing a statistically significant improvement in skin disease activity versus placebo at week 16 (14.7% vs. 2.9%; +11.8%).

Secondary measures indicated early and sustained benefit, with treatment separation seen as early as week 4.

By week 24, litifilimab showed higher response rates across key metrics, including CLASI-50 (40.8% vs. 21%) and CLASI-70 (21.7% vs. 5.8%). Notably, 16.3% of patients achieved minimal or no disease activity, compared to none on placebo.

Biogen Technical Indicators Show Mixed Momentum With Bullish Signals

Biogen is currently trading 0.6% above its 20-day simple moving average (SMA) and 1.1% above its 50-day SMA, indicating short-term strength.

Over the past 12 months, shares have increased 36.55% and are positioned closer to their 52-week highs than lows, reflecting a strong upward trend.

The combination of neutral RSI and bullish MACD suggests mixed momentum, indicating that while the stock is not currently overbought, there is potential for upward movement.

  • Key Resistance: $193
  • Key Support: $181

BIIB Stock Price Activity: Biogen shares were up 1.51% at $186.62 at the time of publication on Monday, according to Benzinga Pro data.

Image via Shutterstock