Biogen Gains Momentum With Positive Lupus Drug Results, Analyst Sees Modest Valuation Upside

On Tuesday, UCB SA UCBJY UCBJF and Biogen Inc. BIIB presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP) for systemic lupus erythematosus.

The drug candidate demonstrated significant clinical improvement in disease activity in patients with moderate-to-severe systemic lupus erythematosus (SLE).

Also Read: Biogen/UCB Partnered Autoimmune Disease Candidate Hits Primary Goal In Late-Stage Study, Sets Stage Another Pivotal Trial

The results were shared at the American College of Rheumatology’s annual meeting. In the 321-subject trial, DZP was administered intravenously every four weeks.

On the primary endpoint measuring improvement of moderate-to-severe disease activity after 48 weeks, study participants receiving DZP plus standard care had a statistically significant 14.6% higher response rate (49.5%) than those receiving SOC alone (34.6%).

On the first secondary endpoint of disease activity response at Week 24, study participants receiving DZP plus SOC had a 7.9% higher response rate (46.6%) than those receiving SOC alone (38.3%). However, the difference did not reach statistical significance.

A greater response was observed across multiple clinical endpoints among participants treated with DZP, including 50% less severe disease flares than participants on standard of care alone.

Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.

In 2024, UCB and Biogen will initiate a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY.

From a stock perspective, William Blair writes that dapirolizumab isn’t significantly impacting Biogen’s valuation, as investors remain focused on Leqembi’s commercial rollout, which is still a work in progress.

The success of Biogen’s late-stage development programs is crucial for future growth, complementing opportunities from Leqembi, Skyclarys, and potentially zuranolone, especially as its multiple sclerosis business continues to feel pressure from generic competition.

Leqembi remains a growth driver, particularly with potential advancements like subcutaneous administration approval, though its progress has been slower than expected. Despite these challenges, Biogen’s modest valuation presents an upside, supported by its commercial portfolio and cost-cutting measures. The analyst maintains an Outperform rating on the stock.

Price Action: BIIB stock is down 0.72% at $154.31 at last check Wednesday.

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