Zenas BioPharma Reports Obexelimab MS Trial Results
Zenas BioPharma announced that results from the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis were presented in a late-breaking oral presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2026, which took place from February 5-7, 2026 in San Diego, California. Obexelimab met the primary endpoint, demonstrating a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium-enhancing T1 hyperintense lesions over week 8 and week 12 compared with placebo. Near-complete suppression of new GdE T1 hyperintense lesions, markers of active inflammation, was observed with obexelimab by 8 weeks of treatment and was sustained through week 12. The adjusted mean number of new GdE T1 hyperintense lesions per scan was 0.01 in the obexelimab group compared to 0.23 with placebo. Over weeks 8 and 12, only two new GdE T1 lesions were observed in obexelimab-treated patients compared to 19 in placebo-treated patients, with 97.2% of obexelimab treated patients free from T1 lesions over this period. Consistent with the inhibitory mechanism of obexelimab, mean B cell values remained within the normal range for obexelimab-treated patients. The safety profile of obexelimab was consistent with that observed in prior completed trials, including cases of infections and hypersensitivity, most commonly mild injection site reactions. Separately announced 24-week data further confirm the robust and durable activity of obexelimab. The highly statistically significant reductions in total GdE T1 lesions observed with obexelimab over weeks 8 and 12 were maintained through week 24; unadjusted means were 0.87 at baseline, 0.08 at week 12 and 0.04 at week 24 for obexelimab indicating a 95% reduction. Obexelimab meaningfully reduced serum Neurofilament Light by 40% through week 24; 15.28 pg/mL at baseline declining to 12.7 pg/mL at week 12 and 9.2 pg/mL at week 24. New and/or enlarging T2 lesions were also lower in the obexelimab arm and the Expanded Disability Status Scale scores were stable, indicating a lack of progression in physical disability. No new safety signals were observed at week 24.
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- Clinical Trial Success: Obexelimab achieved a 95% relative reduction in new Gd-enhancing T1 lesions in the MoonStone trial for Multiple Sclerosis, demonstrating its potential to transform treatment protocols for patients.
- Good Safety Profile: The trial indicated that Obexelimab was well tolerated with no new safety signals observed, which lays a solid foundation for future market introduction and boosts investor confidence.
- Long-term Efficacy Confirmation: Data from the 24-week follow-up showed sustained efficacy of Obexelimab, with Gd-enhancing T1 lesions decreasing from a baseline of 0.87 to 0.04, indicating its effectiveness and tolerability in long-term treatment.
- Broad Market Prospects: Zenas BioPharma plans to submit a Biologics License Application for Obexelimab to the FDA in 2026, which is expected to create significant market opportunities and further solidify its leadership position in the autoimmune disease sector.
- Executive Purchase: Zenas BioPharma CEO Lonnie Moulder bought over $1M worth of company stock at $17.96 per share, acquiring 57,000 shares, which reflects strong confidence in the company's future prospects.
- Increased Stake: Following this transaction, Moulder's total holdings in Zenas have risen to nearly 1.7 million shares, reinforcing his position as founder and chairman, which may enhance investor trust in the company.
- Upcoming Catalysts: Zenas is scheduled to present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11, 2026, which is expected to draw investor attention to the mid-stage trial results for its lead asset targeting systemic lupus erythematosus.
- Market Reaction: Despite earlier declines in Zenas's stock price due to disappointing late-stage trial results for its candidate against IgG4-related disease, the CEO's stock purchase may improve market sentiment and boost the share price.
- Stock Price Plunge: Zenas BioPharma's stock dropped $17.89, or 51.86%, to close at $16.61 on January 5, 2026, following the announcement of its IgG4-RD trial results, indicating market concerns over the drug's commercial viability.
- Trial Results Disappointment: Although Zenas characterized the INDIGO trial results as 'positive,' analysts noted that the drug's efficacy fell short of the necessary threshold for commercial success, leading to diminished investor confidence.
- CEO Acknowledgment of Disappointment: During a conference call on January 6, 2026, Zenas's CEO admitted that the hazard ratio did not meet expectations, causing the stock to fall another $1.41, or 8.49%, further heightening concerns about the company's future.
- Legal Investigation Launched: Pomerantz LLP is investigating whether Zenas and its executives engaged in securities fraud or other unlawful business practices, which could significantly impact the company's future legal liabilities and financial health.
- Securities Fraud Investigation: Pomerantz LLP is investigating whether Zenas BioPharma has engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to further stock declines.
- Clinical Trial Setback: On January 5, 2026, Zenas announced results from the INDIGO trial, which were termed “positive,” yet analysts noted that the drug's efficacy fell short of the commercial viability threshold, potentially impacting future sales prospects.
- Stock Price Volatility: Following the trial results, Zenas's stock plummeted by 51.86% in one day, from $34.50 to $16.61, reflecting strong market concerns regarding the company's future outlook.
- CEO Acknowledges Disappointment: During a conference call on January 6, 2026, Zenas's CEO expressed disappointment that the hazard ratio did not meet expectations, leading to an additional 8.49% drop in stock price, closing at $15.20.

- Stock Option Grant: On January 15, 2026, Zenas BioPharma granted 100,000 non-qualified stock options to a new employee at an exercise price of $19.93, aligning with Nasdaq listing rules to attract talent and enhance competitive positioning.
- Grant Terms: The options have a ten-year term and vest over four years, with 25% vesting after the first year and the remainder vesting in monthly installments, ensuring continued employee contribution during their tenure.
- Core Strategy: Zenas is focused on developing transformative therapies for autoimmune diseases, advancing two late-stage candidates, obexelimab and orelabrutinib, aimed at providing superior clinical benefits and enhancing market competitiveness.
- Product Advantages: Obexelimab, a bifunctional monoclonal antibody, effectively inhibits B cell activity, while orelabrutinib, a selective BTK inhibitor, targets pathogenic B cells in the central nervous system, showing potential in diseases like multiple sclerosis.

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- Increased Demand for Safe Assets: Growing concerns about Federal Reserve independence have led investors to shift towards safe-haven assets like gold, driving up precious metals stocks, which reflects market sensitivity to economic uncertainties and a preference for secure investments.









