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Zenas BioPharma, Inc. Common Stock

Zenas BioPharma, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of immunology-based therapies. Its lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind CD19 and FcγRIIb for the treatment of various immunology and inflammation diseases, including immunoglobulin G4-related disease, multiple sclerosis, and systemic lupus erythematosus. The company also develops ZB002, an anti-TNFα monoclonal antibody; ZB004, a CTLA-4-Ig fusion protein with an extended half-life; and ZB001, an anti-IGF-1R monoclonal antibody. Formerly known as Zenas BioPharma (Cayman) Limited, it changed its name to Zenas BioPharma, Inc. in August 2023, was incorporated in 2019, and is headquartered in Waltham, Massachusetts.

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Biotech & Genomic Medicine

Zenas BioPharma Wins FDA Acceptance for Obexelimab BLA With May 2027 PDUFA Date

Zenas BioPharma said the FDA has accepted its Biologics License Application for obexelimab in IgG4-related disease, setting a target action date of May 27, 2027. The filing rests on Phase 3 INDIGO trial data showing obexelimab cut the risk of an IgG4-RD flare by 56% versus placebo over 52 weeks, with 73.2% of treated patients flare-free versus 45.4% on placebo at a p-value of 0.0005. Partner Bristol Myers Squibb submitted a marketing application to Japan's regulator in August, and new data confirmed a single-dose prefilled autoinjector pen matches the existing prefilled syringe, opening the door to a supplemental filing. The company reported a second-quarter net loss of $111.5 million, more than double the $52.2 million loss a year earlier, as research and development spending rose to $62.9 million from $43.0 million and general and administrative expenses climbed to $15.7 million, alongside a $30.0 million charge for acquired in-process research and development tied to milestone payments owed under licensing agreements with Xencor and InnoCare. Chief Financial Officer and Chief Business Officer Jennifer Fox is moving into an advisory role effective September 30, with President and Chief Operating Officer Joe Farmer stepping in as principal financial and accounting officer in the interim, and the company's stated cash runway into the second quarter of 2029 depends on proceeds still being raised and a milestone payment and debt draw that arrive only upon FDA approval.
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Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Regulation
ZBIO · Capital · Negative Q2 net loss widened to $111.5M on higher R&D/G&A and a $30M acquired-IPR&D charge, with cash runway dependent on future financing and approval milestones.
ZBIO · Regulation · Positive FDA accepted Zenas's BLA for obexelimab in IgG4-RD with a May 2027 PDUFA date, advancing its lead program.
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Zenas BioPharma reports positive Phase 3 results for obexelimab in IgG4-RD

Zenas BioPharma announced positive results from the Phase 3 INDIGO trial of obexelimab for Immunoglobulin G4-Related Disease. The study met its primary and all key secondary endpoints, demonstrating a 56% reduction in flare risk compared to placebo and a significant decrease in glucocorticoid use and related toxicities. The findings were presented at the EULAR 2026 Congress and published in the New England Journal of Medicine. The trial, the largest ever conducted for this disease, showed that over 73% of treated patients remained flare-free through 52 weeks with a safety profile comparable to placebo. Following these results, the company submitted a Biologics License Application to the FDA in May and continues to advance its clinical pipeline, with additional data expected later this year from its Phase 2 trial for systemic lupus erythematosus.
About megatrends
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Regulation
ZBIO · Technology · Positive Positive Phase 3 results for obexelimab in IgG4-RD, meeting primary and secondary endpoints with 56% flare risk reduction.
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Zenas BioPharma CEO Leon Moulder buys 60,000 shares for $1.01 million

Zenas BioPharma CEO Leon Moulder acquired 60,000 shares of the company for approximately $1.01 million on May 18, 2026. The purchase was made at a weighted average price of $16.88 per share, according to an SEC filing. Following the transaction, Moulder directly holds 423,155 shares, with total beneficial ownership exceeding 520,000 shares, or about 0.95% of outstanding shares, plus an additional 1,786,039 shares held indirectly through Tellus BioVentures LLC. The buy comes after Zenas shares fell from a 52-week high of $44.60 in December 2025, and as the company reported a first-quarter net loss of $81 million, up from $33.6 million a year earlier, with cash and investments of $718.5 million at quarter-end.
ZBIO · Capital · Positive CEO insider buying signals confidence in the company's value at current price.
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Zenas BioPharma grants inducement equity awards to new employees

Zenas BioPharma announced inducement grants of stock options and restricted stock units to newly hired employees under Nasdaq Listing Rule 5635(c)(4). The Compensation Committee granted non-qualified stock options to purchase an aggregate of 100,000 shares of common stock and an aggregate of 78,075 restricted stock units on June 15, 2026. The stock options have a ten-year term and an exercise price of $18.71 per share, vesting over four years with 25% after one year and the remainder in 36 equal monthly installments. The restricted stock units vest in four equal annual installments beginning June 15, 2027. The awards were made as an inducement material to the employees' entry into employment with the company.
ZBIO · Capital · Neutral Inducement equity grants to new employees; dilutive but standard hiring practice, no material impact on operations.
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