Zenas files new $200M stock offering as obexelimab BLA review continues
Zenas ended its prior at-the-market stock sale and filed a new $200 million offering under the same sales agreement, while reporting Q3 results and pipeline progress toward a May 2027 PDUFA date.
Zenas BioPharma filed a new prospectus supplement on November 6, 2026 for the sale of up to $200,000,000 of common stock through Jefferies LLC as sales agent. The company is terminating the offering under its prior prospectus supplement and will not make further sales under it, instead filing this new supplement for the same Sales Agreement, effective from the date of the filing.1 Zenas had sold an aggregate of 5,474,099 shares of common stock under the prior prospectus supplement, and aside from that termination, the underlying Sales Agreement remains in full force and effect.1
The filing follows third quarter 2026 results reported November 5, 2026. The FDA's BLA for obexelimab in Immunoglobulin G4-Related Disease, accepted in August, remains under active review with a PDUFA target action date of May 27, 2027.2 Second quarter 2026 clinical data confirmed bioequivalence between obexelimab delivered via prefilled syringe and a single-dose prefilled pen, and Zenas plans to submit that data in a supplemental application to the BLA if it is approved.2
The European Medicines Agency validated Zenas' recently submitted Marketing Authorization Application for IgG4-RD, based on the global Phase 3 INDIGO trial and the bioequivalence data.2 Zenas still expects topline results, including a biomarker subset, from the Phase 2 SunStone trial in Systemic Lupus Erythematosus in the fourth quarter of 2026.2
The Phase 3 PriMroSe trial in primary progressive multiple sclerosis and the Phase 3 Monarch trial in non-active secondary progressive multiple sclerosis, evaluating orelabrutinib, are both ongoing, registered as NCT07067463 and NCT07299019.2 Dosing continues in the single and multiple ascending dose parts of a Phase 1 trial of ZB021, an oral IL-17AA/AF inhibitor, with Zenas expecting to report data in the fourth quarter of 2026.2
As of September 30, 2026, cash, cash equivalents and investments were $647.1 million, which the company said, assuming receipt of a potential $75 million milestone from Royalty Pharma and $75 million drawn from its debt facility with Pharmakon tied to FDA approval of obexelimab, is expected to fund operations at least through the second quarter of 2029.2 Net loss for the quarter was $108.9 million, compared to $51.5 million a year earlier.2
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.