$ZBIO

Zenas BioPharma (ZBIO) reported Q2 results with a doubled net loss but FDA acceptance of its BLA for obexelimab in IgG4-related disease, with a target action date of May 27, 2027. The company also announced pipeline updates, including ongoing trials and international partnerships.

Zenas BioPharma, Inc. (ZBIO) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Zenas BioPharma Reports Second Quarter 2026 Financial Results and Provides Corporate Update - Obexelimab BLA submission for the treatment of IgG4-RD accepted by FDA; PDUFA target action date of May 27, 2027 - - New study data confirm bioequivalence of obexelimab sing

Zenas BioPharma (NASDAQ:ZBIO) reported positive Phase 3 INDIGO trial results for obexelimab in IgG4-related disease on June 2. The study met primary and key secondary endpoints, including a 56% reduction in flare risk vs placebo and lower glucocorticoid use. The company submitted a Biologics License Application to the FDA in May.

Zenas BioPharma (Nasdaq: ZBIO) said it submitted a Biologics License Application to the U.S. FDA for obexelimab in IgG4-related disease, based on Phase 3 INDIGO results. The trial met the primary endpoint with a 56% reduction in flare risk vs placebo (HR 0.44, p=0.0005) and met four key secondary endpoints, with generally good tolerability.

Zenas BioPharma (ZBIO) is progressing with its Phase 3 clinical trial for orelabrutinib, a BTK inhibitor, targeting primary progressive multiple sclerosis (PPMS). The study, which began recruitment in July 2025, aims to assess the drug's efficacy in slowing disability progression in a hard-to-treat patient population. The successful advancement of this trial could significantly enhance Zenas BioPharma's pipeline value, but investors are advised to monitor competitor developments as well.

Tomas Kiselak has resigned from the board of Zenas BioPharma (ZBIO) following the expiration of his term. He did not seek re-election at the company's annual meeting on May 11, 2026, and the board size has been reduced by one position. This information was reported based on an SEC filing (8-K) by Zenas BioPharma.

Zenas BioPharma (ZBIO) reported a Q1 net loss of $1.46 per share, which is slightly better than FactSet's estimated loss of $1.47 per share. The company is a clinical-stage global biopharmaceutical firm focusing on treatments for autoimmune diseases, with its lead product candidate obexelimab addressing conditions like immunoglobulin G4-related disease, relapsing multiple sclerosis, and systemic lupus erythematosus. An analyst consensus rates ZBIO as a "BUY" with an average target price significantly higher than its last close price.

Zenas BioPharma has announced significant progress in its clinical trials and financial standing. The company plans to submit marketing applications for obexelimab for IgG4-RD to the FDA this quarter and to the EMA in H2 2026, based on positive Phase 3 INDIGO trial results. Additionally, Zenas has strengthened its financial position through public offerings and debt financing, extending its cash runway into 2029, despite reporting a net loss of $81 million for Q1 2026 due to increased R&D expenses.

Entities linked to Zenas BioPharma (ZBIO) CEO Leon O. Moulder, Jr. recently purchased 60,000 shares of common stock in the open market. These transactions occurred on April 28 and April 29, 2026, at weighted average prices of $18.02 and $17.62 per share, respectively. Following these purchases, the indirect holdings attributed to these entities total 1,786,039 shares, with additional direct and trust holdings for Moulder.

Leon O. Moulder, Jr. and associated entities have increased their beneficial ownership in Zenas BioPharma, Inc. (ZBIO) to 4.794%, totaling 3,029,921 shares. This updated stake follows recent open-market purchases by Mr. Moulder and Tellus BioVentures, LLC between February and March 2026. The ownership includes shares held directly, through options, and via Tellus BioVentures and a revocable trust.