Apogee Therapeutics, Inc. 8-K

What Happened
On January 6, 2026, Apogee Therapeutics (APGE) announced positive interim results from a Phase 1b, double‑blind, placebo‑controlled trial of zumilokibart (APG777) in adults with mild-to-moderate asthma and reviewed expected 2026 milestones. The company reported the data in a press release and data presentation and held a conference call the same day. The trial randomized 31 patients 3:1 to a single 720 mg dose of zumilokibart or placebo; a pre‑specified analysis population included 19 patients with baseline FeNO ≥25 ppb (a biomarker of Type 2 inflammation).

Key Details

• Safety: Zumilokibart was well tolerated. In the 19‑patient analysis group, only GERD occurred in more than one patient (2 patients); no Grade ≥3 treatment‑emergent adverse events (TEAEs), no serious adverse events, no conjunctivitis, no injection‑site reactions, and no anti‑drug antibodies were observed. In the full safety set (N=31; on treatment N=23) the most common TEAEs on drug were upper respiratory tract infection (3), nasopharyngitis (2), GERD (2), and arthralgia (2).
• Efficacy (biomarker): Maximum mean FeNO reduction of 45 ppb (≈60% decrease from baseline) after a single dose, with durable suppression through 16 weeks for all patients in the analysis group and through 32 weeks for the small subset with available follow‑up (N=3).
• Additional signals: Positive trends in FEV1 (lung function) and across Type 2 biomarkers; observed improvements in ACQ‑5 and SNOT‑22 in a separate APEX Phase 2 Part A atopic dermatitis (AD) trial.
• Program updates & timing: INN approved for zumilokibart; APEX Part A (52‑week maintenance) readout expected Q1 2026; APEX Part B (16‑week induction) readout expected Q2 2026 (APEX enrollment = 347); Phase 3 initiation in AD expected 2H 2026; APG279 (APG777+APG990) vs Dupixent Phase 1b readout expected 2H 2026 (trial upsized to ~80 patients). Company says cash runway into 2H 2028.

Why It Matters
The filing confirms early clinical safety and strong biomarker suppression (FeNO) after a single dose of zumilokibart, supporting its potential as a long‑acting anti‑IL‑13 therapy for Type 2 asthma and informing near‑term readouts in both asthma and AD programs. For investors, the announcement highlights multiple upcoming data milestones in 2026 and a stated cash runway into the second half of 2028 — both items that may influence clinical de‑risking and financing expectations. The company also included standard forward‑looking statement cautions about risks and timing.