APGE Stock Up as Skin Disease Drug Shows Sustained 52-Week Efficacy

Shares of Apogee Therapeutics APGE surged 20% on Monday after the company announced positive 52-week maintenance data from Part A of a mid-stage study of zumilokibart (APG777), a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (AD).

Part A of the phase II APEX clinical study enrolled 123 adult patients who were randomized in a 2:1 ratio to receive zumilokibart or placebo. Patients were given an induction regimen of 720 mg at weeks 0 and 2, followed by 360 mg at weeks 4 and 12. Those who showed clinical benefit continued into the maintenance phase, with assessment of zumilokibart dosing every three or six months.

In 2025, Apogee Therapeutics reported positive top-line data from Part A of the APEX study. At 16 weeks, zumilokibart showed strong efficacy, meeting the primary endpoint with a 71% reduction in Eczema Area Severity Index (EASI) compared with 33.8% for placebo. The candidate had achieved a best-in-class EASI-75 response of 66.9% compared with 24.6% on placebo, with consistent benefits across patients with moderate and severe AD. Outcomes improved with higher exposure levels, with top quartiles reaching EASI-75 rates of 83.3% and 89.5%.

Key secondary endpoints were also favorable, including Validated Investigator’s Global Assessment (vIGA) 0/1 (34.9% vs. 17.3%) and EASI-90 (33.9% vs. 14.7%), while the highest exposure group showed even stronger responses (63.2% for both vIGA 0/1 and EASI-90 at week 16). Zumilokibart also demonstrated rapid itch relief, with statistically significant improvement seen as early as Week 1. The safety profile was favorable and consistent with agents in the class. Adverse events related to treatment were mostly mild to moderate in severity. There were no injection site reactions reported, supporting zumilokibart’s tolerability profile.

In the past six months, Apogee Therapeutics shares have skyrocketed 111.2% compared with the industry’s 14.4% growth.

Image Source: Zacks Investment Research

APGE’s 52-Week Zumilokibart Maintenance Phase Data in Detail

Apogee Therapeutics reported that 52-week results from the phase II APEX Part A study showed sustained efficacy with both three- and six-month maintenance dosing of zumilokibart. The data also indicated continued improvement over time across lesion and itch measures, including in patients who were not initial responders at 16 weeks. This trend contrasts with existing therapies, where benefits often stabilize earlier, and highlights the candidate’s potential for longer-term disease control with less frequent dosing.

Among the 16-week responders, clinical benefits were largely preserved through 52 weeks. EASI-75 responses were maintained in 75% and 85% of patients on the three and six-month regimens, respectively, while vIGA 0/1 responses remained high at 86% and 78%. Outcomes across key endpoints continued to improve with ongoing treatment, supporting the durability of effect across both dosing schedules.

Beyond the responder subset, the broader study population also demonstrated incremental gains through 52 weeks, suggesting that extended therapy may enhance outcomes even in slower responders. This reinforces the consistency of treatment benefit across patient groups and time.

Zumilokibart was generally well-tolerated over 52 weeks, with a consistent safety profile. Overall, the combination of durable efficacy, deepening responses and the potential for as few as two to four dosing days per year underscores zumilokibart’s promise as a convenient, long-acting therapy for AD.

In the same press release, Apogee Therapeutics stated that Part B of the APEX study is currently underway. This dose-optimization portion of the mid-stage study has enrolled 347 patients, randomized equally to receive zumilokibart (high, medium, and low doses) or placebo. Topline 16-week results from Part B are expected in the second quarter of 2026. Based on the current findings and the anticipated Part B data, and subject to clinical and regulatory outcomes, APGE intends to initiate phase III development of zumilokibart in the second half of 2026, eyeing a potential commercial launch in 2029.

Apogee Therapeutics Inc. Price and Consensus

Apogee Therapeutics Inc. price-consensus-chart | Apogee Therapeutics Inc. Quote

APGE’s Zacks Rank & Stocks to Consider

Apogee Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals CPRX, ADMA Biologics ADMA and Inovio Pharmaceuticals INO. While CPRX sports a Zacks Rank #1 (Strong Buy), ADMA and INO carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87. CPRX shares have gained 21.9% over the past six months.

Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.

Over the past 60 days, estimates for ADMA Biologics’ 2026 earnings per share (EPS) have increased from 85 cents to 96 cents. ADMA shares have lost 11.3% over the past six months.

ADMA Biologics’ earnings beat estimates in one of the trailing three quarters, matched once and missed on the remaining occasion, with the average negative surprise being 1.79%.

Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.12. INO shares have plunged 33.8% over the past six months.

Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.

Beyond Nvidia: AI's Second Wave Is Here

The AI revolution has already minted millionaires. But the stocks everyone knows about aren't likely to keep delivering the biggest profits. Little-known AI firms tackling the world's biggest problems may be more lucrative in the coming months and years.

See

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Catalyst Pharmaceuticals, Inc. (CPRX): Free Stock Analysis Report

Inovio Pharmaceuticals, Inc. (INO): Free Stock Analysis Report

ADMA Biologics Inc (ADMA): Free Stock Analysis Report

Apogee Therapeutics Inc. (APGE): Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research