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Apogee Therapeutics (APGE)

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Earnings summaries and quarterly performance for Apogee Therapeutics.

Research analysts covering Apogee Therapeutics.

Recent press releases and 8-K filings for APGE.

Apogee Therapeutics Provides Update on Zumilokibart Clinical Development and 2029 Launch Plans
APGE
New Projects/Investments
Guidance Update
Product Launch
  • Apogee Therapeutics' lead candidate, Zumilokibart, an IL-13 inhibitor, has shown positive Phase 2 data for atopic dermatitis (AD) with rapid itch relief and lesional benefit. The company anticipates proving its every 3- to 6-month dosing paradigm this quarter (Q1 2026) and initiating Phase 3 studies in 2026.
  • Phase 1b data for Zumilokibart in asthma demonstrated significant FeNO reduction and durability, positioning it to address the 30% overlap between AD and asthma and enhance market leadership and payer negotiations.
  • Apogee aims for Zumilokibart to be the next first-line agent in AD, challenging Dupixent with superior efficacy (48-hour itch relief, better EASI-75) and a more convenient dosing schedule.
  • The company is developing APG279, a fixed-dose co-formulation of IL-13 and OX40 ligand, as a potential second-line therapy, which is currently in a head-to-head study against Dupixent.
  • Apogee has over $900 million in cash, providing a runway into the second half of 2028, which covers through its Phase 3 top-line data, with a planned launch for Zumilokibart in 2029.
Feb 12, 2026, 7:00 PM
Apogee Therapeutics Provides Update on Zumilokibart Development and Financial Runway
APGE
New Projects/Investments
Guidance Update
Product Launch
  • Apogee Therapeutics is advancing Zumilokibart (IL-13) as a potential first-line agent for atopic dermatitis and related conditions, with a target launch in 2029 and Phase 3 studies commencing this year.
  • The company reported positive Phase 1b asthma data for Zumilokibart, showing a 60% reduction in FeNO and durability out to 8 months, positioning it competitively against existing treatments.
  • Apogee holds over $900 million in cash, providing a financial runway into the second half of 2028, which is expected to cover its Phase III top-line data.
  • Upcoming milestones include Part A maintenance data this quarter and the fully optimized dose in atopic dermatitis next quarter.
  • Apogee is also developing APG279, a fixed-dose co-formulation of IL-13 and OX40 ligand, which is currently in a head-to-head study against Dupixent.
Feb 12, 2026, 7:00 PM
Apogee Therapeutics Discusses Zumilokibart Development and 2029 Launch Plans
APGE
Product Launch
New Projects/Investments
  • Apogee Therapeutics is on the precipice of proving out a 3- to 6-month dosing paradigm for zumilokibart in atopic dermatitis this quarter (Q1 2026) and plans to kick off Phase III studies this year (2026).
  • The company reported positive Phase 1b asthma data, showing a 60% reduction in FeNO and durability out to 8 months, which is expected to enhance market position and payer negotiations.
  • Apogee holds over $900 million in cash, providing a runway into the second half of 2028, which covers the release of Phase III top-line data.
  • The company anticipates launching zumilokibart as the next first-line agent in 2029, aiming to challenge Dupixent in the atopic dermatitis market.
Feb 12, 2026, 7:00 PM
Apogee Therapeutics Announces Positive Interim Phase 1B Asthma Results for Zumilocobart
APGE
New Projects/Investments
Product Launch
Revenue Acceleration/Inflection
  • Apogee Therapeutics announced positive interim Phase 1B asthma results for its lead program, Zumilocobart (APG-777), demonstrating a robust and durable effect on FeNO comparable to Dupixent.
  • A single 720 mg dose of Zumilocobart achieved a 45 parts per billion decrease from baseline, or 60% decrease from baseline in FeNO, with sustained suppression through 16 weeks for all patients and through at least 32 weeks for a subset.
  • The drug was well tolerated with a favorable safety profile, and these results support a potential dosing strategy of every three or six months in future asthma trials.
  • Apogee anticipates additional significant clinical data readouts in Q1 2026 and Q2 2026 for Zumilocobart in atopic dermatitis, with the initiation of Phase 3 studies in atopic dermatitis planned for 2026.
  • The company also expects to share the first data for APG-279 in a head-to-head trial against Dupixent in the second half of 2026.
Jan 6, 2026, 1:00 PM
Apogee Provides Updates on Zumilokibart Clinical Trials and 2026 Milestones
APGE
New Projects/Investments
Guidance Update
  • Apogee announced positive Phase 1b data for Zumilokibart (APG777) in asthma, demonstrating a robust 45 ppb reduction and 60 percent reduction from baseline in FeNO, comparable to DUPIXENT, with sustained suppression for up to 32 weeks for patients with available follow-up.
  • Enrollment for Zumilokibart's Atopic Dermatitis (AD) Phase 2 Part B trial is complete, with results expected in Q2 2026.
  • The company plans to initiate Zumilokibart AD Phase 3 in 2H 2026 and expects APG279 AD Phase 1b POC readout in 2H 2026.
  • Apogee is well-capitalized with $913 million in cash, providing runway into 2H 2028.
Jan 6, 2026, 1:00 PM
Apogee Therapeutics Reports Positive Interim Phase 1B Asthma Results for Zumilocobart
APGE
New Projects/Investments
Product Launch
Revenue Acceleration/Inflection
  • Apogee Therapeutics announced positive interim Phase 1B results for Zumilocobart (APG-777) in patients with mild to moderate asthma, demonstrating a 45 parts per billion decrease from baseline, or 60% decrease from baseline in FeNO, after a single 720 mg dose.
  • The study showed sustained FeNO suppression through 16 weeks for all patients and through at least 32 weeks (eight months) for a subset of patients, supporting potential every three or six-month dosing in future asthma trials.
  • Zumilocobart was well tolerated with a favorable safety profile, with no grade 3 or higher treatment-emergent adverse events observed.
  • The company is now entering late-stage clinical development in both asthma and atopic dermatitis, with plans to initiate the ASPIRE trial in asthma and upcoming readouts for atopic derm in Q1 and Q2 2026.
  • Apogee believes Zumilocobart has the potential to be the first long-acting biologic approved for both asthma and atopic derm, targeting a growing asthma biologics market expected to exceed $15 billion.
Jan 6, 2026, 1:00 PM
Apogee Therapeutics Announces Positive Interim Phase I-B Asthma Results for Zumilokibart
APGE
New Projects/Investments
  • Apogee Therapeutics announced positive interim phase I-B results for zumilokibart (APG777) in patients with mild to moderate asthma, demonstrating a 45 parts per billion decrease from baseline, or 60% decrease from baseline in FeNO after a single 720 mg dose.
  • The study showed sustained FeNO suppression for at least 16 weeks for all patients, and through 32 weeks (eight months) for a subset, supporting potential every three or six-month dosing in future studies.
  • The magnitude of FeNO reduction was in line with standard-of-care treatments like DUPIXENT, and zumilokibart was well tolerated with no grade 3 or higher treatment-emergent adverse events.
  • Apogee plans to initiate phase III studies for zumilokibart in atopic dermatitis this year, targeting a potential 2029 launch, and will disclose additional plans for its asthma program, including the ASPIRE trial, later this year.
  • The company believes zumilokibart has the potential to be the first long-acting biologic approved for both asthma and atopic dermatitis, offering a significant commercial advantage in markets projected to exceed $15 billion for asthma biologics.
Jan 6, 2026, 1:00 PM
Apogee Therapeutics Announces Positive Interim Phase 1b Results for Zumilokibart in Asthma and Highlights 2026 Milestones
APGE
Guidance Update
New Projects/Investments
Product Launch
  • Apogee Therapeutics announced positive interim results from its Phase 1b trial of zumilokibart (APG777) in patients with mild-to-moderate asthma, demonstrating robust and durable suppression of FeNO (a key biomarker of Type 2 inflammation) with a maximum absolute mean reduction of 45 ppb (60% decrease from baseline) after a single dose.
  • The trial also indicated a favorable safety profile for zumilokibart, with no Grade 3 or higher treatment-emergent adverse events or serious adverse events reported.
  • Key anticipated milestones for 2026 include Phase 2 APEX Part A (Q1 2026) and Part B (Q2 2026) data readouts for atopic dermatitis, and the initiation of a Phase 3 trial by end of 2026 for a potential 2029 launch of zumilokibart.
  • The company reported a strong cash position of $913 million as of September 30, 2025, providing a cash runway into the second half of 2028.
Jan 6, 2026, 12:00 PM
Apogee Therapeutics Outlines Key 2026 Clinical Milestones and Commercial Strategy for APG-777
APGE
New Projects/Investments
Guidance Update
Product Launch
  • Apogee Therapeutics anticipates significant clinical readouts in 2026, including Q1 2026 data for APG-777 in AD (maintenance) and asthma (Phase 1b), Q2 2026 data for APG-777 in AD (Phase II Part B dose response), and H2 2026 data for their IL-13 and OX40 ligand combo trial (Phase 1b, head-to-head against Dupixent).
  • APG-777 for Atopic Dermatitis (AD) aims to offer every three- and six-month dosing, a significant advantage over current treatments, and has demonstrated statistical significance for rapid itch relief at 48 hours.
  • The AD biologic market is currently only 10% penetrated but is growing at 25% annually, with new-to-brand prescriptions up 49%. Apogee expects APG-777, if launched around 2029, to be a first-line agent, with market research indicating 60% of physicians would rank it as their number one biologic.
  • Apogee plans to expand APG-777 into asthma, with Phase 1b data expected in Q1 2026 targeting a FeNO reduction of 15-20 parts per billion, and is developing a combination therapy (APG-279 co-formulation) to achieve greater efficacy than Dupixent, with Phase 1b data expected in H2 2026.
Dec 3, 2025, 2:45 PM
Apogee Outlines Transformative 2026 Clinical Readouts and Market Strategy for APG-777
APGE
New Projects/Investments
Demand Weakening
Revenue Acceleration/Inflection
  • Apogee expects a transformative 2026 with key clinical readouts for its lead program, APG-777, including Q1 data for AD maintenance and asthma, Q2 data for Part B Phase 2 in AD, and second-half data for its IL-13 and OX40 ligand combo trial.
  • APG-777 aims to differentiate itself in the atopic dermatitis (AD) market with a superior dosing profile (every three and six months), strong EASI-75 results, and rapid itch relief within 48 hours.
  • The company identifies a significant market opportunity in AD due to low biologic penetration (10%) and high discontinuation rates for existing treatments like Dupixent, with market research showing strong physician and patient preference for APG-777's profile.
  • Apogee plans to expand APG-777 into asthma, with Phase 1b data in Q1 2026, and is developing a combination therapy (APG-279) for AD and respiratory indications to achieve greater efficacy.
  • Apogee anticipates securing first-line payer access for APG-777, with a potential launch around 2029, driven by the market's need for new options and strong physician preference.
Dec 3, 2025, 2:45 PM