Sign in

You're signed outSign in or to get full access.

Apogee Therapeutics (APGE)

--

Earnings summaries and quarterly performance for Apogee Therapeutics.

Research analysts covering Apogee Therapeutics.

Recent press releases and 8-K filings for APGE.

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
Apogee Outlines 2026 Clinical Milestones and Atopic Dermatitis Strategy
APGE
New Projects/Investments
Guidance Update
Product Launch
  • Apogee anticipates a significant year in 2026 with four clinical readouts, including data for its lead atopic dermatitis drug, which aims for a 2029 launch. The lead drug has already shown rapid itch relief by 48 hours.
  • The company is developing a combination therapy (IL-13, OX40 Ligand) for atopic dermatitis, planning a head-to-head trial against Dupixent in a 50-patient study, targeting an 8-10-point improvement in efficacy.
  • Apogee's strategy includes positioning its monotherapy for atopic dermatitis for dosing every three to six months, with maintenance data for its asthma program expected in Q1 2026.
  • The estimated cost for a phase II global trial is approximately $250,000 per patient.
Nov 19, 2025, 3:00 PM
Apogee Outlines Key 2026 Clinical Milestones and Strategic Development Plans
APGE
New Projects/Investments
Product Launch
  • Apogee anticipates a "very big year" in 2026 with four clinical readouts, including maintenance data for its lead atopic dermatitis (AD) drug in Q1 and an optimized dose in Q2, which will enable Phase 3 trials to launch in 2029.
  • The company's combination study for second-line AD, using IL-13 and OX40 Ligand, is being run head-to-head against Dupixent, targeting an 8-10 point improvement in efficacy.
  • Apogee's strategy involves fixed-dose combinations for multi-targeted agents, offering potential benefits like extended half-life and low single-digit COGS, with an estimated $250,000 per patient cost for incremental patients in a Phase 2 trial.
  • The company expects IL-13 maintenance data in Q1 2026, aiming for every three-month dosing for its AD drug, and is also developing a respiratory portfolio (TSLP) for quarterly or better dosing in asthma.
  • Apogee reports a strong balance sheet to support its pipeline development.
Nov 19, 2025, 3:00 PM
Apogee Outlines Key 2026 Clinical Readouts and Strategic Goals at Jefferies London Healthcare Conference
APGE
New Projects/Investments
Product Launch
Guidance Update
  • Apogee (APGE) anticipates a significant year in 2026 with four clinical readouts, following earlier proof of concept data for its lead atopic dermatitis drug, which demonstrated rapid itch relief by 48 hours.
  • The company aims for its monotherapy to be the future frontline drug of choice in atopic dermatitis, with dosing every three to six months, and plans to kick off Phase 3 trials in 2027 for a 2029 launch.
  • Apogee's combination study (IL-13, OX40 Ligand) is running head-to-head against Dupixent, targeting an 8-10-point improvement in efficacy by 24 weeks at the latest to establish it as a second-line drug of choice.
  • The respiratory portfolio, featuring TSLP, is expected to provide asthma maintenance data in Q1 2026 and has unlocked quarterly or better dosing for all-comer asthma.
  • The company maintains a strong balance sheet to support its growth and estimates the cost for a phase two global trial at approximately $250,000 per patient.
Nov 19, 2025, 3:00 PM