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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 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.
2 days ago
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.
2 days ago
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
Apogee Therapeutics Provides Updates on APG777 Clinical Timelines and Financial Runway
APGE
New Projects/Investments
Guidance Update
  • APG777 asthma data in Q1 2025 aims for 15-20 parts per billion FeNO change, similar to Dupixent, with durability for every three-month dosing, while APG777 atopic dermatitis (AD) 52-week maintenance data, also in Q1 2025, targets meeting or exceeding Dupixent's 72% EC75 and 53% IGA01 maintenance rates.
  • The APG777 AD Part B data in Q2 2025 will explore dose optimization, including exposures up to 2x lebrikizumab, with the goal of replicating or improving upon Part A efficacy. This will inform the Phase 3 studies expected to begin in 2025, targeting a 2029 launch.
  • Apogee Therapeutics has a financial runway into the second half of 2028, supported by $913 million in cash, which is expected to cover top-line Phase 3 data.
  • Data from the APG777 combined with APG990 study is anticipated in H2 2025, aiming to demonstrate superiority over Dupixent with an 8-10 point efficacy improvement on one or more endpoints.
Nov 13, 2025, 5:30 PM
Apogee Outlines Key APG777 Data Readouts and 2029 Launch Target
APGE
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
  • Apogee expects several key data readouts for APG777 in the first half of next year, including asthma data in Q1 targeting a 15-20 parts per billion FeNO change, and 52-week maintenance data in Q1 for atopic dermatitis (AD).
  • Part B data for APG777 in AD is anticipated in Q2 next year, exploring dose optimization, with the mid-dose previously showing two-thirds of patients respond with EASI-75. This study includes 50% European enrollment, which may lead to a more normalized placebo rate.
  • Market research indicates 60% of physicians would select APG777 as their top choice for moderate to severe AD patients, outperforming the market leader by 2 to 1.
  • Apogee plans to initiate Phase 3 studies for APG777 next year, aiming for a 2029 launch. The company's $913 million cash balance provides runway into the second half of 2028, covering top-line Phase 3 data.
  • Data for the APG777 combined with APG990 (OX40L) study is expected in the second half of next year, targeting 8-10 points of efficacy over Ebglyss to demonstrate differentiation.
Nov 13, 2025, 5:30 PM
Apogee Therapeutics Provides Clinical Development and Financial Update
APGE
Guidance Update
New Projects/Investments
  • Apogee Therapeutics reported a cash runway of $913 million extending into the second half of 2028, which covers through their Phase 3 top-line data in 2028.
  • The company is advancing its lead candidate, APG777, in atopic dermatitis, with Phase 2 Part A data showing a 42.5% placebo-adjusted EASI-75 and rapid itch relief. Key upcoming readouts include maintenance dosing data in Q1 2025 and Phase 2 Part B data in Q2 2025, with Phase 3 studies planned to kick off by the end of 2025.
  • Apogee is also developing a combination approach (APG279), which is APG777 plus APG990, with head-to-head data versus Dupixent expected in the second half of 2025.
  • Beyond atopic dermatitis, Apogee expects to release proof-of-concept data for APG777 in asthma in Q1 2025.
Nov 12, 2025, 4:20 PM
Apogee Therapeutics Discusses Pipeline Progress and Market Strategy
APGE
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Apogee Therapeutics is developing best-in-class antibodies, with its lead program, APG 777, an IL-13 antibody for atopic dermatitis, showing rapid itch relief and strong lesion data in Phase 2a.
  • The company plans to kick off Phase 3 trials for APG 777 next year (2026) and aims for approval this decade, supported by over $900 million still on the balance sheet.
  • The atopic dermatitis biologic market is experiencing significant growth, with the market growing north of 25% annually and new-to-brand prescriptions up 49% year-over-year, yet only has about 10% biologic penetration.
  • Apogee is also advancing APG 333 (TSLP) for combination therapy, aiming for quarterly or better dosing, and expects asthma readout in Q1 2026.
Nov 11, 2025, 6:30 PM
Apogee Therapeutics Reports Q3 2025 Financial Results and Pipeline Progress
APGE
Earnings
Guidance Update
New Projects/Investments
  • Apogee Therapeutics reported a net loss of $65.0 million for the third quarter ended September 30, 2025, compared to a net loss of $49.0 million for the same period in 2024.
  • The company's cash, cash equivalents, and marketable securities totaled $588.9 million as of September 30, 2025, which increased to a pro forma $913 million after a $345 million public offering completed in October 2025, extending its cash runway into the second half of 2028.
  • Positive interim Phase 1 results for APG333 in healthy volunteers demonstrated a half-life of approximately 55 days and suppressed key biomarkers for 6 months, supporting potential 3- and 6-month dosing and the development of a co-formulation for respiratory indications.
  • Several key clinical data readouts are anticipated in 2026, including APG777 Phase 1b data in asthma and APEX 52-week Part A data in AD in Q1 2026, APEX 16-week Part B data in AD in Q2 2026, and APG279 Phase 1b head-to-head readout against DUPIXENT in AD in 2H 2026.
Nov 10, 2025, 12:20 PM

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