Duyuru • Dec 02

Apogee Therapeutics Highlights Progress and Best-In-Class Potential of Novel Biologic Programs for I&I Diseases At 2024 Inaugural R&D Day Include

Apogee Therapeutics, Inc., Updated include positive interim results from the APG808 Phase 1 trial, data up to 12 months from the APG777 Phase 1 trial, details around the Company’s strategy for combinations in AD, asthma and COPD to deliver better efficacy and dosing regimens, and the expected significant commercial potential of its programs. Key opinion leaders, Emma Guttman-Yassky, M.D., Ph.D. and David Singh, M.D., FERS, FBPhS, will also discuss the current landscape and need for new treatment opportunities for patients living with I&I conditions. APG808 interim Phase 1 healthy volunteer trial results; The APG808 Phase 1 trial enrolled 32 healthy adult participants into four single-ascending dose (SAD) cohorts. Today, Apogee shared interim data from all four SAD cohorts with at least 3-months follow-up: APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days, supporting the potential for every 2- to 3- month maintenance dosing. Single doses of APG808 demonstrated a deep and sustained effect on pharmacodynamic (PD) markers out to approximately 3 months (longest follow-up available at time of data cut). APG808 was well tolerated across all dose groups. Apogee is also now evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025. Accelerating a leading franchise in AD; Apogee is advancing multiple opportunities for best-in-class monotherapy and first-in-class combination approaches for the treatment of AD that could provide transformational dosing and efficacy compared to current approved and investigational biologics. APG777 is a novel, subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-13 with the potential for best-in-class efficacy and dosing compared to currently approved biologics. APG777 is being evaluated in an ongoing Phase 1 trial, which initiated in August 2023, and a global Phase 2 trial in AD, which initiated in May 2024. Today, Apogee provided updated data from its Phase 1 trial, which is now out to 12 months, including a half-life of 77 days, consistent safety with prior data and favorable PD profile showing near complete inhibition of pSTAT6 for up to 12 months after a single administration and sustained TARC inhibition. These latest data support the potential path for APG777 to be dosed annually, which could create yet another opportunity to disrupt the future $50B+ AD market that is currently served by therapies that require dosing every 2-4 weeks. The Phase 1 data continue to support Apogee’s ongoing Phase 2 trial of APG777 in patients with AD, demonstrating potential for improved clinical responses from greater exposures in induction and maintenance dosing of every 3- or 6-months. Based on strong enrollment in the Phase 2 trial to date, Apogee now expects to report 16-week topline data from Part A of the APG777 Phase 2 trial in mid-2025. The observed strong correlation between Phase 2 and Phase 3 data makes the 16-week induction data a key catalyst. Apogee plans to advance the development of APG777 in asthma and EoE, by initiating a Phase 1b trial in asthma in the first half of 2025, followed by a Phase 2b trial in asthma in the second half of 2025, and launching a Phase 2 trial in EoE in 2026. Raising the bar in AD and beyond via broader inhibition; Apogee plans to take a first-in-class combination approach to AD by targeting Types 1-3 inflammation potentially offering JAK-like inhibition without their associated safety concerns. This approach offers the potential for improved clinical responses over monotherapies and best-in-class dosing. APG777 + APG99; APG990 is a novel, SQ half-life extended mAb targeting OX40L, initially being developed for AD. OX40L is located further upstream in the inflammatory pathway than IL-13 and targeting it could have broader impact on the inflammatory cascade by inhibiting Type 1, Type 2 and Type 3 pathways. Apogee is evaluating APG990 in a Phase 1 healthy volunteer trial to establish safety, tolerability and PK profile, which would enable combination with APG777. The APG777 + APG990 coformulation has been shown to retain stability, injectability, and convenience of individual components. In preclinical studies it has demonstrated broad inhibition of Type 1, Type 2 and Type 3 inflammation with potential for better tolerability than JAK inhibitors. Pending APG990’s Phase 1 results expected in the first half of 2025, Apogee plans to initiate its first combination trial in 2025 – a Phase 1b trial designed to evaluate the safety, PK, PD and efficacy of the combination of APG777 and APG990 against DUPIXENT in approximately 50-75 patients with moderate-to-severe AD with readout expected in second half of 2026. Breaking through the efficacy ceiling in asthma and COPD; Apogee plans to take a combination approach to the treatment of asthma and COPD, leveraging mechanisms that address both central and local drivers of respiratory diseases, potentially enabling enhanced efficacy and extended dosing regimens. APG777 + APG33; APG333 is a novel, SQ extended half-life mAb targeting TSLP, a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions. A Phase 1 trial in healthy volunteers is planned to commence by the end of 2024, with data expected in the second half of 2025. In preclinical studies, the combination of APG777 + APG333 has been shown to drive broader and deeper inhibition of inflammation centrally with deeper impact on local airway responses compared to approved or in-development biologics, with the potential for a significantly less frequent dosing schedule. Apogee plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD.

Duyuru • Mar 05

Apogee Therapeutics, Inc. Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases

Apogee Therapeutics, Inc. announced positive interim Phase 1 data from its first-in-human study of APG777, one of its lead product candidates being developed as a frontline treatment for moderate-to-severe AD and other inflammatory diseases. Pharmacokinetic (PK) data showed a half-life of approximately 75 days across doses tested and Pharmacodynamic (PD) data showed deep and sustained inhibition of key AD biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available, with inhibition still ongoing at time of the data cut). Results from the trial exceeded the Company’s trial objectives and support the potential for APG777, a novel anti-IL-13 antibody, to optimize exposure levels in 16-week induction and be dosed once every three or six months in maintenance. These findings represent the potential for improved clinical responses from greater exposures in induction and significantly less frequent dosing in maintenance compared to currently approved biologic therapies, which are dosed at every two to four weeks, a potential major advancement for patients with AD and other inflammatory diseases. APG777, in single doses up to 1,200mg and multiple doses of 300mg, was well tolerated and showed a favorable safety profile, in line with the existing body of third-party evidence for the safety of the anti-IL-13 class. Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule. APG777 is a novel, subcutaneous extended half-life monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. In head-to-head preclinical studies, APG777 demonstrated equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling. Based on its potentially best-in-class PK profile, APG777 has the potential for improved clinical responses from greater exposures of drug in induction and dosing as infrequently as once every three or six months. AD is a chronic inflammatory skin disorder which can lead to sleep disturbance, psychological distress, elevated infection risk and chronic pain, all of which significantly impact quality of life. Today’s treatments are associated with many challenges, including frequent injection regimens that can lead to poor patient compliance. APG777 represents the first clinical-stage product candidate from the company’s strategic collaboration with Paragon Therapeutics, Inc., an innovative discovery engine for biologics. Key Phase 1 Interim Findings: The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and PK of APG777 in healthy volunteers. The study enrolled 40 healthy adult participants into three single-ascending dose (SAD) and two multiple-ascending dose (MAD) cohorts. Doses of subcutaneous APG777 evaluated in the study included 300mg, 600mg and 1,200mg. Detailed findings from the SAD portion and interim results from MAD portion of the Phase 1 trial are as follows: PK differentiation supports further development of APG777 as a treatment for moderate-to-severe AD and other inflammatory diseases: Potentially best-in-class PK profile, including a half-life of approximately 75 days, supporting: Testing higher exposures of drug in induction to potentially achieve improved clinical responses, Testing of maintenance dosing of every 3- or 6-months, representing 2-4 injections per year compared to the current treatment paradigm of 13-26 injections per year, Dose-proportional increases in serum concentrations and key parameters (e.g., Cmax, AUC) were observed in the Phase 1 trial, PK was consistent across subjects with low variability. Single doses of APG777 demonstrated a deep and sustained effect on PD markers for approximately 3 months (longest follow-up available with inhibition still ongoing at time of data cut): Single doses of APG777 suppressed pSTAT6, one of the first downstream markers of IL-13 pathway inhibition, with near-complete inhibition for approximately 3 months, Single doses of APG777 suppressed TARC, an inflammatory mediator and the most strongly correlated biomarker to AD severity, with deep and sustained inhibition for approximately 3 months. Well tolerated across all dose groups. Single doses of APG777 up to 1,200mg and multiple doses of 300 mg were well tolerated with a favorable safety profile consistent with the existing third-party data supporting the safety of the anti-IL-13 class. The most common treatment-emergent adverse events (TEAEs) were vascular access site pain, vessel puncture site bruise, headache, and vascular access bruising: 60% of participants observed at least one TEAE; 15% of participants observed at least one drug-related AE. There were no Grade 3 TEAEs or severe adverse events (SAEs). No AEs led to study discontinuation. Apogee plans to advance APG777 into a randomized, placebo-controlled, 16-week Phase 2 clinical trial in patients with moderate-to-severe AD.

Toplam Hissedar Getirisi	-13.3%
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Bir sonraki temettü ödeme tarihi	n/a
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Segment	Temettü Verimi
Şirket (APGE)	n/a
Pazarın Alt %25'i (US)	1.4%
Pazarın En İyi %25'i (US)	4.2%
Sektör Ortalaması (Biotechs)	2.4%
Analist tahmini (APGE) (3 yıla kadar)	0%

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/05/25 12:06
Gün Sonu Hisse Fiyatı	2026/05/22 00:00
Kazançlar	2026/03/31
Yıllık Kazançlar	2025/12/31

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

Analist	Kurum
Tazeen Ahmad	BofA Global Research
Julian Harrison	BTIG
Edward Nash	Canaccord Genuity

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Recent updates

Apogee Therapeutics: Targeting Atopic Dermatitis

High number of new and inexperienced directors

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Apogee Therapeutics, Inc., Annual General Meeting, Jun 09, 2026

Apogee Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $350 million.

Apogee Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $300 million.

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Apogee Therapeutics Announces Positive Interim Results from Phase 1B Trial of Zumilokibart (APG777), Its Potentially Best-In-Class Anti-IL-13 Antibody, in Patients with Mild-To-Moderate Asthma

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Apogee Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $300.00003 million.

Apogee Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $300.00003 million.

Apogee Therapeutics, Inc. Announces Late-Breaker Presentation of 16-Week Data from Phase 2 Apex Trial of Apg777 for Moderate-To-Severe At the Upcoming European Academy of Dermatology and Venereology (Eadv) 2025 Congress

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Apogee Therapeutics, Inc. Announces Positive Interim Results from the Phase 1B Trial of Apg808, Its Novel Half-Life Extended Il-4Ra Antibody, in Patients with Mild-To-Moderate Asthma

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Apogee Therapeutics: Engineering Biologic Dominance

Apogee Therapeutics, Inc. Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG990

Apogee Therapeutics, Inc. Announces First Patient Dosed in Part B of Phase 2 APEX Trial of APG777 in Patients with Moderate-To-Severe Atopic Dermatitis

Apogee Therapeutics, Inc. Announces First Participants Dosed in Phase 1 Clinical Trial of APG333, its Novel Half-Life Extended TSLP Antibody for the Treatment of Respiratory and Broader I&I Conditions

Apogee Therapeutics Highlights Progress and Best-In-Class Potential of Novel Biologic Programs for I&I Diseases At 2024 Inaugural R&D Day Include

Apogee Therapeutics Earnings Preview: APG777's Potential In Atopic Dermatitis

Apogee Therapeutics, Inc. Announces Results Up to 9 Months from Phase 1 Trial of APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for Treatment for Atopic Dermatitis and Other Inflammatory Diseases

Apogee Therapeutics, Inc. Appoints Jeff S. Hartness as Chief Commercial Officer

Apogee Therapeutics, Inc. Announces First Participants Dosed in Phase 1 Clinical Trial of APG990 its Novel Half-Life Extended OX40L Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases

Apogee Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $300 million.

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Apogee Therapeutics, Inc. Appoints Lisa Bollinger to Its Board of Directors

Apogee Announces Dosing of First Patient in Phase 2 Atopic Dermatitis Trial of APG777, a Novel Subcutaneous Half-life Extended Anti-IL-13 Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases

Apogee Therapeutics, Inc., Annual General Meeting, Jun 05, 2024

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Ra Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases

Apogee Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $419.999966 million.

Apogee Therapeutics, Inc. has filed a Follow-on Equity Offering.

Apogee Therapeutics' Innovative Leap In Atopic Dermatitis Management

Apogee Therapeutics, Inc. Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases

New minor risk - Share price stability

Apogee Therapeutics, Inc. and Paragon Therapeutics, Inc. Announce Two Abstracts Accepted for Presentation at the 2023 European Academy of Dermatology and Venereology (EADV) Congress

Apogee Therapeutics, Inc. Appoints Mark C. Mckenna as Chairman of Its Board of Directors

Apogee Therapeutics, Inc. has completed an IPO in the amount of $300.05 million.

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