Welcome to our dedicated page for Apogee Therapeutics news (Ticker: APGE), a resource for investors and traders seeking the latest updates and insights on Apogee Therapeutics stock.
About Apogee Therapeutics Inc.
Apogee Therapeutics Inc. (Nasdaq: APGE) is a clinical-stage biotechnology company dedicated to developing innovative biologics for the treatment of inflammatory and immunology (I&I) diseases with significant unmet medical needs. The company focuses on utilizing advanced antibody engineering to design differentiated therapies that optimize efficacy, safety, and dosing schedules. Apogee’s mission is to reshape the standard of care for patients by addressing the limitations of existing treatments, such as frequent dosing and suboptimal clinical responses.
Core Focus and Product Pipeline
Apogee’s research and development efforts are centered around well-established biological mechanisms of action, targeting cytokines and pathways critical in inflammatory diseases. The company’s two lead programs are:
- APG777: A subcutaneously administered, extended half-life monoclonal antibody targeting IL-13, designed for the treatment of atopic dermatitis (AD) and other inflammatory conditions. APG777 aims to improve patient outcomes through less frequent dosing (every three to six months) and enhanced clinical efficacy compared to existing biologics.
- APG808: A novel monoclonal antibody targeting IL-4Rα, developed for chronic obstructive pulmonary disease (COPD), asthma, and other Type 2 inflammatory diseases. APG808 leverages advanced engineering to offer a potentially best-in-class safety and pharmacokinetic profile.
In addition to these programs, Apogee is advancing a robust pipeline, including candidates targeting TSLP, OX40L, and other validated pathways, enabling combination therapies for broader and deeper responses in dermatology and respiratory diseases.
Market Position and Differentiation
Apogee Therapeutics operates in the highly competitive biologics market, addressing conditions such as AD, COPD, and asthma, which represent some of the largest and least penetrated I&I markets. The company differentiates itself through:
- Innovative Antibody Engineering: Incorporating technologies to extend half-life, improve drug exposure during induction, and reduce injection frequency.
- Patient-Centric Solutions: Addressing challenges like poor treatment adherence and suboptimal long-term disease control with therapies that require fewer injections and offer enhanced efficacy.
- Strategic Targeting: Leveraging validated targets and combining therapies to achieve superior outcomes in monotherapy and combination settings.
Commitment to Patient Outcomes
Apogee’s approach reflects a deep commitment to improving the quality of life for patients suffering from chronic inflammatory diseases. By addressing key limitations of current standard-of-care treatments, Apogee aims to provide transformative therapies that enhance clinical responses, reduce treatment burdens, and meet the diverse needs of underserved patient populations.
Conclusion
With a broad pipeline, advanced scientific expertise, and a focus on innovation, Apogee Therapeutics is well-positioned to deliver meaningful value to patients and healthcare providers. Their dedication to overcoming the challenges of existing therapies underscores their potential to make a significant impact in the I&I space.
Apogee Therapeutics (APGE) reported Q3 2024 financial results and pipeline updates. The company highlighted positive 9-month results from APG777's Phase 1 trial, supporting its potential best-in-class profile with a 75-day half-life. Key financial metrics include $753.8M in cash providing runway into 2028, R&D expenses of $45.7M, and a net loss of $49.0M. The company is advancing multiple clinical programs, including APG777 (Phase 2 data expected 2H 2025), APG808 (Phase 1 interim data in Q4 2024), and APG990 (Phase 1 interim data in 1H 2025). Additionally, APG333 was selected as a development candidate with Phase 1 initiation planned for late 2024 or early 2025.
Apogee Therapeutics (APGE), a clinical-stage biotech company focused on inflammatory and immunology treatments, announces its participation in three major investor conferences this November. The company will present at the Guggenheim Inaugural Healthcare Innovation Conference on November 12 at 3:00 p.m. ET, the Stifel 2024 Healthcare Conference on November 18 at 10:20 a.m. ET, and the Jefferies London Healthcare Conference on November 20 at 10:30 a.m. ET. Live and archived webcasts will be accessible through Apogee's website investor section.
Apogee Therapeutics (APGE) announced updated positive results from its Phase 1 trial of APG777, a novel anti-IL-13 antibody for atopic dermatitis treatment. The trial demonstrated a well-tolerated safety profile with doses up to 1,200mg, showing a half-life of approximately 75 days - three to five times longer than current treatments. Key findings include dose-proportional pharmacokinetics, near-complete inhibition of pSTAT6, and sustained TARC inhibition up to 9 months. The company expects to report Phase 2 proof-of-concept data in 2H 2025, with potential for maintenance dosing every 3-6 months compared to current biweekly or monthly treatments.
Apogee Therapeutics (Nasdaq: APGE) has announced an upcoming poster presentation at the American College of Allergy, Asthma & Immunology's (ACAAI) 2024 Annual Scientific Meeting in Boston from October 24-28, 2024. The presentation will showcase data up to 9 months from the ongoing Phase 1 clinical trial of APG777, a novel half-life extended anti-IL-13 antibody for treating atopic dermatitis and other inflammatory diseases.
The poster, titled "APG777, anti-IL-13 monoclonal antibody, demonstrates extended half-life and sustained inhibition of Type 2 inflammatory biomarkers," will be presented on Friday, October 25, from 2:00-6:00 p.m. ET at the Hynes Convention Center. The presentation will be available on Apogee's website on October 24.
Apogee Therapeutics (Nasdaq: APGE), a clinical-stage biotechnology company, has announced its participation in the Stifel 2024 Immunology and Inflammation Summit. The company's management will engage in a fireside chat on September 18, 2024, at 12:30 p.m. E.T. / 9:30 a.m. P.T.
Apogee specializes in developing novel biologics for major inflammatory and immunology (I&I) markets, focusing on treatments for atopic dermatitis, asthma, chronic obstructive pulmonary disease (COPD), and other I&I indications. Their approach aims to offer potentially differentiated efficacy and dosing options.
Interested parties can access a live and archived webcast of the presentation through the News & Events page in the Investors section of Apogee Therapeutics' website.
Apogee Therapeutics (Nasdaq: APGE) has appointed Jeff S. Hartness as Chief Commercial Officer. With over 25 years of biotech industry experience, Hartness brings extensive expertise in product launches, market access strategy, pricing, and policy. He joins from Bausch Health, where he most recently served as Executive Vice President on the Global Executive Leadership Team. Prior to that, he spent 15 years at Sanofi Pharmaceuticals focused on market access and launch execution.
CEO Michael Henderson highlighted Hartness's experience in leading launch strategies for major portfolios and navigating both emerging and established markets. Hartness expressed enthusiasm for Apogee's potential to address unmet needs in inflammatory and immunology conditions, particularly in atopic dermatitis and other I&I diseases.
Apogee Therapeutics (Nasdaq: APGE) has initiated dosing in its Phase 1 clinical trial for APG990, a novel half-life extended monoclonal antibody targeting OX40L for atopic dermatitis (AD) treatment. The trial, involving healthy volunteers, will assess safety, tolerability, and pharmacokinetics. Interim data is expected in 2025.
Apogee plans to start a combination trial of APG777 and APG990 in 2025, potentially offering enhanced efficacy in AD and other inflammatory and immunology (I&I) diseases. This approach combines IL-13 inhibition (APG777) with OX40L inhibition (APG990), targeting multiple inflammation pathways.
The company has advanced three programs to clinical trials within 12 months, demonstrating rapid progress in developing differentiated treatments for major I&I diseases.
Apogee Therapeutics (Nasdaq: APGE) reported pipeline progress and Q2 2024 financial results. Key highlights include:
1. Advancement of APG777 with Phase 2 Part A data expected in 2H 2025
2. APG808 interim Phase 1 data due in Q4 2024
3. APG990 Phase 1 trial initiation accelerated to Q3 2024
4. Addition of APG333, targeting TSLP, to enter clinic in 2025
5. Planned combination studies of APG777+APG990 and APG777+APG333
Financial position: $790 million in cash, cash equivalents, and marketable securities, providing runway into 2028. Q2 2024 R&D expenses were $33.2 million, G&A expenses $10.9 million, and net loss $33.8 million.
Apogee Therapeutics (Nasdaq: APGE), a clinical-stage biotechnology company, announced the appointment of Lisa Bollinger, MD, to its board of directors. Dr. Bollinger, with over 30 years of experience in drug development and regulatory affairs, previously served as VP, Global Regulatory Affairs and Clinical Safety at Merck. She brings extensive expertise in pediatrics and regulatory processes, having held significant roles at the FDA and Amgen. Apogee CEO Michael Henderson emphasized her role in advancing the company's pipeline, including treatments for atopic dermatitis and COPD. Dr. Bollinger expressed enthusiasm for contributing to Apogee's mission to develop innovative therapies for diseases with high unmet needs.
Apogee Therapeutics (Nasdaq: APGE), a clinical-stage biotech company focused on developing biologics for atopic dermatitis, COPD, asthma, and other inflammatory and immunology conditions, announced its participation in two upcoming investor conferences. The Jefferies Global Healthcare Conference will take place on June 6, 2024, at 8:30 a.m. ET, followed by the Goldman Sachs 45th Annual Global Healthcare Conference on June 10, 2024, at 11:20 a.m. ET. Live and archived webcasts of these events will be accessible through the company's website.
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