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Apogee Therapeutics to Participate at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-29 11:30
Company Overview - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immune (I&I) markets, including treatments for atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and other I&I indications [2] - The company's lead program, APG777, targets atopic dermatitis, which is identified as the largest and least penetrated market within the I&I sector [2] - Apogee aims to achieve best-in-class efficacy and dosing through its antibody programs, which are designed to overcome limitations of existing therapies by utilizing advanced antibody engineering [2] Upcoming Events - Management of Apogee Therapeutics will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, at 10:30 a.m. E.T. [1] - A live and archived webcast of the event will be accessible on the company's website [1]
Wall Street Analysts Think Apogee Therapeutics Inc. (APGE) Could Surge 132.72%: Read This Before Placing a Bet
ZACKS· 2025-05-21 15:01
Core Viewpoint - Apogee Therapeutics Inc. (APGE) has shown a significant price increase of 13.6% over the past four weeks, with a mean price target of $93.88 indicating a potential upside of 132.7% from the current price of $40.34 [1] Price Targets - The average price target consists of eight estimates ranging from a low of $78 to a high of $116, with a standard deviation of $11.05, suggesting a variability in analyst estimates [2] - The lowest estimate indicates a potential increase of 93.4%, while the most optimistic estimate suggests an upside of 187.6% [2] Analyst Consensus and Earnings Estimates - Analysts are increasingly optimistic about APGE's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which has historically correlated with stock price movements [4][11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 9.2%, with three estimates moving higher and no negative revisions [12] Zacks Rank - APGE currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, which supports the stock's potential upside [13]
Apogee Therapeutics Inc (APGE) 2025 Conference Transcript
2025-05-13 21:40
Summary of Conference Call for Apogee Therapeutics Inc (APGE) and Amelix Apogee Therapeutics Inc (APGE) Industry and Company Overview - Focus on developing treatments for atopic dermatitis, asthma, and eosinophilic esophagitis (EOE) with a pipeline that includes phase two trials for multiple indications [1][2][4] Core Points and Arguments - **Atopic Dermatitis Trials**: Aiming for a six-month endpoint with reduced dosing frequency, targeting a market similar to psoriasis [1][4] - **Head-to-Head Trials**: Plans to launch a trial against Dupixent, with results expected next year [2][6] - **Market Dynamics**: The atopic dermatitis market is described as "white space," with Dupixent being the primary competitor [4][14] - **Dosing Innovations**: Emphasis on improving dosing frequency to every three months or better, which is expected to enhance efficacy [5][6][12] - **Efficacy Measures**: Data indicates deep and sustained inhibition of type two inflammation, suggesting potential for longer dosing intervals [7][8] - **Market Potential**: The atopic dermatitis market could reach $50 billion, with significant patient preference for less frequent dosing [14][15] Additional Important Content - **Patient Feedback**: Over 80% of surveyed patients preferred a drug with less frequent dosing compared to Dupixent [14] - **Financial Position**: The company has a strong balance sheet with over $680 million, providing a runway into Q1 2028 [17] Amelix Industry and Company Overview - Focus on developing treatments for rare diseases, including post-bariatric hypoglycemia (PBH) and Wolfram syndrome, with a pipeline that includes Avexatide [19][20] Core Points and Arguments - **Lead Asset - Avexatide**: A GLP-1 receptor antagonist with breakthrough therapy designation for PBH, currently in phase three trials [20][36] - **Clinical Data**: Phase two trials showed significant reductions in hypoglycemic events, with a 53% reduction in level two and a 66% reduction in level three events [38][40] - **Unmet Need**: Approximately 160,000 people in the U.S. suffer from PBH, with no approved treatments available [37][42] Additional Important Content - **Wolfram Syndrome**: Positive phase two data showing stabilization or improvement in C peptide levels, indicating better beta cell function [28][31] - **FDA Discussions**: Ongoing discussions with the FDA regarding trial design and endpoints for potential approval [30][40] - **Patient Experience**: High patient satisfaction reported, with most rating the treatment highly due to improvements in energy and reduction of hypoglycemic events [44] This summary encapsulates the key points from the conference call, highlighting the strategic focus, clinical developments, and market potential for both Apogee Therapeutics and Amelix.
Apogee Therapeutics Provides Business Update, Pipeline Progress and Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-12 10:05
Core Insights - Apogee Therapeutics is advancing its clinical pipeline with significant progress in trials for its lead product APG777, targeting atopic dermatitis and asthma, with key data readouts expected in 2025 and 2026 [1][2][8] Pipeline Progress - The Phase 2 APEX trial of APG777 for atopic dermatitis is actively enrolling, with interim 16-week data from Part A expected in mid-2025 and Part B ongoing [1][2][8] - The first patient has been dosed in a Phase 1b trial of APG777 for mild-to-moderate asthma, with results anticipated in the first half of 2026 [1][8] - APG279, a combination of APG777 and APG990, is set to initiate a Phase 1b head-to-head trial against DUPIXENT in 2025, with readout expected in the second half of 2026 [1][8] Clinical Results - Positive interim results from the Phase 1b trial of APG808 in asthma patients showed rapid and sustained suppression of FeNO, a biomarker for Type 2 inflammation, indicating its potential effectiveness [1][8] - APG990's Phase 1 interim results exceeded trial objectives, suggesting a potential for less frequent dosing of the combination therapy [2][8] Market Research Insights - Recent market research indicates strong interest in APG777, with 96% of patients on biologics likely to switch to it, and 80% of physicians likely to prescribe it to new patients [3][4][5] - The AD biologic market is experiencing rapid growth, with a 23% increase in total prescriptions year-to-date, positioning APG777 favorably to capture market share [4][6] Financial Position - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $681.4 million, sufficient to fund operations into Q1 2028 [1][8] - Research and development expenses for Q1 2025 were $46.4 million, up from $28.7 million in Q1 2024, reflecting the advancement of the clinical pipeline [8][12] Upcoming Milestones - The company plans to initiate a Phase 2 trial for eosinophilic esophagitis (EoE) in 2026 and continue its combination approach with APG333 targeting TSLP [8][10] - The first-in-class combination trial of APG279 against DUPIXENT is expected to begin this year, with interim results anticipated in the second half of 2026 [8][10]
Apogee Therapeutics Announces Positive Interim Results from the Phase 1b Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody, in Patients with Mild-to-Moderate Asthma
Globenewswire· 2025-05-12 10:00
Core Insights - APG808 shows significant potential in treating asthma, with a maximal FeNO decrease from baseline of 53% and sustained reduction of 50% at 12 weeks, indicating robust efficacy [1][4] - The drug's optimized formulation and promising pharmacokinetic profile suggest the possibility of extending dosing intervals to every two months or longer, which could redefine treatment standards for asthma patients [1][2][4] - The Phase 1b trial demonstrated a favorable safety profile, with no severe adverse events reported, reinforcing the drug's potential as a best-in-class therapy [2][4] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including asthma, atopic dermatitis, and chronic obstructive pulmonary disease [1][6] - The company aims to overcome limitations of existing therapies by targeting established mechanisms of action and optimizing antibody properties for improved efficacy and dosing [6] Trial Details - The Phase 1b trial was a double-blind, placebo-controlled study involving 22 adult patients with mild-to-moderate asthma, assessing the safety, tolerability, and efficacy of APG808 [2][4] - Key biomarkers evaluated included fractional exhaled nitric oxide concentration (FeNO), TARC, and pSTAT6, with results indicating significant suppression of Type 2 inflammation markers [4][5] Market Context - Asthma affects approximately 40 million adults and 12 million children in major markets, with prevalence rates ranging from 5% to 8%, highlighting the substantial need for effective treatments [3][5]
Wall Street Analysts Believe Apogee Therapeutics Inc. (APGE) Could Rally 134%: Here's is How to Trade
ZACKS· 2025-05-05 15:01
Shares of Apogee Therapeutics Inc. (APGE) have gained 24.1% over the past four weeks to close the last trading session at $40.12, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $93.88 indicates a potential upside of 134%.The average comprises eight short-term price targets ranging from a low of $78 to a high of $116, with a standard deviation of $11.05. While the lowest estimat ...
Apogee Therapeutics to Participate at the Bank of America 2025 Health Care Conference
Globenewswire· 2025-05-01 12:00
Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immune (I&I) markets, including treatments for atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and other I&I indications [2] - The company's lead program, APG777, targets atopic dermatitis, which is identified as the largest and least penetrated market within the I&I sector [2] - Apogee aims to achieve best-in-class efficacy and dosing through its antibody programs, which are designed to address the limitations of existing therapies by utilizing advanced antibody engineering [2] Upcoming Events - Management of Apogee Therapeutics will present at the Bank of America Health Care Conference on May 13, 2025, at 1:40 p.m. P.T. / 4:40 p.m. E.T. [1] - A live and archived webcast of the presentation will be accessible on the company's website [1]
Apogee Therapeutics: Engineering Biologic Dominance
Seeking Alpha· 2025-04-14 12:04
Core Insights - Apogee (NASDAQ: APGE) is positioned for significant value creation as a disruptor in a multi-billion dollar industry, supported by recent financial disclosures and pipeline updates, including promising interim Phase 1 data for its OX40L inhibitor APG990 [1] Company Analysis - The company is focused on high-growth sectors that are expected to experience exponential expansion, indicating a strategic alignment with disruptive technologies and innovative enterprises [1] - The approach taken by the company combines fundamental analysis with future trend predictions, emphasizing the potential for substantial returns through innovation [1]
Apogee Therapeutics' Investigational Atopic Dermatitis Potential Shows Strong Tolerability, Extended Half-Life in Early Trial
Benzinga· 2025-03-03 17:16
On Monday, Apogee Therapeutics, Inc. APGE released interim Phase 1 results from its first-in-human trial of APG990.APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested.Key data from the 40-healthy subject trial showed:APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. The PK profile supports the potential for a single 2 ...
Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial Results
Globenewswire· 2025-03-03 11:05
Core Insights - Apogee Therapeutics is advancing its clinical pipeline, particularly focusing on APG777 for atopic dermatitis (AD) and APG279, a combination therapy with APG990, with significant milestones achieved ahead of schedule [1][2][3] Pipeline Progress - The Phase 2 APEX clinical trial for APG777 has seen over-enrollment in Part A and the initiation of Part B ahead of schedule, with topline data expected by mid-2025 [1][2] - APG279, which combines APG777 and APG990, is set to enter a Phase 1b head-to-head study against DUPIXENT, with interim results anticipated in the second half of 2026 [1][3] - APG777 is a novel monoclonal antibody targeting IL-13, showing a half-life of 77 days and near complete inhibition of pSTAT6 for up to 12 months after a single dose [3] Financial Position - As of December 31, 2024, Apogee reported cash, cash equivalents, and marketable securities totaling $731.1 million, providing a runway into Q1 2028 [1][4] - Research and development expenses for 2024 were $167.9 million, significantly up from $68.4 million in 2023, reflecting ongoing clinical trials and expansion of the R&D team [4][6] - General and administrative expenses also increased to $49.0 million in 2024 from $24.6 million in 2023, driven by personnel-related costs and operational expansion [4][6] Upcoming Milestones - Apogee plans to initiate a Phase 1b trial for APG333 in asthma in the first half of 2025, followed by a Phase 2b trial in the second half of 2025 [3][6] - A Phase 2 trial for APG777 in eosinophilic esophagitis (EoE) is expected to start in 2026 [3][6] - Positive interim data for APG808, another monoclonal antibody targeting IL-4Rα, supports its potential for two- to three-month dosing, with a Phase 1b trial in asthma expected in the first half of 2025 [3][6]