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SAN FRANCISCO and WALTHAM, Mass. - Apogee (NASDAQ:APOG) Therapeutics, Inc. (Nasdaq: APGE), a biotech firm focused on inflammatory and immunology diseases, has started dosing in a Phase 1 clinical trial for APG990, a monoclonal antibody developed for atopic dermatitis (AD). The trial involves healthy volunteers and aims to assess the safety, tolerability, and pharmacokinetics of the drug.
The company's CEO, Michael Henderson, M.D., expressed that this step is part of Apogee's commitment to delivering innovative treatments for AD and other inflammatory diseases. APG990 targets OX40L, which could potentially offer broader inhibition of inflammation pathways compared to current treatments that focus mainly on the Type 2 pathway.
Carl Dambkowski, M.D., Chief Medical Officer at Apogee, added that the heterogeneity of AD warrants a diverse therapeutic approach. By inhibiting OX40L, APG990 may enhance treatment options for patients, particularly those unresponsive to existing therapies. The Phase 1 trial is anticipated to enroll around 40 adults across five cohorts, with interim data expected in 2025.
Pending positive results, Apogee plans to initiate a trial combining APG990 with another of its antibodies, APG777, which targets IL-13. This combination aims to test the efficacy of simultaneously inhibiting multiple inflammation pathways. The first clinical trial for this combination is also slated for 2025.
APG990 has shown promise in preclinical studies, demonstrating comparable or better potency than amlitelimab, a similar therapeutic agent. Notably, APG990 exhibited a half-life of 26 days, suggesting a potential for less frequent dosing, which could be an improvement over the current OX40L antibodies expected to be administered every four to twelve weeks.
Apogee Therapeutics is advancing a portfolio of novel biologics designed to address significant inflammatory and immunology markets, including AD, asthma, chronic obstructive pulmonary disease (COPD), and more. The company's strategy involves optimizing antibody engineering to improve half-life and other properties, aiming for best-in-class efficacy and dosing.
This news is based on a press release statement from Apogee Therapeutics and reflects the company's current expectations for its clinical trials and product development timelines.
In other recent news, Apogee Therapeutics, a biotech firm, has reported significant advancements in its clinical pipeline. Key developments include the progression of APG777, a novel antibody targeting atopic dermatitis (AD) and asthma, with Phase 2 trial data expected in the second half of 2025. The company's APG990 Phase 1 trial, targeting AD, is set to accelerate, with interim data anticipated in 2025. Furthermore, Apogee plans to develop APG777 and APG990 together, potentially improving clinical responses across various inflammatory and immunology diseases.
Financially, Apogee maintains a strong position with $790 million in assets, expected to support the continued development of its pipeline into 2028. Recently, the company announced the appointment of Dr. Lisa Bollinger to its board of directors, bringing valuable regulatory expertise to Apogee's clinical development programs. Stifel, a financial services company, has maintained its Buy rating on Apogee's stock, demonstrating confidence in the company's drug pipeline. These are among the recent developments at Apogee Therapeutics.
InvestingPro Insights
As Apogee Therapeutics, Inc. (Nasdaq: APGE) advances its clinical trials for APG990, investors and industry observers are closely monitoring the company's financial health and market performance. According to InvestingPro data, Apogee Therapeutics has a market capitalization of $2.65 billion and holds more cash than debt on its balance sheet, which could provide the financial flexibility needed to support ongoing research and development efforts.
Despite the company's promising scientific endeavors, InvestingPro Tips suggest caution. Analysts have recently revised their earnings expectations downwards for the upcoming period, and Apogee is not expected to be profitable this year. Additionally, the company has been grappling with weak gross profit margins. These financial indicators are critical as they may impact the company's ability to sustain long-term R&D investment and navigate the costly process of drug development.
Yet, investors may find a silver lining in the company's stock performance. Apogee has experienced a significant price uptick over the last six months, with a 25.97% return, and an even more impressive year-to-date price total return of 61.95%. Over the last year, the return has been a remarkable 86.67%, reflecting investor optimism about the company's potential. These figures underscore the market's response to Apogee's strategic moves and its pipeline's potential impact on inflammatory and immunology diseases treatment.
For those interested in a deeper dive into Apogee's financials and future prospects, InvestingPro offers additional insights and tips, which can be accessed at https://www.investing.com/pro/APGE. With 10 more InvestingPro Tips available, stakeholders can gain a comprehensive understanding of the company's position and make informed decisions.
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