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Adagene Inc. - ADAG STOCK NEWS

Welcome to our dedicated page for Adagene news (Ticker: ADAG), a resource for investors and traders seeking the latest updates and insights on Adagene stock.

Overview

Adagene Inc (NASDAQ: ADAG) is a clinical‐stage, platform-driven biopharmaceutical company that is transforming antibody discovery and engineering with innovative approaches centered on cancer immunotherapy. Leveraging proprietary technologies such as its Dynamic Precision Library (DPL) platform, Adagene harnesses computational biology and artificial intelligence to design and develop novel monoclonal antibodies. Keywords like antibody discovery, immunotherapy, and biopharmaceutical innovation underscore its approach, placing the company at the intersection of advanced research and clinical application.

Core Technology and Platforms

At the heart of Adagene’s operations is its unique Dynamic Precision Library which comprises cutting-edge components such as NEObody™, SAFEbody®, and POWERbody™ technologies. This platform allows the company to generate antibody candidates with functional epitopes and species cross-reactivity that contribute to targeted cancer treatments. The SAFEbody technology, in particular, utilizes precision masking to shield the binding domain of therapeutic antibodies, thus addressing safety and tolerability challenges by minimizing on-target off-tumor toxicity. Such an approach enables a mechanism whereby antibodies are activated specifically within the tumor microenvironment, ensuring more selective targeting of cancer cells while preserving healthy tissues.

Clinical Pipeline and Research

Adagene has built a robust pipeline of antibody-based therapeutics that are advancing through clinical trials. Its lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 antibody designed to selectively target regulatory T cells in the tumor microenvironment. This clinical candidate is being evaluated in combination with anti-PD-1 therapy in patients with microsatellite-stable colorectal cancer (MSS CRC), among other indications. The technology behind ADG126 illustrates the company’s commitment to delivering therapies that overcome the limitations of conventional antibody treatments by enhancing both safety and efficacy through novel molecular designs.

Research and Development Approach

In addition to advancing its clinical pipeline, Adagene is deeply committed to research and development as the core driver of its innovation. By integrating computational models and artificial intelligence methodologies, the company not only accelerates the discovery process but also refines the specificity and properties of therapeutic antibodies. This technological integration supports the development of a diversified portfolio that spans multiple therapeutic modalities, including antibody-drug conjugates, engineered antibodies, and multispecific engagers. The company’s focus on precision engineering reduces immunogenicity and ensures stable pharmacokinetic profiles, providing a solid foundation for clinical validation.

Strategic Collaborations and Market Position

Adagene has established a network of strategic collaborations with global partners that complement its research initiatives and enhance the development of its antibody-based therapies. These collaborations are designed to leverage combined expertise in biotechnology and clinical science, further validating the innovative approaches that underpin Adagene’s pipeline. Within the competitive biopharmaceutical landscape, Adagene is recognized for its unique value proposition, particularly its ability to integrate precision masking technologies with breakthrough computational methodologies, setting it apart from more conventional antibody research organizations.

Operational Excellence and Financial Discipline

With a focus on operational excellence, Adagene prudently manages its financial resources to support continuous innovation and clinical progress. The company has secured multiple rounds of financing from reputable investors, underscoring its credibility and the strong market confidence in its business model. This disciplined approach to funding allows Adagene to sustain its clinical and preclinical programs while also investing in further technological advancements to enhance the therapeutic index of its drug candidates.

Technical and Safety Advantages

A key advantage of Adagene’s platform lies in its ability to de-risk antibody therapies by employing technologies that improve safety profiles. Through precision masking, therapies developed by Adagene can achieve high tumor specificity, thereby mitigating adverse effects typically associated with conventional antibody treatments. This sophisticated method contributes to an improved therapeutic index, which is critical when administering high and repeat dosages required for robust anti-cancer responses.

Industry Impact and Future Relevance

Adagene occupies an important niche within the evolving landscape of cancer immunotherapy. Its emphasis on harnessing advanced computational techniques and integrated platform technologies positions it as a significant contributor to future innovations in antibody-based treatments. In an industry that demands both scientific rigor and clinical applicability, the company’s emphasis on precision and safety continues to resonate with key stakeholders, including regulators, researchers, and strategic partners. The depth and breadth of its pipeline, aligned with rigorous research methodologies and advanced technology platforms, ensure that Adagene remains a relevant case study in leveraging modern biopharmaceutical innovations for unmet clinical needs.

Conclusion

In summary, Adagene Inc is a paradigm of contemporary biopharmaceutical innovation, combining AI-driven computational biology with novel antibody engineering techniques to transform cancer immunotherapy. The company’s strategic emphasis on precision masking and platform technology not only enhances the specificity and safety of its therapeutics but also sets a new benchmark for the antibody discovery process. With a well-structured clinical pipeline, strategic experimental rigor, and robust financial discipline, Adagene continues to push the boundaries of antibody therapeutics, aiming to deliver transformative solutions for complex oncological challenges.

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Adagene Inc. (Nasdaq: ADAG), a pioneer in antibody-based therapy development, has announced its participation in Stifel's 2025 Virtual Targeted Oncology Forum.

The company's Chairman, CEO and President of R&D, Peter Luo, Ph.D., will deliver a corporate update and engage in one-on-one investor meetings during the virtual event scheduled for April 8-9, 2025. The presentation is set for Tuesday, April 8, from 12:30-12:55 PM Eastern Time.

Investors and interested parties can access the presentation webcast through the Investors section of Adagene's website (www.adagene.com), where it will remain available for a minimum of 30 days.

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Adagene (NASDAQ: ADAG) reported its full year 2024 financial results, highlighting significant progress in its clinical programs. The company's Muzastotug Phase 2 dose expansion study showed a 33% overall response rate in MSS CRC patients using a 20 mg/kg loading dose regimen.

Key financial metrics include a cash balance of $85.2 million providing runway into late 2026, net revenue of $0.1 million (down from $18.1 million in 2023), and reduced R&D expenses of $28.8 million (21% decrease from 2023). The company reported a net loss of $33.4 million for 2024.

Pipeline highlights include promising results for ADG126 in combination with pembrolizumab, showing good tolerability with only a 6% discontinuation rate. The company is advancing its SAFEbody technology platform, with two T cell engager programs: ADG138 (HER2-targeted) and ADG152 (CD20-targeted) in development.

Ongoing collaborations with Exelixis, Sanofi, and Roche continue to progress, with milestone payments received and potential future payments totaling up to $2.5 billion plus tiered royalties.

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Adagene (Nasdaq: ADAG), a pioneer in antibody-based therapies, has announced its upcoming presentation at the 11th Annual Immuno-Oncology 360⁰ Summit in Boston on March 26, 2025. The presentation, titled 'ADG126 SAFEbody®: Targeting CTLA-4+ Tregs to Overcome MSS CRC Resistance', is scheduled for 11:30 AM - 11:50 AM Eastern Time at the Sheraton Boston Hotel.

The summit brings together pharmaceutical companies, biotech firms, academia, and investors focused on advancing cancer immunotherapy treatments. The presentation will be held in Track 2, Back Bay Ballroom AB, with slides becoming available on the company's website afterward.

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Adagene (Nasdaq: ADAG), a pioneer in antibody-based therapy development, has announced its participation in Leerink's Global Healthcare Conference 2025. The event will take place from March 10-12 in Miami, Florida.

Dr. Peter Luo, who serves as the company's Chairman, CEO, and President of R&D, will engage in one-on-one investor meetings and deliver a corporate presentation. The presentation is scheduled for Wednesday, March 12, from 10:40-11:20 AM Eastern Time at W South Beach.

Investors and interested parties can access the presentation webcast through the Investors section of Adagene's website (www.adagene.com), where it will remain available for a minimum of 30 days.

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Adagene (NASDAQ: ADAG) has announced an investigator initiated Phase 2 neoadjuvant trial of ADG126 for stage II or III colorectal cancer patients. The trial, identified as NCT06846268, will begin enrollment in April 2025 with expected primary completion in mid-2027.

The study will evaluate ADG126 in combination with KEYTRUDA® before surgery, with a primary endpoint measuring Major Pathologic Response (MPR) in up to 20 patients. MPR is defined as ≤10% residual viable tumor in surgical specimens. Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability.

Led by Dr. Yong Wei Peng from the National University Cancer Institute, Singapore, the trial will also explore pharmacodynamic effects on the tumor microenvironment's immune profile and ADG126's pharmacokinetic profile in tumor tissues.

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Adagene (NASDAQ: ADAG) announced updated clinical data for their Phase 1b/2 study of Muzastotug (ADG126) in combination with KEYTRUDA® for colorectal cancer treatment. The study showed promising results with a 33% overall response rate in microsatellite stable colorectal cancer patients, achieving four confirmed partial responses out of twelve patients using a 20 mg/kg loading dose followed by 10 mg/kg Q3W + pembrolizumab.

The treatment demonstrated a favorable safety profile with no Grade 4/5 treatment-related adverse events and no discontinuations to date. Pruritus was the most common side effect, occurring in 25% of patients. The company plans to expand the study to include patients with liver metastases. All responding patients remain on treatment at maintenance doses of either 10 mg/kg Q3W or Q6W in combination with pembrolizumab.

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Adagene (NASDAQ: ADAG) will present updated clinical data from its Phase 1b/2 study of ADG126 (muzastotug) in combination with KEYTRUDA® for microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal Cancers Symposium. The presentation will take place on January 25, 2025, in San Francisco.

The study previously showed efficacy at 10 mg/kg Q3W dose, and new data will include results from a 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab. The company will also host a virtual KOL event featuring experts from Université Paris-Saclay and City of Hope to discuss the unmet need in MSS CRC treatment and the importance of CTLA-4 targeting for achieving durable responses in this cold tumor type.

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Adagene (Nasdaq: ADAG) has announced a virtual KOL event scheduled for January 25, 2025, at 1:00 PM ET, focusing on their anti-CTLA-4 SAFEbody® ADG126 treatment for advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC).

The event will feature distinguished experts including Dr. Aurélien Marabelle from Université Paris-Saclay and Drs. Daneng Li and Marwan Fakih from City of Hope. They will discuss the unmet needs in MSS CRC treatment and the importance of CTLA-4 targeting for achieving durable responses in this cold tumor type.

The presentation will include updates on the Phase 1b/2 study of ADG126 (muzastotug) in combination with KEYTRUDA® (pembrolizumab), which will be featured at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco. ADG126 is designed to target CTLA-4 on regulatory T cells within the tumor microenvironment, offering potent anti-tumor activity with reduced toxicity.

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Adagene presented two posters at SITC's 39th Annual Meeting showcasing new insights on ADG126 (Muzastotug), their masked anti-CTLA-4 SAFEbody®. The data demonstrates improved safety and efficacy profiles compared to ipilimumab, driven by precision masking and novel epitope-dependent antibody-dependent cellular cytotoxicity. Clinical results show promising outcomes when combining ADG126 with pembrolizumab in MSS CRC patients, with four partial responses reported in the 10 mg/kg Q3W combination cohort. The treatment showed lower rates of adverse events compared to standard therapies, with no Grade 3 or higher colitis reported in combination therapy.

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Adagene Inc. (Nasdaq: ADAG) has announced upcoming poster presentations at the SITC 39th Annual Meeting in Houston, scheduled for November 6-10, 2024. The presentations will focus on Muzastotug (ADG126), a masked anti-CTLA-4 SAFEbody®.

Two posters will be presented on November 9:

  • Abstract 506: Comparing the clinical therapeutic index of Muzastotug to its unmasked form (ADG116) as monotherapy or combined with anti-PD-1 therapy.
  • Abstract 744: Phase 1b/2 study of Muzastotug combined with Pembrolizumab in advanced/metastatic MSS CRCs.

Both posters will be viewable during lunch (12:15-1:45 PM CST) and at the poster reception (7:10-8:30 PM CST) at the George R. Brown Convention Center. The posters will also be available on Adagene's website.

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FAQ

What is the current stock price of Adagene (ADAG)?

The current stock price of Adagene (ADAG) is $1.58 as of April 16, 2025.

What is the market cap of Adagene (ADAG)?

The market cap of Adagene (ADAG) is approximately 72.5M.

What is the core business of Adagene Inc?

Adagene Inc is a clinical-stage biopharmaceutical company focused on transforming antibody discovery and development through advanced computational biology and proprietary platform technologies. Its efforts are primarily directed at developing novel antibody-based cancer immunotherapies.

How does Adagene's technology differentiate its therapeutic pipeline?

The company utilizes its Dynamic Precision Library platform, incorporating technologies like SAFEbody to shield antibody binding domains and enhance tumor specificity. This approach minimizes on-target off-tumor toxicity and improves the overall therapeutic index of its antibody treatments.

What clinical programs are currently in progress?

Adagene’s lead clinical program, ADG126 (muzastotug), is being evaluated in combination with anti-PD-1 therapies for closely monitored patient populations, including those with microsatellite-stable colorectal cancer. The program highlights the integration of innovative masking technology in clinical trials.

What role does computational biology play in Adagene's research?

Computational biology and artificial intelligence are central to Adagene’s research, accelerating the discovery and optimization of novel antibody candidates. This integration allows for efficient design and precise engineering of antibodies tailored for specific tumor targets.

How does Adagene manage safety concerns in antibody therapeutics?

Adagene addresses safety challenges by employing precision masking techniques that limit off-tumor binding and reduce adverse effects. This enhances the safety profile of its therapies, allowing for higher and repeat dosing with improved clinical tolerability.

What distinguishes Adagene from its competitors in the biopharmaceutical industry?

Adagene differentiates itself by combining cutting-edge computational techniques with a proprietary antibody engineering platform. Its focus on technologies like the Dynamic Precision Library and SAFEbody allows for the development of therapies that are both innovative and precisely targeted.

How is Adagene's clinical pipeline structured?

The company’s pipeline is built around its core technologies, with a strong emphasis on clinical-stage programs that validate its unique approach. Its lead assets, such as ADG126, are in advanced clinical evaluations, supported by strategic research and collaborative efforts.

What are the potential applications of Adagene’s platform beyond cancer immunotherapy?

While its primary focus has been on cancer immunotherapy, Adagene’s platform has the potential to be applied to a variety of antibody-based therapeutic modalities. These include Fc enhanced antibodies, antibody-drug conjugates, and various multispecific T-cell engagers, all benefiting from the technology’s precision and safety enhancements.
Adagene Inc.

Nasdaq:ADAG

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