Adagene Inc. Stock Price, News & Analysis

Adagene (Nasdaq: ADAG) announced that its ADG126 (muzastotug) therapy will be featured in two oral presentations at the 2025 CSCO Meeting in Jinan, China from September 10-14. The presentations will highlight ADG126's combination with pembrolizumab in treating microsatellite stable (MSS) colorectal cancer.

The masked anti-CTLA-4 therapy has shown promising results in Phase 1b/2 trials, achieving an objective response rate of ~30% with durable response and over 80% disease control in refractory/resistant MSS CRC patients with no liver metastasis. The treatment demonstrated a median overall survival of 19.4 months in the 10 mg/kg cohorts, while maintaining less than 20% Grade 3 treatment-related adverse events.

Adagene (Nasdaq: ADAG) has appointed renowned immuno-oncology pioneer Dr. Axel Hoos as Executive Advisor. Dr. Hoos, former CEO of Scorpion Therapeutics and creator of the term 'Immuno-Oncology', brings extensive experience including the development of YERVOY®, the first FDA-approved immune checkpoint inhibitor.

The appointment comes as Adagene advances its innovative antibody pipeline targeting CTLA-4, including ADG116 for enhanced T-reg depletion and ADG126 featuring a masked CTLA-4 binder designed for improved efficacy and reduced toxicity. Dr. Hoos highlighted the potential of these programs to expand CTLA-4 targeting in cancer immunotherapy, particularly in cold tumors like MSS CRC where current immunotherapies show limited effectiveness.

[ "Appointment of highly experienced immuno-oncology pioneer Dr. Axel Hoos, former CEO of Scorpion Therapeutics ($2.5B acquisition)", "Development of innovative CTLA-4 targeting antibodies with potential for broader therapeutic applications", "Advanced technology platform (SAFEbody™) showing promise in expanding treatment to new cancer populations", "Strategic timing of appointment coinciding with ADG126's key clinical development phase" ]

Adagene (Nasdaq: ADAG), a company focused on antibody-based therapy development, announced its participation in two upcoming investor conferences in New York this September.

The company's Chief Strategy Officer, Mickael Chane-Du, will attend the H.C. Wainwright Global Investment Conference on September 8 at 11:00 AM ET and the Morgan Stanley Global Healthcare Conference on September 10 at 7:00 AM ET. Both events will feature fireside chats and one-on-one investor meetings.

Webcasts of the presentations will be available on Adagene's website for 30 days following the events.

Adagene (NASDAQ:ADAG) reported significant progress in its H1 2025 financial results and pipeline developments. The company's flagship product ADG126 demonstrated impressive results in Phase 1b/2 trials, showing 19.4-month median overall survival in MSS CRC patients at 10 mg/kg dosing, with 20 mg/kg cohorts' median OS not yet reached. The drug achieved a 29% confirmed overall response rate in MSS CRC.

Notable corporate developments include a strategic investment of up to $25 million from Sanofi, which will conduct a Phase 1b/2 trial of ADG126 combinations. The company reported $62.8 million in cash as of June 30, 2025, with a reduced net loss of $13.5 million compared to $17.0 million in the same period of 2024. FDA alignment on Phase 2 and 3 trial designs positions ADG126 for advancement, with Phase 2 enrollment planned for 2H 2025.

Adagene (NASDAQ:ADAG) has received positive feedback from the FDA following a Type B meeting regarding the clinical development plan for muzastotug (ADG126) in combination with Merck's KEYTRUDA for treating microsatellite stable colorectal cancer (MSS CRC).

The FDA has endorsed key aspects of the Phase 2 trial design, which will enroll approximately 60 patients across two dosing arms (10 mg/kg and 20 mg/kg). Early data shows promising results with ORR increasing from 17% at 10 mg/kg to 29% at 20 mg/kg, while maintaining Grade 3 TRAEs at approximately 20%.

The company plans to begin Phase 2 enrollment in 2H 2025, focusing on late-line MSS CRC patients without liver metastases. The trial's primary endpoint will be overall response rate (ORR), with secondary endpoints including duration of response, progression-free survival, and overall survival.

Adagene (Nasdaq: ADAG) has partnered with ConjugateBio to develop novel bispecific Antibody Drug Conjugates (ADCs). Under the agreement, Adagene will provide a proprietary antibody for ConjugateBio's ADC development programs, receiving an undisclosed upfront payment plus milestone and royalty payments while retaining all non-ADC rights.

The collaboration aims to leverage Adagene's antibody discovery capabilities and ConjugateBio's ADC development expertise in a market expected to reach over $30 billion by 2030. The partnership builds on Adagene's track record with ADG126, demonstrating their ability to create safe and efficacious molecules.

Adagene (NASDAQ:ADAG), a developer of antibody-based therapies, has secured a strategic investment of up to $25 million from Sanofi (Euronext: SAN FP). The investment strengthens their existing partnership and includes Sanofi's exercise of an option for a third SAFEbody discovery program.

The funding will support Adagene's R&D activities, particularly the clinical development of muzastotug (ADG126), an anti-CTLA-4 SAFEbody, through a randomized phase 2 trial in microsatellite stable colorectal cancer. Additionally, Sanofi will sponsor a phase 1/2 clinical trial evaluating muzastotug in combination with other anticancer therapies in over 100 advanced solid tumor patients.

As of December 31, 2024, Adagene reported cash and cash equivalents of $85.2 million. With Sanofi's investment, the company expects to extend its cash runway into 2027. The partnership will be further strengthened by the addition of a Sanofi representative to Adagene's Scientific Advisory Board.

Adagene Inc. (Nasdaq: ADAG), a biotechnology company focused on antibody-based therapies, announced its participation in the Jefferies Global Healthcare Conference 2025. Chief Strategy Officer Mickael Chane-Du will engage in one-on-one investor meetings and participate in a fireside chat on June 5, 2025, from 9:20-9:50 AM ET at the New York Marriott Marquis. The presentation will be available via webcast and accessible through the company's investor relations website for a minimum of 30 days.

Adagene (NASDAQ: ADAG) reported updated data from its Phase 1b/2 study of ADG126 (muzastotug) in combination with KEYTRUDA for colorectal cancer treatment. The study showed promising results with 29% confirmed overall response rate (ORR) in microsatellite stable colorectal cancer at the 20 mg/kg dose. Key highlights include: less than 20% Grade 3 adverse events, all six responders in 20 mg/kg cohorts remaining on treatment, and four patients continuing beyond 40 weeks. The 10 mg/kg cohorts demonstrated a median overall survival of 19.4 months with 17% ORR. The 20 mg/kg Q6W dosing showed equivalent efficacy with reduced toxicity compared to other regimens. The company plans to discuss the dosing regimen with regulatory bodies for the next phase of clinical development.