Adagene Inc. Stock Price, News & Analysis

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.

Adagene Inc. (Nasdaq: ADAG) has appointed Dr. John Maraganore as Executive Advisor to mentor the C-suite and provide strategic guidance. Dr. Maraganore, former CEO of Alnylam (2002-2021), brings extensive experience in developing breakthrough therapeutics and creating substantial market value.

The appointment aligns with Adagene's focus on their proprietary masking technology for checkpoint inhibitors, specifically ADG126, which aims to deliver anti-CTLA-4 therapy selectively to tumor cells while minimizing toxicity. During his tenure at Alnylam, Dr. Maraganore led the company through global approvals of four RNA interference medicines and formed over 20 major pharmaceutical alliances, building over $25 billion in market capitalization.

Adagene (Nasdaq: ADAG) has announced an upcoming poster presentation at the ASCO 2025 Annual Meeting in Chicago. The presentation will focus on their masked anti-CTLA-4 SAFEbody® ADG126 (Muzastotug) therapy. The poster will showcase updated results from a Phase 1b/2 study examining the safety and efficacy of ADG126 in combination with Pembrolizumab for advanced MSS CRC treatment.

The presentation is scheduled for Saturday, May 31, 2025, with poster viewing from 9:00 AM to 12:00 PM CDT at McCormick Place, Chicago (Board #248, Abstract #3579). The poster will be accessible on the company's website Publications page.

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.

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.