Adagene

ADAG

Market cap $90.5M

Adagene jumps 13.8% after the FDA grants Fast Track Status to muzastotug with pembrolizumab for MSS metastatic colorectal cancer.

Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer SAN DIEGO and SUZHOU, China, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck's (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without current or active liver metastases. Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody® engineered to overcome CTLA-4–mediated Treg resistance in tumors with enhanced safety and efficacy, delivering a therapeutic index beyond the reach of existing CTLA-4 therapies.

SAN DIEGO and SUZHOU, China and SPRING HOUSE, Pa., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG) and Third Arc Bio, Inc. (“Third Arc Bio”), today announced a licensing agreement under which Third Arc Bio will utilize Adagene's SAFEbody technology platform to generate masked CD3 T cell engagers against unique tumor associated antigens. Under the terms of the agreement, Third Arc Bio will receive rights to research, develop and commercialize two candidate molecules worldwide. Adagene will receive an upfront payment of $5 million and is eligible to receive development and commercial-based milestones of up to $840 million (if all milestones and conditions are achieved) as well as royalties on end-user sales. In addition, Adagene has a no-cost option to develop and commercialize these candidate molecules in Greater China, Singapore and South Korea.

Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on  previous alignment with FDA

Adagene (ADAG) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Here is how Adagene Inc. Sponsored ADR (ADAG) and Bayer Aktiengesellschaft (BAYRY) have performed compared to their sector so far this year.

SAN DIEGO and SUZHOU, China, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG) today announced an amendment to the 2021 collaboration and license agreement with Exelixis. Under the terms of the amended agreement, Exelixis will utilize Adagene's SAFEbody technology platform to generate a masked monoclonal antibody from the company's pipeline for the development of an antibody-drug conjugate (ADC) against an Exelixis-nominated solid tumor target.

Here is how Adagene Inc. Sponsored ADR (ADAG) and ANI Pharmaceuticals (ANIP) have performed compared to their sector so far this year.

SAN DIEGO and SUZHOU, China, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that ADG126 will be highlighted in two oral presentations at this year's CSCO Meeting, taking place September 10-14 in Jinan, China.

SAN DIEGO and SUZHOU, China, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of antibody-based therapies, today announced the appointment of Dr. Axel Hoos as Executive Advisor.