Abpro Holdings, Inc. 8-K

What Happened
Abpro Holdings, Inc. (ABP) announced on January 6, 2026 (via Form 8-K Item 7.01) that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, the company’s lead multispecific antibody oncology program. The filing notes the program is being co-developed with Celltrion, Inc. A press release announcing the clearance is attached to the 8-K as Exhibit 99.1.

Key Details

• FDA cleared the IND for ABP-102 / CT-P72 (lead multispecific antibody oncology candidate).
• Announcement made via Form 8-K filed January 6, 2026 (Item 7.01 — Regulation FD disclosure).
• Program is co-developed with Celltrion, Inc.
• Press release dated January 6, 2026 is attached as Exhibit 99.1 (Item 9.01 lists the exhibit).

Why It Matters
An IND clearance is a formal regulatory step that allows a drug candidate to proceed toward clinical trials in the U.S., marking a meaningful development milestone for Abpro and its collaboration with Celltrion. For investors, this moves ABP-102 from preclinical/regulatory preparation into the clinical development pathway, which can increase project visibility and potentially trigger future development milestones or partnership value—though the 8-K does not disclose trial start dates, financial impacts, or changes to guidance.