New York, Feb 5, 2026, 15:49 EST — Regular session
Shares of TransCode Therapeutics Inc (RNAZ.O) jumped nearly 19% Thursday following a U.S. regulatory update related to its lead drug program. The stock traded around $10.23, swinging between $9.08 and $12.30, as volume surged to about 11.5 million shares compared to roughly 8,500 the previous day. Investing.com
TransCode has filed an amendment to its Investigational New Drug (IND) application for a Phase 2a trial of TTX-MC138. The effort is in partnership with Quantum Leap Healthcare Collaborative and will run within Quantum Leap’s PRE-I-SPY clinical trial platform. The dose-expansion study aims to enroll up to 45 colorectal cancer patients who show positive circulating tumor DNA markers following standard curative-intent therapy. The trial is slated to kick off in the first half of 2026 under the guidance of Dr. Paula Pohlmann at MD Anderson. “This IND submission marks a pivotal step,” said Sue Duggan, TransCode’s senior vice president of operations. PR Newswire
An IND is the application drug developers submit to the U.S. FDA to get clearance for beginning or expanding human testing; an amendment to that filing supports changes like adding a new study. Circulating tumor DNA, or ctDNA, consists of tumor DNA fragments circulating in the blood and is increasingly used to identify patients who might still have disease post-treatment.
TransCode announced that its Phase 2a trial will evaluate biological and clinical activity in the minimal residual disease setting, targeting the tiny traces of cancer that can remain post-treatment. The study will take place across several PRE-I-SPY platform sites, with a focus on collaboration alongside the Colorectal Cancer Alliance.
TTX-MC138 aims at metastatic tumors with high levels of microRNA-10b, which the company identifies as a marker tied to metastasis. TransCode also mentioned having other early-stage candidates focused on activating the immune system to fight cancer.
On Thursday, TransCode disclosed the announcement via a Form 8-K filing in line with Regulation FD.
The jump in shares comes before some tough tasks lie ahead: the FDA may demand additional data before greenlighting a study. Early-stage oncology trials often miss their endpoints or run longer than expected. Plus, small clinical-stage biotechs risk funding shortfalls if trial expenses climb.
Investors are looking for clues on timing — when sites will go live, first patient dosing, and if the FDA raises concerns about the amended IND. Any new updates on TransCode’s upcoming public milestones will also draw attention. The company’s investor calendar notes Immuno-Oncology 360 scheduled for Feb. 10-12. ir.transcodetherapeutics.com
