HADLEY, MA, UNITED STATES, January 20, 2026 /EINPresswire.com/ — On December 19, 2025, Ernest Pharmaceuticals participated in an FDA INTERACT meeting regarding their lead candidate, EBT-302, which utilizes their patented BacID intracellular delivery platform. This key regulatory milestone provided the FDA’s feedback on the foundational components of Ernest Pharmaceuticals’ therapeutic lead program.
During the productive INTERACT meeting, the FDA provided clear and constructive feedback across Chemistry, Manufacturing, and Controls (CMC) and non clinical plans for EBT-302. This discussion clarified Ernest Pharmaceuticals’ regulatory pathway and strengthened the company’s view that their development strategy is well positioned to file an Investigational New Drug (IND) application by 2027.
Nele Van Dessel, Ernest CEO, stated that, “This productive discussion with FDA reviewers gives Ernest leadership renewed confidence that our development plan is on the right track.”
About Ernest Pharmaceuticals
Ernest Pharmaceuticals is pioneering a new class of intracellular biologics enabled by its BacID platform, a living, programmable delivery system that selectively colonizes tumors and releases therapeutic payloads directly inside cancer cells. The company’s modular platform is designed to overcome the fundamental limitations of systemic biologics, enabling targeted delivery of large molecules that cannot be safely or effectively administered through traditional approaches.
Disclaimer
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events, Ernest’s future operating performance and goals, the anticipated benefits of therapies and combination therapies (that include a Ernest pipeline product), as well as the expectations, beliefs and development objectives for Ernest’s product pipeline and clinical trials. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “goal”, “estimate”, “anticipate”, “believe”, “predict”, “designed,” “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. For example, implicit or explicit statements concerning the following include or constitute forward-looking statements: This productive discussion with FDA reviewers gives Ernest leadership renewed confidence our development plan is on the right track. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Ernest and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties.
Nele Van Dessel
Ernest Pharmaceuticals
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