Aditxt subsidiary targets early 2026 FDA submission for immune therapy

Published 25/08/2025, 14:22
Aditxt subsidiary targets early 2026 FDA submission for immune therapy

MOUNTAIN VIEW, Calif. - Aditxt, Inc. (NASDAQ:ADTX) announced Monday that its wholly owned subsidiary Adimune is preparing to seek FDA submission and approval for first-in-human trials in type 1 diabetes and stiff person syndrome by early 2026. According to InvestingPro data, the company currently maintains a market capitalization of $5.2 million, though financial metrics indicate challenges with a current ratio of 0.02, suggesting potential liquidity concerns.

Adimune is developing a DNA-based therapeutic platform designed to reprogram the immune system. The company’s intellectual property portfolio now includes 96 granted and 22 pending patents that are owned or exclusively licensed by Aditxt.

The company is targeting the global autoimmune therapeutics market, which it estimates will reach over $160 billion by 2030. Adimune’s lead product candidate, ADI-100, is being developed for conditions including type 1 diabetes, psoriasis, and stiff person syndrome.

"Our platform is designed to reprogram the immune system, restoring tolerance without the burden of chronic immunosuppression," said Friedrich Kapp, Co-Chief Executive Officer of Adimune, in the press release. "By combining DNA instructions with our proprietary delivery platform, we are aiming for digital-like precision in how the immune system is retrained."

Aditxt CEO Amro Albanna stated that Adimune’s approach could represent "a fundamental shift" in addressing immune system diseases through programming instructions.

The company is also working toward closing its proposed acquisition of Evofem, announced in an amended merger agreement in July 2024. The transaction is targeted to close in the second half of 2025, subject to Evofem shareholder approval and Aditxt raising approximately $17 million to fulfill its obligations at closing.

Aditxt describes itself as a social innovation platform that accelerates promising health innovations through collaboration with research institutions, industry partners, and shareholders.

In other recent news, Aditxt, Inc. has announced several developments that may interest investors. The company unveiled a new strategy, "bitXbio," to support its biotech ventures by combining Bitcoin reserves with an equity line facility. This initiative aims to strengthen Aditxt’s financial position as it prepares for future commercialization opportunities. Additionally, Aditxt has signed a custody agreement with Crypto.com to establish a custodial crypto account, marking a step towards integrating digital assets into its operations.

Aditxt’s subsidiary, Pearsanta, is also making strides with plans for an initial public offering (IPO) and has engaged Spartan Capital Securities as the lead underwriter. The proposed IPO is intended to support the clinical validation and rollout of Pearsanta’s diagnostic tests. Furthermore, Pearsanta has been invited to submit a full proposal for a U.S. Department of Defense grant, focusing on its MitomicⓇ Ovarian Test for ovarian cancer.

In a move to expand into the women’s health market, Aditxt has appointed Saundra Pelletier, CEO of Evofem Biosciences, to its Board of Directors. Pelletier’s experience in women’s healthcare and pharmaceuticals is expected to contribute to Aditxt’s strategic growth in this sector. These recent developments highlight Aditxt’s efforts to innovate and expand its presence in the biotech and healthcare markets.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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