ImmixBiopharma selected for FDA CEO forum on regulatory framework modernization.

Immix Biopharma, a clinical-stage biopharmaceutical company, was selected by the FDA to attend a CEO forum led by FDA Commissioner Marty A. Makary. The purpose of the meeting was to gather feedback from biotech leaders on how the FDA can modernize its regulatory framework to support innovation and patient access to safe and effective therapies. Immix Bio's attendance highlights its role in shaping the future of drug regulation.

Immix Biopharma, Inc. (IMMX), a clinical-stage biopharmaceutical company, has been selected by the FDA to attend a CEO forum led by FDA Commissioner Marty A. Makary. The forum, held on June 5, 2025, at FDA headquarters in Silver Spring, MD, aimed to gather direct input from biotechnology and pharmaceutical leaders on modernizing the regulatory framework to better support innovation and patient access to safe and effective therapies.

According to a press release, Immix Biopharma was chosen for its significant contributions to the development of cell therapies for AL Amyloidosis and other serious diseases. The company's lead candidate, NXC-201, is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy that has shown promising interim results in clinical trials.

The meeting provided an opportunity for Immix Biopharma to discuss its vision for an efficient regulatory framework with the FDA. Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma, stated, "We share FDA’s vision for an efficient, thoughtful regulatory framework to accelerate patient access to safe and effective therapies. Discussing this topic with FDA Commissioner Dr. Makary and team yesterday offered an unprecedented opportunity."

The forum also highlighted the company's recent achievements. Immix Biopharma has been awarded Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation (ODD) by the FDA and the European Medicines Agency (EMA) for NXC-201. The drug is currently being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis, with interim results presented at ASCO 2025 [4].

The selection of Immix Biopharma for the CEO forum underscores the company's role in shaping the future of drug regulation. The meeting is part of the FDA's ongoing efforts to modernize its regulatory framework and foster innovation in the biopharmaceutical industry.

References:
[1] https://www.marketscreener.com/quote/stock/IMMIX-BIOPHARMA-INC-130728145/news/Immix-Biopharma-Attends-FDA-CEO-Forum-in-Washington-DC-50179682/
[2] https://finance.yahoo.com/news/h-c-wainwright-reiterates-buy-203346352.html
[3] https://finance.yahoo.com/quote/IMMX/
[4] https://www.biospace.com/press-releases/immix-biopharma-announces-primary-endpoint-met-in-positive-nxc-201-interim-results-presented-at-asco-enabling-path-to-best-in-class-therapy-for-relapsed-refractory-al-amyloidosis