Blog | BioInformant

Kyverna Therapeutics and ElevateBio Enter into Commercial Manufacturing and Supply Agreement for Miv-cel

July 27, 2026 By BioInformant Team Leave a Comment

New agreement secures flexible and scalable manufacturing to support the U.S. commercial and global clinical supply of miv-cel

EMERYVILLE, Calif., and WALTHAM, Mass., July 27, 2026 — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases, and ElevateBio, a technology-driven advanced therapy contract development and manufacturing organization (CDMO), today announced a manufacturing agreement for both U.S. commercial and global clinical supply of miv-cel (mivocabtagene autoleucel), Kyverna’s autologous CD19-directed CAR T-cell therapy. [Read more…]

The Pipeline for iPSC-Derived Cell Therapeutics in 2026

July 26, 2026 By Cade Hildreth, Founder & President 6 Comments

Despite progress involving the use of induced pluripotent stem cells (iPSCs) within disease modeling and drug discovery applications, it will be a long path to achieve the broad-scale use of iPSC-derived cell types in human patients. [Read more…]

A Complete List of All Publicly Announced RMAT Designations (165)

July 23, 2026 By Cade Hildreth, Founder & President 8 Comments

To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?

The answer is that 165 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 388 requests and issued 193, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately half of RMAT applications get approved (193 approvals / 388 applications = 49.7%).

[Read more…]

Longevity Medical Institute® Launches Advanced Intranasal Regenerative Neurological Therapy Platform

July 23, 2026 By BioInformant Team Leave a Comment

Non-invasive nose-to-brain delivery system expands treatment options for patients with neurological disorders as an alternative to intrathecal administration.

SAN JOSé DEL CABO, BAJA CALIFORNIA SUR, MEXICO, July 23, 2026 — Longevity Medical Institute^® today announced the launch of its Regenerative Neurological Therapy Program, featuring an advanced intranasal delivery platform designed to transport regenerative therapies toward the brain through the nasal cavity. The technology expands the institute’s comprehensive neurological program by offering patients a non-invasive alternative to intrathecal administration for selected neurological conditions.
[Read more…]

Syntax Bio and Applied StemCell Announce Strategic Collaboration to Advance Stem Cell Innovation

July 13, 2026 By BioInformant Team Leave a Comment

The companies will generate data using Applied StemCell’s induced pluripotent stem cell technologies and Syntax Bio’s Cellgorithm™ platform to support application discovery and development

CHICAGO & MILPITAS, Calif. — Syntax Bio, a synthetic biology company programming the next generation of cell therapies, and Applied StemCell Corp. (ASC), a leader in induced pluripotent stem cell (iPSC) technology and genome engineering, announced a strategic collaboration to help unlock the next generation of regenerative medicine. The collaboration will focus on evaluating ASC’s iPSC and hypoimmune cell lines using Syntax Bio’s proprietary Cellgorithm™ platform to advance stem cell research and therapeutic application discovery and development. [Read more…]