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Cellipont Bioservices Celebrates Release of 100th GMP Batch

August 16, 2026 By BioInformant Team Leave a Comment

Cell therapy CDMO reaches major manufacturing milestone approximately one year after initiating GMP operations at its Texas facility

THE WOODLANDS, Texas, July 28, 2026 — Cellipont Bioservices, a cell therapy contract development and manufacturing organization, announced the successful release of its 100th GMP batch at its manufacturing facility in The Woodlands, Texas.

The achievement is especially significant given that Cellipont initiated GMP manufacturing operations at the facility in June 2025. Reaching 100 GMP batch releases in approximately one year reflects the strength of the company’s operational infrastructure, the growing demand from its clients, and the dedication of its cross-functional teams. [Read more…]

Aspen Neuroscience Receives FDA RMAT for Sasineprocel (ANPD001), an Autologous iPSC-Based Therapy for PD

August 16, 2026 By BioInformant Team Leave a Comment

SAN DIEGO, July 30, 2026 — Aspen Neuroscience, Inc., a clinical-stage regenerative medicine biotechnology company developing personalized, autologous cell therapies, announced that sasineprocel (ANPD001), its lead investigational product, for the treatment of Parkinson’s Disease (PD) was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA). [Read more…]

A Complete List of All Publicly Announced RMAT Designations (169)

August 7, 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 169 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…]

The Emerging Role of Exosome Therapeutics in 2026

August 7, 2026 By Cade Hildreth, Founder & President 4 Comments

Exosomes are extracellular vesicles (EVs) of endosomal origin that range in size between 30 and 150 nanometers. Exosomes are secreted by a wide range of cells, since virtually all living cells utilize exosome-mediated communication. Exosomes carry cell-specific cargos of proteins, lipids, and nucleic acids that are selectively taken up by recipient cells. [Read more…]

Hopstem’s iPSC-Derived hNPC01 Cell Therapy Gains FDA Clearance to Target Three Major Brain Injury Indications

August 5, 2026 By BioInformant Team 1 Comment

Hopstem Receives U.S. FDA IND Clearance and Fast Track designations for hNPC01 in Hemorrhagic Stroke and Traumatic Brain Injury-Expanding Clinical Development Across Three Major Brain Injury Indications

HOUSTON, July 29, 2026 — Hopstem Biotechnology announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application and Fast Track designations for hNPC01, an allogeneic induced pluripotent stem cell (iPSC)-derived forebrain neural progenitor cell therapy, for the treatment of chronic motor dysfunction due to Hemorrhagic Stroke (ICH) and Traumatic Brain Injury (TBI). [Read more…]