Investigational New Drug– tag –
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iPS Cells & Regenerative Medicine
Vertex Pharmaceuticals Secures FDA IND Approval for iPSC-Derived Type 1 Diabetes Therapies, Boosts 2026 Revenue Forecast
Vertex Pharmaceuticals USA Overview Vertex Pharmaceuticals announced robust Q2 2026 financial results and significantly raised its full-year revenue guidance, propelled by key pipeline advancements. The company secured FDA Investigationa... -
iPS Cells & Regenerative Medicine
Stealth Cell Therapy Startup Secures Series B, Accelerating iPSC-Derived Neurodegenerative Candidate Towards IND
Specialized Media / Company Announcement USA Overview An undisclosed cell therapy startup has successfully closed its Series B funding round, securing substantial capital. This investment will accelerate preclinical development and suppo... -
iPS Cells & Regenerative Medicine
Century Therapeutics Pivots iPSC Platform to Type 1 Diabetes Beta Cell Therapy, Targeting 2025 IND with Off-the-Shelf Approach
Century Therapeutics USA Overview Century Therapeutics has announced a strategic realignment of its induced pluripotent stem cell (iPSC) platform, now exclusively dedicated to developing beta islet cell therapy for Type 1 Diabetes. The c... -
Cell Culture Technology
FDA Clears Prime Medicine’s In Vivo Prime Editor for Wilson Disease, Setting Stage for 2027 Data
BioSpace USA Overview Prime Medicine has secured FDA Investigational New Drug (IND) clearance for PM577a, an in vivo Prime Editor designed to correct the H1069Q mutation in Wilson disease. This approval initiates a global Phase 1/2 clini... -
Cell Culture Technology
Atrium Therapeutics Receives FDA IND Clearance for RNA Therapeutic ATR 1072 to Treat PRKAG2 Syndrome, Advancing to Phase 1/2 Corventis Trial
Clival Database USA Overview Atrium Therapeutics announced FDA Investigational New Drug (IND) clearance for ATR 1072, an RNA therapeutic in development for the rare PRKAG2 syndrome. This clearance allows the company to proceed with the P... -
Cell Culture Technology
Umoja Biopharma Secures FDA IND Clearance for UB-VV400, First-in-Industry CD22-Targeted In Vivo CAR T Cell Therapy for Relapsed/Refractory B-Cell Malignancies
Umoja Biopharma (Press Release) USA Overview Umoja Biopharma has received FDA Investigational New Drug (IND) clearance for UB-VV400, a CD22-targeted in vivo CAR T cell therapy candidate for relapsed/refractory B-cell malignancies. This m... -
iPS Cells & Regenerative Medicine
Lyora Launches with Seed Funding to Propel Ophthalmic Gene Therapy Assets, Targeting IND Submission Within 18 Months
Cellgenetherapyreview.com USA Overview Lyora announced on July 14, 2026, the successful completion of its seed funding round and the official launch of operations, aimed at advancing its ophthalmic gene therapy assets. The company plans ... -
New Technology
Lonza Accelerates DNA-to-IND Programs with New GS Ori‑Go™ Vector Technology: Delivers Tox Material in 2 Months, IND-Ready in as Fast as 6 Months
Lonza Press Release Switzerland Overview Lonza announced the enhancement of its preclinical development services, featuring the new GS Ori‑Go™ vector technology, to significantly accelerate DNA-to-IND (Investigational New Drug) programs.... -
iPS Cells & Regenerative Medicine
Fate Therapeutics Receives FDA IND Approval for CAR-T Therapy FT839 for Autoimmune Diseases, Advancing to Phase 1/2 Clinical Trial
GlobeNewswire USA Overview Fate Therapeutics has received U.S. FDA Investigational New Drug (IND) approval for its CAR-T cell therapy candidate, FT839, targeting autoimmune diseases. The company plans to initiate a Phase 1/2 basket clini... -
Cell Culture Technology
UniXell Biotechnology Secures FDA IND Clearance for iPSC Parkinson’s Therapy UX-DA003, Achieving Dual Breakthrough in China and U.S.
BioInformant China Overview UniXell Biotechnology has secured FDA IND clearance for UX-DA003, an iPSC-derived Parkinson's disease therapy, marking a dual breakthrough in both China and the U.S. UX-DA003 is an allogeneic iPSC-derived midb...