MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has reached a significant milestone in the development of its gene-agnostic ... it ...

OCGN’s pipeline currently includes three modifier gene therapies: 1) OCU400, 2) OCU410, and 3) OCU410ST. Recently, all of them have earned EMA Advanced Therapy Medicinal Product [ATMP] status ...

Ocugen, Inc. has announced that the European Commission has given a positive opinion for the classification of its gene therapy product, OCU400, as an Advanced Therapy Medicinal Product (ATMP ...

ATMP status was confirmed due to its potential as a gene therapy medicinal product that targets specific cells and expression of the gene directly within the patient’s body. This approach can ...

The life sciences company Solid Biosciences is merging with the privately-held gene therapy company AavantiBio ... and trade on Nasdaq under ticker symbol ‘SLDB’. AavantiBio’s current ...

clinical stage gene therapy company, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) and Advanced Therapy Medicinal Product (ATMP) designations to ...

The company’s advanced therapy medicinal products (ATMP) business was announced in early 2021. The facility is located in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Center ...

The requirements of ATMP are summarized in the European regulation 1394/2007 where gene therapy medicinal product are now defined (§2) (REGULATION (EC) No 1394/2007 on advanced therapy medicinal ...