Tag: engineering

MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.

Simplified capital structure bolsters ability to rapidly meet customer demand, reduce interest expense, and increase liquidity

Garching / Munich, Germany, and Grenoble, France, June 16, 2025 – ITM Isotope Technologies Munich SE (ITM) and the Institut Laue-Langevin (ILL), today announced an extension of their collaboration for medical radioisotope production, originally established in 2009. Under the terms of the renewed agreement, ITM will receive priority access to half of the available neutron irradiation capacity at ILL’s High-Flux Reactor, its neutron irradiation facility, for the production of non-carrier-added Lutetium-177 (n.c.a. Lu-177), a critical medical radioisotope used for radiopharmaceutical therapies for cancer treatment and diagnosis. As the globally leading manufacturer of n.c.a. Lu-177, ITM is committed to maintaining and expanding its robust manufacturing and production capabilities to meet the growing demand for this vital medical radioisotope.