Hy BioPharma is developing hypericin phototherapeutics for cancers and autoimmune disorders. The Israeli/US start-up is also in Phase I/IIb trials for an oral formulation of hypericin for possible use in combination therapy with Temodar for the treatment of glioblastoma.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Plus deals involving Lilly/Gate Bioscience, Concentra/iTeos, Nicox/Kowa, Ajax/Schrodinger, I-Mab/Bridge Health, Otsuka/Cantargia, JCR/Acumen and more.
Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.
Recent moves in the industry include changes at the top at Trogenix and Quetzal Therapeutics, plus Synendos Therapeutics gains a new CMO from Roche.
