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HIGH IMPACT – Iveric Bio announced topline data from GATHER2, its second phase 3 study of C5 aptamer, Zimura (Avacincaptad pegol) in geographic atrophy. Efficacy (anatomical): 14.3% reduction in mean rate of GA growth (slope; mm) at month 12 (p=0.0064). 17.7% reduction in mean rate of GA growth (slope; mm2) at month 12 (p=0.0039). Point […]
HIGH IMPACT – The European Commission (EC) has granted conditional marketing authorization (CMA) to ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A in adults without Factor VIII inhibitors and without antibodies to AAV5. Roctavian is the first approved gene therapy for hemophilia A. BioMarin stated there are 3,200 patients who will be […]
HIGH IMPACT – Chinese biotech I-Mab announced that its U.S. partner AbbVie will discontinue a phase 1b study evaluating a combination treatment for its anti-CD47 antibody therapy lemzoparlimab + venetoclax + azacitidine in MDS and AML. The decision is not based on specific or unexpected safety concerns. I-Mab is continuing the development of lemzoparlimab with […]
HIGH IMPACT – Neurocrine announced that the FDA accepted its IND for NBI-1117568 (selective M4 agonist). The company says that it anticipates initiating a Phase 2 study evaluating NBI-1117568 in Schizophrenia in H2 2022. Neurocrine is developing NBI-1117568 in partnership with Sosei Heptares under a multi-program muscarinic receptor agonist collaboration agreement established between the two […]
HIGH IMPACT – Small Pharma announced that the United States Patent and Trademark Office (USPTO) will be issuing a patent for its application pertaining to novel injectable formulations of N,N-dimethyltryptamine (DMT) based compounds including the company’s lead assets, SPL026 (DMT) and SPL028 (deuterated DMT). Additionally, the patent also covers novel injectable formulations of other known psychedelic […]
