VBI’s Sci-B-Vac CONSTANT data firmly establishes the hepatitis B vaccine’s advantages over GSK’s longstanding Engerix-B, but it faces a tougher challenge with Heplisav-B from Dynavax. 

Besting Alexion’s Soliris in a head-to-head Phase III trial portends a place in the market for Apellis’ competitor in paroxysmal nocturnal hemoglobinuria. But challenges dog both companies.

Iterum’s antibiotic sulopenem missed its endpoint by the equivalent of one patient. The company believes the Phase III data could still support its NDA for urinary tract infections.

FerGene bladder cancer therapy achieved a complete response in more than half of patients in its pivotal trial. The joint venture now looks to commercialization and potential expansion of indications.

Sage Therapeutics points to patient compliance and selection as factors in its failed trial of SAGE-217. The company sees positive implications in the data as it waits for other SAGE-217 studies. 

Evofem Biosciences is preparing for Phase III trials for Amphora, an on-demand contraceptive that has surpassed Phase II endpoints in preventing bacterial sexually transmitted infections.