|I-Mab Biopharma Co. Ltd., of Shanghai||TJ-202 (MOR-202)||CD38 antibody||Relapsed or refractory multiple myeloma||Dosed first patient in mainland China in registrational study|
|Orphazyme A/S, of Copenhagen||Arimoclomol||Activates heat-shock response||Niemann-Pick disease type C||12-month interim data from open-label extension of phase II/III study show continued positive impact on disease progression over 2 years; separate data from post-hoc genetic subgroup analysis also show efficacy; regulatory submissions in U.S. and Europe expected in the first half of 2020 and second half of 2020, respectively|
|Incyte Corp., of Wilmington, Del.||Itacitinib||Selective JAK1 inhibitor||Acute graft-vs.-host disease||Pivotal Gravitas-301 study in combination with corticosteroids in treatment-naïve patients did not meet primary endpoint of improving overall response rate at day 28 vs. placebo plus corticosteroids (74% vs. 66.4%, p=0.08); no difference observed in non-relapse mortality at month 6, the key secondary endpoint, between treatment and placebo arms|
|Novan Inc., of Morrisville, N.C.||SB-206||Nitric oxide-releasing topical gel||Molluscum contagiosum||Top-line data showed B-Simple program did not achieve primary endpoint in B-Simple1 or B-Simple2, defined as proportion of patients with complete clearance of all treatable lesions at week 12 (p=0.375 and p=062, respectively); multiple sensitivity analyses, however, were supportive and consistent across both studies; the trials remain ongoing, awaiting 24-week safety data|
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