New Pipeline Updates from Janssen, Eli Lilly, Gilead and Lysogene

September 10, 2018

Company Drug/Device Medical Condition Status
Janssen Esketamine nasal spray Treatment-resistant depression in adults Submitted a new drug application to the FDA
EpicGenetics BCG (an inexpensive generic vaccine to prevent tuberculosis) Fibromyalgia Massachusetts General Hospital granted FDA approval for human trial
ARMGO Pharma, Inc. ARM210 (also known as S48168) Ryanodine Receptor Type 1 Related Myopathies (RYR1-RM) Granted Orphan Drug Designation by the FDA
Lysogene LYS-SAF302 Mucopolysaccharidosis Type IIIA (MPS IIIA) Granted Investigational New Drug (IND) clearance by FDA for Phase II-III (AAVance) trial in U.S.
Pfizer Oral Janus kinase 3 (JAK3) inhibitor PF-06651600 Alopecia areata, a chronic autoimmune skin disease that causes hair loss Granted Breakthrough Therapy designation by the FDA
ITF Pharma TIGLUTIK™ (riluzole) oral suspension Amyotrophic lateral sclerosis (ALS) Granted approval by the FDA
Baxter International, Inc. Actifuse Flow Bone Graft Substitute Orthopedic surgical procedures Granted clearance by the FDA
AstraZeneca/MedImmune Anifrolumab Moderate to severe lupus erythematosus (SLE) Flunked Phase III clinical trial
Horizon Pharma plc Teprotumumab Moderate-to-severe active thyroid eye disease (TED) Early completion of enrollment for confirmatory Phase III trial
SillaJen/Lee’s Pharmaceutical Holdings Oncolytic immunotherapy Pexa-Vec (formerly JX-594) Advanced liver cancer First patient enrolled in China in the Phase III PHOCUS clinical trial
Eli Lilly and Company Flortaucipir F 18, a Positron Emission Tomography (PET) imaging agent Predicting brain tau pathology and Alzheimer’s disease diagnosis Phase III trial successfully met two primary endpoints
Advicenne ADV7103 Distal Renal Tubular Acidosis (dRTA) Granted Investigational New Drug (IND) clearance by FDA for ARENA-2 Phase III clinical trial
Gilead Sciences and Galapagos NV Filgotinib, a selective JAK1 inhibitor Active ankylosing spondylitis (AS) in adults Phase II TORTUGA clinical trial met endpoint of greater improvements in AS Disease Activity Score (ASDAS)
Neumentum Non-opioid NTM-001 (pre-mixed bag ketorolac for continuous infusion) Moderately severe acute pain Completed dosing the first cohort of patients in its Phase I trial
PvP Biologics, Inc. Kuma062 Celiac disease Two first-in-human clinical trials initiated