Pipeline

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