Pipeline

June 4, 2018

Company	Drug/Device	Medical Condition	Status
NeoImmune Tech, Inc.	HyLeukin-7	brain cancer	Phase I trial initiated enrolling up to 75 subjects
Atox Bio	Reltecimod	Abdominal sepsis and Stage 2/3 Acute Kidney Injury (AKI)	Phase II trial initiated enrolling 120 subjects at approximately 50 level 1 trauma centers in the U.S.
Atox Bio	Reltecimod	Necrotizing Soft Tissue Infections (NSTI)	Phase III trial initiated enrolling 290 subjects at approximately 70 level 1 trauma sites in the U.S.
Synedgen	Catasyn Advanced Technology Wound Hydrogel	wound care	510(k) clearance granted by the FDA
Novartis	Promacta (eltrombopag)	Severe aplastic anemia (SAA)	sNDA approval granted by the FDA
Nektar Therapeutics	NKTR-181	chronic lower back pain	NDA approval granted by the FDA
Sage Therapeutics	brexanolone (SAGE-547)	postpartum depression (PPD)	NDA approval granted by the FDA
MicroVention, Inc.	Low profile Visualized Intraluminal Support (LVIS) and LVIS Jr. neuro stent devices	wide-necked saccular intracranial aneurysms	PMA granted by the FDA
Dova Pharmaceuticals	Doptelet (avatrombopag)	thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure	Approval granted by the FDA
TherapeuticsMD	Imvexxy (TX-004HR)	moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), symptom of vulvar and vaginal atrophy (VVA)	Approval granted by the FDA
BioMarin Pharmaceutical	Palynziq (pegvaliase-pqpz)	Henylketonuria (PKU)	Approval granted by the FDA
Zeto, Inc.	zEEG	dry electrode electroencephalography (EEG) headset	Approval granted by the FDA
Astellas Pharma Inc.	gilteritinib	Relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation	Priority Review granted by the FDA
Pfizer	Xalkori (crizotinib)	Metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy	Breakthrough Therapy Designation granted by the FDA
Pfizer	tafamidis	Transthyretin cardiomyopathy	Breakthrough Therapy Designation granted by the FDA
Yamo Pharmaceuticals, LLC	L1-79	autism spectrum disorder (ASD)	Fast Track Designation granted by the FDA
Genea Biocells	GBC0905	Facioscapulohumeral muscular dystrophy (FSHD)	Orphan Drug Designation granted by the FDA