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

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