Pipeline

November 24, 2019

Company	Drug/Device	Medical Condition	Status
CStone Pharmaceuticals	ivosidenib	relapsed or refractory acute myeloid leukemia	Phase 1 trial initiated enrolling subjects with IDH1 mutant relapsed or refractory acute myeloid leukemia (R/R AML)
Seelos Therapeutics, Inc.	SLS-002	Central Nervous System (CNS) disorders and rare diseases	Phase 1 trial initiated enrolling 48 healthy volunteers
Spring Bank Pharmaceuticals, Inc.	SB 11285	advanced solid tumors	Phase 1 trial initiated at multiple sites in the U.S.
Celldex Therapeutics, Inc.	CDX-0159	chronic idiopathic urticaria (CIU)	Phase 1a trial initiated enrolling 32 healthy subjects
Medivir AB	MIV-818	liver cancer	Phase 1a trial initiated enrolling nine subjects with advanced liver cancer
Enlivex Therapeutics Ltd.	Allocetra	severe sepsis	Phase 1b trial initiated enrolling 10 subjects
Phoenix Molecular Designs	PMD-026	triple negative breast cancer	Phase 1/1b trial initiated enrolling subjects with metastatic breast cancer and triple negative breast cancer at sites in the U.S.
Sensei Biotherapeutics	SNS-301 in combination with pembrolizumab	ASPH positive head and neck cancer	Phase 1/2 trial initiated enrolling 30 subjects
Axial Biotherapeutics	AB-2004	Autism Spectrum Disorder (ASD)	Phase 1b/2a trial initiated enrolling 25 male adolescent subjects
Inotrem S.A.	nangibotide	septic shock	Phase 2b trial initiated enrolling 450 subjects with septic shock at 48 sites across five countries in Europe and the U.S.
Viking Therapeutics	VK2809	non-alcoholic steatohepatitis	Phase 2b trial initiated enrolling 340 subjects with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3 at multiple sites
BiondVax Pharmaceuticals Ltd.	M-001	universal flu vaccine	Phase 3 trial initiated enrolling 12,463 subjects ages 50 years and older, including 6,291 ages 65 and older at 83 sites in eastern European countries
Achillion Pharmaceuticals, Inc.	danicopan (ACH-4471)	paroxysmal nocturnal hemoglobinuria (PNH) in patients who are not adequately responding to a C5 inhibitor	PRIME Designation granted by the EMA
Carestream	Focus 35C Detector with Image Suite Software	medical imaging	510(k) Clearance Granted by the FDA
Merit Medical Systems, Inc.	WRAPSODY	stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up to the superior vena cava	Breakthrough Device Designation granted by the FDA
Siemens Healthineers	SOMATOM X.cite	single-source computed tomography (CT) scanner	Clearance granted by the FDA
AstraZeneca	Calquence	chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)	Supplemental Approval granted by the FDA
BeiGene	BRUKINSA (zanubrutinib)	mantle cell lymphoma (MCL)	Accelerated Approval granted by the FDA
CooperVision	MiSight 1day contact lens	myopia in children eight to 10 years of age	Approval granted by the FDA
Pfizer	Abrilada (adalimumab-afzb)	rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis	Approval granted by the FDA
CeraPedics, Inc.	i-FACTOR Peptide Enhanced Bone Graft	degenerative cervical disc disease	PMA Approval granted by the FDA
Novartis	Adakveo (crizanlizumab)	sickle cell disease	Approval granted by the FDA
Q Biomed Inc.	Strontium-89	skeletal metastases caused by cancer	Approval granted by the FDA
Alnylam Pharamceuticals, Inc.	GIVLAARI (givosiran) injection	acute hepatic porphyria (AHP)	Approval granted by the FDA