Pipeline

August 26, 2019

Company	Drug/Device	Medical Condition	Status
MyoKardia, Inc.	MYK-224	hypertrophic cardiomyopathy (HCM)	Phase 1 trial initiated enrolling healthy adults
Bio-Thera Solutions, Ltd.	single subcutaneous dose of either BAT2506 or EU-sourced Simponi (golimumab)	ulcerative colitis	Phase 1 trial initiated enrolling 182 subjects
Kite Pharma, a Gilead company	KITE-439	HPV-associated cancers with HPV type 16, a strain which causes about 70% of all cervical cancers worldwide, as well as oropharyngeal, anal, penile and vaginal cancers	Phase 1 trial initiated enrolling subjects who must be HLA-A*02:01 positive, relapsed or refractory after at least one line of therapy at City of Hope in Duarte, CA
NKMax America	SNK	plaque psoriasis	Phase 1 trial initiated enrolling nine subjects with mild to severe plaque psoriasis in Tijuana, Mexico
Forendo Pharma	HSD17B1 inhibitor FOR-6219	endometriosis	Phase 1b trial initiated enrolling healthy premenopausal women
BioInvent International AB	BI-1206 in combination with pembrolizumab (Keytruda)	solid tumors	Phase 1/2a trial initiated enrolling subjects with advanced solid tumors, who have been previously treated with anti-PD1 or anti-PD-L1 antibodies
Rocket Pharmaceuticals, Inc.	RP-L102	Fanconi anemia	Phase 2 trial initiated enrolling up to five pediatric patients who have not developed severe bone marrow failure in Europe
Landos Biopharma	BT-11	mild to moderate ulcerative colitis (UC)	Phase 2 trial initiated enrolling 195 UC subjects with mild to moderate disease in 11 countries with 60 sites throughout the U.S., Europe and Eastern Europe.
Inovio Pharmaceuticals, Inc.	VGX-3100 immunotherapy	human papillomavirus (HPV)	Phase 2 trial initiated enrolling 24 subjects with precancerous lesions of the anus, i.e. anal high-grade squamous intraepithelial lesions (anal HSIL, aka anal intraepithelial neoplasia)
Knopp Biosciences LLC	oral dexpramipexole	eosinophilic asthma	Phase 2 trial initiated enrolling 100 subjects with moderate-to-severe eosinophilic asthma
Emalex Biosciences, Inc.	ecopipam HCl tablets	Tourette Syndrome (TS)	Phase 2b trial initiated enrolling 150 children and adolescent subjects (aged >6 to <18 years) at multiple centers in the United States, Canada, and the European Union
Satsuma Pharmaceuticals, Inc.	STS101 (dihydroergotamine (DHE) nasal powder)	acute treatment of migraine	Phase 3 trial initiated enrolling 1,140 subjects at sites across U.S.
ActoBio Theraputics, Inc.	AG017	celiac disease	IND approval granted by the FDA
Vyaire Medical, Inc.	Vyntus ONE	Pulmonary Function Testing (PFT)	510(k) clearance granted by the FDA
Vyaire Medical, Inc.	Vyntus BODY with SentrySuite Software	Pulmonary Function Testing (PFT)	510(k) clearance granted by the FDA
Moderna, Inc.	mRNA-1893	Zika virus infection	Fast Track designation granted by the FDA
Genentech	Rozlytrek (entrectinib)	ROS1-positive, metastatic non-small cell lung cancer (NSCLC)	Accelerated approval granted by the FDA
CVRx, Inc.	BAROSTIM NEO device for heart failure	Chronic heart failure	Premarket approval granted by the FDA
Nabriva Therapeutics	Xenleta (lefamulin)	community-acquired bacterial pneumonia	Approval granted by the FDA
AbbVie	Rinvoq (upadacitinib)	moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR)	Approval granted by the FDA
Boston Scientific Corporation	ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation (DBS) System	Parkinson's Disease	Approval granted by the FDA
Zimmer Biomet	The Tether anterior vertebral body tethering (AVBT) solution	scoliosis, providing a fusion-less alternative for young patients requiring surgery	Approval granted by the FDA
Celgene	Inrebic (fedratinib) capsules	Myelofibrosis	Approval granted by the FDA
TB Alliance	Pretomanid tablets in combination with bedaquiline and linezolid	Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant (MDR) TB	Approval granted by the FDA
Harmony Biosciences LLC	WAKIX (pitolisant)	excessive daytime sleepiness (EDS) in adult patients with narcolepsy	Approval granted by the FDA