Pipeline

December 17, 2018

Company	Drug/Device	Medical Condition	Status
Bio-Thera Solutions	BAT4306F	CD-20-positive B-cell non-Hodgkins lymphoma	Phase I trial initiated
Alligator Bioscience	ATOR-1015	advanced solid tumor disease	Phase I trial initiated enrolling up to 53 subjects at five clinics in Sweden and Denmark
Rodin Therapeutics	RDN-929	snyaptopathies, a group of over 100 brain diseases characterized by synaptic loss and disfunction	Phase I trial initiated
Protagonist Therapeutics, Inc.	PN-10943	inflammatory bowel disease	Phase I trial initiated
Aridis Pharmaceuticals	AR-501 (gallium citrate)	chronic bacterial lung infections in patients with Cystic Fibrosis	Phase I/II trial initiated enrolling 96 (48 healthy and 48 with Cystic Fibrosis) subjects
Constellation Pharmaceuticals, Inc.	CPI-1205	metsastic castration-resistant prostate cancer (mCRPC)	Phase II trial initiated enrolling up to 35 subjects
KaNDy Therapeutics	NT-814	troublesome post-menopausal symptoms, including hot flashes	Phase II trial initiated enrolling up to 165 menopausal subjects aged 40 to 65 years
Levo Therapeutics, Inc.	intranasal carbetocin (LV-101)	Prader-Willi syndrome (PWS)	Phase III trial initiated
Generex Biotechnology Corporation	AE37 plus Keytruda (pembrolizumab)	triple negative breast cancer	IND clearance granted by the FDA
Virtus Pharmaceuticals, LLC	generic Levorphanol Tartrate 2 mg tablets	severe pain	ANDA approval granted by the FDA
Asana Biosciences	Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) dual inhibitor ASN002	moderate-to-severe atopic dermatitis	Fast Track Designation granted by the FDA
Gibson Oncology, LLC	LMP-400 small molecule topoisomerase 1inhibitor	Ewing sarcoma	Rare Pediatric Disease Designation (RPDD) granted by the FDA
Sandoz, Inc. and Pear Therapeutics, Inc.	reSET-O	Opioid Use Disorder (OUD)	Clearance granted by the FDA
Planmed Oy	new features and intended uses of Planmed Verity orthopedic imaging solution	reconstructive surgeries	Approval granted by the FDA
Genentech	Tecentriq and Avastin	metastatic non-squamous non-small cell lung cancer (NSCLC)	Approval granted by the FDA
Mayne Pharma Group Limited	Tolsura (SUBA-itraconazole)	systemic fungal infections	Approval granted by the FDA