Pipeline

July 9, 2018

Company	Drug/Device	Medical Condition	Status
Prana Biotechnology Ltd	PBT434	Parkinsonian diseases	Phase I trial initiated
Poxel SA	Imeglimin	Metabolic diseases, including type 2 diabetes and non-alcoholic steatohepatitis (NASH)	Phase III trial initiated enrolling 403 subjects in the U.S.
Cellerant Therapeutics, Inc.	romyelocel-L (human myeloid progenitor cells)	serious bacterial and fungal infections in patients with de novo acute myeloid leukemia (AML) undergoing induction chemotherapy	RMAT designation granted by the FDA
Merck & Company	KEYTRUDA in combination with carboplatin-paclitaxel or nab-paclitaxel	First-line treatment for metastatic squamous non-small cell lung cancer (NSCLC)	Priority Review granted for sBLA by the FDA
Merz Neurosciences	Xeomin (incobotulinumtoxinA)	chronic drooling in adults with neurodegenerative diseases	sBLA approved by the FDA
Compugen Ltd	COM701 (first-in-class immunioncology therapeutic antibody targeting PVRIG in patients	advanced solid tumors	IND clearance granted by the FDA
Elite Pharmaceuticals, Inc.	generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII)	management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	aNDA approval granted by the FDA
Acadia Pharmaceuticals Inc.	NUPLAZID (pimavanserin) capsule	Parkinson’s disease psychosis	Approval granted by the FDA
Pulmonx Inc.	Zephyr Endobronchial Valve (Zephyr Valve)	severe emphysema	Approval granted by the FDA
Dermira	Qbrexza	excessive underarm sweating due to primary axillary hyperhidrosis	Approval granted by the FDA
ReCor Medical	Paradise Ultrasound Denervation System	treatment of Hypertension	Approval granted by the FDA
Alkermes plc	Aristada Initio (aripiprazole lauroxil)	schizophrenia in adults	Approval granted by the FDA