New Pipeline from Prana, Poxel, Cellerant and Merck & Company

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