Pipeline

November 19, 2018

Company	Drug/Device	Medical Condition	Status
Stallergenes Greer	Oralair®, an allergy immunotherapy sublingual tablet	Grass pollen-induced allergic rhinitis	Received FDA approval for the extension of the indication to treat patients ages five to nine
REGENXBIO	RGX-181, a one-time treatment candidate	Late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, one of the most common forms of Batten disease	Granted Orphan Drug Designation by the FDA
Eli Lilly and Company	Lasmiditan	Migraine with or without aura in adults	Submitted a New Drug Application (NDA) to the FDA
Eli Lilly and Company	Emgality	Episodic cluster headache	Granted Breakthrough Therapy Designation by the FDA
Lumendi	DiLumen™ EIP	Easier dissection and resection of polyps without the need for surgical intervention	Received 510(k) clearance from the FDA
Theravance Biopharma, Inc. and Mylan N.V.	YUPELRITM (revefenacin), once-daily, nebulized bronchodilator	COPD	Granted approval by the FDA
Biohaven Pharmaceutical Holding Company Ltd	Rimegepant, oral calcitonin gene-related peptide (CGRP) receptor antagonist	Migraine	Enrolled first patient in Phase III clinical trial
AbbVie	Mavyret (glecaprevir/pibrentasvir)	Hepatitis C (HCV)	Results from Phase IIIb EXPEDITION-8 trial: patients receiving the drug for 8 weeks with genotype 1, 2, 4, 5 and 6 had a 100-percent sustained virologic response 12 weeks after treatment
Merck	KEYTRUDA® (PEMBROLIZUMAB)	Advanced or metastatic esophageal or esophagogastric junction carcinoma in patients whose tumors expressed PD-L1	Significantly improved Overall Survival (OS) compared to chemotherapy in Phase III KEYNOTE-181 clinical trial
AbbVie	Elagolix, in combination with add-back therapy	Heavy menstrual bleeding associated with uterine fibroids	Achieved statistically significant reduction in two replicate pivotal Phase III clinical trials
Calliditas Therapeutics	NEFIGARD	IgA nephropathy (IgAN)	First patient enrolled in pivotal Phase III clinical trial
Palvella Therapeutics, Inc.	PTX-022 (novel, high-strength rapamycin topical formulation	Pachyonychia congenita (PC)	Granted Fast Track Designation by the FDA
TWi Biotechnology, Inc.	AC-201CR	Hemophilic arthropathy	Completed patient enrollment in Phase II clinical trial