Pipeline new from Pfizer, Sage, Polyphor, Mithra, Catalyst and QIAGEN

April 30, 2018

Company Drug/Device Medical Condition Status
AOBiome Therapeutics Ammonia Oxidizing Bacteria (AOB) intranasal spray episodic migraine Phase II trial initiated enrolling 303 subjects
Mithra Donesta Vasomotor Symptoms (VMS) in post-menopausal women Phase II top-line results announced evaluating 257 subjects
Concert Pharmaceuticals CTP-543 moderate-to-severe alopecia areata Phase IIa trial initiated evaluating 90 subjects
Aldeyra Therapeutics, Inc. topical ocular reproxalap allergic conjunctivitis Phase III trial initiated enrolling 300 subjects
Catalyst Pharmaceuticals, Inc. Firdapse (amifampridine phosphate) MuSK antibody positive Myasthenia Gravis (MuSK-MG) Phase III trial initiated enrolling 60 subjects in the U.S. and Italy
Pfizer Inc. TRUMENBA (Meningococcal Group B Vaccine) Active immunization to prevent invasive disease caused by Neisseria meningitides group B (MenB) in children ages 1 through 9 years Breakthrough Therapy Designation granted by the FDA
Lumendi, LLC DiLumen C2 second-generation endoscopic accessory indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment 510(k) clearance granted by the FDA
Varian Calypso Anchored Beacon transponder tumor detection 510(k) clearance granted by the FDA
Amerigen Pharmaceuticals Limited and Dipharma S.A. Miglustat 100 mg capsules Adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option aNDA filed with the FDA
Sage Therapeutics intravenous formulation of brexanolone (SAGE-547) postpartum depression (PPD) NDA filed with the FDA
Veloxis Pharmaceuticals A/S de novo indication of ENVARSUS XR (tacrolimus extended-release tablets) Prophylaxis of organ rejection in kidney transplant patients sNDA filed with the FDA
Abeona Therapeutics Inc. ABO-102 AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA) RMAT Designation granted by the FDA
MeiraGTx Limited AAV-RPGR X-linked retinitis pigmentosa (SLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene Fast Track Designation granted by the FDA
Polyphor balixafortide (POL6326) in combination with eribulin patients with HER2-negative metastatic breast cancer who previously received at least two chemotherapeutic regiments in the metastatic setting Fast Track Designation granted by the FDA
QIAGEN PartoSure preterm birth FDA approved