Archives

Pipeline

New Pipeline Updates from Immunovant, Minoryx Therapeutics and Bayer

June 10, 2019

Company Drug/Device Medical Condition Status
Cellenkos, Inc. CK0801 bone marrow failure syndromes, including aplastic anemia, hypoplastic myelodysplasia and primary myelofibrosis Phase I trial initiated
Xencor, Inc. XmAb22841 advanced solid tumors Phase I trial initiated
Alnylam Pharmaceuticals, Inc. ALN-AGT hypertension Phase I trial initiated enrolling 168 subjects
UCB
Neuropore Therapies, Inc.
UCB0599 Parkinson’s disease Phase Ib trial initiated
Amphera B.V. MesoPher pancreatic cancer Phase II trial initiated enrolling 10 adult subjects with surgically resected pancreatic cancer who have received adjuvant standard of care treatment
Immunovant IMVT-1401 moderate-to-severe active Graves' ophthalmopathy (GO) Phase II trial initiated enrolling eight subjects
Rejenevie Therapeutics AR-100 immune restoration therapy immunology Phase II trial initiated enrolling 20 healthy subjects 55 years of age or older in Freeport, Bahamas
Ironwood Pharmaceuticals, Inc.
Allergan PLC
MD-7246 abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) Phase II trial initiated enrolling 400 subjects
Verona Pharma PLC metered-dose inhaler formulation of ensifentrine (RPL554) moderate-to-severe chronic obstructive pulmonary disease (COPD) Phase II trial initiated enrolling 36 subjects at two sites in the UK
Minoryx Therapeutics leriglitazone (MIN-102) Friedreich’s Ataxia Phase II trial initiated enrolling 36 subjects 12 years of age or older at numerous sites across Europe
GENFIT elafibranor nonalcoholic fatty liver disease (NAFLD) Phase II trial initiated enrolling 16 subjects with NAFL as identified with magnetic resonance spectroscopy (H-MRS)
Arcutis, Inc. ARQ-151 atopic dermatitis Phase IIa trial initiated
Akero Therapeutics, Inc. AKR-001 non-alcoholic steatohepatitis (NASH) Phase IIa trial initiated enrolling 80 subjects
Ansun Biopharma, Inc. DAS181 lower respiratory tract parainfluenza virus Phase III trial initiated enrolling immunocompromised subjects at sites in the U.S., Europe and Asia
Eyenovia Inc. MicroPine pediatric progressive myopia Phase III trial initiated enrolling 400 subjects ages three to 12 years of age
Incyte pemigatinib (INCB54828) cholangiocarcinoma Phase III trial initiated enrolling 432 subjects
Allergan plc
Gedeon Richter PLC
VRAYLAR (cariprazine) manic or mixed episodes associated with bipolar I disorder in adults sNDA approval granted by the FDA
Cadent Therapeutics CAD-1883 spinocerebellar ataxia (SCA) Orphan Drug designation granted by the FDA
Bayer Aliqopa (copanlisib) marginal zone lymphoma (MZL) Breakthrough Therapy designation granted by the FDA
Imara, Inc. IMR-687 sickle cell disease Fast Track designation granted by the FDA
NovoCure NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy malignant pleural mesothelioma (MPM) Approval granted by the FDA
AveXis Inc. Zolgensma (onasemnogene abeparvovec-xioi) spinal muscular atrophy (SMA) in children less than two years of age Approval granted by the FDA
Novartis Piqray (alpelisib) tablets in combination with the endocrine therapy fulvestran hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer in postmenopausal women and men Approval granted by the FDA
Novartis Jakafi (ruxolitinib) steroid-refractory acute GVHD in adult and pediatric subjects 12 years and older Approval granted by the FDA
Celgene Corporation REVLIMID (lenalidomide) in combination with a rituximab product (R²) previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) in adults Approval granted by the FDA