Cara Therapeutics
NASDAQ:CARACara Therapeutics, Inc., a development-stage biopharmaceutical company, focuses on developing and commercializing therapeutics treatment of chronic pruritus in the United States. The company's lead product is KORSUVA (difelikefalin) injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing hemodialysis. It also develops Oral difelikefalin, which is in Phase II/III clinical trial to treat chronic pruritus with notalgia paresthetica. The company has license agreements with Maruishi Pharmaceutical Co., Ltd to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and uremic pruritus in Japan; Vifor Fresenius Medical Care Renal Pharma Ltd. development and commercialization of KORSUVA injection for the treatment of moderate-to-severe pruritus in adult patients undergoing hemodialysis; and Chong Kun Dang Pharmaceutical Corporation to develop, manufacture, and commercialize drug products containing difelikefalin in South Korea. Cara Therapeutics, Inc. was incorporated in 2004 and is based in Stamford, Connecticut.
Clovis Oncology
NASDAQ:CLVSClovis Oncology, Inc, a biopharmaceutical company, focuses on acquiring, developing, and commercializing anti-cancer agents in the United States, Europe, and internationally. Its commercial product includes Rubraca (rucaparib) tablet, a small molecule poly ADP-ribose polymerase inhibitor, used as monotherapy for the treatment of patients with deleterious BRCA mutation associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic for Rubraca. As of 4/6/18, Rubraca® (rucaparib) is also approved by the FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. FDA granted regular approval for Rubraca in this second, broader and earlier-line indication on a priority review timeline based on positive data from the phase 3 ARIEL3 clinical trial. Biomarker testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication.
Intra-Cellular Therapies
NASDAQ:ITCIIntra-Cellular Therapies, Inc., a biopharmaceutical company, focuses on the discovery, clinical development, and commercialization of small molecule drugs that address medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms in the central nervous system (CNS) in the United States. The company offers CAPLYTA for the treatment of schizophrenia and bipolar depression in adults. It is also involved in developing Lumateperone, which is in Phase 3 clinical trial for the treatment of various depressive disorders, as well as additional neuropsychiatric indications. In addition, the company is developing Lenrispodun (ITI-214) for the treatment of Parkinson's disease, CNS, and other disorders; ITI-1284 for the treatment of neuropsychiatric disorders and behavioral disturbances in dementia; and ITI-333 for substance use disorders, pain, and psychiatric comorbidities, including depression, anxiety, and sleep disorders. Intra-Cellular Therapies, Inc. was founded in 2002 and is headquartered in New York, New York.
Kura Oncology
NASDAQ:KURAKura Oncology, Inc., a clinical-stage biopharmaceutical company, develops medicines for the treatment of cancer. The company's pipeline consists of small molecule product candidates that target cancer. Its lead product candidates are ziftomenib, an orally bioavailable small molecule inhibitor of the menin-KMT2A interaction for the treatment of genetically defined subsets of acute leukemias, including acute myeloid leukemia and acute lymphoblastic leukemia; tipifarnib, an orally bioavailable farnesyl transferase inhibitor combination with alpelisib for patients with PIK3CA-dependent HNSCC; and KO-2806, a farnesyl transferase inhibitor for the treatment of solid tumors. It has a clinical collaboration with Novartis Pharma AG to evaluate the combination of tipifarnib and alpelisib in patients with head and neck squamous cell carcinoma whose tumors have HRAS overexpression and/or PIK3CA mutation and/or amplification. The company was founded in 2014 and is headquartered in San Diego, California.
Omeros
NASDAQ:OMEROmeros Corporation, a clinical-stage biopharmaceutical company, discovers, develops, and commercializes small-molecule and protein therapeutics, and orphan indications targeting inflammation, complement-mediated diseases, cancers, and addictive and compulsive disorders. The company's clinical programs include Narsoplimab (OMS721/MASP-2) that has completed pivotal studies for hematopoietic stem-cell transplant-associated thrombotic microangiopathy (HSCT-TMA); that is in Phase III clinical trial for immunoglobulin A nephropathy (IgAN); and Phase II clinical trial to treat COVID-19. It also develops OMS1029 that is in phase I clinical trials for long-acting second-generation antibody targeting lectin pathway disorders; OMS906 that is in phase Ib clinical trials for Paroxysmal nocturnal hemoglobinuria, complement 3 glomerulopathy, and other alternative pathway disorders; OMS527 that is in phase I clinical trials for addictions and compulsive disorders, and movement disorders; and OMS405 that is in phase II clinical trials for opioid and nicotine addiction. In addition, the company develops MASP-2-small-molecule inhibitors for the treatment of aHUS, HSCT-TMA, and age-related macular degeneration; GPR174 inhibitors and chimeric antigen receptor T-Cell and adoptive T-Cell therapies for various cancers; and G protein-coupled receptors for treating immunologic, immuno-oncologic, metabolic, CNS, cardiovascular, musculoskeletal, and other disorders. Omeros Corporation was incorporated in 1994 and is headquartered in Seattle, Washington.