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.
Eagle Pharmaceuticals
NASDAQ:EGRXEagle Pharmaceuticals, Inc., a pharmaceutical company, focuses on developing and commercializing product candidates to treat diseases of the central nervous system or metabolic critical care, and oncology in the United States. The company offers Ryanodex for malignant hyperthermia; and Belrapzo and Bendeka for chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma. Its product candidates also include EP-4104, a dantrolene sodium to treat organophosphate exposure; PEMFEXY, a ready-to-use/dilute liquid form of pemetrexed for non-small cell lung cancer and mesothelioma; EA-114 (fulvestrant) for HR+/HER- breast cancer; and Vasopressin injection, which is indicated to enhance blood pressure in adults with vasodilatory shock. The company has license and collaboration agreements with Combioxin, SA for the development and commercialization rights to CAL02, an antitoxin agent for the treatment of severe pneumonia in combination with traditional antibacterial drugs; and AOP Orphan Pharmaceuticals GmbH for the commercial rights of Landiolol, a novel therapeutic product candidate for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. It has a strategic collaboration with Tyme Technologies, Inc. for the development of SM-88 to treat breast cancer (HR+/HER2-) and high-risk metastatic sarcomas. Eagle Pharmaceuticals, Inc. was incorporated in 2007 and is headquartered in Woodcliff Lake, New Jersey.
G1 Therapeutics
NASDAQ:GTHXG1 Therapeutics, Inc., a commercial-stage biopharmaceutical company, engages in the discovery, development, and commercialization of small molecule therapeutics for the treatment of patients with cancer in the United States. The company offers COSELA, which helps to decrease incidence of chemotherapy-induced myelosuppression in adult patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive stage small cell lung cancer. It is also developing Trilaciclib that is in Phase 3 clinical trial for 1L metastatic triple negative breast cancer (mTNBC); and Phase 2 clinical trial as an antibody-drug conjugate combination trial in mTNBC, as well as completed Phase 2 clinical trial for Neoadjuvant TNBC and 1L Bladder cancer. The company has a license agreement with Genor Biopharma Co. Inc. for the development and commercialization of lerociclib using an oral dosage form to treat various indication in humans; Incyclix for the development and commercialization of a CDK2 inhibitor for all human and veterinary uses; and Simcere Pharmaceutical Co., Ltd for the development and commercialization of trilaciclib in all indications. G1 Therapeutics, Inc. was incorporated in 2008 and is headquartered in Research Triangle Park, North Carolina.
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.