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.
Flexion Therapeutics
NASDAQ:FLXNFlexion Therapeutics, Inc. operates as a biopharmaceutical company, which engages in the development and commercialization of novel and local therapies. It specializes in the treatment of patients with musculoskeletal conditions including osteoarthritis. It offers products under the Zilretta brand, an extended-release corticosteroid approved to manage osteoarthritis knee pain. The company was founded by Michael D. Clayman and Neil Bodick on November 5, 2007 and is headquartered in Burlington, MA.
Mirum Pharmaceuticals
NASDAQ:MIRMMirum Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of novel therapies for debilitating rare and orphan diseases. Its lead product candidate is LIVMARLI (maralixibat), an orally administered and minimally absorbed ileal bile acid transporter (IBAT) inhibitor that is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome in the United States and internationally. The company is also involved in the commercialization of Cholbam, a cholic acid capsule, which is approved as treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects and for adjunctive treatment of patients with peroxisomal disorders, including peroxisome biogenesis disorder-Zellweger spectrum disorder and Smith-Lemli-Opitz syndrome; and Chenodal, a tablet, which is approved for the treatment of radiolucent stones in the gallbladder, and under Phase 3 development for the treatment cerebrotendinous xanthomatosis. In addition, it develops Volixibat, an oral and minimally absorbed agent designed to inhibit IBAT, currently under Phase 2b clinical trial for the treatment of adult patients with cholestatic liver diseases. The company was incorporated in 2018 and is headquartered in Foster City, California.
Satsuma Pharmaceuticals
NASDAQ:STSASatsuma Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, developing novel therapeutic products for the acute treatment of migraines. The company's lead product candidate is STS101, a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, which is in SUMMIT Phase 3 efficacy trials and can be self-administered with proprietary pre-filled, single-use, and nasal delivery device. Satsuma Pharmaceuticals, Inc. was incorporated in 2016 and is headquartered in South San Francisco, California.
Zafgen
NASDAQ:ZFGNZafgen, Inc., a clinical-stage biopharmaceutical company, develops therapies for patients suffering from metabolic diseases comprising type 2 diabetes, Prader-Willi syndrome (PWS), and other metabolically related disorders. The company's lead product candidate is ZGN-1061, a fumagillin-class methionine aminopeptidase 2 (MetAP2) inhibitor administered by subcutaneous injection, which is in Phase 2 clinical trial and profiled for its utility in the treatment of type 2 diabetes and other related metabolic disorders. It also develops ZGN-1258, a MetAP2 inhibitor for treatment of PWS. Zafgen, Inc. was founded in 2005 and is headquartered in Boston, Massachusetts.