Avadel Pharmaceuticals
NASDAQ:AVDLAvadel Pharmaceuticals plc operates as a biopharmaceutical company in the United States. Its lead product candidate is LUMRYZ, a formulation of sodium oxybate, which is in a Phase 3 clinical trial for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. The company was formerly known as Flamel Technologies SA and changed its name to Avadel Pharmaceuticals plc in January 2017. Avadel Pharmaceuticals plc was incorporated in 2015 and is headquartered in Dublin, Ireland.
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.
Galera Therapeutics
NASDAQ:GRTXGalera Therapeutics, Inc., a clinical stage biopharmaceutical company, focuses on the development and commercialization of therapeutics for the transformation of radiotherapy in cancer. The company's lead product candidate is avasopasem manganese (GC4419), a small molecule dismutase mimetic, which has completed Phase III clinical trial for the treatment of radiotherapy induced severe oral mucositis in patients with head and neck cancer (HNC); in Phase IIa clinical trial for the treatment of radiotherapy-induced esophagitis in patients with lung cancer; and in Phase IIa clinical trial for patients with HNC undergoing standard-of-care radiotherapy. It is also developing GC4711, a dismutase mimetic product candidate, which is in Phase I/II clinical trial in combination with stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. The company was incorporated in 2012 and is based in Malvern, Pennsylvania.
Kindred Biosciences
NASDAQ:KINKindred Biosciences, Inc. is a development-stage biopharmaceutical company, which focuses on saving and improving the lives of pets. The company was founded by Richard Chin and Denise M. Bevers on September 25, 2012 and is headquartered in Burlingame, CA.
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.