Harmony Biosciences Holdings, Inc. Common Stock
Harmony Biosciences Holdings, Inc., a commercial-stage pharmaceutical company, focuses on developing and commercializing therapies for patients with rare and other neurological diseases in the United States. The company offers WAKIX (pitolisant), a molecule with a novel mechanism of action for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. It also develops Pitolisant that is in Phase 3 clinical trial for the treatment of Prader-Willi Syndrome (PWS); in Phase 2 clinical trial to treat Myotonic Dystrophy (DM1); and is in Phase 1 clinical trials for the treatment of Pitolisant Gastro-Resistant (GR) and High-Dose (HD). In addition, the company's products under development include BP1.15205, an orexin 2 receptor agonist for the treatment of narcolepsy and other potential indications; and HBS-102, a melanin-concentrating hormone receptor type 1 (MCHR1) antagonist. Further, it develops ZYN-002 that is in a Phase 3 registrational trial for the treatment of Fragile X Syndrome (FXS), rare genetic disorder that causes inherited intellectual disability and autism spectrum disorder; and 22q Deletion Syndrome, a disorder caused by a small missing piece on the long arm of the 22nd chromosome. Additionally, the company is developing EPX-100 (clemizole hydrochloride), a serotonin (5HT-2) receptor agonist to treat dravet syndrome and lenox-gastaut syndrome; and EPX-200 (liquid formulation of lorcaserin), a selective 5HT-2C agonist to treat developmental and epileptic encephalopathies (DEE). The company was formerly known as Harmony Biosciences II, Inc. and changed its name to Harmony Biosciences Holdings, Inc. in February 2020. Harmony Biosciences Holdings, Inc. was incorporated in 2017 and is headquartered in Plymouth Meeting, Pennsylvania.
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Verastem, Inc., a development-stage biopharmaceutical company, focuses on developing and commercializing drugs for the treatment of cancer in the United States. Its product candidates are Avutometinib, an orally available small molecule RAF/MEK clamp that inhibits the ras sarcoma RAF/MEK, ERK mitogen activated pathway kinase pathway which is involved in cell proliferation, migration, transformation, and survival of tumor cells; and Defactinib, an oral small molecule inhibitor of FAK and proline-rich tyrosine kinase for various solid tumors. The company is involved in clinical studies, including RAMP 301, a randomized global confirmatory trial to evaluate the combination of Avutometinib and Defactinib for the treatment of patients with recurrent low-grade serous ovarian cancer; RAMP 201, an adaptive two-part multicenter, parallel cohort, randomized open label trial to evaluate the efficacy and safety of Avutometinib and in combination with Defactinib; and FRAME, an investigation of Avutometinib and Defactinib in patients with KRAS mutant cancers and subsequent analyses; and RAMP 204 and 205. It has license agreements with Chugai Pharmaceutical Co., Ltd. for the development, commercialization, and manufacture of products containing Avutometinib; and Pfizer Inc. to research, develop, manufacture, and commercialize products containing Pfizer's inhibitors of FAK for therapeutic, diagnostic, and prophylactic uses in humans. In addition, it has a clinical collaboration agreement with Amgen, Inc. to evaluate the combination of Avutometinib with Amgen's KRAS-G12C inhibitor LUMAKRAS which in Phase 1/2 trial entitled RAMP 203; and a discovery and development collaboration with GenFleet Therapeutics to advance new programs targeting RAS pathway-driven cancers. Verastem, Inc. was incorporated in 2010 and is headquartered in Needham, Massachusetts.
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