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.
Bicycle Therapeutics
NASDAQ:BCYCBicycle Therapeutics plc, a clinical-stage biopharmaceutical company, develops a class of medicines for diseases that are underserved by existing therapeutics in the United States and the United Kingdom. Its product pipeline comprising BT8009, a bicycle toxin conjugate (BTC) which is in phase I/II and phase II/III clinical trial for the treatment of high nectin-4 expressing tumors; BT5528, a BTC which is in phase I/II clinical trial for the treatment of Ephrin type A receptor 2 expressing tumor; BT7480, a Bicycle TICA molecule which is in phase I/II targeting Nectin-4 and agonizing CD137; and BT7455, a Bicycle TICA molecule targeting Ephrin type A receptor 2 and CD137 and is in preclinical trial. The company also developing BT1718, a bicycle toxin conjugate (BTC), which is in Phase I/IIa clinical trials targeting tumors that express Membrane Type 1 matrix metalloprotease; and BT7401, a multivalent bicycle CD137 agonist which is in phase IIa to treat advanced solid tumors. In addition, it develops Novel anti-infective, which is in preclinical trial targeting anti-infectives disease; CNS targets, which is in preclinical trial targeting CNS disease; and Novel neuromuscular targets, which is in preclinical trial targeting neuromuscular disease. Further, the company collaborates with biopharmaceutical companies and organizations to develop programs in therapeutic areas. The company has collaboration and license agreement with Bayer Consumer Care AG; Novartis Pharma AG; Cancer Research UK; Cancer Research Technology Ltd; and Oxurion NV. Bicycle Therapeutics plc was incorporated in 2009 and is headquartered in Cambridge, the United Kingdom.
MannKind
NASDAQ:MNKDMannKind Corporation, a biopharmaceutical company, focuses on the development and commercialization of inhaled therapeutic products for endocrine and orphan lung diseases in the United States. It offers Afrezza, an inhaled insulin used to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults. The company's product pipeline also includes Tyvaso DPI (Treprostinil), an inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease; MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial lung disease; MNKD-201, a dry-powder formulation of nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). In addition, it has collaboration and license agreement with United Therapeutics Corporation for development, regulatory, and commercial activities of Tyvaso DPI; co-promotion agreement with Vertice Pharma to promote Thyquidity; and collaboration agreement with Thirona to evaluate the therapeutic for the treatment of pulmonary fibrosis. Further, the company has supply and distribution agreement with Biomm S.A. for the commercialization of Afrezza in Brazil; and license and distribution agreement with Cipla Ltd. for the marketing and distribution of Afrezza in India. MannKind Corporation was incorporated in 1991 and is headquartered in Danbury, Connecticut.
Osmotica Pharmaceuticals
NASDAQ:OSMTOsmotica Pharmaceuticals Plc engages in the development and commercialization of products for neurology and women's health. Its products include Upneeq, M-72, Arbaclofen ER, OS870, Divigel, OB Complete, Methylphenidate ER, Venlafaxine ER tablets (VERT), Hydromorphone ER, Sodium Benzoate/Sodium Phenylacetate, Oxybutynin ER, Prescription Prenatal Vitamins, Chlorzoxazone (Lorzone AG), Tramadol ER (ConZip AG), Nitrofurantoin and Osmodex ANDAs. The company was founded in 1986 and is headquartered in Bridgewater, NJ.
Verastem
NASDAQ:VSTMVerastem, 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.