Business
PureTech Announces Orphan Drug Designations Granted by the U.S. Food and Drug Administration and European Commission for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis
BOSTON, February 19, 2026--PureTech Announces Orphan Drug Designations Granted by the U.S. Food and Drug Administration and European Commission for Deupirfenidone in IPF
About this update from Puretech Health Plc
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":7367,"height":2362,"url":"https://media.zenfs.com/en/business-wire.com/c191cdda41b6da056b2acf7ccbffee4a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/.e5xEx6u25OciJ.JIrXN2g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTMwODtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/c191cdda41b6da056b2acf7ccbffee4a","width":960,"height":308},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/qEJ8ZP2FkFtMAiMBrbrzaQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTI0MDA7aD03NzA7Y2Y9d2VicA--/https://media.zenfs.com/en/business-wire.com/c191cdda41b6da056b2acf7ccbffee4a","width":1200,"height":385}},"lazy":false},{"type":"text","content":"Designations provide market exclusivity as well as other development incentives","length":79,"tagName":"p","attribs":{}},{"type":"text","content":"BOSTON, February 19, 2026--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, today announced that the U.S. Food and Drug Administration (FDA) and European Commission have granted Orphan Drug Designation to deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF), a rare, progressive, and fatal lung disease. Deupirfenidone is being advanced by Celea Therapeutics, a Founded Entity established by PureTech to lead its late-stage development and potential commercialization.","length":678,"tagName":"p"},{"type":"text","content":"Orphan Drug Designation is intended to support the development of therapies for rare diseases, defined as conditions affecting fewer than 200,000 people in the United States or fewer than 5 in 10,000 individuals in the European Union. These designations provide sponsors with a range of incentives intended to encourage the development of medicines for diseases with high unmet medical needs.","length":392,"tagName":"p"},{"type":"text","content":""Orphan Drug Designation from both the FDA and European Commission underscores the urgent need for more effective therapies for people living with IPF," said Robert Lyne, Chief Executive Officer of PureTech Health. "Critically, only a minority of patients with this progressive and...