Business
Positive FDA Feedback on Follica
Positive FDA Feedback on Follica.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \n \n RNS Number : 8994O\n PureTech Health PLC\n 04 June 2020\n \n \n \n \n 4 June 2020\n \n \n PureTech Health plc\n \n \n \n \n \n PureTech Founded Entity Follica Announces Positive Feedback from FDA as it Prepares to Advance its Lead Programme in Male Androgenetic Alopecia into Phase 3 Development\n \n \n \n \n \n Follica plans to initiate its Phase 3 programme this year\n \n \n \n \n \n \n \n PureTech Health plc\n \n \n \n (LSE: PRTC) (\"PureTech\"), \n a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases,\n is pleased to note that its Founded Entity, Follica, today announced\n positive feedback from an End of Phase 2 meeting with the \n US Food and Drug Administration\n (FDA) for its lead programme to treat male androgenetic alopecia. \n The company plans to advance the programme into Phase 3 development this year following the successful safety and efficacy optimisation study announced in December 2019. \n \n \n \n \n \n Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech, said:\n \n \"This positive feedback from FDA enables Follica to move forward with its pivotal trial this year. Current treatments for the progressive hair loss caused by androgenetic alopecia are inadequate, and we are pleased with Follica's progress towards Phase 3 development, bringing us another step closer to a potential new treatment for the millions of people seeking safe, effective, non-surgical treatments to grow new hair.\" \n \n \n \n \n \n The full text of the announcement from Follica is as follows:\n \n \n \n \n \n \n Follica Announces Positive Feedback from \n \n \n End of Phase 2 Meeting with \n \n \n FDA \n \n \n for its Lead Programme to Treat Male Androgenetic Alopecia\n \n \n \n \n \n \n Company plans to initiate its Phase 3 programme this year\n \n \n \n \n \n BOSTON, June 4, 2020 -- \n \n \n Follica, Inc.\n \n \n (\"Follica\"), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial ageing and other related conditions, today announced positive feedback from a meeting with the US Food and Drug Administration (FDA) as the company prepares to advance its lead programme into Pha...