MONTRÉAL, June 17, 2022 – ExCellThera Inc. (ExCellThera), an advanced clinical-stage biotechnology company delivering molecules and bioengineering solutions to expand and engineer various cell lines for use in next generation cell and gene therapies, announced today that it has submitted a Type II Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for UM171, a proprietary molecule being studied for use in the expansion and rejuvenation of hematopoietic stem cells.
Read MoreLAVAL, Québec, May 18, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST) announced today that the top line results of its pharmacokinetic (PK) bridging study with IV GTX-104, the Company’s lead drug candidate for the treatment of Subarachnoid Hemorrhage (SAH), met all its planned study endpoints. The primary objective of the study was to evaluate the relative bioavailability of IV GTX-104 compared to oral nimodipine in healthy adult male and female subjects, while the secondary objective was to assess its safety and tolerability. The Company plans to submit these results to the US Food and Drug Administration (FDA), along with its proposed study design for the Phase 3 safety study which is on track to start in the second half of 2022. The safety study is expected to be the final step required to seek regulatory approval under the 505(b)(2) regulatory pathway before submitting a New Drug Application to the FDA.
Read MoreMontreal, Canada – February 4, 2021 – Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that the United States Food and Drug Administration (FDA) has granted fast track designation to TH1902 as a single agent for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy.
Read More
