TORONTO, Canada – Apotex Inc. (“Apotex” or the “Company”), the largest Canadian-based pharmaceutical company, today announced that Health Canada has granted a Notice of Compliance (NOC) for LOQTORZI® (toripalimab) for the treatment of nasopharyngeal carcinoma (NPC), an ultra-rare and aggressive cancer. This approval marks a significant milestone. LOQTORZI is the first and...
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NEW YORK, NY — Applied Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for...
NEW YORK, NY — Applied Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for govorestat (AT-007)...
NEW YORK, NY – Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced positive interim 12-month results from the ongoing Phase 3 INSPIRE trial, in which the primary endpoints and...
NEW YORK, NY — Applied Therapeutics, Inc. (APLT), a clinical-stage company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA)...
Key takeaways: At 1 year, apraglutide reduced parenteral support volume by 52% in patients with short bowel syndrome with intestinal failure and colon-in-continuity. The treatment had an acceptable safety profile. Treatment with apraglutide resulted in a 52% reduction in weekly parenteral support volume at 1 year among nine patients with...
Preclinical data demonstrate potent single-agent and combination effects in head and neck squamous cell carcinoma (HNSCC) models, including synergy with anti–PD-1 therapy Initial Phase 1 clinical update shows early disease control in first HPV+ patient treated with APR-1051 DOYLESTOWN, Pa. — Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a...
SEATTLE, WA – Aptevo Therapeutics (“Aptevo” or “the Company”) (NASDAQ:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology therapeutics, today announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial evaluating mipletamig, the Company’s first-in-class CD123 x CD3 bispecific antibody, in combination with venetoclax +...
NEW YORK & LONDON & PARIS – Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical stage biopharmaceutical company focused on novel technologies including the targeting of oncological diseases, announced that the group has received clearance from the US FDA regarding the IND application to initiate...
AUSTIN, Texas — IntraBio Inc., a biopharmaceutical company focused on developing therapies for rare neurological diseases, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of AQNEURSA® (levacetylleucine) for the treatment of Niemann-Pick disease type C (NPC)....