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...
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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 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...
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...
Aqilion has strengthened its pipeline with an innovative development program in the field of chronic inflammation. With this acquisition, Aqilion is taking over all rights to the program, now under the name Regulus, from LEO Pharma. The project is ready for clinical trials and Aqilion plans to begin clinical development in...
REDWOOD CITY, Calif. — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that new clinical data from its Phase 1 study of CART-ddBCMA in patients with relapsed or refractory multiple myeloma will...
SAN DIEGO, Calif. — Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and medicines to treat unmet medical needs within liver and respiratory rare diseases, today announced that the European Commission (EC), based on a positive...
Amsterdam, Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its plan to continue the development of efgartigimod to Phase 3 in adults with primary Sjögren’s disease (SjD), following the analysis of topline...