VIENNA, Austria – Since 2017, PharmaEssentia had repeatedly attempted to terminate the agreement with AOP Orphan concerning BESREMi® (Ropeginterferon alfa-2b). After two and a half years of arbitral proceedings, in October 2020, the ICC Arbitral Tribunal issued its award in the matter. The arbitral award states that PharmaEssentia’s multiple attempts...
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CAMBRIDGE, Mass. – Apic Bio, Inc., an innovative gene therapy company developing novel treatment options for patients with rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for APB-102, the Company’s lead gene therapy candidate designed to treat...
BETHESDA, Md. and WASHINGTON – The Aplastic Anemia and MDS International Foundation (AAMDSIF) and the National Organization for Rare Disorders (NORD®) today launched the largest-ever study to research Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare bone marrow failure disease. PNH is characterized by the destruction of red blood cells, blood clots and impaired...
FOSTER CITY, Calif. — Apollomics Inc., a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, today announced the completion of enrollment in its Phase 3 bridging study evaluating uproleselan (APL-106), an investigational, first-in-class E-selectin antagonist, added to a standard chemotherapy regimen for the treatment of adults with relapsed or...
ROCKVILLE, Md. – GlycoMimetics (Nasdaq: GLYC) today announced that Apollomics has dosed the first patient in China in a Phase 1 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). In February of this year, Apollomics initiated two Phase 1...
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...