FDA clearance received to proceed with investigator- led multi-center double blind randomized clinical study in the U . S . with nomacopan following prior expanded access program Following initial proof of principle study in Brazil and subsequent Data and Safety Monitoring Board (DSMB) review, a
The EMA and the FDA have both agreed to a Phase III randomized placebo-controlled study with nomacopan in moderate to severe bullous pemphigoid (BP) patients with a primary endpoint of disease remission on minimal oral corticosteroids (OCS) Nomacopan has been granted orphan drug designation by the
NEW YORK and LONDON , Sept. 29, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated,
NEW YORK and LONDON , Sept. 10, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated,
International clinical development program of nomacopan for the potential treatment of COVID-19 pneumonia announced Pivotal Phase III study in patients with bullous pemphigoid (BP) expected to start H1 2021 following recent successful end-of-Phase II meeting with FDA Enrollment in the pediatric
Clinical studies both underway and planned for patients with COVID-19 pneumonia in the U.S. , U.K. , and Brazil Proposed multi-center U.S. randomized clinical program in regulatory submission following the treatment of patients via expanded access programs In Brazil , patient recruitment completed
Phase III randomized placebo-controlled study in moderate to severe bullous pemphigoid (BP) patients with a primary endpoint of complete disease remission on minimal oral corticosteroids (OCS) agreed to with the FDA. Treatment arms will be tapered to minimal OCS and an important secondary
NEW YORK and LONDON, July 01, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics , Plc (“Akari” or the “Company”) (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and
NEW YORK and LONDON, July 01, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics , Plc (“Akari” or the “Company”) (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement
Open pivotal study in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) with orphan and fast track approval Preparing for pivotal study in bullous pemphigoid (BP) following recent completion of successful Phase II study Positive EMA opinion on orphan