Akari Therapeutics plc ADR (0.01 USD) - AKTX STOCK NEWS

Akari Therapeutics has announced positive Phase II trial results for nomacopan, an experimental treatment for bullous pemphigoid (BP), a severe autoimmune disease. The FDA and EMA have approved progression to a Phase III randomized placebo-controlled study, which is set to begin in H1 2021. Nomacopan has received orphan drug designation in the U.S. and Europe. The upcoming poster presentation at the EADV Congress on October 29, 2020, will detail the safety and efficacy data. BP affects over 100,000 patients in the U.S. and Europe, with current treatments often resulting in severe side effects.

Akari Therapeutics (Nasdaq: AKTX) has received FDA clearance to proceed with a multi-center, double-blind randomized clinical study of its drug nomacopan for treating COVID-19 pneumonia in the U.S. and Brazil. This follows positive results from initial studies indicating effective use without up-dosing. The new study aims to evaluate the time to oxygen normalization and hospital discharge among over 120 patients, with treatment lasting up to 14 days. Nomacopan may address severe lung inflammation, a significant issue in COVID-19 pneumonia, by targeting multiple inflammatory pathways.

Akari Therapeutics (AKTX) announced its financial results for Q2 2020, reporting a net loss of approximately $8.3 million, up from $4.1 million in the prior year. The company has cash reserves of roughly $12.7 million, boosted by recent tax credits. Akari is advancing clinical programs for nomacopan, with a Phase III trial for bullous pemphigoid set for H1 2021 and enrollment for pediatric HSCT-TMA starting in Q4 2020. Notably, clinical trials for COVID-19 pneumonia are underway in multiple countries, leveraging nomacopan's dual-action mechanism.

Akari Therapeutics (Nasdaq: AKTX) is advancing nomacopan as a treatment for COVID-19 pneumonia through clinical trials in the U.S., U.K., and Brazil. The company has initiated proof of principle studies and aims to progress to randomized trials in Q4 2020. Nomacopan's dual action targeting both complement C5 and leukotriene B4 may reduce severe inflammation and improve outcomes for hospitalized patients. The AGILE initiative in the U.K. has chosen nomacopan for its trials, with data on approximately 50 patients expected soon, highlighting its potential efficacy.

Akari Therapeutics announces a pivotal Phase III trial for nomacopan in treating moderate to severe bullous pemphigoid (BP), following a successful EOP2 meeting with the FDA. The trial consists of two parts and aims for minimal oral corticosteroid use. Nomacopan has orphan drug designation in both the U.S. and Europe, with potential to replace long-term steroid treatments in vulnerable patients. The trial is set to begin in H1 2021, underscoring its significance in addressing a chronic condition lacking approved therapies.

Akari Therapeutics (NASDAQ: AKTX) has signed a Securities Purchase Agreement with Aspire Capital to raise up to $30 million through the sale of American Depositary Shares (ADSs). This follows a previous $9.3 million raise from Aspire in Q2 2020. The funds will support the development of nomacopan for conditions like bullous pemphigoid and COVID-19. The agreement allows Akari significant control over timing and amounts sold without any restrictive covenants. Additionally, Akari will issue 40,760,900 shares as a commitment fee to Aspire Capital.

Akari Therapeutics, Plc (NASDAQ: AKTX) has appointed Dr. Torsten Hombeck as Chief Financial Officer, enhancing its executive team. With over two decades of biopharmaceutical experience, Dr. Hombeck will oversee finance, investor relations, and business development from the New York office. His expertise in financial strategy and capital markets is expected to support Akari's growth, particularly in developing therapies for orphan autoimmune and inflammatory diseases. The company continues to focus on innovative treatments, notably nomacopan, a promising drug candidate.

Akari Therapeutics (Nasdaq: AKTX) announced a positive EMA opinion for orphan designation of nomacopan in treating bullous pemphigoid (BP). The Phase II study showed that 7 of 9 patients had significant reductions in BPDAI scores without serious adverse events. Nomacopan, a dual inhibitor of C5 and LTB4, has potential applications in treating COVID-19 pneumonia. The EMA's opinion may lead to market exclusivity and reduced regulatory fees within 30 days. CEO Clive Richardson emphasizes BP's therapeutic potential for nomacopan, also indicating broader applications for other inflammatory conditions.