Akari Therapeutics Plc - AKTX STOCK NEWS

On April 14, 2023, Akari Therapeutics (Nasdaq: AKTX) announced a virtual key opinion leader event scheduled for May 22, 2023, at 2 PM ET. This session will delve into the treatment landscape for geographic atrophy (GA) and the potential of long-acting PAS-nomacopan, an investigational therapy aimed at addressing significant unmet needs in this area. The event will feature Dr. Elias Reichel from Tufts University School of Medicine, who will discuss the development program for PAS-nomacopan. Following the presentations, a live Q&A session will be held. Interested individuals can register for the event through the provided link, and a replay will be available on the Akari website.

Akari Therapeutics is focused on developing advanced therapies for autoimmune and inflammatory diseases, with nomacopan as its lead asset. The company has received various designations for nomacopan related to its pediatric healthcare applications.

Akari Therapeutics, Plc (Nasdaq: AKTX) is set to participate in ARVO 2023 from April 23 to 27 in New Orleans. The event gathers around 10,000 professionals in vision research to discuss advancements in the field. Akari’s primary focus is on its investigational drug, nomacopan, a bispecific inhibitor targeting complement C5 and leukotriene B4, currently in pre-clinical development for geographic atrophy. Akari is also advancing nomacopan through a Phase 3 trial for pediatric HSCT-TMA, supported by FDA designations including Orphan Drug and Fast Track. The company aims to connect with researchers and potential partners at ARVO 2023 to drive innovation in autoimmune and inflammatory disease therapies.

Akari Therapeutics (Nasdaq: AKTX) announced a case study presentation titled Clinical Response to Nomacopan in the Paediatric HSCT-TMA Setting, scheduled for April 23, 2023, during the European Society for Blood and Marrow Transplantation (EBMT) in Paris. Nomacopan, an investigational bispecific inhibitor, is currently in Phase 3 clinical trials targeting pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). The company plans to advance into pivotal Part B trials later this year. Akari holds multiple FDA designations for nomacopan and is developing it for both pediatric and adult indications.

Akari Therapeutics (Nasdaq: AKTX) has secured approximately $4 million in gross proceeds through a direct offering involving institutional and accredited investors, including its Board of Directors. The company will issue around 26.67 million American Depository Shares (ADSs) at a price of $0.15 per ADS. Proceeds will fund two key pipeline initiatives: advancing a Phase 3 trial for nomacopan in severe pediatric conditions and a preclinical study for geographic atrophy. The offering excludes warrants and is expected to close on March 31, 2023.

Akari Therapeutics (Nasdaq: AKTX) has announced that regulatory agencies in Poland and the U.K. approved amendments to its Investigational Medicinal Product Dossier and Clinical Trial Authorisation for the third-generation manufacturing process of nomacopan, which significantly boosts its yield by at least 5-fold. This enhancement is set to improve cost efficiencies as Akari moves into pivotal Part B of the Phase 3 clinical trial for nomacopan, targeting pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). The trial includes sites in Poland, the U.K., and the U.S.

The 'Asthma Pipeline Insight – 2023' report by DelveInsight reveals a dynamic landscape in asthma therapies, highlighting over 90 active pharmaceutical players developing more than 95 pipeline treatments. Key companies include GlaxoSmithKline, AstraZeneca, and Verona Pharma. Notably, dexpramipexole received an Innovation Passport from the UK's MHRA and is entering Phase III trials. Additionally, Pulmatrix, Inc. initiated a Phase IIb trial for PUR1900, targeting Allergic Bronchopulmonary Aspergillosis. Olatec Therapeutics secured $40 million in Series A funding to advance dapansutrile into clinical development. This report offers insights into asthma clinical trials, therapeutic assessments, and drug mechanisms.

Akari Therapeutics (Nasdaq: AKTX) has made significant strides in its Phase 3 Part A clinical trial of nomacopan for pediatric HSCT-related thrombotic microangiopathy (HSCT-TMA). A case study presented on February 16 at a major transplantation conference highlighted the positive outcomes for a 6-year-old patient who showed improvement after receiving nomacopan treatment.

Notably, the patient achieved critical therapeutic milestones, including normalization of key biomarkers and resolution of related health complications. Nomacopan is recognized as a promising therapy in a field lacking approved options for severe cases, potentially addressing an 80% mortality rate in untreated patients.

Akari Therapeutics announced progress on its pre-clinical program for long-acting PAS-nomacopan, targeting geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). An Investigational New Drug (IND) application is set for submission to the FDA in the first half of 2024. The company filed a composition of matter patent application for long-acting versions, providing protection until 2042. The new PAS-nomacopan versions exhibit significant improvements, allowing for increased dosing intervals beyond three months, potentially reducing the need for frequent intravitreal injections.

Akari Therapeutics (Nasdaq: AKTX) has announced the progression into Part B of its Phase 3 clinical trial for nomacopan, targeting pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Following favorable FDA feedback indicating that pharmacokinetic/pharmacodynamic data from Part A aligns with predictions, Akari will advance its study for patients aged 2 to <18 years. To support this, a new pipeline program for adult HSCT-TMA treatment with nomacopan is being initiated, given the larger adult patient population. The company's prompt actions highlight a commitment to addressing unmet medical needs in both pediatric and adult demographics.