Welcome to our dedicated page for Akari Therapeutics Plc news (Ticker: AKTX), a resource for investors and traders seeking the latest updates and insights on Akari Therapeutics Plc stock.
About Akari Therapeutics Plc
Akari Therapeutics Plc (Nasdaq: AKTX) is a clinical-stage biopharmaceutical company dedicated to advancing innovative therapies for the treatment of rare autoimmune and inflammatory diseases. Akari’s core focus lies in addressing critical unmet medical needs by targeting the complement component 5 (C5) and leukotriene B4 (LTB4) pathways, which are implicated in a range of severe and often life-threatening conditions.
Innovative Drug Development Pipeline
Akari’s lead asset, nomacopan, is a bispecific recombinant inhibitor that simultaneously targets C5 activation and LTB4 activity. This dual mechanism of action positions nomacopan as a potentially transformative therapy for diseases with complex inflammatory and immune-mediated components. Currently, nomacopan is undergoing a Phase 3 clinical trial for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA), a rare and severe complication of stem cell transplantation with no approved treatments. The company has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the U.S. FDA, underscoring the significance of this program.
Additionally, Akari is advancing the development of a long-acting version of nomacopan, known as PAS-nomacopan, for the treatment of geographic atrophy (GA), a progressive and sight-threatening condition affecting millions worldwide. This program aims to improve patient outcomes by offering a longer dosing interval and reducing risks associated with existing therapies.
Strategic Expansion and Market Focus
In a strategic move to broaden its pipeline, Akari has announced a merger with Peak Bio Inc., combining Akari’s expertise in autoimmune and inflammatory diseases with Peak Bio’s proprietary antibody-drug conjugate (ADC) platform. This merger is expected to enhance Akari’s capabilities in addressing significant unmet medical needs in oncology and inflammation, further diversifying its portfolio.
Akari operates within the competitive biotech landscape, leveraging its proprietary technologies and focus on orphan diseases to differentiate itself. By targeting niche markets with high barriers to entry and significant clinical needs, Akari is well-positioned to create value for patients and stakeholders alike.
Commitment to Innovation and Patient-Centric Solutions
Akari’s mission is rooted in scientific innovation and patient-centricity. The company’s approach combines cutting-edge research with a deep understanding of disease biology to develop therapies that address the root causes of complex conditions. Akari’s dedication to advancing its pipeline, coupled with strategic collaborations and regulatory achievements, underscores its commitment to transforming the treatment landscape for rare diseases.
The paroxysmal nocturnal hemoglobinuria (PNH) market is projected to reach USD 1,100 million in 2021, with anticipated growth driven by rising cases and new therapies from major companies like Hoffmann-La Roche, Alexion, and Novartis. DelveInsight's report indicates approximately 12K prevalent cases in the 7MM (U.S., EU-4, U.K., Japan) as of 2021. Key pipeline therapies include Crovalimab and Iptacopan. Despite advancements, challenges like continuous hemolysis and the impending expiration of eculizumab patents in 2024 and 2027 could impact market dynamics. This report covers market trends through 2032, focusing on treatment efficacy, barriers, and emerging drugs.
On January 4, 2023, Akari Therapeutics (Nasdaq: AKTX) announced that President and CEO Rachelle Jacques will present at the Biotech Showcase 2023 on January 9 at 9 am ET. The presentation will cover significant updates on two pipeline programs: a Phase 3 trial of nomacopan for treating severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy, and a pre-clinical program for long-acting PAS-nomacopan targeting geographic atrophy. Akari is focused on therapies for autoimmune and inflammatory diseases.
Akari Therapeutics (Nasdaq: AKTX), a biotechnology firm, announced participation in the Cantor Medical and Aesthetic Dermatology Conference in Miami on December 7-8, 2022. President and CEO Rachelle Jacques will join an ophthalmology panel on December 8, discussing 'Vision for the Future: Dry AMD, Other Greenfield Opportunities, and Late-Stage Stories to Shake Things Up.' The management team will also conduct 1:1 investor meetings to address their pre-clinical program for long-acting PAS-nomacopan in geographic atrophy (GA). Akari's investigational drug, nomacopan, targets autoimmune diseases.
Akari Therapeutics, Plc (Nasdaq: AKTX) announced participation in BTIG's Ophthalmology Day on November 29, 2022, with a fireside chat led by CEO Rachelle Jacques at 9:30 am ET. The company will discuss advancements in long-acting PAS-nomacopan for geographic atrophy (GA), highlighting positive pre-clinical results that may support moving towards IND/IMPD for clinical trials. Akari is focused on developing therapies for autoimmune and inflammatory diseases, with its lead candidate, nomacopan, having received several FDA designations for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy.
Akari Therapeutics (Nasdaq: AKTX) announced that the FDA granted Rare Pediatric Disease Designation to its investigational drug, nomacopan, for treating pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). This designation complements the existing Orphan Drug and Fast Track designations. The CEO emphasized the urgent need for effective treatments, highlighting the high mortality rates associated with the condition. The FDA's designation also offers potential benefits, including eligibility for a Priority Review Voucher upon approval of nomacopan.
Akari Therapeutics (Nasdaq: AKTX), a biotechnology firm focused on autoimmune and inflammatory diseases, will attend the Jefferies London Healthcare Conference from November 15-17, 2022. Rachelle Jacques, President and CEO, along with the management team, will hold one-on-one meetings with registered investors. The company is advancing its lead product, nomacopan, which targets severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy, and is also exploring long-acting formulations for geographic atrophy.
Akari Therapeutics has appointed Dr. John F. Neylan, III, as Executive Vice President and Chief Medical Officer, effective immediately. Dr. Neylan brings over 20 years of experience in medical and clinical development, having previously led research efforts at several biotech firms, including Angion Biomedica and Keryx Biopharmaceuticals. His expertise will support Akari's advancement of nomacopan, currently in a Phase 3 trial for HSCT-TMA, and in pre-clinical research for geographic atrophy. This leadership change aims to strengthen clinical development and accelerate the company’s drug development pipeline.
Akari Therapeutics, Plc (Nasdaq: AKTX) announced its participation in the Sidoti November Virtual Micro-Cap Conference on November 9, 2022, with President and CEO Rachelle Jacques presenting at 1:45 PM Eastern time. The management team will also engage in scheduled 1:1 investor meetings. A recording of the presentation will be available on the company's website post-event. Akari focuses on therapies for autoimmune and inflammatory diseases, particularly its lead asset, investigational nomacopan, which targets complement C5 activation and leukotriene B4 activity.
Akari Therapeutics (Nasdaq: AKTX) received a Nasdaq Listing Qualifications letter stating it is non-compliant with the $1.00 minimum bid price requirement. The company has a 180-day compliance period ending April 24, 2023, to rectify this by maintaining a closing bid price of at least $1.00 for ten consecutive business days. Failure to comply may lead to potential delisting. Currently, there is no immediate effect on trading, and Akari’s shares will continue to trade under the symbol AKTX during this grace period.
Akari Therapeutics has successfully closed a registered direct offering and concurrent private placement, raising approximately $12.8 million. The funds will support the company's focused pipeline, particularly the Phase 3 Part A clinical trial of nomacopan for severe pediatric HSCT-TMA, with data expected in the first half of 2023. The company is also advancing the development of long-acting PAS-nomacopan for geographic atrophy. Despite recent financing success, net loss for Q2 2022 rose to approximately $5.7 million due to increased research and administrative costs.
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