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

Welcome to our dedicated page for Akari Therapeutics plc ADR (0.01 USD) news (Ticker: AKTX), a resource for investors and traders seeking the latest updates and insights on Akari Therapeutics plc ADR (0.01 USD) stock.

Akari Therapeutics Plc (Nasdaq: AKTX) is a clinical-stage biopharmaceutical company developing innovative treatments for autoimmune and inflammatory diseases. The company's lead asset, nomacopan, is a bispecific recombinant inhibitor targeting complement C5 and leukotriene B4 (LTB4) pathways. This dual-action therapeutic is currently being investigated in a Phase 3 trial for severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA), a rare and serious complication with high mortality rates. Nomacopan has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA, as well as orphan drug designation from the European Commission.

Akari's pipeline also includes PAS-nomacopan, a long-acting version of the drug designed for the treatment of geographic atrophy (GA), a leading cause of blindness. PAS-nomacopan is in the final stages of pre-clinical development and aims to offer extended dosing intervals with potentially improved safety and efficacy compared to existing therapies.

The company's strategic focus recently expanded through a definitive merger agreement with Peak Bio Inc. (OTC: PKBO), expected to close in Q3 2024. This merger will create a robust pipeline featuring both Akari's autoimmune and inflammatory disease therapeutics and Peak Bio's antibody-drug conjugate (ADC) platform technology for cancer treatment.

Financially, Akari is focused on operational efficiency and value creation. The company has taken significant measures to reduce costs and secure funding, including a successful private placement raising approximately $7.6 million. Dr. Samir R. Patel, an experienced life sciences entrepreneur, has recently been appointed Interim CEO to lead the company through this transformative phase. Dr. Patel's compensation is solely equity-based, aligning his interests with those of the shareholders.

For more information, visit akaritx.com.

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Akari Therapeutics (Nasdaq: AKTX) has announced a strategic shift to prioritize two key pipeline programs. The company will focus cash and resources on the Phase 3 clinical trial of nomacopan for severe pediatric HSCT-TMA, with initial data anticipated in H1 2023. Additionally, the promising pre-clinical program for PAS-nomacopan in geographic atrophy will receive attention following positive results. Conversely, Akari is discontinuing the clinical evaluation of nomacopan in bullous pemphigoid. This decision stems from a reassessment of timelines and costs to enhance pipeline value.

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Akari Therapeutics (NASDAQ: AKTX) announced positive pre-clinical results for PAS-nomacopan aimed at treating geographic atrophy (GA) in dry age-related macular degeneration (dAMD), a condition with no current treatments. The studies highlighted tolerability and the potential for extended dosing intervals of over three months, which could ease patient burden. New pharmacokinetic measurements indicate improved half-life for the drug in the eye. CEO Rachelle Jacques emphasized the supportive data for advancing toward regulatory applications necessary for clinical trials by year-end.

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Akari Therapeutics (NASDAQ: AKTX) recently announced significant progress in its clinical trials and financial results for Q1 2022. The Phase 3 Part A trial of nomacopan for severe pediatric HSCT thrombotic microangiopathy (TMA) has enrolled four out of seven planned patients. Additionally, ten sites have opened for the ARREST-BP Phase 3 trial in bullous pemphigoid (BP), aiming to enroll 48 patients. Financially, cash increased to approximately $16.7 million, with a net loss of $5.2 million. The company continues to advance pre-clinical programs for geographic atrophy in dAMD.

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Akari Therapeutics (Nasdaq: AKTX) announced a patient has completed treatment in the Phase III clinical trial of nomacopan for pediatric HSCT-TMA, a serious post-stem cell transplant complication. Nomacopan, a bispecific inhibitor, shows promise as it is currently the only investigational therapy with Orphan Drug and Fast Track designations from the FDA. The trial aims to recruit seven pediatric patients in the U.S., U.K., and Poland. While one patient was discharged after over 60 days of treatment, another unfortunately died from unrelated complications. The mortality rate for severe HSCT-TMA is 80%. The study's primary endpoints focus on red blood cell transfusion independence and urine protein levels.

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Akari Therapeutics, Plc (Nasdaq: AKTX) announced the appointment of Melissa Bradford-Klug as Chief Operating Officer, effective July 1, 2022. With over 25 years of experience across biotech and healthcare sectors, she will drive business development strategies and oversee the advancement of nomacopan, Akari's lead asset, targeting conditions like bullous pemphigoid. Bradford-Klug's appointment is expected to strengthen Akari's operational capabilities and accelerate clinical trials, enhancing the company's growth prospects and commitment to addressing unmet medical needs.

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Akari Therapeutics (Nasdaq: AKTX) presented findings from its CASCADE and CORONET studies on COVID-19 pneumonia at the ATS 2022 Annual Meeting. The CASCADE study revealed elevated inflammatory biomarkers in COVID-19 pneumonia patients compared to healthy controls. The CORONET study demonstrated that 6 out of 7 hospitalized patients treated with the investigational drug nomacopan survived, showcasing its potential in reducing COVID-19 complications. No adverse effects were reported. The company focuses on therapies for autoimmune and inflammatory diseases, with nomacopan targeting complement activation.

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Akari Therapeutics has initiated Phase III studies of nomacopan for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy and bullous pemphigoid, addressing critical unmet needs with no current approved treatments. The company's preclinical program for long-acting PAS-nomacopan shows promise in treating geographic atrophy/dry age-related macular degeneration. Financially, Akari reported a net loss of approximately $17.4 million for 2021, with cash reserves down to $9.4 million. The company increased manufacturing yield of nomacopan significantly, enhancing its development capabilities.

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Akari Therapeutics (Nasdaq: AKTX) announced the presentation of two posters at the ATS 2022 Annual Meeting, highlighting findings from the CORONET and CASCADE studies related to COVID-19 pneumonia. The CORONET study assessed nomacopan's compassionate use in hospitalized patients, while the CASCADE study focused on biomarker correlations for risk stratification. Presentations are scheduled for May 17, 2022, at the Moscone Center in San Francisco. Akari aims to enhance understanding of inflammation's role in COVID-19, contributing valuable insights to the medical community.

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Akari Therapeutics (Nasdaq: AKTX) announced positive Phase II results for nomacopan in treating bullous pemphigoid (BP), a severe autoimmune skin disease. In the study, nine patients received nomacopan; 77.8% responded, with three showing over 80% reduction in disease activity by day 42. Notably, no severe treatment-related adverse events were reported, underscoring nomacopan's safety. This research, published in JAMA Dermatology, supports further development of nomacopan, which could address the unmet need for effective therapies in BP.

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Akari Therapeutics (Nasdaq: AKTX) presented promising preclinical results for PASylated-nomacopan at the ARVO 2022 Annual Meeting, focusing on its efficacy in treating geographic atrophy (GA) and choroidal neovascularization (CNV). The findings indicated that PAS-nomacopan significantly reduced CNV in animal models, with a potential dosing interval of three months, thereby addressing patient burden associated with frequent injections. Additionally, nomacopan showed effectiveness in reducing inflammation linked to ocular diseases compared to traditional treatments.

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FAQ

What is the current stock price of Akari Therapeutics plc ADR (0.01 USD) (AKTX)?

The current stock price of Akari Therapeutics plc ADR (0.01 USD) (AKTX) is $0.97 as of December 20, 2024.

What is the market cap of Akari Therapeutics plc ADR (0.01 USD) (AKTX)?

The market cap of Akari Therapeutics plc ADR (0.01 USD) (AKTX) is approximately 26.5M.

What is the focus of Akari Therapeutics?

Akari Therapeutics focuses on developing innovative therapies for autoimmune and inflammatory diseases, including severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) and geographic atrophy (GA).

What is nomacopan?

Nomacopan is Akari's lead drug, a bispecific recombinant inhibitor targeting complement C5 and leukotriene B4 (LTB4) pathways. It is currently in Phase 3 clinical trials for treating HSCT-TMA.

What designations has nomacopan received?

Nomacopan has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA, as well as orphan drug designation from the European Commission.

What is PAS-nomacopan?

PAS-nomacopan is a long-acting version of nomacopan, currently in pre-clinical development for treating geographic atrophy (GA), a leading cause of blindness.

What are the recent developments at Akari Therapeutics?

Recent developments include a merger agreement with Peak Bio Inc., raising $7.6 million in a private placement, and appointing Dr. Samir R. Patel as Interim CEO.

What is the significance of the merger with Peak Bio?

The merger is expected to combine Akari's therapeutic pipeline with Peak Bio's ADC platform technology for cancer treatment, expanding the company's capabilities and market potential.

How is Dr. Samir R. Patel compensated?

Dr. Samir R. Patel's compensation as Interim CEO is solely equity-based, aligning his interests directly with those of Akari's shareholders.

What financial measures has Akari taken recently?

Akari has implemented a reduction-in-force to cut costs and has successfully raised $7.6 million through a private placement to fund its operations and strategic initiatives.

What is the timeline for the merger with Peak Bio?

The merger with Peak Bio is expected to close in the third quarter of 2024, subject to customary closing conditions and shareholder approvals.

Where can I find more information about Akari Therapeutics?

For more information, visit Akari Therapeutics' website at akaritx.com.

Akari Therapeutics plc ADR (0.01 USD)

Nasdaq:AKTX

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26.47M
20.19M
11.91%
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0.18%
Biotechnology
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