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Akari Therapeutics, Plc (AKTX)

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1.6800-0.0200 (-1.18%)
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Neutralpattern detected
Previous Close1.7000
Open1.7300
Bid1.6800 x 3200
Ask1.7700 x 1000
Day's Range1.6800 - 1.7400
52 Week Range0.8700 - 2.7900
Volume92,584
Avg. Volume187,223
Market Cap56.894M
Beta (5Y Monthly)1.40
PE Ratio (TTM)N/A
EPS (TTM)-0.9670
Earnings DateMar 31, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est5.00
  • GlobeNewswire

    Akari Therapeutics Announces Further Clinical Trial Progress Using Nomacopan to Treat COVID-19 Pneumonia

    * 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 double blind randomized clinical study with nomacopan is recruiting patients in Brazil * Akari to present an update of its COVID-19 pneumonia program at the 4th Annual Complement-Based Drug Development Summit on October 15, 2020 NEW YORK and LONDON, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announces further progress in its COVID-19 pneumonia program with nomacopan in the U.S. and Brazil.Clive Richardson, Chief Executive Officer of Akari Therapeutics said, “We are pleased to be able to report continued progress with our COVID-19 pneumonia program. In addition to its potential to treat COVID-19 pneumonia, we believe nomacopan’s dual complement and leukotriene inhibition has applicability in a range of other severe lung inflammatory conditions which we are exploring and like COVID-pneumonia have proven difficult to treat due to the involvement of multiple inflammatory pathways.”COVID-19 pneumonia is believed to be a major cause of death in patients with COVID-19 and despite improvements in standard of care, remains difficult to treat. Accumulating data across a range of clinical studies in patients with COVID-19 pneumonia continues to point at the central role of complement C5a and C5b9 as well as neutrophil accumulation in the lung leading to severe inflammation and dramatic reductions in the delivery of blood through the capillary bed of the lung and ultimately other organs. Nomacopan has been shown to inhibit all these pathways directly; by binding C5, nomacopan inhibits production of C5a and C5b9 which have inflammatory and prothrombotic effects, and by preventing LTB4 from interacting with its cell surface receptors nomacopan may directly inhibit the migration of neutrophils to the lung and subsequent damaging cytokine release.The Company’s initial proof of principle studies have demonstrated that the 45mg standard dose of nomacopan can be used to treat patients with COVID-19 pneumonia without the need for up-dosing. The studies showed rapid onset of action of nomacopan, as well as no reported adverse safety signals in this fragile patient group. In addition, the Company believes that the relatively fast offset of nomacopan activity once dosing has been discontinued is a beneficial safety feature potentially allowing early patient discharge from hospital without the risk of long term immunosuppression. Furthermore, nomacopan was dosed alongside both antivirals and steroids (current standard of care) and may have an additive effect as steroids do not directly inhibit complement activation or LTB4.Both studies in the U.S. and Brazil are double blind randomized clinical studies (2:1 in favor of nomacopan treatment) of over 60 patients each, with a primary endpoint of time to oxygen normalization and hospital discharge. The secondary endpoints will include the need for intubation and mortality. Patients will receive either a daily subcutaneous dose of nomacopan and standard of care or placebo and standard of care. Treatment is for up to 14 days, with study monitoring and completion after two months.Akari Therapeutics has been invited to present an update on its COVID-19 pneumonia program at the 4th Annual Complement-Based Drug Development Summit 2020 on October 15, 2020. The presentation will explore the association between COVID-19 morbidity, complement activation and LTB4, as well as the current trials with nomacopan in patients with COVID-19 pneumonia. Akari’s presentation at the conference will be available by visiting ‘Events’ in the Investor Relations section on the Company’s website at www.akaritx.com.About Akari Therapeutics Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's lead drug candidate, nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity.Cautionary Note Regarding Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. You should not place undue reliance upon the Company’s forward looking statements. Except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this press release. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result therefrom; difficulties enrolling patients in our clinical trials; our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected; risks associated with the impact of the outbreak of coronavirus; risks associated with the SEC investigation; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.Investor Contact:Peter Vozzo Westwicke +1 (443) 213-0505 peter.vozzo@westwicke.comMedia Contact:Sukaina Virji / Lizzie Seeley Consilium Strategic Communications +44 (0)20 3709 5700 Akari@consilium-comms.com

  • GlobeNewswire

    Akari Therapeutics to Present Its Phase III Plans at the International Pemphigus & Pemphigoid Foundation (IPPF) Patient Education Conference

    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, today announced that Miles Nunn, Ph.D., Chief Scientific Officer of Akari Therapeutics, and James Fettiplace, M.D., Medical Director, Akari Therapeutics, will present the Company’s Phase III planned pivotal study of nomacopan in patients with moderate to severe bullous pemphigoid (BP) at the International Pemphigus & Pemphigoid Foundation (IPPF) Virtual Patient Education Conference. The IPPF’s main focus is to improve the quality of life for all those affected by pemphigus and pemphigoid through early diagnosis and support. The 2020 Virtual Patient Education Conference will be an educational event for all stakeholders in the field of bullous disease as the conference will present on disease research and trends, educate on disease management, and elevate awareness.“The IPPF community is excited to have Akari Therapeutics participating in the 2020 IPPF Virtual Patient Education Conference,” said Marc Yale, IPPF Advocacy & Research Coordinator. “Research and drug development in pemphigoid are on the horizon, and clinical trials, like the use of nomacopan in bullous pemphigoid, will advance our understanding of the disease and address the unmet medical need of patients. We are pleased to be working together with patients, physicians, researchers, and industry to ensure that we fulfil this promise."“Akari very much looks forward to partnering with the IPPF to understand as much as possible the perspective of patients and carers in bullous pemphigoid. This vital understanding will ensure that the Phase III study has patients at the center of our thinking,” said James Fettiplace, Medical Director, Akari Therapeutics.Details of Akari’s presentation are as follows:Event: 2020 IPPF Virtual Patient Education Conference Session Title Current and Future Clinical Trials Session Date/Time: October 4, 2020, 3:30 pm - 5:30 pm PT (6:30 pm - 8:30 pm ET) Presentation Title: Pivotal-BP Study: Nomancopan for the Treatment of Moderate to Severe BP To access the live webcast and subsequent archived recording of the presentation, please visit the ‘Events’ page in the Investor Relations section of the Company’s website at www.akaritx.com and register for the IPPF conference. You may also register directly for the IPPF conference here: IPPF Conference Registration.About Akari TherapeuticsAkari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's lead drug candidate, nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan is currently being clinically evaluated in four target indications: bullous pemphigoid (BP), thrombotic microangiopathy (TMA), atopic keratoconjunctivitis (AKC), and COVID-19 pneumonia.Cautionary Note Regarding Forward-Looking StatementsCertain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. You should not place undue reliance upon the Company’s forward looking statements. Except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this press release. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to successfully develop nomacopan as a treatment for COVID-19 related pneumonia and to successfully commercialize any product in that indication; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general and risks specific to the development of potential treatments for COVID-19 related illnesses; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result therefrom; difficulties enrolling patients in our clinical trials; our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected; risks associated with the impact of the outbreak of coronavirus; risks associated with the SEC investigation; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the US Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.For more information Investor Contact:Peter Vozzo Westwicke (443) 213-0505 peter.vozzo@westwicke.comMedia Contact:Sukaina Virji / Lizzie Seeley Consilium Strategic Communications +44 (0)20 3709 5700 Akari@consilium-comms.com

  • GlobeNewswire

    Akari Therapeutics to Participate in Two September Virtual Investor Conferences

    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, today announced that Clive Richardson, Chief Executive Officer, will participate and host investor meetings during the following upcoming virtual investor conferences: Event: H.C. Wainwright 22nd Annual Global Investment Conference Date: Tuesday, September 15, 2020 Presentation: 1:30 p.m. ET Event: Oppenheimer Fall Healthcare Life Sciences & MedTech Summit Date: Wednesday, September 23, 2020 Presentation: 10:50 a.m. ET Investors interested in arranging a virtual meeting with the Company's management during either conference should contact the respective conference coordinator.A live webcast and subsequent archived recording of each presentation will be available by visiting ‘Events’ in the Investor Relations section on the Company’s website at www.akaritx.com.  About Akari TherapeuticsAkari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's lead drug candidate, nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan is currently being clinically evaluated in four target indications: bullous pemphigoid (BP), thrombotic microangiopathy (TMA), atopic keratoconjunctivitis (AKC), and COVID-19 pneumonia.Cautionary Note Regarding Forward-Looking StatementsCertain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. You should not place undue reliance upon the Company’s forward looking statements. Except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this press release. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to successfully develop nomacopan as a treatment for COVID-19 related pneumonia and to successfully commercialize any product in that indication; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general and risks specific to the development of potential treatments for COVID-19 related illnesses; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result therefrom; difficulties enrolling patients in our clinical trials; our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected; risks associated with the impact of the outbreak of coronavirus; risks associated with the SEC investigation; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the US Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.For more information Investor Contact:Peter Vozzo Westwicke (443) 213-0505 peter.vozzo@westwicke.comMedia Contact:Sukaina Virji / Lizzie Seeley Consilium Strategic Communications +44 (0)20 3709 5700 Akari@consilium-comms.com