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Akari Therapeutics, Plc (AKTX)
Chart Events
Performance Outlook
| Previous Close | 1.8600 |
| Open | 1.8700 |
| Bid | 1.8100 x 1000 |
| Ask | 1.8300 x 1000 |
| Day's Range | 1.7800 - 1.9400 |
| 52 Week Range | 1.4200 - 4.2100 |
| Volume | 691,732 |
| Avg. Volume | 467,538 |
| Market Cap | 69.637M |
| Beta (5Y Monthly) | 1.15 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -0.5410 |
| Earnings Date | Dec 11, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | N/A |
Fair Value
Related Research
- Benzinga
Akari Therapeutics' Nomacopan Secures Expediated Review Tag For Blistering Skin Disorder
The FDA has granted Fast Track designation to Akari Therapeutics Plc's (NASDAQ: AKTX) nomacopan to treat patients with moderate and severe Bullous Pemphigoid (BP). Nomacopan has also been granted orphan drug designation for nomacopan to treat BP by the FDA and the European Medicines Agency (EMA). Fast track is a process designed to facilitate the development and expedite the review of drugs. BP is a severe orphan autoimmune inflammatory blistering skin disease wherein both terminal complement activation (via complement component C5), and the lipid mediator leukotriene B4 (LTB4) have a central role in driving the disease. Akari's lead drug candidate, Nomacopan, is a C5 complement inhibitor that independently and specifically binds to and inhibits leukotriene B4 (LTB4) activity. Price Action: AKTX shares are up 2.13% at $2.39 during the market trading session on the last check Wednesday. See more from BenzingaClick here for options trades from BenzingaU.S. Government Bolsters Moderna COVID-19 Vaccine Contract To .25BGlaxoSmithKline Q1 Profit, Sales Decline As COVID-19 Vaccination Delay Other Treatments; Backs 2021 Outlook© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
- GlobeNewswire
Akari Therapeutics Receives FDA Fast Track Designation for Nomacopan for the Treatment of Bullous Pemphigoid
A multicenter Phase III study of nomacopan for the treatment of moderate and severe bullous pemphigoid (BP) has been initiatedNomacopan has potential to replace long term steroid treatment (standard of care) in BP, which has multiple adverse effects and increases mortality in this elderly and frail populationRecently announced U.S. Food and Drug Administration (FDA) approval of the Investigational New Drug Application (IND) enables clinical sites to be opened in the U.S. Clinical sites are planned to open in Europe mid-2021. NEW YORK and LONDON, April 28, 2021 (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 leukotriene systems are implicated, today announced that the FDA has granted Fast Track designation to nomacopan for the treatment of patients with moderate and severe BP. Nomacopan has also been granted orphan drug designation for nomacopan for the treatment of BP by the FDA and the European Medicines Agency (EMA). Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation benefits from more frequent communications and meetings with the FDA to review the drug's development plan including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval. Success in BP could potentially open up a range of other severe dermatological conditions for treatment with nomacopan where C5 and LTB4 are implicated, including hidradenitis suppurativa, epidermolysis bullosa acquisita and mucous membrane pemphigoid. About Bullous Pemphigoid (BP) BP is a severe orphan autoimmune inflammatory blistering skin disease with no approved treatments in the U.S. and Europe. This disease of the elderly is primarily treated with steroids and immunosuppressants for six months or more which bring with them deleterious side effects and an approximately three-fold increase in mortality in the BP treated population. The prevalence of BP is estimated to be approximately 120,000 patients in U.S. and EU5 with moderate and severe patients making up around three-quarters of the patient population. In BP patients there is evidence that both terminal complement activation (via complement component C5) and the lipid mediator leukotriene B4 (LTB4) have a central role in driving the disease. 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 binds to and 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. 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; 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 departure of our former Chief Executive Officers and other executive officers; 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. For more information Investor Contact: Peter VozzoWestwicke/ICR(443) 213-0505peter.vozzo@westwicke.com Media Contact: Sukaina Virji / Ashley Tapp / Maya BennisonConsilium Strategic Communications+44 (0)20 3709 5700Akari@consilium-comms.com
- GlobeNewswire
Akari Therapeutics Announces Poster Presentation of Phase II Bullous Pemphigoid Disease and Phase III Trial Design at American Academy of Dermatology Association Virtual Meeting Experience
NEW YORK and LONDON, April 22, 2021 (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 leukotriene systems are implicated, announced today that it will present a poster at the American Academy of Dermatology Association (AAD) Virtual Meeting Experience (VMX) taking place April 23-25, 2021. The poster will be made available on AAD’s VMX platform beginning April 23, 2021, and the Akari corporate website at http://investor.akaritx.com/news-and-events/presentations following the meeting. Poster Details Title: “Disease Remission During a Short-term Treatment Phase II Study of Nomacopan in Mild-to-moderate Bullous Pemphigoid” Category: Immunodermatology & Blistering Disorders Presentation date: April 23, 2021 Presentation Time: Beginning 9:00 a.m. CT The poster describes results from the completed Phase II study (NCT04035733) of nomacopan for treatment of bullous pemphigoid (BP), with a specific focus on the disease control recorded at each clinical visit during the short-term (6-week) treatment period. Disease control is an important variable, as it will be used to decide when to taper the adjunct oral corticosteroid dose in the upcoming 24-week nomacopan treatment Phase III BP randomized controlled trial whose design is also presented in the poster. The Phase III trial in moderate to severe BP patients was refined following successful end of Phase II meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The trial is anticipated to open for recruitment in the U.S. and Europe mid-2021. Earlier this month, Akari announced that the FDA investigational new drug application (IND) is now open in the U.S. for the BP Phase III trial. 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 binds to and 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. 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; 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 departure of our former Chief Executive Officers and other executive officers; 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. For more informationInvestor Contact: Peter VozzoWestwicke/ICR(443) 213-0505peter.vozzo@westwicke.com Media Contact: Sukaina Virji / Nicholas Brown / Lizzie SeeleyConsilium Strategic Communications+44 (0)20 3709 5700Akari@consilium-comms.com
