Akari Therapeutics

Akari Therapeutics Plc is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of therapeutics to treat orphan autoimmune and inflammatory diseases. Its lead product candidate, Nomacopan, is a second-generation complement inhibitor. The company was founded on October 7, 2004 and is headquartered in London, the United Kingdom.

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Akari Therapeutics Plc is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of therapeutics to treat orphan autoimmune and inflammatory diseases. Its lead product candidate, Nomacopan, is a second-generation complement inhibitor. The company was founded on October 7, 2004 and is headquartered in Boston, MA.

NEW YORK and LONDON, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that Akari will change the ratio of its American Depositary Shares (ADSs) to ordinary shares from one ADS representing one hundred ordinary shares to a new ratio of one ADS representing two thousand ordinary shares. The ratio change is expected to be effective on August 17, 2023.

Akari Therapeutics, Plc Announces ADS Ratio Change

NEW YORK and LONDON, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of Beth-Anne Lang, as Senior Vice President, Regulatory Affairs. Ms. Lang has more than 20 years of experience in regulatory strategy, regulatory affairs, and drug development. She will start at Akari in this role on September 1, 2023.

Akari Therapeutics Announces the Appointment of Beth-Anne Lang as Senior Vice President, Regulatory Affairs

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NEW YORK and LONDON, July 27, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that the European Commission granted orphan drug designation to nomacopan as a treatment in hematopoietic stem cell transplantation following the European Medicines Agency positive opinion in June. Akari is currently conducting a registrational Phase 3 study of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Additionally, the company is moving forward into a Phase 3 double-blind placebo-controlled clinical trial of nomacopan in adult HSCT-TMA with enrollment expected to begin in 2024.

Akari Therapeutics Granted Nomacopan Orphan Drug Designation from the European Commission for Treatment in Hematopoietic Stem Cell Transplantation

NEW YORK and LONDON, July 19, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of experienced life sciences executive Wendy DiCicco as interim Chief Financial Officer (CFO). Ms. DiCicco has more than 25 years of experience in the life sciences industry, currently serving as an independent financial and board advisor to companies, often in the role of interim CFO.

Akari Therapeutics Appoints Experienced Life Sciences Executive Wendy DiCicco as Interim Chief Financial Officer

NEW YORK and LONDON, July 13, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced updates in the development programs investigating nomacopan in pediatric and adult hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Akari is on track to begin patient enrollment in the registrational Phase 3 study of nomacopan in pediatric HSCT-TMA that is expected to produce safety and efficacy data supportive of a potential regulatory filing and approval. Akari also is planning to move forward into a Phase 3 double-blind placebo-controlled clinical trial of nomacopan in adult HSCT-TMA and to open enrollment in 2024.

Akari Therapeutics Provides Updates on Development of Nomacopan in Pediatric and Adult HSCT-TMA

NEW YORK and LONDON, July 11, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced updates on the development of long-acting PAS-nomacopan as a potential treatment for geographic atrophy (GA). Resulting from extensive pre-clinical development work, Akari has selected the version of long-acting PAS-nomacopan that it plans to advance into clinical trials. The selected version has a product profile with characteristics important for a GA therapy, including fully active drug potency, planned small (

Akari Therapeutics Provides Update on Development of Long-Acting PAS-Nomacopan for Treatment of Geographic Atrophy

NEW YORK and LONDON, July 06, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the company's application for orphan drug designation for nomacopan as a treatment in hematopoietic stem cell transplantation. The application included nomacopan clinical data from the treatment of patients with pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Akari is currently conducting a registrational Phase 3 clinical trial of nomacopan in pediatric HSCT-TMA.

Akari Therapeutics Receives Positive Opinion on Orphan Drug Designation from the European Medicines Agency for Nomacopan for Treatment in Hematopoietic Stem Cell Transplantation

NEW YORK and LONDON, July 05, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of industry veteran Wa'el Hashad to the Akari Board of Directors as an independent director. Mr. Hashad, who will serve on both the Audit Committee and Nominating and Governance Committee, brings more than 35 years of biopharmaceutical experience to Akari's Board of Directors with focus on drug approval and commercialization, mergers and acquisitions, and business development.

Akari Therapeutics Appoints Industry Veteran Wa'el Hashad to Board of Directors

NEW YORK and LONDON, May 16, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that the company will participate in Alliance Global Partners' Virtual Healthcare Conference being held May 23-24, 2023. During the event, the Akari management team will attend 1:1 investor meetings.

Akari Therapeutics to Participate in A.G.P.'s Virtual Healthcare Conference

NEW YORK and LONDON, May 01, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced financial results and highlights for the full year ended December 31, 2022, as well as recent company updates. Akari's lead asset is investigational nomacopan, a novel bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4). Nomacopan is currently in a Phase 3 clinical trial for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Long-acting PAS-nomacopan is in pre-clinical development as a potential treatment for geographic atrophy (GA).

Akari Therapeutics Reports Full-Year 2022 Financial Results and Highlights

NEW YORK and LONDON, April 25, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that it has received notification from Nasdaq that Akari has been granted an additional 180-day period, or until October 23, 2023, to regain compliance with the Nasdaq minimum bid price requirement. Akari can regain compliance by maintaining a minimum closing bid price of $1.00 per share for a minimum of ten consecutive business days.

Akari Therapeutics Granted 180-Day Extension by Nasdaq to Meet Minimum Bid Price Requirement

NEW YORK and LONDON, April 14, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the company will host a virtual key opinion leader event on May 22, 2023 at 2 pm ET to discuss the treatment landscape in geographic atrophy (GA) and the potential for long-acting PAS-nomacopan to address significant unmet needs. Akari's lead asset is investigational nomacopan, a novel bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4). Long-acting PAS-nomacopan is currently in pre-clinical development as a potential treatment for GA.

Akari Therapeutics to Host Key Opinion Leader Webinar on Geographic Atrophy and the Potential of Long-Acting PAS-Nomacopan to Address Significant Unmet Needs

NEW YORK and LONDON, April 11, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that management team representatives will attend ARVO 2023, the annual meeting of The Association for Research in Vision and Ophthalmology to meet with researchers, thought leaders, and potential partners. Akari's lead asset is investigational nomacopan, a novel bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4). Long-acting PAS-nomacopan is currently in pre-clinical development as a potential treatment for geographic atrophy.

Akari Therapeutics to Attend ARVO 2023, the Annual Meeting of The Association for Research in Vision and Ophthalmology

NEW YORK and LONDON, April 03, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the upcoming presentation of a case study, Clinical Response to Nomacopan in the Paediatric HSCT-TMA Setting, on Sunday, April 23rd at 8:30 am (GMT+2). The poster presentation will take place at The European Society for Blood and Marrow Transplantation (EBMT) in Paris, France.

Akari Therapeutics Announces a Case Study from the Phase 3 Part A Clinical Trial of Nomacopan in Pediatric HSCT-TMA Will Be Presented at The European Society for Blood and Marrow Transplantation (EBMT) 49th Annual Meeting

NEW YORK and LONDON, March 30, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that it has entered into definitive agreements with certain institutional investors and accredited investors. The direct offering includes participation by all members of the Akari Board of Directors, including Chairman Dr. Ray Prudo, as well as Akari President and CEO Rachelle Jacques. Akari is expected to receive gross proceeds of approximately $4 million. The definitive agreements include no warrants.

Akari Therapeutics, Plc Announces $4 Million Registered Direct Offering

NEW YORK and LONDON, March 29, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced  regulatory authorities in Poland (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products/URPL) and the U.K. (Medicines & Healthcare products Regulatory Agency/MHRA) have approved amendments to the company's Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Authorisation (CTA), respectively, for clinical use of the third-generation drug substance manufacturing process that increases the final yield of nomacopan by at least 5-fold. Nomacopan is an investigational bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4) currently in Phase 3 clinical trials for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

Poland and U.K. Regulatory Authorities – URPL and MHRA – Approve Use of New, Higher-Yielding Manufacturing Process for Nomacopan in Pivotal Clinical Study

NEW YORK and LONDON, Feb. 21, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the late-breaker presentation of a patient case study from the Phase 3 Part A clinical trial of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). The case study, Clinical Response to Nomacopan in the Pediatric HSCT-TMA Setting, was presented on Thursday February 16, at 5:45 pm ET at the Transplantation & Cellular Therapy Tandem Meetings in Orlando, Florida. Nomacopan is an investigational bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4).

Akari Therapeutics Announces Presentation of a Case Study from Phase 3 Part A Clinical Trial of Nomacopan in Pediatric HSCT-TMA as a Late-Breaker at The Transplantation & Cellular Therapy Tandem Meetings

NEW YORK and LONDON, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced updates on progress in the pre-clinical development program for long-acting PAS-nomacopan as a potential treatment for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD).

Akari Therapeutics Announces Pre-Clinical Development Progress Toward Potential IND on Long-Acting PAS-Nomacopan for Geographic Atrophy (GA)

NEW YORK and LONDON, Feb. 13, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the Phase 3 clinical trial of nomacopan in pediatric patients with hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) is moving into Part B sooner than expected and the company is beginning the planning and design for the pivotal study in pediatric patients over 2 years of age. Akari also announces it has added a new pipeline program that will develop nomacopan as a potential treatment for adult HSCT-TMA, which will include a study that is supportive of the pediatric program. Study enrollment for the adult program is expected in 2024. Nomacopan is a novel bispecific inhibitor of complement C5 and leukotriene B4 (LTB4) in clinical development for pediatric and adult HSCT-TMA. Long-acting PAS-nomacopan is in pre-clinical development for geographic atrophy secondary to dry age-related macular degeneration.

Akari Therapeutics Announces Acceleration of the Phase 3 Clinical Trial of Nomacopan for Treatment of Pediatric HSCT-TMA into Pivotal Part B and Addition of a New Pipeline Program Developing Nomacopan for HSCT-TMA in Adults

NEW YORK and LONDON, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that Akari President and CEO Rachelle Jacques will present a company overview at Biotech Showcase 2023 on Monday, January 9, 2023 at 9 am ET. The presentation will include progress highlights from Akari's two priority pipeline programs: a Phase 3 clinical trial of nomacopan, a novel bispecific inhibitor of complement C5 and leukotriene B4 (LTB4), for the treatment of severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy, and a pre-clinical program investigating long-acting PAS-nomacopan as a potential treatment for geographic atrophy.

Akari Therapeutics to Present at Biotech Showcase™ 2023

NEW YORK and LONDON, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the company will participate in the investor-focused Cantor Medical and Aesthetic Dermatology, Ophthalmology and Medtech/Diagnostic Conference taking place in Miami December 7-8, 2022. Akari President and CEO Rachelle Jacques will take part in an ophthalmology panel on December 8 at 1:45 pm ET, Vision for the Future: Dry AMD, Other Greenfield Opportunities, and Late-Stage Stories to Shake Things Up. The Akari management team also will attend 1:1 investor meetings at the conference to discuss progress in the promising pre-clinical program that is investigating long-acting PAS-nomacopan in geographic atrophy (GA).

Akari Therapeutics to Participate in the Cantor Fitzgerald Medical and Aesthetic Dermatology, Ophthalmology and Medtech/Diagnostic Conference

NEW YORK and LONDON, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that the company will participate in the Ophthalmology Day at BTIG on November 29, 2022. President and CEO Rachelle Jacques will participate in a fireside chat scheduled for 9:30 am ET.

Akari Therapeutics to Participate in the Ophthalmology Day at BTIG

NEW YORK and LONDON, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Rare Pediatric Disease Designation to nomacopan for the treatment of pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). The Rare Pediatric Disease Designation is an important addition to the Orphan Drug and Fast Track designations previously granted by the FDA for nomacopan in pediatric HSCT-TMA.

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