C5

Akari Therapeutics Reports Full-Year 2023 Financial Results and Recent Highlights

Retrieved on: 
Monday, April 1, 2024
Diagnosis, Civil service commission, Research, AATD, Growth, Akari, C5, Patient, Choroidal neovascularization, Sale, B4, PRV, Mortality, Hot game, Clinical trial, Therapy, Priority review, Safety, NEI, European Commission, ADC, Geographic atrophy, Hematopoietic stem cell transplantation, CNV, Pharmaceutical industry

BOSTON and LONDON, April 01, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, has reported financial results for the full year 2023 as well as recent company highlights.

Key Points: 
  • BOSTON and LONDON, April 01, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, has reported financial results for the full year 2023 as well as recent company highlights.
  • The combined entity will operate as Akari Therapeutics, Plc, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX.
  • Akari is continuing to recruit patients into the Part A portion of the Phase 3 clinical trial that has treated 10 patients to date.
  • During 2023, Akari also advanced the long-acting version of nomacopan (PASylated nomacopan) into the final stages of pre-clinical development as a treatment for geographic atrophy (GA).

VOYDEYA™ approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis in adults with the rare disease PNH

Retrieved on: 
Monday, April 1, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Factor D, Arthralgia, Chest pain, Confusion, Neuropsychological test, Infection, Eculizumab, Risk, Headache, ALPHA, PNH, C5, Patient, Orphan, Mitigation, Vaccine, Light, Paroxysmal nocturnal hemoglobinuria, EVH, Bacteria, University, Chills, MD, Breakthrough therapy, Cough, European Medicines Agency, Fatigue, Nausea, Rash, Fever, Priority, Safety, Immune system, REMS, Division, Vomiting, Hematology, Patient safety, Medicine

VOYDEYA has also been granted Orphan Drug Designation in the US, European Union (EU) and Japan for the treatment of PNH.

Key Points: 
  • VOYDEYA has also been granted Orphan Drug Designation in the US, European Union (EU) and Japan for the treatment of PNH.
  • You must complete or update meningococcal vaccine(s) and streptococcus vaccine(s) at least 2 weeks before your first dose of VOYDEYA.
  • If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting VOYDEYA.
  • Carry it with you at all times during treatment and for 1 week after your last VOYDEYA dose.

Rallybio Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Pregnancy, Administration, Risk, C5, Patient, Corporation, Acquisition, EMA, European Medicines Agency, Woman, Injection site reaction, Research and development, Clinical trial, Workforce, Pharmacokinetics, Safety, Antiphospholipid syndrome, Data, Pharmaceutical industry

The workforce reduction included 19 roles and will be substantially complete by the end of the first quarter of 2024.

Key Points: 
  • The workforce reduction included 19 roles and will be substantially complete by the end of the first quarter of 2024.
  • In November 2023, Rallybio announced preliminary data from the completed multiple dose cohort of the Phase 1 safety and pharmacokinetics (PK) study for RLYB212.
  • Research & Development (R&D) Expenses: R&D expenses were $15.9 million for the fourth quarter of 2023, compared to $10.8 million for the same period in 2022.
  • General & Administrative (G&A) Expenses: G&A expenses were $5.2 million for the fourth quarter of 2023, compared to $6.3 million for the same period in 2022.

Akari Therapeutics and Peak Bio Announce Definitive Agreement to Merge as Equals Creating an Expanded Pipeline That Features a Novel Antibody Drug Conjugate (ADC) Toolkit

Retrieved on: 
Tuesday, March 5, 2024
Therapy, DLA Piper, Leukotriene B4, NEI, C5, CNV, OTC, Inflammation, Bayer, Choroidal neovascularization, ADC, Risk, AATD, American depositary receipt, Geographic atrophy, Haematopoietic system, Patient, Autoimmunity, McKinsey & Company, Hot game, LTB4, Cancer, Pharmaceutical industry

Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages.

Key Points: 
  • Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages.
  • An assessment of the pipeline is planned, including program prioritization, updated timelines, near-term value creation opportunities, and other considerations.
  • Key highlights of the merger include:
    The merged pipeline features a robust ADC toolkit with novel payload and linker technologies.
  • Goodwin Procter LLP is serving as legal advisor to Akari and DLA Piper LLP is serving as legal advisor to Peak Bio.

Akari Therapeutics and Peak Bio Announce Definitive Agreement to Merge as Equals Creating an Expanded Pipeline That Features a Novel Antibody Drug Conjugate (ADC) Toolkit

Retrieved on: 
Tuesday, March 5, 2024
Therapy, DLA Piper, Leukotriene B4, NEI, C5, CNV, OTC, Inflammation, Bayer, Choroidal neovascularization, ADC, Risk, AATD, American depositary receipt, Geographic atrophy, Haematopoietic system, Patient, Autoimmunity, McKinsey & Company, Hot game, LTB4, Cancer, Pharmaceutical industry

Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages.

Key Points: 
  • Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages.
  • An assessment of the pipeline is planned, including program prioritization, updated timelines, near-term value creation opportunities, and other considerations.
  • Key highlights of the merger include:
    The merged pipeline features a robust ADC toolkit with novel payload and linker technologies.
  • Goodwin Procter LLP is serving as legal advisor to Akari and DLA Piper LLP is serving as legal advisor to Peak Bio.

Rallybio Highlights Portfolio Advances and Outlines Expected Milestones in 2024

Retrieved on: 
Thursday, January 4, 2024
Research, Finance, Clinical Trials, Professional Services, Biotechnology, Health, Pharmaceutical, General Health, Science, Conference, Geographic atrophy, Food, GMG, Risk, Woman, EMA, Paratriathlon, Data, Injection site reaction, AbCellera, HPP, Antiphospholipid syndrome, European Medicines Agency, Pregnancy, Corporation, DSM-IV codes, C5, Hypophosphatasia, ENPP1, Investment, Webcast, Patient, Therapy, Pharmaceutical industry

Rallybio expects to initiate its Phase 2 dose confirmation study for RLYB212 in the second half of 2024.

Key Points: 
  • Rallybio expects to initiate its Phase 2 dose confirmation study for RLYB212 in the second half of 2024.
  • Rallybio expects to complete this manufacturing work and provide an update on the development plan for RLYB116 in the second half of 2024.
  • Rallybio and EyePoint expect to provide an update on this collaboration in the first half of 2024.
  • Rallybio and Exscientia plan to provide an update on the progress of the program in the second half of 2024.

Human medicines European public assessment report (EPAR): Epysqli, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, Protein, Risk, Immune system, Infection, ATC, Neisseria meningitidis, Paroxysmal nocturnal hemoglobinuria, Bleeding, PNH, Disease, Headache, Pharmacist, LDH, Language, Vaccination, Medicine, Blood, Laboratory, European Medicines Agency, C5, Select, Cell, Safety, Hemolysis, Bacteria, Anatomy, Paroxysmal attack, Anemia, Hematology, IIA, Skin, Medical device

Human medicines European public assessment report (EPAR): Epysqli, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Epysqli, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, Meningococcal disease, Protein, Acetylcholine receptor, Autoantibody, INN, GMG, Immune system, Fatigue, Risk, ATC, Antibody, Pain, International, Disease, Nose, Language, Muscle weakness, Vaccination, Neisseria meningitidis, European Medicines Agency, C5, Select, Bruise, Safety, Time, Anatomy, Contract management, Disorder, IIA, Medical device

Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Rallybio Announces Preliminary Phase 1 Multiple Ascending Dose Data for RLYB116, an Innovative Subcutaneously Injected Inhibitor of Complement Component 5

Retrieved on: 
Wednesday, December 20, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, GMG, ISR, Aes, Half-life, Incidence, Injection site reaction, Pharmacokinetics, PD, History, Hepatitis, Antiphospholipid syndrome, Corporation, C5, Investment, Webcast, Patient, Safety, Pharmaceutical industry

Rallybio Corporation (Nasdaq: RLYB) today announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB) today announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases.
  • The Phase 1 MAD study for RLYB116 evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous RLYB116 in healthy participants with multiple dose administration.
  • The reduction in free C5 at 24 hours after the first dose of 100 mg was greater than 99%.
  • “The preliminary results from this Phase 1 multiple ascending dose study of RLYB116 support continued development in patients with gMG,” said Eric Watsky, M.D., RLYB116 Program Lead for Rallybio.

Himiway Set to Take Center Stage at CES 2024: Premiering Future-Forward Electric Bicycles Redefining the Landscape of Sustainable Transportation

Retrieved on: 
Thursday, December 28, 2023
Carbon, Carbon-fiber-reinforced polymers, C3, Multimedia, C1, Consumer Electronics Show, Ageing, Exhibition, Torque, C5, Discovery, Safety, CES, Road

At CES 2024, Himiway aims to solidify its position as an innovative leader in the electric bicycle industry.

Key Points: 
  • At CES 2024, Himiway aims to solidify its position as an innovative leader in the electric bicycle industry.
  • The event serves as a significant milestone for tech companies globally, and Himiway is poised to make waves with the unveiling of eight new electric bike models, each set to launch in 2024.
  • Himiway will introduce four new series, namely the Discovery series, Family series, All Terrain series, and Ultra series, each featuring unique and groundbreaking models.
  • The COO from Himiway expressed enthusiasm about the upcoming CES exhibition, stating, "Our new electric bike models showcase our dedication to providing cutting-edge solutions for a sustainable future.