Moisture sensitivity level

Akari Therapeutics Presents Results from the CASCADE and CORONET Studies in COVID-19 at the American Thoracic Society (ATS) 2022 Annual Meeting

Retrieved on: 
Thursday, May 19, 2022
Thrombotic microangiopathy, Inflammation, Risk, Autoimmunity, Annual general meeting, Private Securities Litigation Reform Act, American Thoracic Society, U.S. Securities and Exchange Commission, Nasdaq, Moisture sensitivity level, Patient, Therapy, Pneumonia, Eye, BP, COVID-19, Failure, C5a, FDA, Observational study, Leukotriene B4, ATS, Intellectual property, EMA, Biomarker, Pathology, Degenerative disease, Drug development, LTB4, TMA, SEC, GLOBE, Annual report, Akari, Pharmaceutical industry

NEW YORK and LONDON, May 19, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on developing advanced therapies for autoimmune and inflammatory diseases, presented results from the CASCADE and CORONET studies in patients with COVID-19 pneumonia at the American Thoracic Society (ATS) 2022 Annual Meeting.

Key Points: 
  • NEW YORK and LONDON, May 19, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on developing advanced therapies for autoimmune and inflammatory diseases, presented results from the CASCADE and CORONET studies in patients with COVID-19 pneumonia at the American Thoracic Society (ATS) 2022 Annual Meeting.
  • The CORONET study evaluated compassionate use of investigational nomacopan in the treatment of hospitalized COVID-19 pneumonia patients at two centers in the United States.
  • As seen in CASCADE and other studies, the innate immune system plays a potentially important role in driving the pathology of COVID-19 pneumonia.
  • Akari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company focused on developing advanced therapies for autoimmune and inflammatory diseases.

InflaRx Announces Presentation at J.P. Morgan Healthcare Conference and Other Investor Events

Retrieved on: 
Wednesday, January 5, 2022
University, UNC School of Medicine, Inflammation, Founder, Therapy, Investor, Company, Phase, C5a, Conference, EST, MD, Moisture sensitivity level, Complement, Autoimmunity, GLOBE, Associate, Nasdaq, Pharmaceutical industry, Hidradenitis suppurativa, Medicine, Dermatology

40th Annual J.P. Morgan Healthcare Conference: Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, will give a corporate presentation on Thursday, January 13th at 11:15 am EST (5:15 pm CET) followed by a 20-minute Q&A.

Key Points: 
  • 40th Annual J.P. Morgan Healthcare Conference: Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, will give a corporate presentation on Thursday, January 13th at 11:15 am EST (5:15 pm CET) followed by a 20-minute Q&A.
  • A live audio webcast and replay of the presentation will be provided on the InflaRx website in the Investors - Events & Presentations section.
  • H.C. Wainwright virtual BioConnect Conference: A corporate presentation will be available on demand starting Monday, January 10th at 7:00 am EST (1:00 pm CET).
  • A link to the presentation will be available on the InflaRx website in the Investors - Events & Presentations section.

InflaRx Initiates Phase III Clinical Program with Vilobelimab in Hidradenitis Suppurativa

Retrieved on: 
Wednesday, January 5, 2022
Blood, CSCC, COVID-19, Agency, Inflammation, Review, Therapy, Company, Patient, Abscess, III, Phase, End organ damage, C5a, Hidradenitis suppurativa, Pyoderma, Moisture sensitivity level, Complement, FDA, Squamous cell carcinoma, Autoimmunity, GLOBE, Nasdaq, ANCA, Anti-neutrophil cytoplasmic antibody, Pharmaceutical industry, Medical device, HS

We have incorporated the FDAs feedback into the trial design and can now move forward with initiating the Phase III trial.

Key Points: 
  • We have incorporated the FDAs feedback into the trial design and can now move forward with initiating the Phase III trial.
  • InflaRx completed a Type A meeting with the U.S. Food & Drug Administration (FDA) in September 2021 to align on the Phase III HS study design.
  • InflaRx incorporated the FDAs input and submitted the Phase III protocol to the Agency in late November 2021.
  • The Company will provide an update on vilobelimab development in HS, including details on the Phase III program.

DNP Develops Lead Frame for Miniaturized, Highly Reliable Semiconductor Package QFN(Quad Flat Non-leaded)

Retrieved on: 
Thursday, October 28, 2021
Semiconductor, Automotive Manufacturing, Technology, Manufacturing, Other Manufacturing, Hardware, Dai, JEDEC, Technology, QFN, Industry, Heat, View, Moisture sensitivity level, Communication, Semiconductor, MSL, Photomask, Absorption, Joint Electronics Type Designation System, Multimedia, DNP, Solution, Printing, Adhesive bonding, FY, Printed circuit board

View the full release here: https://www.businesswire.com/news/home/20211027005428/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20211027005428/en/
    Newly developed lead frame (Photo: Business Wire)
    By providing this high definition, highly reliable lead frame we aim to expand the use of semiconductor Quad Flat Non-leaded package (QFN) for vehicles.
  • DNP has taken advantage of our microfabrication technology developed over many years to successfully achieve the configuration of lead frame silver plated area of 25um.
  • It has also been possible to maintain high level reliability by improving the adhesion of the mold compound and the lead frame.
  • DNP will propose the newly developed high definition, highly reliable lead frame to post-processing manufacturers and expand this business.

InflaRx Awarded up to EUR 43.7 Million (~USD 50.7 Million) Grant by German Government to Advance the Development of Vilobelimab for Treatment of Severe COVID-19

Retrieved on: 
Tuesday, October 19, 2021
German Federal Archives, Cabinet of Germany, CFO, Technology, COVID-19, Complement, EUR, Autoimmunity, C5a, Disease, Federation, Education, Nasdaq, Jean-Louis Vincent, Phase, GLOBE, Patient, Moisture sensitivity level, Plasma protein binding, Therapy, Inflammation, Company, Pharmaceutical industry

The grant was awarded as part of a government initiative, which the German Federal Government announced earlier this year, to accelerate the development of promising therapeutic options for the treatment of COVID-19 in patients at all stages of disease.

Key Points: 
  • The grant was awarded as part of a government initiative, which the German Federal Government announced earlier this year, to accelerate the development of promising therapeutic options for the treatment of COVID-19 in patients at all stages of disease.
  • We are pleased to receive this significant grant from the German Federal Government, which has recognized the need to invest in the late-stage development of new and promising therapies to treat patients with COVID-19.
  • The purpose of the grant is to advance clinical development activities in COVID-19 and to secure manufacturing capacity for vilobelimab in Germany.
  • The initial tranche amounts to EUR 25.8 million (approximately USD 29.9 million) and is structured as reimbursement of 80% of certain pre-specified expenses related to the clinical development and manufacturing of vilobelimab.

InflaRx Completes Enrollment of Vilobelimab Phase III Study in Severe COVID-19

Retrieved on: 
Tuesday, October 12, 2021
Patient, Kidney, Autoimmunity, Database, ANCA, Death, Phase, COVID-19, Jean-Louis Vincent, Moisture sensitivity level, End organ damage, Standard of care, Blood, GLOBE, Mortality, Complement, Anti-neutrophil cytoplasmic antibody, Inflammation, C5a, Squamous cell carcinoma, Hidradenitis suppurativa, Pyoderma, Therapy, CSCC, Technology, Nasdaq, Pharmaceutical industry

JENA, Germany, Oct. 12, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients.

Key Points: 
  • JENA, Germany, Oct. 12, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients.
  • The randomized, double-blind and placebo-controlled Phase III part of the Phase II/III study enrolled 369 mechanically ventilated patients with COVID-19 across sites in the EU, South America and other regions.
  • The Phase II part of the study evaluated vilobelimab treatment plus best supportive care compared to best supportive care alone for up to 28 days.
  • The data from the Phase II part of the study have been published in the peer-reviewed journal, The Lancet Rheumatology .

InflaRx to Proceed with Pivotal Development for Vilobelimab in Hidradenitis Suppurativa with New Primary Endpoint

Retrieved on: 
Wednesday, September 8, 2021

InflaRx had submitted the Type A meeting request to the FDA in July to align on the Phase III HS study design.

Key Points: 
  • InflaRx had submitted the Type A meeting request to the FDA in July to align on the Phase III HS study design.
  • The meeting discussion focused on reaching consensus on the overall study population and the primary endpoint measure.
  • InflaRx is still in active dialogue with the FDA on the final details of the pivotal study design.
  • Once the protocol is approved by the Agency, the Company will provide more details about the study, including the primary endpoint.

InflaRx Announces Positive Data from Second Interim Analysis of Ongoing Phase IIa Open Label Study with Vilobelimab in Pyoderma Gangraenosum

Retrieved on: 
Tuesday, August 10, 2021
ANCA, Patient, COVID-19, Hypersensitivity, Rheumatoid arthritis, PG, Skin, Moisture sensitivity level, Inflammation, Ulcer, Anti-neutrophil cytoplasmic antibody, Nasdaq, PGA, Safety, Disease, Hidradenitis suppurativa, Squamous cell carcinoma, C5a, Degenerative disease, Arthritis, Inflammatory Bowel Diseases, Prevalence, GLOBE, Technology, Blood, Therapy, Ulcerative colitis, Hematologic disease, Autoimmunity, Multiple myeloma, Complement, Pain, Pyoderma, CSCC, Global Assessment of Functioning, End organ damage, Pharmaceutical industry

JENA, Germany, Aug. 10, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the first 10 evaluable patients in the ongoing Phase IIa open label study with vilobelimab in Pyoderma Gangraenosum (PG).

Key Points: 
  • JENA, Germany, Aug. 10, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the first 10 evaluable patients in the ongoing Phase IIa open label study with vilobelimab in Pyoderma Gangraenosum (PG).
  • As previously announced, enrollment in the proof-of-concept study was completed with 19 patients, with 12 in the first two dose cohorts.
  • The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG.
  • Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases.