HAE

KalVista Pharmaceuticals Awarded UK Innovation Passport for Sebetralstat

Retrieved on: 
Tuesday, February 20, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Cardiology, AAAAI, Hereditary angioedema, Annual general meeting, Safety, Health care, HAE, KALV, MHRA, American Academy, Pharmaceutical industry

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Innovation Passport for sebetralstat, an investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).

Key Points: 
  • KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Innovation Passport for sebetralstat, an investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).
  • The Innovation Passport is the first step in the UK’s Innovative Licensing and Access Pathway (ILAP), which is designed to accelerate a product’s time to market and facilitate patient access to innovative medicines.
  • “As a company which has its roots in the UK, we are pleased to receive the ILAP designation, which will enable us to further accelerate our regulatory submission for sebetralstat,” said Andrew Crockett, Chief Executive Officer of KalVista.
  • The Company will be presenting late-breaking KONFIDENT trial data on February 25, 2024, at the upcoming American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

Haemonetics to Present at Raymond James 45th Annual Institutional Investors Conference

Retrieved on: 
Wednesday, February 21, 2024
Haemonetics, HAE, Conference

BOSTON, Feb. 21, 2024 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that Chris Simon, President and CEO, will participate in a fireside chat with investors at the Raymond James 45th Annual Institutional Investors Conference on Tuesday, March 5, 2024 at 7:30 a.m.

Key Points: 
  • BOSTON, Feb. 21, 2024 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that Chris Simon, President and CEO, will participate in a fireside chat with investors at the Raymond James 45th Annual Institutional Investors Conference on Tuesday, March 5, 2024 at 7:30 a.m.
  • ET.
  • The public may access a live webcast of the fireside chat at Haemonetics' Investor Relations website or at the following link: https://wsw.com/webcast/rj129/hae/1445840 .
  • A replay of the recorded webcast will become accessible 12 hours after the event and will be available for 90 days on Haemonetics' Investor Relations website.

Haemonetics to Present at Citi's 2024 Unplugged Medtech and Life Sciences Access Day

Retrieved on: 
Wednesday, February 21, 2024
Citigroup, Haemonetics, HAE

BOSTON, Feb. 21, 2024 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that Chris Simon, President and CEO, will participate in a fireside chat with investors at Citi's 2024 Unplugged Medtech and Life Sciences Access Day on Thursday, February 29, 2024 at 8:45 a.m.

Key Points: 
  • BOSTON, Feb. 21, 2024 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that Chris Simon, President and CEO, will participate in a fireside chat with investors at Citi's 2024 Unplugged Medtech and Life Sciences Access Day on Thursday, February 29, 2024 at 8:45 a.m.
  • ET.
  • The public may access a live webcast of the fireside chat at Haemonetics' Investor Relations website or at the following link: https://kvgo.com/unplugged-medtech-life-sciences-access-day/haemonetics-... .
  • A replay of the recorded webcast will become accessible 12 hours after the event and will be available for 90 days on Haemonetics' Investor Relations website.

Pharvaris Announces Extraordinary Meeting of Shareholders

Retrieved on: 
Friday, February 16, 2024
EST, HAE, Hereditary angioedema

ZUG, Switzerland , Feb. 16, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the extraordinary general meeting of shareholders will take place on Wednesday, March 6, 2024, at 12:00 CST (6:00 a.m. EST).

Key Points: 
  • ZUG, Switzerland , Feb. 16, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the extraordinary general meeting of shareholders will take place on Wednesday, March 6, 2024, at 12:00 CST (6:00 a.m. EST).
  • All relevant documents and information relating to the extraordinary general meeting, including the notice and agenda for the extraordinary general meeting, are or will be made available in the “Investors” section of Pharvaris’ website under “Events & Presentations”.
  • The documents will also be made available on the SEC’s website at www.sec.gov.
  • Shareholders who wish to attend the meeting should register as described in the notice and agenda for the extraordinary general meeting.

KalVista Pharmaceuticals to Present Phase 3 Sebetralstat Data at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

Retrieved on: 
Friday, February 16, 2024
Pharmaceutical, Health, Clinical Trials, AAAAI, Return, Anxiety, Convention center, HAE, Quality of life, Hereditary angioedema, Abstract, KALV, Patient, Q&A, Impact, American Academy, Pharmaceutical industry

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the acceptance of multiple abstracts at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place in Washington, DC from February 23-26.

Key Points: 
  • KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the acceptance of multiple abstracts at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place in Washington, DC from February 23-26.
  • Results shared as an oral poster presentation and Q&A
    Delayed On-demand Treatment of Hereditary Angioedema Attacks: Patient Perceptions and Associated Barriers (#216): Sandra Christiansen, Maeve O’Connor, Julie Ulloa, Sherry Danese, Vibha Desai, Shawn Czado, Paul Audhya, Paula Busse.
  • Results shared as an oral poster presentation and Q&A
    Anxiety Associated with On-Demand Treatment for Hereditary Angioedema (HAE) Attacks (#257): James Wedner, Cristine Radojicic, Julie Ulloa, Sherry Danese, Vibha Desai, Shawn Czado, Paul Audhya, Sandra Christiansen.
  • Results shared as an oral poster presentation and Q&A
    Characterizing the Perspective of Patients with HAE on Prophylactic Treatment (#270): Stephen Betschel, Cristine Radojicic, Sally van Kooten, Neil Malloy, Markus Heckmann, Julie Ulloa, William Lumry.

KalVista Pharmaceuticals Reports Phase 3 KONFIDENT Trial Meets All Endpoints for Sebetralstat as First Oral On-demand Therapy for Hereditary Angioedema

Retrieved on: 
Tuesday, February 13, 2024
Science, Biotechnology, Research, Pharmaceutical, Managed Care, Health, Genetics, Clinical Trials, Hereditary angioedema, Clinical trial, Caregiver, HAE, Șaeș, Patient, KALV, Pharmaceutical industry

The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile.

Key Points: 
  • The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile.
  • Treatment-related adverse event rates were 2.3% for 300 mg sebetralstat, 2.2% for 600 mg sebetralstat, and 4.8% for placebo.
  • “We are thrilled to announce positive phase 3 results for the KONFIDENT trial, which we believe position sebetralstat to become the first oral, on-demand therapy for the treatment of HAE.
  • Hereditary Angioedema Association Center at the University of California, San Diego, and an investigator for the KONFIDENT phase 3 trial.

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

Retrieved on: 
Tuesday, February 13, 2024
Acquisition, Warfarin, CSL Behring, Depreciation, Research, Ministry, Messenger, CIDP, Marketing, CSL, Growth, Plasmapheresis, Primary immunodeficiency, Von Willebrand disease, Antibody, S&M, Immunodeficiency, ASX, Income tax, Haemophilia, HAE, Ministry of Health, CSL Vifor, Hereditary angioedema, Plasma, COVID, Patient, Webcast, Phase, Diagnosis, G&A, CC3, Pressure, CSL Limited, Vaccine

MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.

Key Points: 
  • Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.
  • Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand.
  • HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by  patient diagnosis rates.
  • However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year.

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

Retrieved on: 
Tuesday, February 13, 2024
Acquisition, Warfarin, CSL Behring, Depreciation, Research, Ministry, Messenger, CIDP, Marketing, CSL, Growth, Plasmapheresis, Primary immunodeficiency, Von Willebrand disease, Antibody, S&M, Immunodeficiency, ASX, Income tax, Haemophilia, HAE, Ministry of Health, CSL Vifor, Hereditary angioedema, Plasma, COVID, Patient, Webcast, Phase, Diagnosis, G&A, CC3, Pressure, CSL Limited, Vaccine

MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.

Key Points: 
  • Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.
  • Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand.
  • HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by  patient diagnosis rates.
  • However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year.

BioCryst to Present New ORLADEYO® (berotralstat) Real-world Data at 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

Retrieved on: 
Monday, February 5, 2024
Abstract, Convention center, AAAAI, Tolerability, Washington Convention Center, Hereditary angioedema, Walter, Poster, Effectiveness, HAE, BioCryst Pharmaceuticals, American Academy, Prior, Pharmacy, Nightclub

The meeting will take place at the Walter E. Washington Convention Center in Washington, D.C., from February 23-26, 2024.

Key Points: 
  • The meeting will take place at the Walter E. Washington Convention Center in Washington, D.C., from February 23-26, 2024.
  • The five abstracts that BioCryst will present are:
    Berotralstat Prophylaxis Reduces HAE Attack Rates Regardless of Baseline Attacks: Real-World Outcomes; Poster #012; Friday, February 23, 3:15-4:15 p.m.
  • ET; Convention Center, Level 2, Hall D
    Consistently Low Hereditary Angioedema Attack Rates with Berotralstat Regardless of Prior Prophylaxis: Real-World Outcomes; Poster #008; Friday, February 23, 3:15-4:15 p.m.
  • ET; Convention Center, Level 2, Hall D
    Real-World Effectiveness of Berotralstat in HAE With and Without C1-Inhibitor Deficiency; Poster #281; Saturday, February 24, 9:45-10:45 a.m.

Intellia Therapeutics Announces Publication of Positive Interim Phase 1 Data for NTLA-2002 in Patients with Hereditary Angioedema in the New England Journal of Medicine

Retrieved on: 
Wednesday, January 31, 2024
Anxiety, Angioedema, Hereditary angioedema, NTLA, Patient, HAE, Intellia Therapeutics, Therapy, CRISPR, Medicine, NEJM, Fatigue, Pharmaceutical industry

“Despite currently available treatments, people living with hereditary angioedema continue to face frequent anxiety about their next swelling attack.

Key Points: 
  • “Despite currently available treatments, people living with hereditary angioedema continue to face frequent anxiety about their next swelling attack.
  • The interim NTLA-2002 clinical data published suggest that a single dose of NTLA-2002 may eliminate angioedema attacks for people suffering from hereditary angioedema,” said Intellia President and Chief Executive Officer John Leonard, M.D.
  • Further, all patients who discontinued concomitant long-term HAE prophylaxis treatment after NTLA-2002 administration (n=6) have reported no HAE attacks since discontinuation.
  • The data were previously shared in a late-breaking presentation at the 2023 European Academy of Allergy and Clinical Immunology Hybrid Congress.