HAE

KalVista Pharmaceuticals Presents Data on Unmet Needs in HAE from a Patient Perspective at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

Retrieved on: 
Tuesday, February 27, 2024

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 that it presented real-world data from US patient surveys that assessed the experience of HAE patients using injectable on-demand treatments at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting that took place in Washington, DC.

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 that it presented real-world data from US patient surveys that assessed the experience of HAE patients using injectable on-demand treatments at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting that took place in Washington, DC.
  • The following presentations occurred at AAAAI 2024:
    Characteristics of Hereditary Angioedema Attacks Among Long-Term Prophylaxis Users: Bob Geng, Allergy and Immunology, University of California, San Diego, California, United States (Poster Presentation)
    Among HAE patients who had treated a recent attack, the location and duration of the most recent attacks were similar between long-term prophylaxis (LTP) and on-demand only users
    Earlier on-demand treatment was associated with a shorter attack duration, regardless of LTP use
    Delayed On-demand Treatment of Hereditary Angioedema Attacks: Patient Perceptions and Associated Barriers: Sandra Christiansen, University of California San Diego, La Jolla, CA, United States (Poster Presentation)
    The most common barriers to earlier treatment were uncertainty if attack was real, thinking the attack would be mild, and wanting to save treatment for a severe attack
    Anxiety Associated with On-Demand Treatment for Hereditary Angioedema (HAE) Attacks: James Wedner, Washington University School of Medicine, St Louis, MO, United States (Poster Presentation)
    Both adults and adolescents with HAE reported moderate to extreme anxiety when anticipating use of parenteral on-demand treatment, irrespective of use of on-demand only or on-demand plus LTP
    The results of this study highlighted the association between delayed treatment and treatment-related anxiety, with a higher proportion of patients who delayed treatment experiencing moderate to extreme anxiety
    Anxiety Associated with Refilling On-demand Therapy for HAE Attacks Contributes to Treatment Delay and Non-Treatment: Autumn Burnette, Division of Allergy and Immunology, Howard University Hospital, Washington, DC, United States (Poster Presentation)
    Anxiety associated with not being able to refill on-demand treatment quickly impacted treatment decisions, which contributed to treatment delay or resulted in non-treatment of HAE attacks
    Characterizing the Negative Impact of Delayed On-Demand Treatment of HAE Attacks: Princess Ogbogu, Division of Pediatric Allergy, Immunology, and Rheumatology, University Hospitals Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States (Poster Presentation)
    The Impact of On-demand Treatment on Quality of Life of People with HAE: Paula Busse, Department of Medicine, Division of Clinical Immunology, Mount Sinai, New York, United States (Poster Presentation)
    Characterizing the Perspective of Patients With HAE on Prophylactic Treatment: Stephen Betschel, Division of Allergy and Immunology, Department of Medicine, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada (Poster Presentation)
    Only 35% of LTP patients always carried on-demand treatment when away from home, while 43% of prophylaxis patients cited avoiding potential triggers as a reason for not carrying on-demand treatment at all times
    Treatment Patterns of Patients Requiring Redosing of an On-demand Treatment After the Return of an HAE Attack: Constance Katelaris, Department of Medicine, Campbelltown Hospital and Western Sydney University, Sydney, NSW, Australia (Poster Presentation)
    “The results of these surveys clearly conveyed the challenges faced by patients trying to manage their HAE attacks with injectable on-demand treatments.
  • The resulting non-compliance with treatment guidelines may lead to poor clinical outcomes, even among patients receiving LTP,” said Andrew Crockett, Chief Executive Officer of KalVista.
  • “We believe the efficacy and safety data from our phase 3 trial for sebetralstat show a potential path forward to address these persisting unmet needs.”

KalVista Pharmaceuticals Presents Additional Phase 3 KONFIDENT Data at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

Retrieved on: 
Monday, February 26, 2024

Additional safety analyses demonstrated that the safety profiles associated with one dose or two doses of sebetralstat 300 mg or 600 mg were comparable to placebo.

Key Points: 
  • Additional safety analyses demonstrated that the safety profiles associated with one dose or two doses of sebetralstat 300 mg or 600 mg were comparable to placebo.
  • Data presented as a supplement also showed that the median time to all endpoints was shorter for attacks with higher initial severity, at both dose levels.
  • “If approved, we believe that a single dose of sebetralstat 300 mg would appear to be appropriate for most HAE attacks.
  • “We believe that these additional efficacy and safety data only strengthen the case for sebetralstat to become the first, oral on-demand treatment available to the HAE community.”

KalVista Pharmaceuticals Awarded UK Innovation Passport for Sebetralstat

Retrieved on: 
Tuesday, February 20, 2024

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

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

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

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

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

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

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

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.