HAE

Pharvaris to Present at the WSAAI Annual Meeting 2024

Retrieved on: 
Friday, January 26, 2024
HAE, Hereditary angioedema, Treatment, Bradykinin receptor B2, Safety, Abstract, Pharmaceutical industry

ZUG, Switzerland, Jan. 26, 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 acceptance of two abstracts for poster presentation at the Western Society of Allergy, Asthma & Immunology (WSAAI) Annual Meeting 2024, to be held from February 4-8, 2024, at the Grand Hyatt Kauai Resort & Spa in Koloa, Hawaii.

Key Points: 
  • ZUG, Switzerland, Jan. 26, 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 acceptance of two abstracts for poster presentation at the Western Society of Allergy, Asthma & Immunology (WSAAI) Annual Meeting 2024, to be held from February 4-8, 2024, at the Grand Hyatt Kauai Resort & Spa in Koloa, Hawaii.
  • Title: Efficacy and Safety of Bradykinin B2 Receptor Antagonism with Deucrictibant Immediate-Release Capsule for Treatment of Hereditary Angioedema Attacks: Results of RAPIDe-1 Phase 2 Trial
    The posters will be made available throughout the conference and on the Investors section of the Pharvaris website at the beginning of the poster session at: https://ir.pharvaris.com/news-events/events-presentations .

Pharvaris Announces FDA Lifting of the Clinical Hold of Deucrictibant for the Prophylactic Treatment of HAE Attacks

Retrieved on: 
Monday, January 22, 2024
Investigational New Drug, Attack, HAE, Hereditary angioedema, IND, Food, FDA, Pharmaceutical industry

We will request an End-of-Phase 2 meeting with the FDA to align on key elements of CHAPTER-3, the anticipated global Phase 3 study of deucrictibant extended-release tablets (PHVS719) for the prophylactic treatment of HAE attacks.”

Key Points: 
  • We will request an End-of-Phase 2 meeting with the FDA to align on key elements of CHAPTER-3, the anticipated global Phase 3 study of deucrictibant extended-release tablets (PHVS719) for the prophylactic treatment of HAE attacks.”
    In August 2022, the FDA placed clinical studies of deucrictibant, including CHAPTER-1, on hold.
  • Pharvaris notified ex-U.S. country-specific regulatory authorities of the clinical hold in the U.S., and the regulatory status of deucrictibant outside the U.S. was not affected.
  • In June 2023, Pharvaris announced the FDA’s removal of the clinical hold of deucrictibant for the on-demand treatment of HAE in the U.S. following FDA review of data from a preplanned interim analysis of a 26-week rodent toxicology study.
  • In December 2023, Pharvaris announced positive top-line clinical data from the Phase 2 CHAPTER-1 study of deucrictibant for the prophylactic treatment of HAE attacks.

Haemonetics Sets Date for Publishing Third Quarter Fiscal Year 2024 Results: February 8, 2024

Retrieved on: 
Thursday, January 11, 2024
HAE, Haemonetics, Conference, PIN, Webcast, Broadcasting

BOSTON, Jan. 11, 2024 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that the Company intends to publish third quarter fiscal year 2024 financial results at 6:00 am ET on Thursday, February 8, 2024.

Key Points: 
  • BOSTON, Jan. 11, 2024 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that the Company intends to publish third quarter fiscal year 2024 financial results at 6:00 am ET on Thursday, February 8, 2024.
  • The Company will hold a conference call with investors and analysts to discuss results and answer questions at 8:00 am ET on February 8, 2024.
  • The call can be accessed via teleconference at: Q3 2024 Haemonetics Corporation Earnings Conference Call .
  • Once registration is completed, participants will receive a dial-in number along with a personalized PIN to access the call.

Pharming Group announces updated full year 2023 guidance and Joenja® U.S. launch update

Retrieved on: 
Monday, January 8, 2024
APDS, PIK3CD, VUS, FDA, Disease, Immunodeficiency, PIK3R1, Laboratory, Euronext Amsterdam, Growth, Patient, Pids, HAE, Pharmaceutical industry

For the full year 2023, total revenues are expected to increase by 19% to approximately US$245 million (preliminary and unaudited*).

Key Points: 
  • For the full year 2023, total revenues are expected to increase by 19% to approximately US$245 million (preliminary and unaudited*).
  • We expect 10% growth in RUCONEST® revenues, significantly exceeding our previous guidance for low single digit annual revenue growth.
  • In 2023, Pharming saw the first full-year, post-pandemic benefit of its first quarter 2020 restructuring and expansion of its U.S. salesforce.
  • Pharming expects to issue full financial results for the fourth quarter and full year 2023 in March 2024.

Pharvaris Provides Business Update and Outlines 2024 Strategic Priorities

Retrieved on: 
Friday, January 5, 2024
Hereditary angioedema, Quality of life, Conference, Toxicology, Reason (argument), IND, Scale, Research, FDA, Executive Committee, Bradykinin receptor B2, Attack, Patient satisfaction, Angioedema, Trial of the century, Incidence, American Academy, Annual general meeting, AAAAI, Doctor of Philosophy, ACE, Virtual, Safety, Publication, ODT, Therapy, HAE, General Atlantic, Pharmaceutical industry

“Pharvaris enters the new year having demonstrated deucrictibant’s potential to be the preferred option for both the prevention and treatment of HAE attacks,” said Berndt Modig, Chief Executive Officer of Pharvaris.

Key Points: 
  • “Pharvaris enters the new year having demonstrated deucrictibant’s potential to be the preferred option for both the prevention and treatment of HAE attacks,” said Berndt Modig, Chief Executive Officer of Pharvaris.
  • The next years will be incredibly important to the company, and Jochen’s continued strategic guidance will be invaluable.”
    Anticipated initiation of RAPIDe-3 within 1H2024.
  • Jochen Knolle, Ph.D., co-founder of Pharvaris, transitions to strategic advisor to the CEO and Executive Committee.
  • I look forward to continuing to contribute to the strategic transformation of Pharvaris in my new capacity.”
    Oppenheimer 34th Annual Healthcare Life Sciences Conference.

Intellia Therapeutics Highlights its Three-Year Strategic Priorities and Anticipated 2024 Key Milestones

Retrieved on: 
Thursday, January 4, 2024
Liver, Conference, Science, Gene editing, Biotechnology Innovation Organization, Amyloidosis, BIO, CRISPR, Phase 1, Tissue, DNA, Cardiomyopathy, Therapy, ATTR, Intellia Therapeutics, NTLA, Clinical trial, Polyneuropathy, NK, AATD, Lung, Hereditary angioedema, Webcast, Patient, Medicine, HAE, BLA, Pharmaceutical industry

Organizational Streamlining: Following an internal strategic review, Intellia will be streamlining company-wide operations to further focus resources on key strategic priorities and programs.

Key Points: 
  • Organizational Streamlining: Following an internal strategic review, Intellia will be streamlining company-wide operations to further focus resources on key strategic priorities and programs.
  • Cash Runway: Intellia ended the fourth quarter of 2023 with approximately $1.0 billion in cash, cash equivalents and marketable securities.
  • Prepare for the Phase 3 study of NTLA-2001 for the treatment of ATTR amyloidosis with polyneuropathy (ATTRv-PN) in 2024.
  • A live webcast will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website, www.intelliatx.com .

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Date of authorisation: 22/11/2018, Revision: 12, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, Hereditary angioedema, INN, IIA, ATC, Pain, Blood, International, Injection, Angioedema, Ageing, Bradykinin, Language, Swelling, Abdomen, Red, European Medicines Agency, Face, Select, Caregiver, Bruise, Anatomy, HAE, Skin, Erythema, Medical device

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Date of authorisation: 22/11/2018, Revision: 12, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Date of authorisation: 22/11/2018, Revision: 12, Status: Authorised

BioCryst Announces Publication of Data from Open-label Extension of the APeX-2 Pivotal Trial of ORLADEYO® (berotralstat)

Retrieved on: 
Tuesday, December 19, 2023
Hereditary angioedema, Quality of life, Internal medicine, BioCryst Pharmaceuticals, Congress, EAACI, American Academy, University, AAAAI, Asthma, Manuscript, Patient, Safety, Journal, OLE, HAE, Pharmaceutical industry

“We are pleased to share long-term efficacy and safety data from APeX-2 as published in JACI: In Practice.

Key Points: 
  • “We are pleased to share long-term efficacy and safety data from APeX-2 as published in JACI: In Practice.
  • These data further illustrate the potential lasting outcomes that can be appreciated by patients who are treated with oral, once-daily ORLADEYO.
  • In part 3 of the study (weeks 49-96), all patients (n=81) were treated with open-label ORLADEYO at 150 mg.
  • JACI: In Practice is an official journal of the American Academy of Allergy, Asthma, and Immunology (AAAAI).

Pharvaris Presents Deucrictibant Clinical Data and Analysis of Endpoints for Trials of On-demand Treatment of HAE at the GA²LEN UCARE Conference 2023

Retrieved on: 
Friday, December 8, 2023
Patient, Hereditary angioedema, EST, Conference, BST, Treatment, Capsule, Disease, Data, Attack, Angioedema, EOP, HAE, Pharmaceutical industry

Prof. Markus Magerl, M.D., presented an oral session titled “ Treatment of HAE Attacks with Deucrictibant: RAPIDe-1 Phase 2 Trial Results ” on Friday, December 8, 11:18-11:26 a.m. BST (9:18-9:26 a.m. EST).

Key Points: 
  • Prof. Markus Magerl, M.D., presented an oral session titled “ Treatment of HAE Attacks with Deucrictibant: RAPIDe-1 Phase 2 Trial Results ” on Friday, December 8, 11:18-11:26 a.m. BST (9:18-9:26 a.m. EST).
  • Prof. Marcus Maurer, M.D., presented a poster titled “ Early-Onset Response to Treatment of Hereditary Angioedema Attacks with Deucrictibant ” on Friday, December 8, 7:00-8:00 p.m. BST (5:00-6:00 p.m. EST).
  • Primary and post-hoc analyses of the RAPIDe-1 study were conducted to evaluate end of progression (EoP) and symptom relief in response to treatment of HAE attacks with PHVS416.
  • The onset of symptom relief was achieved at approximately two hours and clinically meaningful improvement within two hours after administration of deucrictibant.

Pharvaris Announces Pricing of $300 Million Underwritten Offering of Ordinary Shares and Pre-funded Warrants

Retrieved on: 
Wednesday, December 6, 2023
Telephone, Hereditary angioedema, Sale, Attention, State Street, SVB Securities, Legal Department (Hong Kong), HAE, Morgan Stanley, General Atlantic, Security (finance)

The gross proceeds to Pharvaris from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $300 million.

Key Points: 
  • The gross proceeds to Pharvaris from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $300 million.
  • All shares and pre-funded warrants in the offering are to be sold by Pharvaris.
  • The offering is expected to close on or about December 8, 2023, subject to satisfaction of customary closing conditions.
  • The shares and pre-funded warrants are being offered by Pharvaris pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the “SEC”).