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So far Steen Bjerre has created 185 blog entries.

Additional investment in global launch of Orladeyo (berotralstat)

2021-11-23T14:18:38+01:00November 23, 2021|HAEi News|

BioCryst Pharmaceuticals, Inc. announces transactions totaling 350 million USD in new funding, among other things supporting additional investment in the global launch of Orladeyo (berotralstat), which is on a trajectory to become the market-leading prophylactic HAE therapy. “The focused execution of our plan this year, with the successful launch of Orladeyo, has led to further [...]

Ionis initiates Phase 3 clinical program

2021-11-19T18:15:51+01:00November 19, 2021|HAEi News|

Ionis Pharmaceuticals, Inc. initiates OASIS-HAE, the registrational study in the donidalorsen (formerly IONIS-PKK-LRx) Phase 3 clinical program. Donidalorsen is an investigational antisense medicine designed to reduce the production of prekallikrein, which plays a key role in the activation of inflammatory mediators associated with acute attacks of HAE. Donidalorsen uses Ionis' LIgand-Conjugated Antisense, or LICA, technology. "Initiating [...]

Pharvaris continues to execute on clinical development strategy

2021-11-11T22:00:25+01:00November 11, 2021|HAEi News|

Reporting the financial results for the third quarter ended 30 September 2021, Pharvaris co-founder and CEO Berndt Modig says: “This quarter we continued to execute on our robust clinical development strategy as we seek to advance novel treatments for HAE patients that offer efficacy without compromising on convenience. We continue enrolling patients in RAPIDe-1, our Phase [...]

STAR-0215 has potential to be most patient-friendly preventative treatment option

2021-11-11T09:13:21+01:00November 11, 2021|HAEi News|

At the 2021 American College of Allergy, Asthma and Immunology Annual Scientific Meeting, Astria Therapeutics, Inc. presents new preclinical data including demonstration of the high potency of STAR-0215 to bind to and inhibit plasma kallikrein on a site different than lanadelumab and introduction of YTE technology to extend half-life. “These preclinical data support the potential of [...]

KalVista development team finalizes Phase 3 trial protocol

2021-11-10T19:29:27+01:00November 10, 2021|HAEi News|

KalVista Pharmaceuticals, Inc. provides an update on the clinical trial progress for KVD900 in development for oral on-demand treatment of HAE. “We had a productive End-of-Phase 2 meeting with the FDA and recently received meeting minutes which confirmed that our Phase 3 trial design, similar to our recent successful Phase 2 trial, is expected to be [...]

Positive results from Phase 2 study of investigational antisense medicine

2021-11-10T10:26:36+01:00November 10, 2021|HAEi News|

At the American College of Asthma, Allergy & Immunology (ACAAI) Annual Scientific Meeting, Ionis Pharmaceuticals, Inc. presents positive results from the Phase 2 study of its investigational antisense medicine, donidalorsen (formerly IONIS-PKK-LRx). The Phase 2 study results support the clinical profile of donidalorsen as a potential, best-in-class prophylactic treatment for patients with HAE, and underscore Ionis' [...]

Oral on-demand treatment demonstrates early therapeutic effect

2021-11-10T10:18:37+01:00November 8, 2021|HAEi News|

At the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, KalVista Pharmaceuticals, Inc. presents data on Phase 2 for KVD900, KalVista’s lead program for oral on-demand treatment of HAE attacks. “Current guidelines recommend effective on-demand therapy for every patient with HAE to reduce symptom severity and attack duration,” says Jonathan Bernstein, FAAAAI, FACAAI, FACP, [...]

BioCryst presents new long-term efficacy and safety data

2021-11-05T13:29:55+01:00November 5, 2021|HAEi News|

At the 2021 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), BioCryst Pharmaceuticals, Inc. presents new long-term efficacy and safety data from studies evaluating oral, once-daily Orladeyo (berotralstat) for the prophylactic treatment of HAE. “We continue to see improvement in key indicators that demonstrate the value of oral, once-daily Orladeyo as an [...]

Ionis anticipate phase 3 study before year-end

2021-11-05T13:16:26+01:00November 5, 2021|HAEi News|

From the Ionis Pharmaceuticals, Inc. financial results for the three and nine months ended 30 September 2021: "We are looking forward to multiple near-term catalysts, beginning with the presentation of donidalorsen Phase 2 data in patients with HAE this month. We anticipate initiating the donidalorsen Phase 3 study before year-end", says Brett P. Monia, Ph.D., [...]

BioCryst sees strong, consistent demand from new patients

2021-11-03T12:31:30+01:00November 3, 2021|HAEi News|

Announcing the financial results for the third quarter ended 30 September 2021, BioCryst Pharmaceuticals, Inc. President and CEO Jon Stonehouse says: “With the significant revenue we expect to generate with Orladeyo - our oral, once-daily treatment for prevention of HAE attacks - in its first year of launch, BioCryst plans to repeat our clinical and commercial success with [...]

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