News

HAE therapy ADX-324 hits Phase 3 milestone with first treatment

The first adult participant with hereditary angioedema (HAE) has been dosed in STOP-HAE, a Phase 3 clinical trial evaluating the efficacy of ADARx Pharmaceuticals’ investigational therapy ADX-324. Designed as a long-acting preventive treatment, ADX-324 aims to reduce the frequency of swelling attacks while requiring fewer injections. The…

Access to preventive treatment for HAE attacks limited: Brazil study

Many patients in Brazil lack access to first-line treatments such as Takhzyro (lanadelumab) to prevent swelling attacks in hereditary angioedema (HAE), a study found. “Despite recent advances, access to first-line therapies for long-term prophylaxis of HAE attacks remains limited,” the researchers wrote. These limitations “may likely be encountered in…

Biocryst to acquire Astria, getting experimental navenibart for HAE

Biocryst Pharmaceuticals is preparing to acquire Astria Therapeutics, and with it navenibart, a still-experimental, long-acting prophylactic (preventive) treatment that could improve care for people with hereditary angioedema (HAE) by reducing how often patients need injections. Navenibart is now in Phase 3 clinical testing, after earlier data…

Ekterly eases most HAE attacks within 20 minutes, trial data show

For most people with hereditary angioedema (HAE) given on-demand treatment in clinical trials with the now-approved therapy Ekterly (sebetralstat), swelling attacks stopped getting worse within 20 minutes of the oral medication being administered. That’s according to new data that Kalvista Pharmaceuticals, Ekterly’s developer, shared earlier this month…

Phase 3 trial tests navenibart across 10 EU nations

Patient enrollment has started at sites in the European Union for a global Phase 3 clinical trial evaluating the safety and efficacy of navenibart, an antibody-based therapy designed to prevent swelling attacks in people with hereditary angioedema (HAE). Dubbed ALPHA-ORBIT trial (NCT06842823), the pivotal trial is testing the…

Biocryst sells European rights to HAE therapy Orladeyo for $250M

Biocryst Pharmaceuticals has sold the European rights to Orladeyo (berotralstat), its approved oral therapy for preventing swelling attacks in people with hereditary angioedema (HAE), to the Italian pharmaceutical company Neopharmed Gentili. Under the terms of the deal, according to a Biocryst press release, the company “will…

Acquired angioedema may be first sign of underlying lymphoma

Acquired angioedema was the first sign of an underlying extranodal marginal zone lymphoma (EMZL) — a type of non-Hodgkin lymphoma — in a 45-year-old woman, according to a case study. After a comprehensive evaluation involving cancer and immunology specialists, she received treatment with rituximab. The therapy resolved her…