–ORLADEYO now first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older–-Oral pellet formulation provides child-friendly method of administration- –Showed early and sustained reductions in monthly attack rates in APeX-P– RESEARCH TRIANGLE PARK, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation ...

Pharvaris is developing oral treatments for hereditary angioedema (HAE), leveraging its bradykinin B2 antagonist franchise.Morgan Stanley set a price target of $41 for PHVS, indicating a potential increase of approximately 39.62%.The company's strong phase 2 results and high probability of phase 3 success have led to a buy rating and a target price of $40.Pharvaris (NASDAQ:PHVS) is a biopharmaceutical company focused on developing oral treatments for hereditary angioedema (HAE). The company is gaining atten ...

Core Viewpoint - BioCryst Pharmaceuticals has received approval from INVIMA in Colombia for ORLADEYO (berotralstat) as a prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 and older, marking a significant advancement in treatment options for HAE in the pan-Latin America region [1][2]. Group 1: Product Information - ORLADEYO is the first and only oral therapy specifically designed to prevent HAE attacks in adults and pediatric patients aged 12 years and older, administered as one capsule daily [4]. - The drug functions by inhibiting plasma kallikrein, which is involved in the pathophysiology of HAE [4]. - ORLADEYO has already received regulatory approvals in several Latin American countries, including Chile, Argentina, Brazil, Mexico, and Peru [3]. Group 2: Commercial Strategy - BioCryst has an exclusive collaboration with Pint Pharma GmbH for the registration and promotion of ORLADEYO in the pan-Latin America region, with Pint responsible for obtaining marketing authorizations and commercialization [3]. - Following the approval from INVIMA, BioCryst is working with Pint Pharma to ensure the availability of ORLADEYO to patients in Colombia [2]. Group 3: Safety and Usage Information - ORLADEYO is indicated for the prophylaxis of HAE attacks but is not approved for the treatment of acute HAE attacks [5][6]. - The recommended dosage is 150 mg once daily, with a reduced dosage of 110 mg for patients with moderate or severe hepatic impairment [7]. - Common adverse reactions include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease, occurring in 10% or more of patients [7].