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Noticias de BCRX
Eventos de BCRX
BioCryst Receives FDA Approval for Orladeyo Oral Pellet
BioCryst announced the FDA has approved its supplemental new drug application, or sNDA, for use of the oral pellet formulation of once-daily Orladeyo for prophylactic therapy in adults and adolescents aged 12 years and older. The new 150 mg Orladeyo pellet formulation provides an alternative administration option for adults and adolescents who may have difficulty swallowing, prefer not to take a capsule or choose to remain on a pellet formulation beyond age 12. With this approval, prescribers can now provide their adult and adolescent patients with the option to take once-daily, orally administered Orladeyo for prophylaxis to prevent attacks of HAE in either capsule or pellet formulation. The Orladeyo pellet formulation is sprinkle-like in appearance and size and can be poured directly into the mouth and swallowed immediately with water or milk, or sprinkled over a spoonful of soft, non-acidic food.
BioCryst Receives Japan Approval for Orladeyo in Pediatric Patients
BioCryst announced that Japan's Ministry of Health, Labor and Welfare has granted marketing approval for once-daily Orladeyo for prophylactic therapy in pediatric patients with hereditary angioedema aged 2 to less than 12 years.
BioCryst Appoints David Jenkins as Chief Scientific Officer
BioCryst (BCRX) announced the appointment of David Jenkins to the newly created position of chief scientific officer, effective immediately, reporting to Sandeep Menon, chief research and development Officer. In this role, Jenkins will build and lead a research team focused on leveraging external innovation, capabilities and partnerships to accelerate the delivery of rare disease therapies to patients. He will be based in the company's Boston office. He most recently served as senior VP, head of research and external innovation at Ipsen (IPSEY).
Wedbush: Vertex Acquires Crinetics for $85/Share
Wedbush notes that Vertex Pharmaceuticals (VRTX) agreed to acquire Crinetics Pharmaceuticals (CRNX) for $85/share in cash. Crinetics now trades essentially at the deal price, reflecting high confidence in closing. For Vertex, the firm views this as a sound, if modestly dilutive near-term, strategic deal. Wedbush would expect Vertex's underperformance to be temporary as the deal reinforces the durability of its M&A-driven pipeline diversification strategy following recent moves in kidney disease and other rare-disease areas. The firm tells investors to watch other commercial-stage rare/endocrine-disease names such as BioCryst Pharmaceuticals (BCRX) and Ascendis Pharma (ASND) as potential next targets, given the rich premium paid here.
BioCryst Announces Closure of Internal Discovery Programs by End of 2026
BioCryst announced that it will discontinue its internal discovery programs and close its Discovery Center of Excellence facility in Birmingham, Alabama by the end of 2026. Following a strategic review and scientific diligence of its research capabilities, programs and priorities, BioCryst said that prioritizing external innovation will be the most nimble and capital efficient path to building a sustainable rare disease pipeline beyond its current clinical stage programs. As a part of this strategic shift, the company will discontinue its internal discovery programs and focus on identifying and advancing opportunities.
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