Japan Approves ORLADEYO for Pediatric HAE, Expanding Market
BCRX sits 61% above its 52-week low of $6.
Summary
Japan's MHLW approved ORLADEYO for prophylactic treatment of HAE in children aged 2 to <12 years, making it the first oral option for this age group in Japan. The approval is based on positive interim APeX-P trial data showing reduced attack rates and a consistent safety profile. Launch will follow NHI reimbursement pricing, with OrphanPacific as the marketing partner. This expands ORLADEYO's addressable market in Japan, where the capsule form is already approved for ages 12 and older. The company has also filed for pediatric approval in Europe and Canada.
At the time of this announcement, BCRX was trading at $9.65 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.5B. The 52-week trading range was $6.00 to $11.22. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.