EMA grants PRIME designation for BioCryst's ALK-2 inhibitor, BCX9250

The European Medicines Agency (EMA) has granted access to the Priority Medicines (PRIME) scheme for BCX9250, a novel, oral activin receptor-like kinase-2 (ALK-2) inhibitor discovered and developed by BioCryst Pharmaceuticals (Nasdaq: BCRX) for the treatment of fibrodysplasia ossificans progressiva (FOP).

The news was a welcome development and pushed the US biotech firm’s up 5.7% to $19.03 by mid-morning trading. Earlier this month BioCryst lost more than 30% of its value when it announced that had paused enrollment in clinical trials with BCX9930 while the company investigates elevated serum creatinine levels seen in some patients.

PRIME is a program launched by the EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early dialogue with developers of promising medicines and is designed to optimize development plans and speed up evaluation so these medicines can potentially reach patients earlier. According to the EMA, developers of medicines that are eligible for PRIME can expect additional opportunities for scientific advice and be eligible for accelerated assessment at the time of application for a marketing authorization.