Shield Therapeutics PLC - Newcastle, England-based commercial-stage pharmaceutical company - Says the US Food & Drug Administration grants an additional three years of data exclusivity for Accrufer. The exclusivity remains in place until December 19, 2028, in addition to the Accrufer/Feraccru patent coverage valid until the mid-2030s.
"This exclusivity is a significant milestone for Shield and recognises the value of the essential clinical investigation conducted to support the pediatric indication, reflecting the strength of the phase three Fortis trial. We are well positioned to continue expanding access to Accrufer and addressing unmet needs in both adult and pediatric populations," says Jackie Mitchell, vice president of Regulatory, Quality, Clinical and Regulatory Affairs at Shield.
Current stock price: 9.75 pence, up 1.6% on Monday morning in London
12-month change: more than doubled from 3.50p
By Michael Hennessey, Alliance News reporter
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