Broker Cavendish says additional US protection strengthens long-term outlook and reiterates buy rating.
Shares in Shield Therapeutics PLC (AIM:STX, OTCQB:SHIEF) jumped as much 11% earlier in the session after the company said US regulators had granted an additional three years of data exclusivity for its oral iron therapy Accrufer.
The AIM-listed pharmaceuticals group said the US Food and Drug Administration had extended exclusivity to December 19 2028, following a clinical investigation supporting an expanded indication to include paediatric patients aged 10 years and older.
The decision adds to existing Accrufer and Feraccru patent protection that runs into the mid-2030s, further shielding the product from generic competition in Shield’s largest market.
Cavendish said the extension represented an important regulatory milestone that validated the company’s clinical strategy and reinforced the strength of its late-stage data package.
The broker highlighted that the paediatric label expansion was underpinned by positive results from the phase III FORTIS trial, which confirmed the efficacy, safety and tolerability of the new oral liquid formulation in children with iron deficiency anaemia.
Cavendish also pointed to recent operational momentum, including the delivery of positive operating cash flow in the fourth quarter and guidance for an operating profit in 2026.
Progress in China and balance sheet simplification further strengthened the investment case, the broker said, as it reiterated its ‘buy. recommendation and 23p target price.
After its initial burst, the share price settled back to 10.14p, representing a rise of 5% on the day.
