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Shield Therapeutics Wins FDA Nod to Extend ACCRUFeR Use to Adolescents

Story Highlights
  • Shield Therapeutics gained FDA approval to extend ACCRUFeR’s indication to patients aged ten and older.
  • The company plans a further filing for infants and a liquid form, broadening ACCRUFeR’s market reach.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Shield Therapeutics Wins FDA Nod to Extend ACCRUFeR Use to Adolescents

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Shield Therapeutics ( (GB:STX) ) has provided an update.

Shield Therapeutics has secured U.S. Food and Drug Administration approval to extend the indication for its oral iron therapy ACCRUFeR (ferric maltol) to include pediatric patients aged 10 years and older, following a priority review supported by positive Phase 3 pediatric trial data. The company plans to seek a further indication expansion to cover children from 1 month of age using a new ferric maltol suspension formulation, which could also benefit adults unable to swallow capsules, strengthening ACCRUFeR’s clinical reach and reinforcing Shield’s position in the growing iron deficiency market.

The most recent analyst rating on (GB:STX) stock is a Hold with a £12.00 price target. To see the full list of analyst forecasts on Shield Therapeutics stock, see the GB:STX Stock Forecast page.

Spark’s Take on GB:STX Stock

According to Spark, TipRanks’ AI Analyst, GB:STX is a Neutral.

The overall stock score is primarily influenced by the company’s robust technical momentum and positive corporate events, which are offset by significant financial challenges and valuation concerns. The strong technical indicators and strategic corporate developments provide optimism, but financial instability remains a critical risk.

To see Spark’s full report on GB:STX stock, click here.

More about Shield Therapeutics

Shield Therapeutics plc is a commercial-stage specialty pharmaceutical company focused on treating iron deficiency and iron deficiency anemia through its innovative oral iron therapy ACCRUFeR/FeRACCRU (ferric maltol). The company has launched ACCRUFeR in the U.S. via an exclusive collaboration with Viatris and has licensed commercialization rights to partners across Europe, Canada, Asia-Pacific and selected Asian markets, targeting a U.S. iron deficiency market estimated at about 20 million patients and $2.3 billion. ACCRUFeR/FeRACCRU, protected by patents until the mid-2030s, is currently the leading branded prescription oral iron in the U.S. market.

Average Trading Volume: 3,151,079

Technical Sentiment Signal: Hold

Current Market Cap: £119.5M

See more data about STX stock on TipRanks’ Stock Analysis page.

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