Shield Therapeutics PLC: FDA approves broad label for Feraccru
STX has clearly made very considerable strides since floating in February 2016 – it listed with a market capitalisation of £160mln at a share price of 150p. Since then it has achieved approval and out-licensed the lead product in Europe and Switzerland prior to the recent US approval. The current valuation is still mismatched in these respects particularly given the potential for ongoing US licensing discussions to lead to attractive terms.
STX has clearly made very considerable strides since floating in February 2016
We look forward to the upcoming news flow including:
- Outcomes from US commercial partner discussions for Accrufer
- Further news on commercialisation progress in partnered territories Europe, Switzerland, Central and Eastern Europe - first half (H1) business update
- Publication of peer-reviewed Feraccru data from the AEGIS H2H study
- Initiation of a paediatric study in infants over 1 month starting in H219
- News on next steps with PT20 including outcomes of ongoing re-formulation work
- News on partnering in new geographies – notably China in the next 12 months.
Shield Therapeutics is a speciality pharmaceutical company focused on the development and commercialisation of late-stage pharmaceuticals. The company's lead asset, Feraccru is an oral treatment for iron deficiency with or without anaemia. Feraccru is approved and marketed in Europe and was recently approved in the US to be marketed as Accrufer. It also has a pipeline of prescription pharmaceutical assets, the most advanced of which is PT20, a phase III-ready treatment for the electrolyte disorder, hypophosphataemia, which is extremely common in patients with chronic kidney disease.
Feraccru is approved and marketed in Europe and was recently approved in the US to be marketed as Accrufer
Unmet need in ID and IDA
Iron deficiency (ID) and iron deficiency anaemia (IDA) are caused by low levels of iron in the body. IDA is a common disorder: anaemia affects around 33% of the world’s population (source: WHO) and about half the cases are due to iron deficiency. Children and non-pregnant women are among the groups most affected. Commonly ID is the precursor to IDA so that treatment of the first signs of ID can prevent progression. Moderate to severe IDA may cause fatigue or tiredness, breathing problems or chest pain. The most common reasons for ID are insufficient iron intake in the diet, an inability to absorb iron well in the body and/or loss of iron in the blood through bleeding. Treating ID and IDA - which are common and often serious complications in people suffering from chronic heart or kidney disease, cancers or gastrointestinal diseases - can help improve patients’ symptoms and quality of life.
Quick facts: Shield Therapeutics PLC
Price: 184 GBX
Market Cap: £215.63 m
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