Shield Therapeutics plc (LSE:STX) announced that its partner MEDLEAP Pharma has enrolled the first patient in a Phase II clinical trial in Japan assessing ACCRUFeR (ferric maltol) for the treatment of pulmonary arterial hypertension (PAH). The exploratory study has been supported by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and builds on previous clinical work conducted in Europe, the UK, and the United States, with the aim of progressing toward a Phase III programme.
The trial marks an expansion of ferric maltol beyond its established use in iron deficiency into the Japanese PAH market, estimated at over US$230 million. Iron supplementation is already widely recommended for eligible PAH patients, and successful clinical development could extend Shield’s therapeutic reach, deepen its collaboration with MEDLEAP, and create a new commercial opportunity in a specialised cardiovascular segment.
The company’s outlook remains constrained by weak financial fundamentals, including continued losses, negative operating and free cash flow, and a negative equity position. However, improving revenue trends and margins, along with moderately positive share price momentum, offer some support. Valuation remains challenged due to the absence of profitability and dividend income.
More about Shield Therapeutics
Shield Therapeutics is a commercial-stage pharmaceutical company specialising in treatments for iron deficiency, with or without anaemia. Its lead product, ACCRUFeR (also marketed as FeRACCRU), is an oral iron therapy approved in the United States and commercialised across Europe, Canada, and other regions through partnerships. The product is protected by patents extending into the mid-2030s and targets a global market for iron deficiency and anaemia estimated at around US$2.3 billion.
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