Specialist pharmaceutical maker Shield Therapeutics (STX) delivered investors more good news with the potential approval of ACCRUFeR in China. The firm’s local partner ASK has filed for marketing authorisation and expects approval this quarter.
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APPROVAL THIS QUARTER
ACCRUFeR is an oral therapy for adults and children over 10 with clinically low iron levels. The condition can cause serious health problems for adults of all ages across multiple therapeutic areas.
ASK, aka Beijing Aosaikang Pharmaceutical Co, plans to include positive data from Shield’s Phase 3 clinical pediatric trial with the application. The same data was used to receive US FDA approval to extend ACCRUFeR’s indication to include children 10 and older.
Around 20 million people in the US suffer from iron deficiency and associated anemia, making it a $2.3 billion market annually. ACCRUFeR is the first and only FDA approved oral treatment and is the number one prescription.
As well as paying Shield a development milestone of $7.9 million, ASK will pay up to $3 million linked to the drug’s final price in China. It will also pay royalties of up to 10% on annual net sales of the treatment.
This is the third piece of good news from AIM-listed Shield in the last couple of months. In December, it announced ACCRUFeR had won the US extension to children 10 years and older.
Last week, Shield posted its Q4 trading update showing positive free cash flow and annual sales of $50 million. ACCRUFeR accounted for $46 million, with growth of 56% thanks to growth in pricing and prescriptions.
‘Reaching cash flow positivity is a significant milestone in the company’s history,’ said CEO Anders Lundstrom. The CEO also said Shield expected to post a positive operating profit for the first time in FY26.
Read the press release here: https://shieldtherapeutics.com/investor-overview
Read related news here: https://sharesify.com/shield-therapeutics-wins-us-extension/
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