US FDA to Review Shield Therapeutics’ Ferracru New Drug Application
Abraham Darwyne
Company News
14:52, 3rd December 2018

Shield Therapeutics (STX) FOLLOW announced today that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Feraccru®, Shield's lead product.

Feraccru® is already approved in the EU for iron deficiency treatment in adults and in Switzerland for iron deficiency in adults with inflammatory bowel disease, the company said. 

Carl Sterritt, CEO of Shield Therapeutics, added: "News that the NDA has been validated and accepted for review by the FDA brings us a major step closer to Feraccru potentially being approved in the USA in 2019.”

The US represents over a third of the global pharmaceutical market. Shield retains full ownership of Feraccru® in US markets, as well as complete control of the global intellectual property rights.

The company said the FDA will shortly confirm the expected target date in 2019 for completion of the NDA review and STX will provide a further update at that time.

Shares in STX were trading at 33.5p each on the day of the announcement

Follow News & Updates from Shield Therapeutics here: FOLLOW

vox markets

Recent Articles
  • Cobra Resources IPO Insights
    13th Dec 2018

    As part of the listing, the company raised £523,500 before expenses through a share placing. It has also issued warrants that if they were all exercised would raise a further £1.3 million.

  • Hummingbird Resources (HUM) Europa Metals (EUZ) Block Energy (BLOE) and Chris Bailey on (SDRY) (BON) (TCG) (PZC)
    13th Dec 2018

    On today's podcast: Hummingbird Resources discuss 2019 guidance and its drill results from the 2018 exploration campaign. Europa Metals talks about their Scoping Study. Block Energy discusses the advanced technology they have secured for their multi-well programme in Georgia. Chris Bailey covers: Superdry, Bonmarche, Thomas Cook Group, Tui Group & PZ Cussons.

  • See Today's AIM Risers Featuring Thor Mining Upgrading its Mineral Resource
    Abraham Darwyne
    AIM Risers
    13th Dec 2018

    See Today's AIM Risers Featuring Thor Mining Upgrading its Mineral Resource.

  • SP Angel . Morning View . Metals rise as tariff trade tensions ease
    13th Dec 2018

    SP Angel morning look at commodities featuring: Bacanora Lithium (BCN LN) – Blackrock cuts stake Erris Resources (ERIS LN) – Exploration update Hummingbird Resources (HUM LN) – Progress report on exploration drilling Savannah Resources (SAV LN) – High-quality saleable by-product from Mino do Barroso lithium project Thor Mining (THR LN) – Mineral resource update at Pilot Mountain

  • Hummingbird Resources Releases High-Grade Gold Mine Drill Results
    13th Dec 2018

    Hummingbird Resources, an African gold producer, released the second set of drill results from their exploration campaign in Mali. The company aims to transform its resources into reserves and eventually extend the life of their Yanfolila Gold Mine.

  • US FDA Confirms Target Date For Completion Of Feraccru Review
    Abraham Darwyne
    Company News - 2 min read
    13th Dec 2018

    Shield Therapeutics (STX) announced today that the US Food and Drug Administration has confirmed that the target date for completion of the New Drug Application review of Feraccru is 27 July 2019, under the terms of the Prescription Drug User Fee Act.

  • Morning Financial Press Round-Up
    13th Dec 2018

    Sainsbury’s hit by Asda deal doubts, Dixons £460m loss fuels fears of High St bloodbath but new boss insists turnaround plan is still on track

  • 5 Things You Need To Know, Today, on Thursday 13th December 2018
    13th Dec 2018

    Five financial stories, trending today in a 70 second podcast, including: Theresa May is heading to Brussels for an EU summit, less than 24 hours after surviving a vote of confidence. The prime minister is seeking legally binding pledges from EU leaders on the Irish backstop - a key obstacle for MPs who oppose her Brexit deal.

  • IPO Insights with Golden Saint Technologies
    12th Dec 2018

    GST is an innovative global technology and investment company. Its main business is its profitable, 28-year old, Singapore - based subsidiary - EMS Wiring - that provides integrated Information and Communication Technology (ICT) solutions worldwide.

  • Tekcapital (TEK), Reabold Resources (RBD) and Mining Analyst John Meyer
    12th Dec 2018

    On today's podcast: Dr. Clifford Gross, Chairman at Tekcapital give an update on their portfolio companies. Sachin Oza, Co-Chief Executive Officer of Reabold Resources provides an update on their operations. John Meyer covers BHP Billiton Rio Tinto, Anglo-American Mining, Mkango Resources, Anglo-Asian Mining & Bluejay Mining.