Company
Shield Therapeutics PLC
LON:STX
Shield Therapeutics PLC is a commercial-stage specialty pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer ® /Feraccru ® (ferric maltol). The group has launched Accrufer® in the US and Feraccru ® is commercialized in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive license agreement with Beijing Aosaikang Pharmaceutical for the development and commercialization of Accrufer ® / Feraccru ® in China, Hong Kong, Macau and Taiwan, with Korea Pharma Co in the Republic of Korea, and with KYE Pharmaceuticals in Canada.
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Shield Therapeutics gets positive initiation from broker Stifel
The US investment bank set an initial 15p target price on the shares, around 150% upside to the current share price
Shield Therapeutics says lead product expected to gain Korean regulatory approval in 2023
The Korean Food and Drug Administration has agreed that a single pharmacokinetic study is the only additional requirement to support a New Drug Application submission for Accrufer
Shield Therapeutics’ lead product Accrufer has shelf-life extended to 48 months
FDA approval provides additional supply-chain flexibility for pharmaceutical company’s lead product
Peel Hunt thinks the commercial prospects for Shield Therapeutics' Accrufer anaemia treatment remain "very good"
The Peel Hunt analysts noted that Shield's first half 2022 revenues were £2.0mln with prescriptions for Accrufer up 350% from a year earlier
Shield Therapeutics sees revenues climb as US sales ramp up
The average net selling price for its anaemia treatment Accrufer rose by 350% to US$152
Shield Therapeutics PLC jumps as AOP confirms stake
Austria-based AOP, which specialises in treatments for relatively rare or orphan treatments, lent Shield US$10mln in June
Shield Therapeutics completes the formalities on US$10mln loan
AOP Health International Management has provided the facility
Shield Therapeutics partner makes new drug submission in Canada
The regulator is expected to complete its review by the middle of next year
Shield Therapeutics off to a solid start in 2022 as Acrrufer prescriptions rise sharply
"Based on all our collective insights, we are even more confident today about Accrufer becoming the oral iron of choice," said Greg Madison, the chief executive officer of Shield Therapeutics.
Shield Therapeutics partner submits iron deficiency drug for approval in Canada
Marketing approval for Shield-developed Accrufer is expected in the first half of next year
Shield Therapeutics on track; says gains traction in the US
America is the key thrust for the group as it looks to roll out its ferric maltol product
Shield Therapeutics signs Canada licence agreement for Accrufer with KYE Pharmaceuticals
Shield will receive up to £1mln in upfront, development and sales milestones
Shield Therapeutics says 40mln patients in US have access to iron deficiency treatment
Accrufer placed on formulary 1, a continually updated list of prescription drugs approved for reimbursement in the US
Shield Therapeutics building a solid brand base says new Proactive research
In Europe, the drug is branded as Ferracru and marketed by partner Norgine
Shield Therapeutics names Jose A. Menoyo as chief medical officer
Dr. Menoyo's expertise in establishing and executing medical affairs strategies "will be extremely valuable to Shield for the launch of Accrufer in the US,” said CEO Greg Madison
Shield Therapeutics pleased with progress to date on US launch of Accrufer
During the first quarter, the group changed tack in the US, shifting away from its out-licensing model to launch Accrufer off its own bat in the US
Shield Therapeutics surges as it inks licence agreement for Accrufer in South Korea
Under the deal with Korea Pharma Co Ltd, the company said it will receive an upfront payment of £0.5mln as well as £1.5mln upon first commercial sale and up to £4mln in milestone payments
Shield Therapeutics flags up academic article showcasing positive results from phase III trial
Investigators assessed the potential of Feraccru (known as Accrufer in the US, and also called ferric maltol)
Shield Therapeutics to launch Accrufer in US next week
The iron deficiency product will be available to doctors and other prescribers in all parts of the US
Shield Therapeutics appoints CEO with 'deep knowledge' of the iron deficiency market
Greg Madison will take over on June 1 from Tim Watts, who will remain as an executive director until September 30
Shield Therapeutics doing its homework ahead of launch next month of Accrufer in the US
Preparatory work on the launch has accelerated dramatically in the last couple of months
Shield Therapeutics says study demonstrates long-term effectiveness of ferric maltol
The company’s focus is on addressing iron deficiency with its lead product Feraccru/Accrufer (ferric maltol)
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Shield Therapeutics opens the doors to US investors with OTCQX Best Market listing
Chief executive Tim Watts said: "With the upcoming launch of Accrufer in the US I believe that Shield will be of increasing relevance to US-based investors"
Shield Therapeutics appoints two new non-execs
They are Fabiana Lacerca-Allen and Anders Lundstrom
Shield Therapeutics looks forward to US launch of Accrufer after transformational year
Increasing sales in the US are estimated to turn the monthly cash flow positive between 15-18 months after launch
Shield Therapeutics welcomes real-world data that points lead drug's potential in inflammatory bowel disease
Ferric maltol was used in patients with both IBD and iron-deficiency anaemia
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Shield Therapeutics names new chief financial officer
Hans-Peter Rudolf is a Swiss national with extensive international experience, particularly in the US.
Shield Therapeutics fundraise totals £29.2mln as open offer oversubscribed
“We will be continuing to develop our launch plans for Accrufer in the United States"
Shield Therapeutics PLC takes bold approach in the US
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Shield Therapeutics receives Australian regulatory green light for iron deficiency drug
The product has already been approved in the UK, European Union, Switzerland and the United States
Shield Therapeutics raises £25mln for US launch of Accrufer
Sales might exceed US$100mln from the third year according to forecasts
Shield Therapeutics receives additional support from shareholder loans
The pharmaceuticals firm said AOP Orphan International AG and board member Christian Schweiger have stated that they would be prepared to collectively lend the group up to £4.4mln
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Shield Therapeutics CEO hails positive year as European sales grow 70%
“We aim to give clarity on the US by the end of March and I am sure that 2021 will be a transformational year for Shield," said Tim Watts
Shield Therapeutics updates on commercialisation efforts for Accrufer in the US
The company said it has received numerous indicative proposals from potential commercialisation partners, adding that COVID-19 has accentuated Accrufer as an iron deficiency treatment
Shield Therapeutics says TEVA has withdrawn patent challenge
Shield’s general counsel, Lucy Huntington-Bailey, said: "We are delighted that the European Patent Office has decided not to continue proceedings following the withdrawal of the opposition by TEVA and saw no reason to amend the patent as or
Shield Therapeutics confident of securing a US deal this year as profits return
The profit followed an US$11.4mln upfront payment from ASK Pharm, the group's partner in China
Shield Therapeutics strongly supported for commercialisation, pricing of Feraccru after new data, says analyst
A licensing deal in the US, where it would be called Accrufer, can start to unlock the world’s largest iron replacement market
Shield Therapeutics supported in negotiations with prospective US partners by new findings, says Peel Hunt
Analysts say completing the negotiations represents significant further upside potential for the company
Shield Therapeutics soars as reanalysis of Feraccru study finds positive results
"We are very pleased that the reanalysis of the AEGIS-H2H study data demonstrates that Feraccru/Accrufer is a credible alternative to IV therapy and offers economic advantages,” said Tim Watts.
Shield Therapeutics to take kidney disease treatment forward to phase III study
Hyperphosphatemia is a condition where due to renal failure there is too much phosphorus present in the blood
Shield Therapeutics brings co-founder Christian Schweiger back onto the board
The iron deficiency specialist said he has "substantial experience working with both large and small pharmaceutical companies"
Shield Therapeutics notes publications concerning Feraccru/Accrufer product
One study concluded that ferric maltol, a component of Feraccru/Accrufer, was “well tolerated” by patients suffering from pulmonary hypertension and resulted in “significant improvements in iron status and haemoglobin levels"
Shield Therapeutics announces appointment of Hans Peter Hasler as its non-executive chairman from June 18
The group announced on May 21 that its current chairman, James Karis would not seek re-election and would be stepping down at the AGM
Shield Therapeutics CEO says finding a US partner for lead drug is "top priority" for 2020
Tim Watts' comment was made alongside the company’s 2019 results, which charted a period of significant progress
Shield Therapeutics says plenty of interest from potential US partners for iron deficiency treatment
Sales of Feraccru in Germany and the UK rose during the first quarter of 2020 according to European partner Norgine