GlaxoSmithKline shares decreased 0.6% to 1,761.8p in early morning trading on Tuesday, after the company announced its accepted Food and Drug Administration (FDA) application for its chronic kidney disease anaemia treatment daprodustat.
The application was reportedly accepted following GlaxoSmithKline’s ASCEND phase three programme, which consisted of five trials which successfully met their primary efficacy and safety endpoints in both non-dialysis and dialysis patients.
The trials covered 8,000 patients over 4.2 years, with the results presented at the American Society of Nephrology’s Kidney Week last year.
The pharmaceutical giant commented that the drug was developed to provide patients with a convenient oral treatment for chronic kidney disease-linked anaemia complications.
The treatment was based on Nobel Prize-winning scientific breakthroughs, which demonstrated how cells sense and adapt to the availability of oxygen in the human body.
The move marks the third regulatory step in the treatment’s advancement after it achieved marketing authorisation approval from the European Medicines Agency (EMA) and secured regulatory submission acceptance and approval in Japan under the label Duvroq for renal anaemia.
AstraZeneca and Daiichi Sankyo announced that in the United States, Enhertu was granted Priority Review for patients with HER2-mutant metastatic non-small cell lung cancer who had previously been treated.
The supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the United States with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received prior systemic therapy has been accepted, according to AstraZeneca and Daiichi Sankyo. Priority Review has also been given to the application.
Priority Review is granted by the Food and Drug Administration (FDA) to applications for medicines that, if approved, would provide significant benefits over existing options by demonstrating improved safety or efficacy, averting serious conditions, or improving patient compliance.
The FDA action date for their regulatory decision under the Prescription Drug User Fee Act (PDUFA) is in the third quarter of 2022.
The FDA approved Enhertu Breakthrough Therapy Designation in this cancer type in May 2020, prompting the Priority Review for AstraZeneca.
Lung cancer is the second most frequent disease worldwide, with over two million new cases expected to be diagnosed by 2020.
Patients with metastatic NSCLC have a particularly bad prognosis, with just about 8% living longer than five years following diagnosis.
There are presently no HER2-directed treatments licenced particularly for the treatment of HER2-mutant NSCLC4, which affects 2%-4% of non-squamous NSCLC patients.
Supplemental Biologics License Application
The sBLA is supported by the Phase I trial published in Cancer Discovery and is based on results from the registrational DESTINY-Lung01 Phase II trial published in The New England Journal of Medicine.
As assessed by independent central review, primary results from previously-treated patients with HER2-mutations of DESTINY-Lung01 revealed a confirmed objective response rate of 54.9% in patients treated with Enhertu (6.4mg/kg).
A total of one (1.1%) complete response and 49 (53.8%) partial replies were found.
A proven disease control rate of 92.3% was recorded, with most patients experiencing a reduction in tumour size.
AstraZeneca’s Enhertu’s median duration of response was 9.3 months after a median follow-up of 13.1 months.
The median progression-free survival was 8.2 months, with a 17.8-month median overall survival.
AstraZeneca’s Enhertu is currently being evaluated in a large clinical trial that will look at its efficacy and safety in a variety of HER2-targetable malignancies, including breast, gastric, lung, and colorectal cancers.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, commented, ” The DESTINY-Lung01 trial confirmed the HER2 mutation as an actionable biomarker in non-small cell lung cancer.”
“If approved, Enhertu has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic non-small cell lung cancer who currently have no targeted treatment options.”
“The results of DESTINY-Lung01 showed that Enhertu is the first HER2-directed therapy to demonstrate a strong and robust tumour response in more than half of patients with previously treated HER2-mutant metastatic non-small cell lung cancer,” added Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
“Seeking approval in the US for a third tumour type in three years further demonstrates the significant potential of Enhertu in treating multiple HER2-targetable cancers.”
AstraZeneca shares dropped 0.1% to 10,526p on Tuesday despite announcing the Priority Review for Enhertu.
The education publisher, Pearson announced on Tuesday that the company’s Online Program Management (OPM) partnership with Arizona State University (ASU) will come to an end in June 2023. The group reiterated the existing financial guidance remains unaltered.
The groundbreaking partnership between Pearson and ASU has helped the university improve and extend its online learning offerings and resources over the last ten years.
Pearson and ASU have a shared goal of making a positive difference in the lives of students, and their very successful cooperation has aided tens of thousands of students in realising their full potential through a college education.
The contract termination will have a minor earnings impact in 2022 and 2023, however, this will be mitigated by cutting related costs and re-directing investment to Pearson’s strategic development opportunities in the following years.
The group’s financial forecast for 2022 which was provided in its preliminary results in February this year remains unchanged, as does the medium-term group level guidance.
As Pearson spends to drive growth, they estimate group revenue to grow at a mid-single-digit CAGR from 2022 to 2025, and group margins to stay relatively steady in the near term, improving to the mid-teens by 2025.
Contracted revenues may seem a good thing, but they are not necessarily secured. That is especially true of pharma services companies. Medical imaging technology provider IXICO (LON: IXI) found this out when phase III clinical trial for a Huntington’s disease drug was suspended.
The client has subsequently confirmed that it is closing its open label extension study in May. That will reduce expected revenues by £300,000 in the year to September 2022 and it was expected to generate revenues for three more years. Total revenues are forecast to fall from £9.2m to £8.7m. Profit was going to be lowe...
Dotdigital (LON: DOTD) is a company that has fallen foul of investors after enjoying a heady rating. The market is unforgiving, and a large share price fall has happened to many highly rated companies that have disappointed. The email and digital marketing services provider is still growing but the rate of growth is slowing. Longer-term prospects for international growth are still good.
The recent results from Dotdigital led to a forecast downgrade but it was relatively modest when compared with the share price slump, which has been 54.8% since the beginning of 2022. The share price is current...
Growth companies will always run into problems, and some may not recover their momentum. For others it is a short-term blip. Musical instruments retailer Gear4Music (LON: G4M) has disappointed the market in the past year. Management is sorting out the online retailer’s problems and diversification into new markets will enable additional long-term growth.
Gear4Music has a strong market position in the UK and Europe and it has successfully built up its market share.
A particularly strong performance for sales during the year to March 2021 has exacerbated the slump in profit in 2021-22. Pre-tax p...
The UK Investor Magazine was delighted to welcome Adam Davidson, the CEO of Trident Royalties, to the Podcast for a deep dive into rising metals prices and mining royalties.
Trident Royalties is a London-listed mining royalties company with a portfolio consisting of over 20 royalties spanning a range of metals including gold, lithium and iron ore.
Having raised £16 million at 20p through its listing on London’s AIM, Trident Royalties shares are now trading at a whisker under 50p.
Adam describes in detail what a mining royalty is, and how mining royalties are driving value creation for Trident Royalties shareholders. There is particular attention paid to benefits of investing in a mining royalty company compared to a junior miner engaged in exploration and production operations.
Indeed, Adam says investors could view mining royalty companies such as Trident Royalties as an option to fill the gap between junior explorers and the world’s largest diversified miners.
Blackbird (LON: BIRD) has been quoted on AIM for more than two decades, having floated as Forbidden Technologies in 1999. That was still the early days of development of the real-time video editing technology, and it is much more sophisticated and has moved to being cloud-based following the investment that has been ploughed into the software. Blackbird has yet to see a financial return on that investment, but it does have valuable technology and it is moving towards profitability.
The software means that less of the expensive broadcast and editing hardware is required. A move into licensing t...
The European Central Bank declined to raise interest rates today, despite a 7.5% rate of Eurozone inflation and rate hikes issued by the Bank of England and the US Federal Reserve over the last couple of months.
The Bank reportedly intends to cut bond buys under its Asset Purchase Programme, with a level of 30 billion euros in May followed by 20 billion euros in June from its existing 40 billion euro pace, with buys planned to end at sometime in the third quarter.
The choice was forecast by analysts before the decision was announced, due to the uncertainty surrounding Russia’s invasion of Ukraine and the impact on the economy over the long haul.
“The ECB are in a tricky situation as the Eurozone is facing a deteriorating growth outlook due to the war in Ukraine, whilst also trying to tame rampant inflation,” said BRI Wealth Management portfolio manager Tom Hopkins.
“The war is likely to mean that rates will stay lower for longer, until the economic consequences of the conflict are fully understood.”
“Lagarde’s message in March was ‘any increase in the ECB policy rate will be gradual and come only after its bond-buying programme ends’ which is estimated to be concluded in Q3, albeit could be revised if the economic outlook continues to deteriorate warranting a change in the programme.”
Analysts weighed in on several matters broached during the conference, including rumblings concerning a new asset purchase programme and the ECB’s focus moving into shocks to the market as the Ukraine war escalates and inflation rises.
“To probably tackle the recent debate on how the ECB could deal with widening bonds spreads and rumours about a new asset purchase programme, the ECB stressed that the reinvestments of the Pandemic Emergency Purchase Programme could be used to tackle market fragmentation,” said ING Global Head of Macro Carsten Brzeski.
“Europe is different and the ECB is different. Instead of any panic reaction, the ECB continues with its very gradual normalisation, which in our view is bringing an end to net asset purchases over the summer and an end to the era of negative interest rates before the end of the year.”
The impact of a full-blown Russian energy embargo was also speculated, with experts commenting that the knock-on effect would tilt Europe into the worst case recession scenario.
“Recession in Europe is already our base case, but its magnitude and duration crucially depend on the nature of further sanctions on Russia,” said Fidelity International Global Macro Analyst Anna Stupnytska.
“We believe as the growth shock becomes more evident in the data over the next few weeks, the ECB’s focus will likely shift away from high inflation towards trying to limit economic and market distress as the invasion of Ukraine and its consequences continues to ripple through the system.”
“Contrary to market pricing, we do not expect the European Central Bank to hike rates until Q4 this year or early 2023.”
There are 68 AIM companies where the share price has fallen by 40% or more since the beginning of 2022. The worst performer is Sensyne Health (LON:SENS), which has slumped by more than 97% having run into financial difficulties. There is uncertainty about the future of the healthcare technology company so investing at this time is a gamble.
However, there are some fallers that do provide recovery potential because they have growing businesses and strong balance sheets. In the next few days, there will be articles about some of these prospects which are in a good position to bounce back over th...
