A Phase 3 clinical trial, DERIVE, assessing AstraZeneca's (AZN -0.1%) FARXIGA (dapagliflozin 10 mg) in patients with type 2 diabetes with moderate renal impairment met the primary and secondary endpoints. The data were presented at the Endocrine Society Annual Meeting in Chicago.
Treatment with dapagliflozin, an SGLT2 inhibitor, produced a statistically significant reduction in HbA1C versus placebo (-0.37% vs. -0.03%; p<0.001).
It also produced a statistically significant average reduction in body weight (-3.17 kg vs. -1.92 kg; p<0.001), mean fasting glucose from baseline to week 24 (-21.46 mg/dL vs. -4.87 mg/dL; p=0.001) and mean systolic blood pressure from baseline to week 24 (-4.8 mm Hg vs. -1.7 mm Hg; p<0.05).
Maybe they remember back to when Pfizer were willing to offer £55 in 2014, they may be thinking they'll be back or the promise to " raise revenues by more than three quarters over the next decade" may be about to start kicking in.
Societe Generale today reaffirms its buy investment rating on AstraZeneca PLC (LON:AZN) and set its price target at 7800p. Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk
AstraZeneca on Monday said it expects to deliver final analysis of its phase III MYSTIC trial of Imfinzi in the second half of 2018 rather than the first half of the year as was previously anticipated. The MYSTIC trial is a randomised, open-label, multi-centre, global Phase III trial of Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus SoC in treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally-advanced or metastatic (Stage IV) 1st-line NSCLC. Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. Story provided by StockMarketWire.
The European Medicines Agency (EMA) accepts for review AstraZeneca's (NYSE:AZN) marketing application seeking approval for Forxiga (dapagliflozin) for adjunctive treatment of adults with type 1 diabetes (T1D).
If approved, it will be the first selective SGLT-2 inhibitor available in the EU as an oral adjunct to insulin.
Forxiga was first approved in Europe in November 2012 for type 2 diabetes.
AstraZeneca and MedImmune, its global biologics research and development arm, said Monday that the US Food and Drug Administration (FDA) approved Imfinzi for the treatment of Stage III unresectable non-small cell lung cancer. Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. The approval of Imfinzi was based on the positive PFS data from the Phase III PACIFIC trial. Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: 'The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy.' 'Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.' Story provided by StockMarketWire.com
Edited highlights below - all sounds solid enough. Looks like AZN is still Citi's "preferred name" in the secor globally, though I would be more neutral at the current SP...
"Despite the strong quarter and above consensus revenue guidance, 2018 Core EPS guidance may disappoint some investors. We anticipated the increase in SG&A associated with the launch of several new drugs in our recent report ... but it appears we may have under-appreciated the near-term negative impact on gross margin, associated with launch of biologics Imfinzi and Fasenra, on top of LOE for mature products. Despite this, we view the revenue outlook as key however. Profitability from both COGS and OPEX will follow, assuming revenue meets or exceeds our expectations.
We underline our confidence in AZNs c.20% LT Core EPS CAGR outlook (ex externalisation revenues) given the breadth and depth of its small and large molecule pipeline. It remains our global preferred name in the sector. We prefer BUY-rated Bayer in EU. We prefer BUY-rated LLY, BMY and MRK among the US majors.
What's New? AZN reported a strong quarter with notable beats in diabetes (Onglyza, Farxiga), respiratory and Tagrisso leading to a 5% revenue beat. The 62% EPS beat versus consensus for the quarter reflected the contribution from lower R&D (post MRK deal) and a significant contribution from other operating income. AZN reported Core EPS of $1.30 compared with Citi 4Q estimate of $1.17. Guidance for 2018 revenue is slightly ahead of consensus, but the mid-point of EPS guidance ($3.35) is 4% below consensus expectations.
Implications Market should overlook near-term margin pressure in 2018, and focus on new products revenue opportunities.."
The announced tie up between Syndax pharma and ANZ has pushed Syndax up 10% today.
This could be the breakthrough in cancer treatment, injecting the tumour with a combination of the ANZ and Syndax drugs, which kills off the tumour and activates the immune system to kill off all secondary tumours as well.
90% of mice were cured with only one treatment, and all the rest were cured with a second treatment. That is all mice were cured! Pretty impressive, and not too expensive.
I believe the ANZ drug is already approved for human use and the Syndax drug is undergoing human trials.
The US Food and Drug Administration has accepted AstraZeneca's regulatory submission for Tagrisso for the treatment of patients with metastatic non-small cell lung cancer. AstraZeneca said the FDA had accepted a supplemental new drug application for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the first-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC. AstraZeneca said the submission acceptance was based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current first-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC. Story provided by StockMarketWire.com
AstraZeneca has submitted a supplemental new drug application for its lung cancer drug Tagrisso to Japan's Pharmaceuticals and Medical Devices Agency. AstraZenecahas submitted the sNDA for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). The Japan sNDA is based on data from the phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC. Story provided by StockMarketWire.com
"When Equilibrium's Mike Deverell built our Long-Term Growth portfolio in the spring, he was cautious about the stockmarket. Holly Black reports on what's changed since.With only around half of his notional Â£100,000 invested in equities, and much ..."
"Thirty years ago, the notion of robots replacing humans was the vision of dystopian science fiction. However, huge technological advances since then mean that 'intelligent' systems now pose a threat to many occupations - including fund managers, ..."
The FDA grants accelerated approval for AstraZeneca's (AZN +0.9%) BTK inhibitor Calquence (acalabrutinib) for the treatment of adult patients with mantle cell lymphoma who have received at least one prior line of therapy.
The company obtained the rights to the drug via its majority stake in Dutch biotech Acerta Pharma in 2016.
The European Medicines Agency accepts for review AstraZeneca's (NYSE:AZN) marketing application seeking approval for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) that has not progressed following platinum-based chemo.
Stage III NSCLC represents about 1/3 of NSCLC cases.
AstraZeneca has announced that the US Food and Drug Administration has granted breakthrough therapy designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Executive vice-president, global medicines development and chief medical officer at AstraZeneca,Sean Bohen, said: 'The breakthrough therapy designation acknowledges not only Tagrisso's potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease. 'The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis.' Story provided by StockMarketWire.com
Results from a large-scale Phase 3 clinical trial, EXSCEL, assessing the cardiovascular risk of AstraZeneca's (AZN +0.1%) BYDUREON (exenatide extended-release) in type 2 diabetics showed similarity to placebo. The data were presented at European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon and simultaneously published online in the New England Journal of Medicine.
Patients who received once-weekly BYDUREON did not experience more major adverse cardiac events (MACE) than those receiving placebo (non-inferiority).
The incidence of CV events was actually lower in the treatment arm (11.4% vs. 12.5%) but the difference was not statistically valid (p=0.061). Patients in the exenatide arm had 14% less risk of death from all causes (hazard ratio = 0.86).
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The company is working with regulatory authorities to include the data in the drug's label.
AstraZeneca Update on clinical trials AstraZeneca this morning announced an update on two new treatments, both of which exceeded expectations.
In the first release, AstraZeneca and MedImmune, its global biologics research and development arm, presented the full progression-free survival (PFS) data from a planned interim analysis of the Phase III PACIFIC trial
Results show that Imfinzi (durvalumab) demonstrated a statistically-significant and clinically-meaningful improvement in PFS compared to current standard of care with active surveillance in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT)
Results of the Phase III PACIFIC trial show an improvement in PFS of more than 11 months in patients treated with Imfinzi compared to placebo (full details in table below)
In the second release, the company presented the full results of the Phase III FLAURA trial, which support Tagrisso's (osimertinib) clear potential as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC)
Results of the Phase III FLAURA trial demonstrated a superior, clinically-meaningful PFS advantage with Tagrisso compared with current SoC EGFR-TKIs (erlotinib or gefitinib).
AstraZeneca has announced that a study has shown that Duaklir significantly improves lung function in chronic obstructive pulmonary disease patients while a trial showed that tezepelumab cuts exacerbations in severe asthma. AstraZeneca announced positive top-line results from the phase III AMPLIFY trial for Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily), which met its primary endpoints, demonstrating a statistically-significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease (COPD) compared to each individual component (either aclidinium bromide or formoterol). In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily. Dr. Sanjay Sethi, Professor and Chief, Pulmonary, Critical Care and Sleep Medicine at University at Buffalo, The State University of New York, USA and the lead investigator of the trial, said: "These results demonstrate the improvement in lung function achieved by the combination of aclidinium and formoterol compared to single LAMA bronchodilators tiotropium and aclidinium, with comparable safety." AstraZeneca and Amgen Inc announced results from the PATHWAY phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a first-in-class anti-TSLP monoclonal antibody being developed by MedImmune, AstraZeneca's global biologics research and development arm, in collaboration with Amgen. The trial results were published today in the New England Journal of Medicine, and will be followed by an oral presentation on 12 September at the ERS International Congress 2017 in Milan. The PATHWAY trial achieved its primary efficacy endpoint, showing annual asthma exacerbation rate reductions of 61%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every four weeks or 280mg every two weeks, respectively (p<0.001 for all comparisons to placebo). In the trial, tezepelumab was given as an add-on therapy to patients with a history of asthma exacerbations and uncontrolled asthma despite receiving inhaled corticosteroids/long-acting beta-agonists with or without oral corticosteroids and additional asthma controllers. Story provided by StockMarketWire.com
Potential share-moving presentations ahead at key European cancer meeting
Aug. 30, 2017 3:38 PM ET|By: Douglas W. House, SA News Editor
The abstract drop for the European Society for Medical Oncology (ESMO) will launch in less than six hours. The conference will take place September 8-12 in Madrid. Presentations to watch:
AstraZeneca (NYSE:AZN): Top-line data from Phase 3 FLAURA study assessing Tagrisso (osimertinib) in EGFR+ NSCLC patients. Primary endpoint: PFS.
What is expected to boost Keytruda sales even more, is the collaboration between Merck and AstraZeneca (AZN). The two companies entered a strategic oncology collaboration to co-develop AstraZenecas drug Lynparza for a number of cancer types. Lynparza will be developed as monotherapy and in combination trials with other medicines. The drug will also be developed and commercialized in combination with Mercks Keytruda and AstraZenecas Imfinzi. Mercks management had this to say about the collaboration:
In addition, we are very much looking forward to collaborating with AstraZeneca in oncology as announced yesterday. We believe LYNPARZA can be a very important product in different indications over time. And the combination of our proven commercial success in oncology launching KEYTRUDA, with AstraZeneca's strong experience, will enable us together to make this product a tremendous success.
The collaboration gives Merck access to more patients, thus enabling Keytruda to generate more revenue
AstraZeneca's breast cancer drug Faslodex has received approval from the the US Food and Drug Administration. AstraZeneca said the FDA had approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. It said the FDA approval was based on data from the phase III FALCON trial, which were published in the November 2016 issue of The Lancet. Executive vice-president, head of the oncology business unit, Jamie Freedman, said: "We're pleased that the landmark FALCON trial results demonstrated the efficacy of Faslodex as initial monotherapy treatment for women who are living with HR+ HER2- advanced breast cancer. "This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive Faslodex earlier in the treatment journey." Story provided by StockMarketWire.com
Aug. 24, 2017 4:10 AM ET|By: Yoel Minkoff, SA News Editor
Novartis (NYSE:NVS) has received EU approval for its breast cancer drug Kisqali, boosting its oncology portfolio with a medicine it believes could potentially provide billions of dollars in revenues.
Roche (OTCQX:RHHBY) has been granted a priority review by the FDA for emicizumab, expediting the examination process for its haemophilia drug.
Meanwhile, results from a clinical trial have shown that Astrazeneca's (NYSE:AZN) blood-thinner Brilinta reduces cardiovascular mortality risks by 29% in patients with a history of heart problems.
What the author doesn't comment on is that the share price movement for Hikma's generics competitors (TEVA and Mylan) exactly shadows that of Hikma. This movement is directly related to the generics market and not just a function of short selling.
BTW the correct spelling is Boehringer Ingleheim.
Important message from the Financial Conduct Authority:
Posting inside information that is not public knowledge, or information that is false or misleading, may constitute market abuse.
This could lead to an unlimited fine and up to seven years in prison.
If you have any information, concerns or queries about market abuse, click here.
The content of the messages posted represents the opinions of the author, and does not represent the opinions of Interactive Investor Trading Limited or its affiliates and has not been approved or issued by Interactive Investor Trading Limited.
You should be aware that the other participants of the above discussion group are strangers to you and may make statements which may be misleading, deceptive or wrong.
Please remember that the value of investments or income from them may go down as well as up and that the past performance of an investment is not a guide to its performance in the future.
The discussion boards on this site are intended to be an information sharing forum and is not intended to address your particular requirements.
Whilst information provided on them can help with your investment research you need to consider carefully whether you should make (or refraining from making) investment or other decisions based on what you see without doing further research on investments you are interested in.
Participating in this forum cannot be a substitute for obtaining advice from an appropriate expert independent adviser who takes into account your circumstances and specific investment needs in selected investments that are appropriate for you.