AstraZeneca's Imfinzi secures FDA approval 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
Re: +91p today, I wonder why
More re eek £1.336p divi seems better than a £1.13 share price drop, so I suppose that's an improvement. Anyone want some National Grid shares?
Re: eek Don't panic ex-div today, all is well!
eek Assume large fall tomorrow as it will go ex div?Whats the reason for todays fall?
Re: Citi on FY results "all sounds solid enough"famous last words there William -- it's all seemed solid enough for years now according to the analysts of various groups at each moment in time, yet for some reason the business keeps declining.Games
Citi on FY results 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.."
Re: Syndax pharma tie-up If you're happy, I'm happy.
Re: Syndax pharma tie-up Yep! No banks involved.
Re: Syndax pharma tie-up That's great news on the fighting cancer front. And even better news if you mean AZN and not ANZ!!!
Syndax pharma tie-up 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.Good news,Regards,
Re: Just Bought in Hi Floss nice to see you are still around, used to see you on XEL board, not sure how you made 2 million on XEL but I think a lot lost money on that share. Robbery of the century that one.So safer with this large company, no doubt be on the up soon, think its the dollar weakening that caused the fall yesterday but rate rises expected in usa should strengthen it.
Just Bought in And immediately the price drops over a pound. I am sorry if it was me wot dun it but maybe there is another explanaFlon?
AstraZeneca lung cancer drug granted priority review in US 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
AZ submits Tagrisso application in Japan 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