Key Developments: AstraZeneca PLC (AZN.L)

AZN.L on London Stock Exchange

31 Oct 2014
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Latest Key Developments (Source: Significant Developments)

AstraZeneca PLC Board recommends first interim dividend
Thursday, 31 Jul 2014 02:02am EDT 

AstraZeneca PLC:Board has recommended first interim dividend of $0.90 (53.1 pence, 6.20 Swedish crown).Amount of the dividend reflects the Board's aim of setting the first interim dividend at around a third of the prior year dividend, which last year was $2.80.Record date for first interim dividend payable on Sept. 15 is Aug. 15.Shares will trade ex-dividend from Aug. 13.  Full Article

AstraZeneca and Kyowa Hakko Kirin partner on immuno-oncology clinical study
Wednesday, 30 Jul 2014 02:07am EDT 

AstraZeneca PLC:Enters into clinical study collaboration with Kyowa Hakko Kirin for Phase I/Ib immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumours.Study will evaluate AstraZeneca's anti-PD-L1 antibody, MEDI4736, in combination with Kyowa Hakko Kirin's anti-CCR4 antibody, mogamulizumab, and AstraZeneca's anti-CTLA-4 antibody tremelimumab, in combination with mogamulizumab.MEDI4736, tremelimumab, and mogamulizumab are part of a new class of cancer treatments known as immunotherapies, which use the body's own immune system to help fight cancer.MEDI4736 and tremelimumab block the signals that help tumours avoid detection by the immune system, while mogamulizumab suppresses some of the immune cells that shield the tumour from the immune system.Under the terms of the agreement, AstraZeneca and Kyowa Hakko Kirin will co-fund the study, which will be conducted by Kyowa Hakko Kirin.Phase I part of the study is expected to establish a recommended dose regimen and Phase Ib will assess the safety and efficacy of the two combinations.Results from these studies will determine the future clinical development of the combinations.  Full Article

AstraZeneca PLC announces strategic respiratory transaction with Almirall
Wednesday, 30 Jul 2014 02:02am EDT 

AstraZeneca PLC:Says agreement to transfer to the company the rights to Almirall's respiratory franchise for an initial consideration of $875 mln on completion, and up to $1.22 bln in development, launch, and sales-related milestones.Says it will own the rights for the development and commercialisation of Almirall's existing respiratory business, including rights to revenues from Almirall's existing partnerships, as well as its pipeline of investigational therapies.Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of devices, will also transfer to AstraZeneca.  Full Article

Qiagen NV and AstraZeneca collaborate to develop liquid biopsy-based companion diagnostic to advance EGFR Mutation Profiling in Lung Cancer Patients
Monday, 28 Jul 2014 02:00am EDT 

Qiagen NV and AstraZeneca:To collaborate for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer.Companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples.  Full Article

AstraZeneca PLC announces FDA Advisory Committee votes on olaparib
Thursday, 26 Jun 2014 02:00am EDT 

AstraZeneca PLC:Says US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that current evidence from clinical studies does not support.Says an accelerated approval for use of olaparib as maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy.ODAC provides the FDA with independent, expert advice and recommendations, however the final decision regarding approval is made by the FDA.Filed US regulatory submission for olaparib in Feb. 2014.FDA granted priority review status for the NDA in April and set a Prescription Drug User Fee Act (PDUFA) action date of Oct. 3.NDA filing was based on subgroup analysis of Phase II data recently published in Lancet Oncology1.Phase II study was a randomised, double-blind, placebo-controlled trial which evaluated olaparib versus placebo as maintenance treatment in platinum-sensitive relapsed serous ovarian cancer patients.In addition, as part of its commitment to bring the potential benefits of olaparib to ovarian cancer patients, AstraZeneca has initiated and is committed to complete the Phase III SOLO programme.Designed to evaluate the efficacy and safety of olaparib as a maintenance monotherapy in ovarian cancer patients who have a BRCA mutation who are in complete or partial response following platinum-based chemotherapy in the relapsed setting.  Full Article

FDA AdCom recommends no CV trial for AstraZeneca PLC's PAMORA class
Friday, 13 Jun 2014 02:00am EDT 

AstraZeneca PLC:Says majority of Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that FDA should not require cardiovascular outcomes trials for peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs.Says which includes MOVANTIKTM (naloxegol oxalate), an investigational treatment for opioid-induced constipation (OIC) for patients with chronic non-cancer pain.Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety.Says If approved, MOVANTIK has potential to be first once-daily, oral PAMORA for the treatment of OIC for patients with chronic non-cancer pain.MOVANTIK is also under regulatory review with health agencies in the European Union and Canada.  Full Article

AstraZeneca Plc announces global licence agreement with Synairgen Plc
Thursday, 12 Jun 2014 02:00am EDT 

AstraZeneca Plc:Announces a global licence agreement with Synairgen Plc for SNG001.SNG001 supports the immune system by correcting a deficiency which makes patients vulnerable to respiratory tract viral infections.Under the terms of the exclusive licence agreement, AstraZeneca will pay Synairgen a $7.25 mln up-front fee and potential development, regulatory and commercial milestones of up to $225 mln.In addition, AstraZeneca will pay tiered royalties ranging from single-digit up to mid-teens on commercial sales.AstraZeneca will be responsible for future development costs.  Full Article

AstraZeneca PLC's board rejects Pfizer's final proposal
Monday, 19 May 2014 02:08am EDT 

AstraZeneca PLC:Rejected final proposal from Pfizer Inc, comprising 24.76 pounds in cash (45%) and 1.747 Pfizer shares (55%) per AstraZeneca share, representing a value of 55.00 pounds per AstraZeneca share.Says this proposal undervalues the Company and its attractive prospects and has been rejected by the Board of AstraZeneca.  Full Article

Pfizer Inc makes final proposal to AstraZeneca PLC
Sunday, 18 May 2014 05:03pm EDT 

Pfizer Inc:Announces its final proposal to combine Pfizer and AstraZeneca.This is fourth proposal Pfizer has made and Pfizer believes that this final proposal provides clear basis for AstraZeneca to extend period for making firm offer under Code and to meaningfully engage with Pfizer.Under terms of final proposal AstraZeneca shareholders would receive, for each AstraZeneca share, 1.747 shares in combined entity and 2,476 pence in cash, representing an indicative value of 55.00 pounds ($92.53) per share.This proposal is final and will not be increased, except in the circumstances set out below.Relative to Pfizer's 2 May proposal, final proposal represents.An increase of cash consideration of 8.78 pounds per share, or 11.3 bln pounds.An increase in cash component as a proportion of total consideration from 33 pct. to about 45 pct.A substantial increase in current indicative value of about 15 pct.An aggregate increase in total current indicative value of about 9.1 bln pounds or $15.3 bln.Under final proposal, Pfizer and AstraZeneca shareholders would own about 74 pct. and 26pct., respectively, of the combined company.  Full Article

Incyte Corp and AstraZeneca PLC biologics research arm announces collaboration on Immuno Oncology combination clinical trial
Wednesday, 14 May 2014 02:00am EDT 

Incyte Corp:Says the company and MedImmune, the biologics research and development arm of AstraZeneca have entered into clinical study collaboration.The Phase I/II oncology study will evaluate the efficacy and safety of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360.Both MEDI4736 and INCB24360 are investigational compounds that are part of a new class of cancer treatments known as immunotherapies.Under the terms of the agreement, MedImmune and Incyte will collaborate on a non exclusive basis on the study, to evaluate the combination in multiple solid tumors including metastatic melanoma, non small cell lung cancer, squamous cell carcinoma of the head and neck and pancreatic cancer.The Phase I part of the trial is expected to establish a recommended dose regimen of both MEDI4736 and INCB24360 and the Phase II part of the study will assess the safety and efficacy of the combination.Results from the study will be used to determine whether further clinical development of this combination is warranted.The study will be co-funded equally by Incyte and MedImmune and conducted by Incyte.  Full Article


AstraZeneca wins U.S. approval for two-in-one diabetes pill

LONDON - A new two-in-one diabetes pill from AstraZeneca has been approved by U.S. regulators, the British drugmaker said on Thursday.

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