Key Developments: AstraZeneca PLC (AZN.L)

AZN.L on London Stock Exchange

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19 Dec 2014
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Latest Key Developments (Source: Significant Developments)

AstraZeneca Plc's LYNPARZA approved by the US FDA
Friday, 19 Dec 2014 12:40pm EST 

AstraZeneca Plc:Says that the US Food and Drug Administration has approved LYNPARZA(olaparib) capsules (400mg twice daily) as first monotherapy.Approves for patients with deleterious or suspected deleterious germline BRCA-mutated (g BRCAm) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.Olaparib has been approved under the FDA's Accelerated Approval programme, based on existing objective response rate and duration of response data.Continued approval for this indication is contingent upon verification of clinical benefit in ongoing confirmatory Phase III trials.Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells.It is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, as detected by an FDA approved companion diagnostic test, BRACAnalysis CDx.  Full Article

AstraZeneca Plc receives marketing authorisation from European Commission for Lynparza
Thursday, 18 Dec 2014 02:00am EST 

AstraZeneca Plc:Says the European Commission (EC) has granted Marketing Authorisation for Lynparza (olaparib) capsules (400mg twice daily).As the first therapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.Says the approval of olaparib was based on data from Study 191, a Phase II clinical trial that evaluated its efficacy and safety compared to placebo in platinum-sensitive relapsed high grade serous ovarian cancer patients.Says the study showed that olaparib maintenance therapy significantly prolonged progression free survival (PFS) compared with placebo in patients with BRCA-mutated ovarian cancer: median PFS 11.2 months vs 4.3 months (PFS Hazard Ratio = 0.18; 95 pct Confidence Interval 0.10-0.31; p<0.0001).Says the most common adverse events associated with olaparib monotherapy to date were generally mild to moderate and included nausea, vomiting, fatigue and anaemia.  Full Article

Amgen And AstraZeneca to present results from Phase 3 AMAGINE-1 Study
Thursday, 11 Dec 2014 04:01pm EST 

Amgen and AstraZeneca:Says additional results from AMAGINE-1, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in patients with moderate-to-severe plaque psoriasis will be presented at the Psoriasis: From Gene to Clinic International Congress in London on Dec. 13.Brodalumab is only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor.The IL-17 receptor and cytokine family play a central role in the development and clinical manifestations of plaque psoriasis.  Full Article

AstraZeneca PLC announces New Drug Application for IRESSA accepted by US FDA
Tuesday, 2 Dec 2014 02:01am EST 

AstraZeneca PLC:Says the US FDA has accepted for filing the New Drug Application (NDA) for IRESSA (gefitinib) as a targeted monotherapy for the first line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC).Prescription Drug User Fee Act goal date for IRESSA will be in the third quarter 2015.  Full Article

AstraZeneca Plc and Amgen announce positive results from Brodalumab phase III study
Wednesday, 26 Nov 2014 02:01am EST 

AstraZeneca Plc and Amgen:Says that AMAGINE-2TM, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara (ustekinumab) and placebo at week 12.Says all key secondary endpoints comparing brodalumab with placebo were met.Says the first key secondary endpoint comparing PASI 100 for brodalumab (140 mg) with Stelara at week 12 was numerically greater but not statistically significant (p=0.078).Says the secondary endpoints against Stelara were also numerically greater (all nominal p-values were less than 0.05), but could not be deemed statistically significant due to the sequential testing method.  Full Article

AstraZeneca PLC presents data from Phase III studies of Lesinurad in combination with Allopurinol in Gout Patients
Sunday, 16 Nov 2014 10:00pm EST 

AstraZeneca PLC:Says that it presented top-line results of two pivotal Phase III trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), when used in combination with xanthine oxidase (XO) inhibitor allopurinol.Says the results show that about twice as many patients met the primary endpoint with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0 mg/dL at month 6, compared to those treated with allopurinol alone.Says that Lesinurad is an investigational agent that inhibits the uric acid transporter URAT1 in the kidney, increasing uric acid excretion and thereby lowering sUA.Says the two replicate Phase III studies, CLEAR1 and CLEAR2, evaluated lesinurad (200mg or 400mg oral) in combination with allopurinol in symptomatic gout patients not achieving target sUA levels on their current allopurinol dose.  Full Article

AstraZeneca PLC and Amgen positive phase iii brodalumab results
Wednesday, 12 Nov 2014 02:01am EST 

AstraZeneca and Amgen:Announces that AMAGINE-3TM, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints.Says it met its primary endpoints while compared with both Stelara (ustekinumab) and placebo at week 12.Results showed that 36.7 percent of patients in the brodalumab 210 mg group.27 percent of patients in the brodalumab 140 mg group.18.5 percent of patients in the Stelara group and 0.3 percent of patients in the placebo group achieved total clearance of skin disease (PASI 100).  Full Article

Aegerion Pharmaceuticals, Inc. acquires Myalept from AstraZeneca PLC
Thursday, 6 Nov 2014 02:11am EST 

Aegerion Pharmaceuticals, Inc:Enters into a definitive agreement with AstraZeneca to acquire Myalept (metreleptin for injection), an orphan product.Says under the terms of the agreement, Aegerion will pay AstraZeneca $325 mln upfront to acquire the global rights to develop, manufacture and commercialize Myalept.This is subject to an existing distributor license with Shionogi covering Japan, South Korea, and Taiwan.Transaction does not include the transfer of any AstraZeneca employees or facilities.Expect the transaction to complete in January 2015.  Full Article

AstraZeneca PLC declares dividend
Thursday, 6 Nov 2014 02:01am EST 

AstraZeneca PLC:Says the record date for the second interim dividend for 2014, payable on March 23, 2015, will be Feb. 20, 2015.  Full Article

AstraZeneca PLC raises FY 2014 guidance and gives FY 2015 guidance
Thursday, 6 Nov 2014 02:00am EST 

AstraZeneca PLC:Says that for FY 2014 it is increases its revenue and Core EPS guidance.Sees FY 2014 revenue to increase in low single digits at constant exchange rates (CER).Sees Core EPS for FY 2014 is now expected to decrease at around 10 pct. at CER.Says that for FY 2015 it is targeting Core EPS to be no less than the lower end of the range of the upgraded guidance for Core EPS for FY 2014.  Full Article

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AstraZeneca CEO says new Pfizer bid unlikely: Swedish daily DI

STOCKHOLM - U.S. Pfizer is unlikely to come back with a fresh bid for AstraZeneca, the Anglo-Swedish pharmaceuticals group's top executive was quoted as saying by Swedish business daily Dagens Industri on Saturday.

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