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The Latest Breaking News from AstraZeneca Plc

AstraZeneca top heart drug sees potential to reach more patients

One of AstraZeneca Plc’s top-selling drugs Farxiga, a diabetes treatment, is beneficial to a wider pool of patients than previously indicated, a study shows, bolstering the product’s blockbuster potential.

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Recap of Monday's Biotech Catalysts - End Of the Day Summary

Kodiak Sciences Inc. (NASDAQ:KOD) announced positive topline results its BEACON Phase 3 study of tarcocimab tedromer (KSI-301; tarcocimab) in patients with macular edema due to retinal vein occlusion. Kodiak shares traded in a range of $10.02 to $11.79 on a day volume of 4.05 million shares, closed regular trading session…

Benzinga

Daily Biotech Pulse: KKR Invests In Medicine Start-Up, Revelation Bio Aces Allergic Rhinitis Study, Tonix Pharma Ends COVID-19 Antiviral Pact

Here's a roundup of top developments in the biotech space over the last 24 hours:

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Oxford Biomedica Inks New Three Year Deal To Make AstraZeneca's COVID-19 Vaccine

Oxford Biomedica plc (OTC:OXBDF) signed a new three-year agreement to potentially make AstraZeneca Plc's (NASDAQ:AZN) COVID-19 vaccine beyond 2022. The new agreement represents an expansion of the original master supply and development agreement announced between the two companies in September 2020. The manufacture of COVID-19 vaccines at Oxford Biomedica's Oxbox facility, as part of the…

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AstraZeneca Says Imfinzi/Chemo Combo Shows Promising Action In Late-Stage Lung Cancer Study

AstraZeneca Plc (NASDAQ:AZN) announced high-level results from a planned interim analysis of the AEGEAN Phase 3 trial of Imfinzi (durvalumab) combined with neoadjuvant chemotherapy in patients with resectable non-small cell lung cancer (NSCLC). The data showed that Imfinzi plus neoadjuvant chemo before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete…

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AstraZeneca's ALXN1840 Shows Promising Action Against Copper Metabolism Disorder

AstraZeneca Plc (NASDAQ:AZN) announced detailed results from the positive FoCus Phase 3 trial of ALXN1840 in Wilson's disease, an inherited condition in which the body's pathway for removing excess copper is compromised. The data showed that ALXN1840 met its primary endpoint demonstrating three-times greater copper mobilization from tissues compared to the standard of…

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Short Volatility Alert: AstraZeneca PLC

On Tuesday, shares of AstraZeneca PLC (NASDAQ: AZN) experienced volatile short activity. After the activity, the stock price went up 2.85% to $62.83. The overall sentiment for AZN has been Bullish.

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Why Mereo BioPharma Shares Are Jumping Today

AstraZeneca plc (NASDAQ:AZN) is rumored to be eyeing take over of Mereo BioPharma Group plc (NASDAQ:MREO), according to a report in The Times. The Times' report says that "Mereo would accept $5, equating to $500 million including American depositary receipts or ADRs. Evercore and Citigroup are said to be involved as advisers." Mereo's lead…

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Innoviva Acquires AstraZeneca-Spin Off At $2.20/Share

Innoviva Inc (NASDAQ:INVA) has agreed to acquire Entasis Therapeutics Holdings Inc (NASDAQ:ETTX) at $2.20 per share in cash. Innoviva currently owns approximately 60% of the outstanding shares of Entasis common stock. The acquisition consideration values Entasis' equity at $113 million on a fully diluted basis. "This acquisition will build upon our overall strategy to acquire differentiated,…

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AstraZeneca In-Licenses New Suite Of COVID-19 Antibody Candidate(s)

AstraZeneca plc (NASDAQ:AZN) moved to bolster its COVID-19 portfolio of antibodies with a $157 million licensing deal for experimental therapies developed by newly-launched UK-based biotech, RQ Biotechnology Ltd. In addition to the initial sum, AstraZeneca will pay possible royalty payments as part of the exclusive license to develop pre-clinical COVID antibodies engineered by RQ…

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AstraZeneca's Combination Inhaler Shines In Phase 3 Asthma Trial

AstraZeneca Plc (NASDAQ:AZN) posted full results from the positive MANDALA Phase 3 trial of PT027, an albuterol/budesonide fixed-dose combination rescue medication in patients with asthma. The data exhibited that PT027 at two different strengths of budesonide demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue. Compared with…

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Almost 400M COVID-19 Vaccine Doses Lost Due To Emergent's Baltimore Plant Fiasco

According to a recent report from the US House select subcommittee on the coronavirus crisis, Emergent Biosolutions Inc (NYSE:EBS) might have destroyed nearly 400 million doses of COVID-19 vaccines after failing to meet quality standards. Initially, 75 million - 85 million doses of drug substance were said to be destroyed after contamination. "Despite major…

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Sanofi-AstraZeneca Say New Nirsevimab Data Reinforce Efficacy Against RSV

Sanofi SA (NASDAQ: SNY) and AstraZeneca plc (NASDAQ: AZN) have announced results from a prespecified pooled analysis of nirsevimab in respiratory syncytial virus (RSV).

Benzinga

FDA Approval For AstraZeneca - Daiichi's Enhertu Expands To Earlier Use In Metastatic Breast Cancer

The FDA has approved AstraZeneca plc (NASDAQ:AZN) and Daiichi Sankyo's (OTC:DSKYF) Enhertu (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive breast cancer. The approval covers patients who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within…

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The Daily Biotech Pulse: FDA Approves Bristol Myers' Oral Heart Disease Drug, European Approval For Merck's Keytruda, Genocea Restructures, Zymeworks' Takeover Bid

Here's a roundup of top developments in the biotech space over the last 24 hours.

Benzinga

AstraZeneca Clocks Q1 COVID Vaccine Sales Of $1.2B, Keeps Overall FY22 Outlook

AstraZeneca Plc's (NASDAQ:AZN) total revenue jumped 60% Y/Y at CER to $11.39 billion in Q1 FY22, beating the consensus of $10.99 billion. The growth reflects the contribution of the Alexion medicines and several Vaxzevria contracts that are expected to complete the delivery by half year 2022. Core EPS came in at $1.89,…

Benzinga

Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer

The FDA has granted Breakthrough Therapy Designation (BTD) to Daiichi Sankyo (OTC:DSKYF) and AstraZeneca Plc's (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. The designation covers patients who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months…

Benzinga

AstraZeneca's COVID-19 Antibody Provides Protection For At Least Six Months In High-Risk Individuals

AstraZeneca plc (NASDAQ:AZN) shared detailed results from the PROVENT Phase 3 pre-exposure prophylaxis (prevention) trial of Evusheld (tixagevimab and cilgavimab), formerly AZD7442. The data showed that Evusheld reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and 83% in the six-month follow-up analysis, compared to placebo. There were no…

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Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer

The FDA has accepted for review AstraZeneca plc (NASDAQ:AZN) - Daiichi Sankyo's (OTC:DSNKY) supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for non-small cell lung cancer (NSCLC) setting. The application covers unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received prior systemic therapy. The application has also been…

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Japan's Health Ministry Panel OKs Approval Of Novavax's COVID-19 Vaccine: Report

Japan's health ministry panel authorized a plan to approve Novavax Inc's (NASDAQ:NVAX) COVID-19 vaccine, which is set to be the fourth such vaccine to be approved in Japan. It will be available for first and second shots with an interval of three weeks. The Novavax product is a recombinant protein vaccine that uses…

Benzinga

AstraZeneca Bets $25M On Preclinical Bispecific Antibody

Harbour BioMed has announced a global out-license agreement with AstraZeneca plc (NASDAQ:AZN) for CLDN18.2xCD3 bispecific antibody (HBM7022). HBM7022 is a novel bispecific antibody generated from HBM's HCAb Based Immune Cell Engagers (HBICE) Platform. HBM7022 is currently in the preclinical stage, which crosslinks tumor cells and T cells by targeting a tumor-associated antigen (Claudin18.2) and…

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AstraZeneca's Ultomiris Shows Sustained Improvements In Functional Activities In Neuromuscular Disease

AstraZeneca Plc (NASDAQ:AZN) shared new and prolonged follow-up results from the Phase 3 CHAMPION-MG trial open-label extension (OLE) of Ultomiris (ravulizumab-cwvz) in generalized myasthenia gravis (gMG). Ultomiris demonstrated long-term efficacy, with improvements in activities of daily living, muscle strength, and quality of life sustained through 60 weeks. Ultomiris was also well tolerated throughout…

Benzinga

AstraZeneca's Imfinzi Flunks In Late-Stage Advanced Cervical Cancer Study

AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) and chemoradiotherapy did not achieve the primary goal of improving survival in patients with locally advanced cervical cancer. The Phase 3 study, dubbed "CALLA," tested progression-free survival of patients with the combination against chemoradiotherapy alone. "While the results were not what we hoped for, insights from the trial…

Benzinga

AstraZeneca Mulls Ditching US Approval For Its COVID-19 Vaccine: FT

Citing AstraZeneca Plc's (NASDAQ: AZN) head of research and development, the Financial Times reported that the Company

Benzinga

Europe Kickstarts Reviewing AstraZeneca Application For Its COVID Antibody

European Medicines Agency has started reviewing AstraZeneca Plc's (NASDAQ:AZN) application for antibody-based COVID-19 therapy but gave no timeline for a conclusion. Infections from COVID-19 are still rising in parts of the world, including Europe. On Tuesday, China posted a steep jump in daily COVID-19 infections, with new cases more than doubling from a…

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