Based on ECHO Phase III trial which demonstrated CALQUENCE combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy Submission to be reviewed under Project Orbis AstraZeneca's supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditi

Arcus and AstraZeneca to evaluate their respective molecules in combination to establish a potential first- and best-in-class treatment for clear cell renal cell carcinoma (ccRCC) This is the second clinical collaboration between Arcus and AstraZeneca Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced a clinical trial collaboration agreement with AstraZeneca (NASDAQ:AZN) to evaluate casdatifan (AB521), Arcus's investigational HIF-2a inhibitor, in combination with volrustomig, AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody,

Based on DESTINY-Breast06 Phase III trial which demonstrated a statistically significant and clinically meaningful progression-free survival benefit for ENHERTU If approved, AstraZeneca and Daiichi Sankyo's ENHERTU will be the first HER2 directed therapy and ADC for patients prior to receiving chemotherapy for metastatic breast cancer ENHERTU also granted Breakthrough Therapy Designation in the US for this patient population AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC

Based on DESTINY-Breast06 phase 3 trial which demonstrated a statistically significant and clinically meaningful progression-free survival benefit for ENHERTU If approved, Daiichi Sankyo and AstraZeneca's ENHERTU will be the first HER2 directed therapy and antibody drug conjugate for patients prior to receiving chemotherapy for metastatic breast cancer Daiichi Sankyo (TSE: 4568) and AstraZeneca's (NASDAQ:AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 w

Based on LAURA Phase III trial results which showed TAGRISSO extended median progression-free survival by more than three years AstraZeneca's TAGRISSO® (osimertinib)​ has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT). TAGRISSO is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by a FDA-approved test. The approval follows a Priority Review by the Food and Drug Administration (FDA) that was based on results

Survival results for AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan in TROPION-Breast01 did not achieve statistical significance versus chemotherapy Trial previously met the dual primary endpoint of progression-free survival High-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) compared to investigator's choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previo

Survival results for Daiichi Sankyo and AstraZeneca's datopotamab deruxtecan in TROPION-Breast01 did not achieve statistical significance versus chemotherapy Trial previously met the dual primary endpoint of progression-free survival Topline results from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to investigator's choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previous

Only influenza vaccine approved for self- or caregiver-administration at home, expanding options for influenza protection FLUMIST® has been approved in the US as the only self-administered influenza vaccine. FLUMIST, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.1 The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FLUMIST to eligible individuals 2-49 years of age.1 Ravi Jhaveri, MD, Divisio

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids AstraZeneca's FASENRA® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).1 EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.2,3 The approval by the US Food and Drug Administration (FDA) was based on positive results from the MANDARA Phase III trial published in The New England Journal of Medicine,4 which compared the efficacy and safety of FASENRA to the only approved

NEW YORK, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Deutsche Bank today announced the lineup for its Depositary Receipts Virtual Investor Conference ("dbVIC") on Tuesday, September 24 and Wednesday, September 25, featuring live webcast presentations from international companies with American Depositary Receipt (ADR) programs in the US. Representatives from participating companies based in China, France, Hong Kong, Netherlands, Philippines, Portugal, Spain, Switzerland, and the United Kingdom will respond to questions during formal presentations. The conference is targeted to all categories of investors and analysts interested in international companies. There is no fee for participants to log i

Deutsche Bank downgraded AstraZeneca from Hold to Sell

Goldman initiated coverage of AstraZeneca with a rating of Buy and set a new price target of $97.00

Deutsche Bank upgraded AstraZeneca from Sell to Hold

Deutsche Bank downgraded AstraZeneca from Hold to Sell

Morgan Stanley initiated coverage of AstraZeneca with a rating of Overweight and set a new price target of $85.00

UBS resumed coverage of AstraZeneca with a rating of Sell

Jefferies downgraded AstraZeneca from Buy to Hold and set a new price target of $70.00 from $78.50 previously

HSBC Securities initiated coverage of AstraZeneca with a rating of Buy and set a new price target of $78.00

Jefferies upgraded AstraZeneca from Hold to Buy and set a new price target of $80.00 from $66.50 previously

HSBC Securities initiated coverage of AstraZeneca with a rating of Buy

SC 13G/A - ASTRAZENECA PLC (0000901832) (Subject)

SC 13G/A - ASTRAZENECA PLC (0000901832) (Subject)

ROCKVILLE, Md., June 6, 2024  /PRNewswire/ -- I-Mab (NASDAQ:IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today announced the appointment of Dr. Phillip Dennis as Chief Medical Officer. Dr. Dennis, who will join I-Mab effective June 17, 2024, will lead the Company's global clinical development efforts and serve as a member of I-Mab's Executive Leadership Team. "I am pleased to welcome Dr. Phillip Dennis as our Chief Medical

In recognition of Rare Disease Day on February 29, Alexion welcomes people across the country to join the international colourUp4RARE challenge and learn more about the impact of rare diseases on an estimated three million Canadian families MISSISSAUGA, ON, Feb. 26, 2024 /CNW/ - Alexion Pharma Canada Corp., AstraZeneca's Rare Disease group, is marking Rare Disease Day on February 29 by launching colourUp4RARE. The international campaign aims to raise awareness of how to improve quality of life of people living with rare diseases in Canada, and around the world. Approximately,

NIH data show that globally less than 2% of genetic information being studied today originates from people of African ancestry1 The newly established Diaspora Human Genomics Institute (DHGI) will manage the Together for CHANGE initiative, which aims to increase available genomic data for people of African ancestry and enhance representation in STEM careers NASHVILLE, Tenn. and TARRYTOWN, N.Y. and WILMINGTON, Del. and BAGSVAERD, Denmark and BASEL, Switzerland, Oct. 18, 2023 (GLOBE NEWSWIRE) -- Meharry Medical College, along with partners Regeneron Genetics Center® (RGC™), AstraZeneca, Novo Nordisk, and Roche, today announced the launch of the Together for CHANGE™ ("Changing Healthcare for

Cristian Massacesi, M.D., Appointed to Replay Board of Directors Cristian Massacesi, M.D., Chief Medical Officer of AstraZeneca and Alexion and Oncology Chief Development Officer of AstraZeneca, to support Replay in advancing genomic medicine and cell therapy pipelineDr. Massacesi brings over 20 years of research and medicines development experience to the Replay Board San Diego, California and London, UK, May 25, 2023 – Replay, a genome writing company reprogramming biology by writing and delivering big DNA, today announced the appointment of Cristian Massacesi, M.D., as a member of its Board of Directors, with immediate effect. Dr. Massacesi is a leading expert in medical oncology, wi

On Thursday, AstraZeneca Plc (NASDAQ:AZN) reported second-quarter sales of $12.94 billion, up 13% year over year (+17% at constant currency), beating the consensus of $12.75 billion.  The company’s adjusted EPADS reached $0.99, inline with consensus. The adjusted EPS was $1.98 (1 ADR = 2 Common Shares) Also Read: China Approves AstraZeneca’s Tagrisso-Chemotherapy Combo Regime For Previously Untreated Lung Cancer Patients. AstraZeneca’s top business, oncology, delivered a 15% jump (up 19% on constant currency) in second-quarter sales to $5.33 billion. Tagrisso, Imfinzi, and Calquence were the top-selling cancer drugs, generating $1.61 billion, $1.15 billion, and $790 million, res

AstraZeneca (NASDAQ:AZN) reported quarterly adjsuted earnings of $0.99 per share which missed the analyst consensus estimate of $1.20 by 17.5 percent. This is a 7.91 percent decrease over earnings of $1.07 per share from<p>AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) reported quarterly adjsuted earnings of $0.99 per share which missed the analyst consensus estimate of $1.20 by 17.5 percent. This is a 7.91 percent decrease over earnings of $1.07 per share from the same period last year. The company reported quarterly sales of $12.98 billion which beat the analyst consensus estimate of $12.75 billion by 1.83 percent. This is a 13.73 percent in

On Thursday, Sanofi SA (NASDAQ:SNY) reported a second-quarter business operating income of 2.8 billion euros ($3.03 billion), up 3.2% year-over-year and 8.3% in constant currency. The company reported second-quarter sales of $11.57 billion (10.75 billion euros), beating the consensus of $11.37 billion. Sales increased 7.8% year over year and 10.2% on constant currency. Also Read: Europe Approves Sanofi/Regeneron’s Dupixent for ‘Smoker’s Lungs’ A Month After US FDA Asks For Data. The French drugmaker reported adjusted EPS of $0.93 (1.73 euros), beating the consensus estimate of $0.86, down 0.6% reported and up 4.0% at CER. Sales of Dupixent, Sanofi’s blockbuster eczema drug, rose

Sentiment continues to be jittery, with the major index futures priming for a lower opening on Thursday as traders look ahead to the first read of second-quarter GDP data and more earnings. The tech space could once again drag the broader market after a few disappointing earnings reports from the likes of Franco-Italian chipmaker STMicroelectronics N.V. (NYSE:STM), which predominantly supplies to the automotive end market, and semiconductor test-equipment company Teradyne, Inc. (NASDAQ:TER). Traders may also stay glued to second-quarter GDP data to confirm the slowdown suggested by some recent data does not point to a hard landing. That said, bond yields are dipping as the market, factori

With U.S. stock futures trading higher this morning on Thursday, some of the stocks that may grab investor focus today are as follows: Wall Street expects Honeywell International Inc. (NASDAQ:HON) to report quarterly earnings at $2.42 per share on revenue of $9.41 billion before the opening bell. Honeywell shares gained 0.5% to $214.80 in after-hours trading, according to data from Benzinga Pro. AstraZeneca PLC (NASDAQ:AZN) posted better-than-expected revenue for its second quarter and increased its sales and profit guidance for 2024. AstraZeneca shares fell 0.3% to $79.46 in the after-hours trading session. Analysts are expecting Northrop Grumman Corporation (NYSE:NOC) to post qua

Guidance Due to strong underlying growth in Product Sales and Alliance Revenue, the Company raises its Total Revenue and Core EPS guidance for FY 2024 at CER, based on the average foreign exchange rates through 2023.  Total Revenue is expected to increase by a mid teens percentage  (previously a low double-digit to low teens percentage)   Core EPS is expected to increase by a mid teens percentage (previously a low double-digit to low teens percentage)  An increase in Collaboration Revenue is not assumed in the upgraded guidance (previously assumed a substantial increase) ‒ Other operating income is expected to decrease substantially (FY 2023 included a $241m gain on the disposal of Pulmico

AstraZeneca (NASDAQ:AZN) reported quarterly adjsuted earnings of $0.99 per share which missed the analyst consensus estimate of $1.20 by 17.5 percent. This is a 7.91 percent decrease over earnings of $1.07 per share from the same period last year. The company reported quarterly sales of $12.98 billion which beat the analyst consensus estimate of $12.75 billion by 1.83 percent. This is a 13.73 percent increase over sales of $11.42 billion the same period last year.

On Tuesday, Merck & Co Inc (NYSE:MRK) shared topline results from its Phase 2b/3 clinical trial (MK-1654-004) of clesrovimab (MK-1654). Clesrovimab is the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. Clesrovimab met its primary safety and efficacy endpoints in the trial, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150. Participants were randomized to receive either a single dose of clesrovimab or a placebo. Detailed study findings will be presented at an upcoming scientific congress, and Merck plans to file these data with global regul