AstraZeneca (AZN) and partner Daiichi Sankyo announced that the FDA has accepted the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu for HER2-low metastatic breast cancer.The companies are seeking approval for Enhertu to treat unresectable or metastatic HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting.The sBLA looks to expand the currently approved indication of Enhertu in HER2- ...

AstraZeneca (AZN) stock has risen 13.6% in the past six months, outperforming an increase of 7.1% for the industry. AstraZeneca’s stock has also outperformed the sector as well as the S&P 500 index, as seen in the chart below. The stock has also been trading above its 200-day moving average since mid-March.AstraZeneca Stock Outperforms Industry, Sector & S&PImage Source: Zacks Investment ResearchAstraZeneca has a diverse product portfolio and a global footprint. Its key drugs like Lynparza, Tagrisso, Imfinz ...

AstraZeneca (AZN) announced that the FDA has approved its blockbuster drug, Tagrisso (osimertinib) for expanded use in lung cancer.The regulatory body has approved Tagrisso for the treatment of unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) in adult patients whose disease has not progressed following treatment with chemoradiotherapy.Following the latest nod, Tagrisso is now indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations, as determined b ...

The drug and biotech sector has outperformed the broader equity market this year, backed by the launch of promising new medicines, pipeline successes and an increase in merger and acquisition (M&A) activity. Obesity drugs of Novo Nordisk and Eli Lilly (LLY) have witnessed tremendous success, which has played a key role in the industry’s outperformance. The Zacks Large Cap Pharmaceuticals industry has outperformed the broader Medical sector as well as the S&P 500 index this year, as seen in the chart below.I ...

AstraZeneca (AZN) and Japanese partner Daiichi Sankyo announced that their antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), failed to achieve statistical significance in the final overall survival (OS) analysis in a study for a metastatic breast cancer indication.The TROPION-Breast01 phase III study evaluated Dato-DXd,a TROP2-directed ADC for treating inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at ...

AstraZeneca PLC (NASDAQ:AZN) Deutsche Bank's Depositary Receipts Virtual Investor Conference September 24, 2024 11:30 AM ET Company Participants Elizabeth Walton - Director, Investor Relations Conference Call Participants Zafar Aziz - Deutsche Bank Hello and welcome to the Deutsche Bank Depositary Receipts of Virtual Investor Conference. My name is Zafar Aziz from the Deutsche Bank team. I'm pleased to announce our next presentation will be from AstraZeneca from the U.K. Before I show our speaker, a few poi ...

AstraZeneca PLC (NASDAQ:AZN) Deutsche Bank's Depositary Receipts Virtual Investor Conference September 24, 2024 11:30 AM ET Company Participants Elizabeth Walton - Director, Investor Relations Conference Call Participants Zafar Aziz - Deutsche Bank Hello and welcome to the Deutsche Bank Depositary Receipts of Virtual Investor Conference. My name is Zafar Aziz from the Deutsche Bank team. I'm pleased to announce our next presentation will be from AstraZeneca from the U.K. Before I show our speaker, a few poi ...

AstraZeneca (AZN) announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma drug Fasenra (benralizumab) in eosinophilic granulomatosis with polyangiitis (EGPA) indication.EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues. The AZN filing seeks marketing authorization for Fasenra as an add-on treatment for adult patients with relapsing or refractory ...

In my investing career, I have learned that quality is just as important of a consideration as valuation. The simultaneous presence of high-quality and a reasonable/discounted valuation usually bodes well for investment performance.Hi, my name is Kody. Aside from my four to five weekly articles here on Seeking Alpha, I am also a contributor to Sure Dividend, Dividend Kings, and iREIT on Alpha. I have been investing since September 2017 and interested in dividend investing since about 2009.Since July 2018, I ...

Key TakeawaysA breast cancer drug being developed by AstraZeneca failed to "achieve statistical significance" in helping patients live longer than with chemotherapy in a phase 3 trial.The trial included over 700 patients with inoperable or metastatic breast cancer.The company said it will present the new data to regulators who are weighing approval of the drug. Its shares fell Monday morning. British drugmaker AstraZeneca (AZN) said Monday that a Phase 3 trial of a developmental drug failed to achieve "sta ...