AstraZeneca Group plcNYSE
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  • Yesterday, 7:38 AM
    • Results from a Phase 3 clinical trial, AURA3, evaluating AstraZeneca's (NYSE:AZN) TAGRISSO (osimertinib) for the second-line treatment of epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic non-small cell lung cancer (NSCLC) showed a significant treatment benefit. The data were presented at the 17th World Conference on Lung Cancer in Vienna, Austria.
    • AURA3 showed that treatment with TAGRISSO produced a statistically significant improvement in progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy with a 70% reduction in the risk of death (10.1 months vs. 4.4 months; p<0.001; hazard ratio = 0.30).
    • In a pre-specified exploratory subgroup analysis, 34% of patients with central nervous system metastases, PFS in the TAGRISSO group was 8.5 months versus 4.2 with platinum-pemetrexed chemo (hazard ratio = 0.32).
    • The safety profile of TAGRISSO was similar to earlier studies. Grade 3 (severe) or higher treatment-related adverse events were observed in 6% (n=16) of the TAGRISSO cohort compared to 34% (n=46) in the chemo cohort.
    • The FDA approved TAGRISSO in November 2015 for this type of lung cancer patient who has progressed on or after EGFR TKI therapy. It was approved in the EU in February and Japan in March. The marketing application in China is currently under review.
    | Yesterday, 7:38 AM
  • Mon, Dec. 5, 7:45 AM
    • AstraZeneca (NYSE:AZN) has finalized its agreement with Johnson & Johnson's (NYSE:JNJ) Cilag GmbH International for the divestment of  the ex-U.S. rights to Rhinocort Aqua, a nasal spray for allergic and non-allergic rhinitis and nasal polyps.
    • Under the terms of the deal, AstraZeneca received a payment of $330M. The payment will be recorded as "Other Operating Income" this quarter.
    | Mon, Dec. 5, 7:45 AM
  • Tue, Nov. 22, 2:51 AM
    • AstraZeneca (NYSE:AZN) announces that the FDA has lifted the partial clinical hold on the enrollment of new patients with head and neck squamous cell carcinoma ("HNSCC") for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.
    • The Phase III KESTREL trial has already re-opened for new patient enrolment at some clinical study sites and the EAGLE trial is expected to resume recruitment shortly, without amendments to either protocol. AstraZeneca will progressively resume enrollment for all HNSCC trials across the participating sites in the US and globally, subject to national health authority and ethics committee approval where required. The status of active recruitment will be reflected on in the coming days.
    • The partial clinical hold on new patient enrollment was communicated on 27 October, after preliminary findings from ongoing clinical trials related specifically to head and neck cancer. The FDA lifted the partial clinical hold following a review of the comprehensive analysis provided by AstraZeneca of bleeding events that were observed as part of the routine safety monitoring of the Phase III KESTREL and EAGLE trials.
    | Tue, Nov. 22, 2:51 AM | 2 Comments
  • Thu, Nov. 17, 7:51 AM
    | Thu, Nov. 17, 7:51 AM | 6 Comments
  • Fri, Nov. 11, 12:27 PM
    | Fri, Nov. 11, 12:27 PM | 5 Comments
  • Thu, Nov. 10, 11:59 AM
    • Westport, CT-based Accelerated Pharma (Pending:ACCP) is set for its IPO of 1,888,889 shares of common stock at $8 - 10.
    • The clinical stage biopharmaceutical firm employs its genomic technology to enhance the development of pre-existing pharmaceutical products for the treatment of a range of cancers and to prospectively identify patients who may be the best responders to therapy.
    • Its lead product candidate is Picoplatin, a next-generation platinum-based chemotherapeutic. Its value proposition is less unwanted side effects and improved ability to overcome platinum resistance. Phase 2 studies in colorectal cancer and squamous head and neck cancer should commence this month.
    • Picoplatin was originally developed by a subsidiary of AstraZeneca (NYSE:AZN). It was then sold to Genzyme (NYSE:SNY) who licensed it to Poniard Pharmaceuticals. In early November 2009, Poniard announced that a Phase 3 study in small cell lung cancer failed to achieve its primary efficacy endpoint and stopped development. In 2013, Encarta (predecessor to Tallikut Pharmaceuticals) acquired certain assets from Poniard including the Genzyme license. Accelerated Pharma obtained the rights via an exclusive license with Tallikut in June 2014.
    • 2016 Financials (9 mo.)($M): Operating Expenses: 2.7 (+114.0%); Net Loss: (2.7) (-114.0%); Cash Burn: (1.7) (-43.1%).
    | Thu, Nov. 10, 11:59 AM | 1 Comment
  • Thu, Nov. 10, 9:17 AM
    | Thu, Nov. 10, 9:17 AM
  • Thu, Nov. 10, 7:35 AM
    • As expected, the European Commission approves Pfizer's (NYSE:PFE) IBRANCE (palbociclib), in combination with an aromatase inhibitor [e.g., AstraZeneca's (NYSE:AZN) Arimidex (anastrozole)] for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The approval also covers the use of IBRANCE in combination with fulvestrant (AZN's FASLODEX) who have received prior endocrine therapy.
    • Palbociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6, downstream signaling pathways which lead to cellular proliferation. When combined with an antiestrogen, it inhibits the growth of breast cancer by interfering with these pathways and promoting the deterioration of cancer cells (senescence).
    • The advisory committee CHMP adopted a positive opinion in mid-September backing approval.
    | Thu, Nov. 10, 7:35 AM | 2 Comments
  • Thu, Nov. 10, 7:22 AM
    • AstraZeneca (NYSE:AZN) Q3 results ($M): Total Revenues: 5,699 (-4.1%); Product Sales: 5,025 (-14.1%); U.S.: 1,538 (-35.3%); Europe: 1,265 (-2.8%); Emerging Markets: 1,395 (-2.2%); China: 643 (+3.4%).
    • Segment Sales: Cardiovascular & Metabolic: 1,845 (-21.4%); Oncology: 867 (+19.1%); Respiratory: 1,110 (-9.8%); Other: 1,203 (-22.1%).
    • Net Income: 1,014 (+31.7%); EPS: 0.80 (+31.1%); CF Ops: 811 (-53.5%).
    • Key Product Sales: Symbicort: 697 (-17.8%); Crestor: 688 (-43.5%); Nexium: 516 (-19.5%); Pulmicort: 224 (+0.9%); Farxiga: 220; Brilinta/Brillique: 208 (+22.4%); Faslodex: 207 (+11.3%).
    • Consensus view was EPS of $0.74 on revenues of $5.6B.
    • Shares are down 3% premarket on average volume.
    | Thu, Nov. 10, 7:22 AM
  • Thu, Nov. 10, 6:10 AM
    • AstraZeneca (NYSE:AZN): Q3 EPS of $1.32 beats by $0.58.
    • Revenue of $5.7B (-4.2% Y/Y) misses by $250M.
    • Shares -3.01% PM.
    • Press Release
    | Thu, Nov. 10, 6:10 AM | 2 Comments
  • Wed, Nov. 9, 5:30 PM
    | Wed, Nov. 9, 5:30 PM | 3 Comments
  • Wed, Nov. 9, 8:08 AM
    • Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
    • Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN+3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
    | Wed, Nov. 9, 8:08 AM | 48 Comments
  • Wed, Nov. 9, 3:03 AM
    • Healthcare stocks, the weakest sector this year, may become winners, as Obamacare reforms are set to be "repealed and replaced" and major legislation Clinton proposed is unlikely to be imposed on drugmakers.
    • While Trump hasn't set out a comprehensive alternative to the Affordable Care Act (which may see 22M Americans lose current coverage), he said he'll encourage competition between markets in different states.
    • Insurance stocks: UNH, AET, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY
    • Drugmakers premarket: MYL +5.8%, NVS +3.4%, SNY +2.9%, AZN +2.4%, GSK +1.9%, PFE +1.8%, CELG +1%, ABBV, MRK, BMY, LLY, JNJ, ABT, ACET, ZTS, BIIB, REGN
    • #Election2016
    | Wed, Nov. 9, 3:03 AM | 14 Comments
  • Thu, Oct. 27, 3:56 PM
    • AstraZeneca (AZN -3.6%) heads south on triple normal volume on the heels of its announcement that the FDA has placed a partial clinical hold on its clinical trials assessing durvalumab in patients with head and neck squamous cell carcinoma (HNSCC).
    • The partial clinical hold, which suspends recruitment, was instituted so an analysis can be made on adverse events related to bleeding. The effort is part of routine safety monitoring of the Phase 3 KESTREL and EAGLE studies.
    • Bleeding is a common complication in therapies to treat HNSCC due to the nature of the disease, the proximity of tumors to major blood vessels and prior treatments such as surgery and radiation.
    • Durvalumab is a human monoclonal antibody that binds to programmed death ligand-1 (PD-L1) which is expressed by some tumors to evade detection by the immune system by binding to PD-1 on cytotoxic T lymphocytes. Blocking the interaction between PD-L1 and PD-1 enhances the immune system's ability to detect and kill cancer cells.
    | Thu, Oct. 27, 3:56 PM
  • Wed, Oct. 26, 8:42 AM
    • Results from a Phase 3 clinical trial, SOLO-2, assessing AstraZeneca's (NYSE:AZN) LYNPARZA (olaparib) for the maintenance treatment of platinum-resistant, BRCA mutation-positive ovarian cancer showed treatment with 300 mg twice daily as monotherapy extended progression-free survival (PFS) compared to placebo. The results were clinically meaningful and statistically significant. PFS substantially exceeded what was observed in a Phase 2 study, Study 19, in the same profile of patients.
    • Complete data will be submitted for presentation at a future medical conference. Plans for regulatory submissions are in process.
    • LYNPARZA inhibits an enzyme called poly ADP-ribose polymerase (PARP). It kills cancer cells by exploiting tumor DNA repair pathway deficiencies. It is approved in over 40 countries for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in partial or complete response to platinum-based chemo. In the U.S. it is approved for patients with deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemo. It is the first PARP inhibitor approved in the U.S.
    • Shares are off 1% premarket.
    | Wed, Oct. 26, 8:42 AM
  • Mon, Oct. 24, 7:52 AM
    • Ardelyx (NASDAQ:ARDX) appoints Reginald Seeto, MBBS, as Chief Operating Officer effective immediately. He joins the firm from AstraZeneca (NYSE:AZN) where he was VP, Partnering and Strategy.
    | Mon, Oct. 24, 7:52 AM