AstraZeneca Group plcNYSE
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 clinicaltrials.gov 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.
Thu, Nov. 17, 7:51 AM
- Allergan (NYSE:AGN) finalizes its licensing agreement with AstraZeneca's (NYSE:AZN) MedImmune unit for IL-23 monoclonal antibody MEDI2070. The product candidate is in mid-stage development for Crohn's disease and ulcerative colitis.
- Previously: AstraZeneca signs $1.5B antibody deal with Allergan (Oct. 3)
Fri, Nov. 11, 12:27 PM
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, 9:17 AM
- Gainers: TUBE +82%. SODA +18%. AHT +11%. AEG +10%. ZLTQ +10%. NAT +9%. TASR +9%. MTL +9%. SHAK +8%. KSS +8%. EBIO +8%. UBS +8%. PUK +7%. FCEL +8%. ARIA +6%. FCX +6%. RBS +6%. ENDP +6%. BCS +6%. CS +5%.
- Losers: SUNW -31%. ANTH -19%. BVX -14%. NVAX -11%. WUBA -11%. BBD -8%. SEDG -7%. RRR -6%. AZN -6%. VIV -6%. SBS -5%. NGG -5%.
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, 7:22 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, 6:10 AM
Wed, Nov. 9, 5:30 PM
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, 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
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.
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.
Mon, Oct. 24, 7:52 AM
Tue, Oct. 18, 9:58 AM
- The FDA accepts for review AstraZeneca's (AZN +1.5%) resubmitted New Drug Application (NDA) seeking approval of ZS-9 for the treatment of hyperkalemia (elevated potassium in the blood). The agency has categorized the refiling as a Class 2 Resubmission which means it may include a presentation to an advisory committee and requires a reinspection of its manufacturing facility. An action date (PDUFA) is not disclosed.
- In May, the company received a Complete Response Letter (CRL) regarding its original filing. The CRL cited deficiencies observed during an on-site inspection of the manufacturing facility and the receipt of new data that it had not had time to review.
- AstraZeneca acquired the rights to ZS-9 via its $2.7B takeover of ZS Pharma in December 2015.
- Previously: FDA rejects AstraZeneca's ZS-9 NDA; competitor Relypsa up 29% premarket (May 27)
Mon, Oct. 10, 12:22 PM
- The FDA grants tentative approval for Intellipharmaceutics' (IPCI +18.5%) generic version of AstraZeneca's (AZN -0.6%) Seroquel XR (quetiapine fumarate), an oral antipsychotic medicine indicated for the treatment of schizophrenia and manic/mixed episodes associated with bipolar disorder.
- The approval is tentative because the company cannot launch the product until November 1 pursuant to a July 2012 settlement agreement with AstraZeneca. Also, there are two other companies with first-to-file status that may launch their versions on the same date. There is a 180-day exclusivity period related to first-to-file so Intellipharmaceutics' launch may be delayed until after this period.