Thu, Feb. 4, 4:51 AM
- AstraZeneca (NYSE:AZN): Q4 EPS of $0.94 beats by $0.03.
- Revenue of $6.4B (-4.8% Y/Y) beats by $130M.
- The board declared semi-annual dividend of $1.90/share bringing total annual dividend to $2.80/share. The dividend is payable on March 21 to shareholders of record of Feb. 17.
- FY16 CER guidance: Total Revenue and core EPS to decline in low to mid single-digit percentage including dilutive effects from recent transactions.
Thu, Feb. 4, 4:01 AM
- Credit Suisse (NYSE:CS) reported its first annual loss since 2008 as it wrote off billions of dollars in goodwill, set aside litigation provisions and suffered a trading downturn.
- Statoil (NYSE:STO) slashed its capital spending budget but said it would keep its dividend steady after topping fourth quarter expectations.
- Driven by a robust performance in its retail and wholesale divisions, ING posted a better-than-expected Q4 and announced a full-year dividend of €0.65 per share.
- AstraZeneca (NYSE:AZN) expects low to mid-single digit percentage drops in earnings this year, in part due to a flood of generic cholesterol drugs.
- Vodafone (NASDAQ:VOD) met expectations with a 1.4% rise in revenue during FQ3, its sixth consecutive quarter of growth, as a recovery in Europe gained pace.
Wed, Feb. 3, 5:30 PM
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Wed, Feb. 3, 8:59 AM
- As expected, the European Commission clears AstraZeneca's (NYSE:AZN) TAGRISSO (osimertinib) 80 mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.
- TAGRISSO received a positive advisory committee endorsement in December.
- Previously: AstraZeneca keeping Europe's CHMP busy with three positive reviews (Dec. 18, 2015)
Tue, Feb. 2, 8:02 AM
- The FDA designates privately held Cambridge, MA-based Nimbus Therapeutics' NDI-010976 for Fast Track review for the treatment of nonalcoholic steatohepatitis (NASH).
- NDI-010976 inhibits an enzyme called aceyl-COa carboxylase that plays a key role in the metabolism of fatty acids. A Phase 2 clinical trial is expected to commence in H1.
- NASH-related tickers: (NASDAQ:ICPT)(NASDAQ:TBRA)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:DRRX)(NASDAQ:CNAT)(NASDAQ:VBLT)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)(OTCPK:GNFTF)(NYSEMKT:CANF)
Tue, Feb. 2, 7:38 AM
- AstraZeneca (NYSE:AZN) completes its acquisition of 55% of Dutch biotech Acerta Pharma for an upfront payment of $2.5B plus a second payment of $1.5B triggered by the earlier of the first regulatory approval of acalabrutinib for any indication in the U.S. or the end of 2018.
- Acalabrutinib (ACP-196) is an orally available second generation inhibitor of an enzyme called Bruton's tyrosine kinase (BTK) that is in development for the treatment of a range of cancers.
- Previously: AstraZeneca buys 55% of Acerta Pharma for $4B (Dec. 17, 2015)
Mon, Feb. 1, 11:52 AM
- Results from a Phase 2 clinical trial run by Eli Lilly (LLY -1.1%) assessing LY2944876 (Transition Therapeutics' (TTHI -31.5%) TT401) for the treatment of type 2 diabetes showed statistically significant improvements (up to reductions of 1.43%) in HbA1c levels compared to placebo but similar to AstraZeneca's (AZN +0.6%) Bydureon (exenatide).
- On the plus side, patients receiving the 50 mg dose of TT401 experienced statistically valid weight loss of up to 3.3 kg versus both placebo and exenatide at Weeks 12 and 24.
- The data will be presented at a future scientific meeting.
- TT401 has a dual mechanism of action, similar to Lilly's Trulicity (dulaglutide). Investors appear to perceive that Lilly may opt out of proceeding to Phase 3 development since there was no significant advantage in lowering HbA1c levels over Bydureon. Lilly abandoned another Transition diabetes candidate, TT-223, in 2008.
Fri, Jan. 29, 7:34 AM
- Allergan plc (NYSE:AGN) and AstraZeneca (NYSE:AZN) ink a global agreement to develop and commercialize ATM-AVI, an investigational fixed-dosed combination antibiotic, aztreonam and avibactam, for the treatment of serious infections caused by metallo-beta-lactamase (MBL)-producing Gram-negative bacteria, a difficult-to-treat subtype of carbapenem-resistant Enterobacteriaceae for which there are limited treatment options.
- Under the terms of the agreement, Allergan owns commercialization rights in the U.S. and Canada and AstraZeneca owns commercialization rights elsewhere.
- ATM-AVI is the first drug candidate developed under a September 2015 public-private partnership between AZN and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. The aim of the alliance is to develop drugs to treat illnesses caused by bioterrorism agents and antibiotic-resistant infections.
Thu, Jan. 28, 11:24 AM
- The FDA designates AstraZeneca's (AZN -0.8%) LYNPARZA (olaparib) a Breakthrough Therapy for the treatment of BRCA1/2 or ATM gene-mutated metastatic Castration Resistant Prostate Cancer in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent.
- LYNPARZA inhibits an enzyme called poly ADP-ribose polymerase (PARP). It kills cancer cells by exploiting tumor DNA repair pathway deficiencies. It was cleared by the FDA in December 2014 for the treatment of a certain type of ovarian cancer.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
Wed, Jan. 27, 7:46 AM
- Results from a Phase 2b clinical trial assessing Boehringer Ingelheim's GIOTRIF/GILOTRIF (afatinib) compared to AstraZeneca's (NYSE:AZN) IRESSA (gefitinib) showed afatinib's superiority in reducing the risk of cancer progression and the risk of treatment failure by 27% in patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). The data are being presented today at the 14th Annual British Thoracic Oncology Group Conference in Dublin, Ireland.
- Data from the study, called LUX-Lung 7, showed an improvement in progression-free survival (PFS) in the afatinib cohort over time compared to gefitinib. At 18 months, the proportions of patients alive and progression-free were 27% and 15%, respectively. At 24 months, the proportions were 18% and 8%, respectively. Patients receiving afatinib experienced a significantly longer time on treatment (27% lower risk of treatment failure) and demonstrated a greater proportion who experienced a clinically meaningful reduction in tumor size (70% versus 56%). The median duration of response also favored afatinib (10.1 months vs. 8.4 months).
- Adverse events (AEs) were consistent with known safety profiles of both drugs. The frequency of serious AEs was higher for afatinib (44.4% vs. 37.1%) while the rate of treatment-related discontinuation was similar (6.3%). The most common grade 3 or higher afatinib-related AEs were diarrhea (12.5%) and rash/acne (9.4%).
- Afatinib is approved in over 60 countries for the first-line treatment of EGFR+ NSCLC.
Mon, Jan. 25, 10:00 AM
- The FDA accepts for review the Biologics License Application (BLA) submitted by AstraZeneca (AZN +0.8%), in partnership with Valeant Pharmaceuticals (VRX -0.5%), seeking clearance of brodalumab for the treatment of moderate-to-severe plaque psoriasis. The agency's action date (PDUFA) is November 16.
- Valeant has exclusive rights to develop and commercialize brodalumab worldwide, except in Japan and certain other Asian countries where Kyowa Hakko Kirin owns the rights. It acquired the rights after Amgen (AMGN +0.4%) backed out due to the potential adverse side effect increased suicidal thoughts.
- Brodalumab is a human monoclonal antibody that binds to interleukin-17 (IL-17), thus blocking its binding to its receptor and inhibiting inflammatory signaling.
- Previously: Valeant strikes psoriasis-drug deal with AstraZeneca (Sept. 1, 2015)
- Previously: Amgen terminates brodalumab co-development deal with AstraZeneca (May 22, 2015)
Fri, Jan. 22, 8:38 AM
- Zafgen's (NASDAQ:ZFGN) recent bullish action gets some attention: FBR & Co. upgrades to Outperform from Market Perform. Price target raised to $20 (120% upside) from $9; RBC Capital upgrades to Outperform from Sector Perform. Price target raised to $21 (131% upside).
- Anthem (NYSE:ANTM) upgraded to Buy from Neutral by Goldman Sachs. Price target raised to 168 (21% upside) from $160.
- Kite Pharma (NASDAQ:KITE) upgraded to Outperform from Market Perform by FBR & Co. Price target raised to $75 (47% upside) from $72.
- AstraZeneca (NYSE:AZN) upgraded to Equal Weight from Underweight by Barclays. Price target raised to ₤50 from ₤44.
- LifePoint Health (NASDAQ:LPNT) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $78 (17% upside) from $81.
Wed, Jan. 20, 7:54 PM
- Dynavax (NASDAQ:DVAX) gained 9.3% after its announcement that an amendment to its collaboration deal with AstraZeneca (AZN -0.1%) means that AstraZeneca, not Dynavax, will conduct a Phase 2a trial of AZD1419 in asthma patients.
- The safety and efficacy trial will take place this year. A previous Phase 1a study showed ascending doses of AZD1419 were well tolerated in patients.
- The treatment is a second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use.
- After hours today: AZN -0.8%.
Mon, Jan. 11, 8:51 AM
- Incyte (NASDAQ:INCY) and AstraZeneca (NYSE:AZN) enter into a new collaboration to assess the combination of Incyte's JAK1 inhibitor, INCB39110, and AstraZeneca's Tagrisso (osimertinib) as second-line treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the T790M resistance mutation.
- Under the terms of the agreement, both companies will collaborate on a Phase 1/2 study conducted by Incyte. The first phase will establish the recommended combination dose and the second will assess its safety and efficacy. Late-stage development will depend of the results from the trial.
Mon, Jan. 11, 8:37 AM
- AstraZeneca (NYSE:AZN) enters into a new collaboration with Moderna Therapeutics to discover, co-develop and commercialize messenger RNA (mRNA) therapeutic candidates for the treatment of a range of cancers. This new partnership adds to their 2013 collaboration to develop mRNA candidates in cardiovascular, metabolic and renal diseases, in addition to selected targets in cancer.
- The collaboration will leverage AstraZeneca unit MedImmune's protein engineering and cancer biology know-how with Moderna's mRNA platform.
- Under the terms of the deal, the companies will collaborate on two specific immuno-oncology programs. Moderna, through its oncology-focused venture, Onkaido, aims to deliver one Investigational New Drug (IND) application-ready molecule for each of the programs. AstraZeneca will be responsible for early clinical development, led by MedImmune, while both AstraZeneca and Moderna will share the costs of late-stage development. They will co-commercialize the products in the U.S. on a 50:50 profit sharing basis. AstraZeneca will lead ex-U.S. commercialization with Moderna receiving tiered royalties up to the high double digits on ex-U.S. sales.
- Under their original strategic agreement, AstraZeneca has exclusive access to any target of its choice in the cardiometabolic space, as well as specific cancer targets, for up to five years. Several projects are progressing toward clinical development with the first in-human study expected to commence by the end of the year.
Tue, Jan. 5, 8:01 AM
- Ardelyx (NASDAQ:ARDX) completes its open label pharmacodynamic study of hyperkalemia candidate RDX022 in healthy adult volunteers. The results showed that RDX022 effectively binds to potassium in the gastrointestinal tract. All doses (up to 27.5 g/day) were generally well-tolerated.
- According to the company, RDX022 overcomes the limitations of other drugs used to treat hyperkalemia (abnormally high levels of potassium in the blood) due the absence of sodium as a counter-ion while being better tasting.
- A Phase 3 trial is planned for H2 2016.
- Hyperkalemia-related tickers: (NASDAQ:RLYP)(NYSE:AZN)
AstraZeneca Plc is a global research-based biopharmaceutical company, which primarily focuses on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. The... More
Industry: Drug Manufacturers - Major
Country: United Kingdom
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