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Stock Market & Financial Investment News

News Breaks
June 26, 2013
05:55 EDTPFE, PFE, PFE, DNA, DNA, DNA, MACK, MACK, MACK, AMGN, AMGN, AMGN, IMGN, IMGN, IMGN, RHHBY, RHHBY, RHHBYIBC Life Sciences to hold a summit
8th Annual Next Generation Protein Therapeutics Summit is being held in San Diego, California on June 26-28.
News For PFE;DNA;MACK;AMGN;IMGN;RHHBY From The Last 14 Days
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April 22, 2015
05:27 EDTRHHBYRoche reports Q1 group sales CHF 11.83B vs. CHF 11.50B
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April 21, 2015
19:06 EDTAMGNOn The Fly: After Hours Movers
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17:07 EDTAMGNAmgen shares higher by 2.69% after Q1 results, guidance
16:04 EDTAMGNAmgen raises FY15 EPS view to $9.35-$9.65 from $9.05-$9.40, consensus $9.32
Narrows FY15 revenue view to $20.9B-$21.3B from $20.8B-$21.3B, consensus $20.98B.
16:02 EDTAMGNAmgen reports Q1 EPS $2.48, consensus $2.10
Reports Q1 revenue $5.03B, consensus $4.91B.
15:28 EDTAMGNNotable companies reporting after market close
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13:51 EDTAMGNEarnings Watch: Amgen's Enbrel, Neulasta sales key for Q1 results
Amgen (AMGN) is scheduled to report first quarter earnings after the market close on Tuesday, April 21 with a conference call scheduled for 5:00 pm ET. Amgen, a biotechnology medicines company, engages in the discovery, development, manufacture, and marketing of human therapeutic products in the areas of supportive cancer care, inflammation, nephrology, and bone diseases. EXPECTATIONS: Analysts are looking for earnings per share of $2.10 on revenue of $4.91B, according to First Call. The consensus range for EPS is $1.91-$2.25 on revenue of $4.62B-$5.13B. LAST QUARTER: Amgen reported fourth quarter EPS of $2.16 against estimates of $2.05 on revenue of $5.33B against estimates of $5.2B. With its Q4 report, Amgen also reiterated its fiscal year EPS view of 9.05-$9.40, on revenue of of $20.8B-$21.3B. Total product sales increased 8% for Q4 versus Q4 of 2013. The increase was driven primarily by Enbrel, Neulasta, Prolia, XGEVA and Vectibix .Growth for the quarter was due primarily to higher unit demand, and to a lesser extent, price. Product sales increased 6% for the full year driven by strong performance across the portfolio. STREET RESEARCH: On March 23, Piper Jaffray said the "positive" trial data Teva (TEVA) reported for its anti-CGRP antibody in migraines is another important validation for the class of drugs that is also being worked on by Amgen, Eli Lilly (LLY), and Alder Biopharmaceuticals (ALDR). The firm said it thinks Amgen is one of the leaders in CGRP antibody space and reiterated its Overweight rating and $187 price target on Amgen shares. On March 16, RBC Capital said it believes that data presented by Amgen on its evolocumab drug for hyperlipidemia.was "very positive." The firm expects the drug to be approved in late summer. It predicts that revenue from the drug will ramp modestly and steadily, and then accelerate after positive studies of the drug's effects are released in 2017. RBC Capital estimates that worldwide revenue from the drug will peak at $2.5B+. It keeps an Outperform rating on Amgen. PRICE ACTION: Amgen shares are higher by around 6% since its last earnings report on January 27, and are up 1.25% to to $168.06 in afternoon trading ahead of Tuesday's earnings report.
10:01 EDTPFEPfizer receives FDA breakthrough therapy designation for Xalkori
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09:22 EDTMACKOn The Fly: Pre-market Movers
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08:18 EDTPFEPain Therapeutics resumes responsibility for Remoxy
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08:10 EDTMACKMerrimack to present updated clinical data from Phase 1 study of MM-141
Merrimack Pharmaceuticals announced updated clinical data from a multi-arm Phase 1 study of MM-141, a bispecific antibody targeting IGF-1R and ErbB3. The data were presented in an oral session at the 2015 American Association for Cancer Research Annual Meeting in Philadelphia, PA. The trial evaluated the safety and tolerability of MM-141 as a monotherapy and in combination with everolimus or with nab-paclitaxel and gemcitabine in patients with advanced solid tumors.
08:06 EDTPFEPfizer says Phase 3 inotuzumab ozogamicin study met first primary endpoint
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07:06 EDTRHHBYBina Tech, AstraZeneca announce collaborative agreement for GMS
Bina Technologies, a member of the Roche Group (RHHBY), and AstraZeneca (AZN) announced that they have entered into an agreement for AstraZeneca to become the first member to join the Bina Alliance Program and to further develop the Bina Genomic Management Solution. AstraZeneca will utilize the Bina GMS as an enterprise platform to support its development work across three main therapeutic areas: oncology, cardiovascular and metabolic disease, and respiratory, inflammation and autoimmunity. Bina’s proprietary technology enables translational and academic researchers to perform fast and scalable analyses to maximize the value of genomic data. Under the terms of the agreement, AstraZeneca will adopt Bina GMS globally to support enterprise genomic data analysis and management. Bina in turn will provide AstraZeneca with direct access to its scientific and engineering teams to further develop the Bina GMS for pharmaceutical applications.
06:01 EDTMACKMerrimack price target raised to $16 from $13 at Mizuho
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05:33 EDTRHHBYInovio, Roche initiate clinical trial for DNA immunotherapy to treat HCB
Inovio Pharmaceuticals (INO) announced that it has initiated a Phase I trial to evaluate Inovio's DNA immunotherapy in patients who are chronically infected with hepatitis B. In 2013, Roche (RHHBY) and Inovio entered into a partnership to co-develop and commercialize Inovio's hepatitis B immunotherapy. This trial initiation triggers a $3M milestone payment from Roche to Inovio. This phase I, randomized, open-label, active-controlled, dose escalation study will evaluate the safety, tolerability, and immunogenicity of Inovio's hepatitis B immunotherapy, INO-1800, alone or in combination with INO-9112, Inovio's IL-12-based immune activator. This international study will enroll patients in the United States and Asia Pacific region with a primary endpoint of safety and tolerability of the therapy. The secondary endpoints will evaluate the cellular and humoral immune response to INO-1800 and investigate the therapy's effect on several viral and antiviral parameters. All trial subjects are also medicated with standard-of-care antiviral therapies.
April 20, 2015
16:07 EDTMACKMerrimack announces final clinical results for MM-302 Phase 1 study
Merrimack Pharmaceuticals announced updated and final clinical results for the Phase 1 study of MM-302, a novel HER2-targeted liposomal doxorubicin, in HER2-positive metastatic breast cancer. Data described the safety and promising clinical activity of MM-302 in patients with advanced HER2-positive metastatic breast cancer. Results from the trial showed that the group of patients treated with 30 mg/m2 or more of MM-302 alone, in combination with trastuzumab or with trastuzumab and cyclophosphamide, had a median progression free survival, or mPFS, of 7.6 months and an overall response rate, or ORR, of 11%. Of note, 25 patients who had not been previously treated with anthracyclines had an mPFS of 11 months and an ORR of 24%. The most frequent adverse events occurring in greater than 20% of the population in this Phase 1 study were constipation, cough, decreased appetite, diarrhea, dyspnea, fatigue, nausea, neutropenia, stomatitis and vomiting. The most common Grade 3/4 adverse event was neutropenia observed in 8 patients. Six out of 69 patients 9% had protocol-defined asymptomatic declines in left ventricular ejection fraction, or LVEF. In 1 of the 6 patients, this was reported as a Grade 1 cardiac failure that was possibly related to study treatment. Merrimack is currently enrolling the HERMIONE study that is designed to support a potential application for accelerated approval in the U.S. and conditional marketing authorization in the E.U. The HERMIONE study is for HER2-positive, metastatic breast cancer patients who are anthracycline-naive and have not been previously treated with pertuzumab and T-DM1-containing regimens.
08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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07:20 EDTMACK, IMGNAmerican Association for Cancer Research to hold annual meeting
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07:18 EDTDNAAmerican Academy of Neurology to hold annual meeting
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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