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News Breaks
July 1, 2014
09:05 EDTGLYC, PFEGlycoMimetics announces agreement with FDA for rivipansel
GlycoMimetics (GLYC) announced today that Pfizer (PFE) has reached agreement with the U.S. Food & Drug Administration under a special protocol assessment for a Phase 3 trial for rivipansel. A SPA is a written agreement between a trial’s sponsor and the FDA regarding the design, endpoints and statistical analysis approach of a Phase 3 clinical trial, results from which could potentially support approval of a New Drug Application. Rivipansel is being developed as a potential therapy for treatment of patients with sickle cell disease who are hospitalized for vaso-occlusive crisis. Rivipansel has previously received both Orphan Drug and Fast Track status for the treatment of VOC from the FDA. Pfizer plans to begin the Phase 3 program before the end of 2014.
News For GLYC;PFE From The Last 14 Days
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May 21, 2015
07:37 EDTPFEPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
07:46 EDTPFEDeutsche Bank positive on potential Pfizer, GSK merger
Deutsche Bank analyst Gregg Gilbert believes a large foreign deal for Pfizer (PFE) may make sense and says a buyout of GlaxoSmithKline (GSK) could be "materially" accretive to earnings while improving the company's tax situation over time. Gilbert assumes a $60 per share buyout price for GlaxoSmithKline in a research note this morning titled "Introducing 'PfizerKline'". The stock closed yesterday up 2c to $44.68. Gilbert reiterates a Buy rating on Pfizer with a $41 price target. Shares ended yesterday up 23c to $34.21.
May 19, 2015
09:30 EDTGLYCGlycoMimetics initiates Phase 1/2 clinical trial of GMI-1271
GlycoMimetics announced that the first patient has been dosed in a Phase 1/2 clinical study designed to evaluate the safety, pharmacokinetics and efficacy of GMI-1271, a novel and proprietary E-selectin antagonist in the company’s pipeline, when used in combination with chemotherapy in patients with acute myeloid leukemia. GlycoMimetics is initially exploring the clinical use of the drug candidate in hematologic malignancies following the successful completion of a Phase 1 healthy volunteer study late last year. The company announced last week that the U.S. FDA has granted Orphan Drug designation to GMI-1271 for treatment of AML. This Phase 1/2, open-label multicenter study is designed to determine safety, PK and efficacy of GMI-1271 in combination with chemotherapy in male and female adult patients with AML. Study sites are located in the United States, Australia and Ireland. While the primary objective is to analyze safety, additional endpoints include: mobilization of AML blasts, effect on neutropenia, time to and duration of remission, evaluation of event-free survival and evaluation of the overall survival probability at six- and 12-months. Approximately 77 subjects will be enrolled. The study will include a dose escalation phase followed by expansion of the study once the dose for the Phase 2 portion has been selected.
06:55 EDTPFEGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 18, 2015
06:58 EDTPFEActavis CEO says chances of Pfizer offer are 'unlikely', Financial Times says
Actavis (ACT) CEO Brent Saunders said the chances of Pfizer (PFE) making an offer are "incredibly unlikely," reports the Financial Times. Saunders said he has heard the gossip that Actavis could become a takeover target for a larger group, but he spends "zero time thinking about it." Reference Link
May 15, 2015
09:31 EDTPFEAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
May 14, 2015
12:29 EDTPFEPfizer receives 'second request' from FTC regarding potential Hospira merger
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10:31 EDTGLYCGlycoMimetics granted orphan drug designation for GMI-1271 for treatment of AML
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09:03 EDTGLYCGlycoMimetics receives orphan status for AML treatment
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08:39 EDTPFETargacept, Catalyst Biosciences amend definitive merger agreement
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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May 13, 2015
19:17 EDTPFEHospira and FDA detect security vulnerabilities in infusion pumps
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17:19 EDTPFEPfizer, Merck KGaA to present data at ASCO for avelumab
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13:43 EDTPFEHospira shareholders approve merger with Pfizer
Hospira (HSP) announced that Hospira shareholders voted in favor of the proposal to adopt the merger agreement with Pfizer (PFE) at a special meeting of stockholders held May 13 in Denver, Colorado. On February 5, Hospira and Pfizer announced they had entered into a merger agreement under which Pfizer will acquire Hospira for $90 per share in cash for a total enterprise value of approximately $17B. The merger is subject to customary closing conditions, one of which was approval of the merger by Hospira's shareholders. Additional closing conditions to be met include obtaining regulatory approvals in several jurisdictions. Hospira and Pfizer continue to expect the merger to close in the second half of 2015.
07:31 EDTPFEHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
May 11, 2015
17:36 EDTPFEAthersys down 10.1% after Pfizer notified that it will terminate agreement
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17:34 EDTPFEAthersys receives notification that Pfizer will terminate agreement
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16:33 EDTPFEPfizer takes minority interest in AM-Pharma, secures option to acquire company
AM-Pharma and Pfizer announced that Pfizer has acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury related to sepsis. There are no drugs currently approved for this condition and the only treatment option is dialysis and supportive care. Results from the current Phase II trial for recAP are expected in the second half of 2016. Under the terms of the agreement, Pfizer has made an upfront payment of $87.5M for the minority equity interest and exclusive option, with additional potential payments of up to $512.5M upon option exercise and potential launch of any product that may result from this agreement. Other terms of the transaction were not disclosed. “Pfizer is committed to advancing the science to address the high unmet medical need in Acute Kidney Injury,” said Mikael Dolsten, M.D., Ph.D., president, Worldwide Research and Development at Pfizer. “Clinical data for recAP show the potential to uniquely address Acute Kidney Injury in the setting of sepsis, and we look forward to working with our partners at AM-Pharma as we aim to accelerate the development of recAP into a potential first-in-class treatment for patients.”

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