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Stock Market & Financial Investment News

News Breaks
May 13, 2014
14:25 EDTARIA, ARIA, ARIA, RXDX, RXDX, RXDX, RHHBY, RHHBY, RHHBY, PFE, PFE, PFE, PBYI, PBYI, PBYI, NVS, NVS, NVS, MRTX, MRTX, MRTX, MRK, MRK, MRK, INCY, INCY, INCY, EXEL, EXEL, EXEL, CLVS, CLVS, CLVS, BMY, BMY, BMY, AZN, AZN, AZN, TSRO, TSRO, TSROLeerink pharma and biotech analysts hold an analyst/industry conference call
Biotech and Pharmaceuticals Analysts provide updates on lung cancer, in conjunction with the upcoming ASCO Annual Meeting, on an Analyst/Industry conference call to be held on May 20 at 3 pm.
News For ARIA;AZN;BMY;CLVS;EXEL;INCY;MRK;MRTX;NVS;PBYI;PFE;RHHBY;RXDX;TSRO From The Last 14 Days
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February 20, 2015
10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
07:23 EDTBMY, AZN, RHHBY, PFEAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTAZN, MRK, NVSAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
06:35 EDTARIASarissa Capital seeks retirement of ARIAD CEO, board seats
Sarissa Capital disclosed in a regulatory filing that it has been in negotiations with members of ARIAD's board in an attempt to avoid a potential proxy contest. Sarissa said it indicated its belief that the board undertake measures to effect and facilitate the imminent retirement of Harvey Berger as CEO and that any settlement of a potential proxy contest must include the CEO’s retirement. It added that no settlement has been reached. Sarissa believes the board "as currently constructed is not up to the task of providing the stewardship necessary to optimally navigate" the company. On February 19, Sarissa notified ARIAD that it intends to appear at the company's 2015 annual meeting of stockholders to nominate and seek to elect Richard Mulligan, Ph.D. and Anna Protopapas to the eight member staggered board of directors. Sarissa intends to seek to unseat Harvey Berger, ARIAD's Chairman and CEO, and Wayne Wilson, the lead independent director, with its two nominees. Sarissa added that it is "extremely concerned" with the conduct of certain members of the board, "particularly with respect to compensation, governance and financial matters." The hedge fund said it may ultimately initiate court proceedings to seek to remove one or more directors for cause based on potential breaches of their fiduciary duties. Sarissa Capital has a 6.9% stake in ARIAD.
05:53 EDTTSROTESARO price target raised to $50 from $44 at Mizuho
Mizuho raised its price target for TESARO shares to $50 citing increased confidence and market opportunity for niraparib following the company's Q4 results. The firm expects approval for rolapitant in Q3 and reiterates a Buy rating on the stock.
February 19, 2015
18:25 EDTRHHBY, PFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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16:13 EDTTSROTESARO reports Q4 EPS ($1.33), consensus ($1.03)
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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10:32 EDTEXELHigh option volume stocks:
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09:12 EDTEXELOn The Fly: Pre-market Movers
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09:09 EDTRHHBYLeerink's life science tools analyst holds an analyst/industry conference call
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08:38 EDTMRKNewLink reports clinical development milestone achieved with Merck for rVSV-EBOV
NewLink Genetics (NLNK) announced that it had received notification from Merck (MRK) that the milestone event specified in the license and collaboration agreement between the two companies relating to the further development of the rVSV-EBOV, Ebola, vaccine candidate had been achieved. Under the terms of the agreement, NewLink Genetics will receive a payment of $20M in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.
07:39 EDTARIAARIAD expects to file IND application for AP32788 this year
ARIAD says "We expect to file an investigational new drug application for AP32788 this year and to begin a Phase 1/2 proof-of-concept trial in 2016. This will be our third IND filing of an internally discovered oncology development candidate in the past eight years." The company also says "We anticipate presenting updates from the ongoing Phase 1/2 clinical trial of brigatinib at the 2015 European Lung Cancer Conference and the American Society of Clinical Oncology meetings later this year. Additionally, we expect to present preliminary data from the brigatinib ALTA trial in the second half of 2015."
07:38 EDTARIAARIAD sees FY15 net product revenues from sales of Iclusig $130M-$140M
Net product revenues from sales of Iclusig are expected to be in the range of $130M-$140M. This guidance includes sales of Iclusig in the U.S., Europe, and other select countries where ARIAD has distributorships in place. R&D expenses are expected to be in the range of $185M-$195M, reflecting increased development activities for Iclusig, brigatinib, and AP32788, as well as ongoing discovery research efforts. Expenses related to Iclusig represent approximately 50% of total R&D expenses and include the three new planned trials to begin this year, as well as all ongoing trials. Expenses related to brigatinib represent approximately 35% of total R&D expenses and include the two ongoing trials and NDA-enabling pre-clinical studies.
07:37 EDTARIAARIAD reports Q4 EPS (3c), consensus (20c)
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07:12 EDTNVS, PFEWharton Health Care Club to hold a conference
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06:45 EDTRHHBYStudy shows Roche's treatments equal to Eylea in most cases, NY Times says
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05:31 EDTEXEL, RHHBYExelixis announces acceptance of NDA for Genentech cobimetinib
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05:26 EDTRHHBYFDA grants Genentech cobimetinib priority review for combination use
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February 18, 2015
08:13 EDTINCYIncyte shares poised to rise further, says Argus
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