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News Breaks
June 18, 2014
10:17 EDTAMGN, ABBV, AGN, BIIB, BMY, SHPG, GILD, VRXShire rises after analyst predicts Allergan takeover
Shares of Irish drug maker Shire (SHPG) are climbing after an analyst at SunTrust predicted that Allergan (AGN) would soon look to buy the Irish company. WHAT'S NEW: A bid for Shire by Allergan is imminent, wrote SunTrust analyst John Boris in a note to investors earlier today. An acquisition of Shire would be more advantageous for Allergan shareholders than the proposed hostile takeover of the company by Valeant (VRX), Boris contended. An acquisition of Shire would boost Allergan's stock more than a Valeant deal, and would enable Allergan's shareholders to avoid the risk of holding Valeant's stock, the analyst stated. Following an acquisition of Shire by Allergan, the combined company would have sustainable, transparent revenue growth of about 10%, a diversified sales mix, high value research and development programs and a tax inversion, the analyst believes. Additionally, the transaction would boost Allergan's profit by 50% in its first year and would enable its profit growth to accelerate significantly, according to Boris. He kept a $200 price target and Buy rating on Shire shares. ALSO TODAY: Valeant announced that it has commenced an exchange offer for Allergan, taking its buyout proposal directly to stockholders. Under the terms of the offer, Allergan stockholders would be able to elect to exchange each of their Allergan shares for $72.00 in cash and 0.83 Valeant common shares, or an amount of cash, or a number of Valeant common shares, in each case subject to proration. The offer is scheduled to expire at 5:00 p.m., New York City time, on August 15. WHAT'S NOTABLE: On June 16, Reuters reported that Shire had hired Citigroup (C) as an adviser to prepare for takeover bids. Bankers believe that Shire could be an attractive takeover target for Bristol Myers (BMY), Abbvie (ABBV), Gilead (GILD), Biogen (BIIB) or Amgen (AMGN), the news service reported. PRICE ACTION: In early trading, Shire is up 4%, or $6.61, to $193.77 while Allergan is up 1%, or $1.27, to $161.80. Valeant is little changed at $118.90.
News For SHPG;AGN;VRX;BMY;ABBV;GILD;BIIB;AMGN From The Last 14 Days
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April 8, 2015
08:06 EDTBMYBristol-Myers completes acquisition of Flexus Biosciences
Bristol-Myers Squibb Company announced that it has completed the previously announced planned acquisition of Flexus Biosciences, Inc. The transaction includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.
07:24 EDTBIIBNeurotechnology Industry Organization to hold a conference
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05:30 EDTABBVEnanta announces data on regimens containing protease inhibitors paritaprevir
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April 7, 2015
17:58 EDTGILDGilead submits NDA for investigational combination for treatment of HIV-1
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16:00 EDTGILDOptions Update; April 7, 2015
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10:10 EDTSHPGJazz patent on Xyrem latest to be challenged by Kyle Bass
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08:10 EDTSHPGShire shares pricing in worst case scenario for patents, says Citigroup
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07:31 EDTBIIB, ABBVBiogen to present data on neurological disease therapies at AAN meeting
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07:14 EDTBMY, BIIBEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:13 EDTSHPGShire patent challenges only modest threat, says Jefferies
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05:23 EDTSHPGShire reaches agreement with FDA on clear regulatory path for SHP465
Shire announces that it has reached an agreement with the FDA on a clear regulatory path for SHP465, an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder, or ADHD, in adults. Shire has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD. While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population. The company anticipates the clinical trial's first patient, first visit to take place in August 2015, with study completion targeted by the last quarter of 2016. Shire then expects to submit to the FDA by 2Q17 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a 6-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017. This update follows Shire's announcement on October 9, 2014, that it was engaging the FDA to determine the parameters of clinical data requirements in order to submit the Class 2 resubmission.
April 6, 2015
16:17 EDTBMYOn The Fly: Closing Wrap
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12:44 EDTBMYOn The Fly: Midday Wrap
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12:13 EDTBMYuniQure price target raised to $40 from $35 at Piper Jaffray
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09:09 EDTSHPGShire says will defend patents 'vigorously' after Hayman petitions
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08:13 EDTBMYCelldex announces initiation of Phase 1/2 study of Varlilumab combination
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07:36 EDTGILDGilead Q1 HCV revenue poised to beat expectations, says RBC Capital
After analyzing weekly prescription data, RBC Capital believes that Gilead's weekly hepatitis C prescriptions are tracking towards $3.5B-$3.6B of revenue from hepatitis C drugs for Q1, versus the consensus outlook of about $2.6B. The firm keeps an Outperform rating on Gilead.
07:33 EDTBMYBristol-Myers announces strategic collaboration with uniQure
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05:19 EDTAMGNAmgen announces EC approval of Vectibix in combination with Folfiri
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April 5, 2015
14:43 EDTGILDActavis seeks FDA approval to market generic version of Gilead's Letairis
Actavis (ACT) on Friday, confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Ambrisentan Tablets, 5 mg and 10 mg. Actavis' ANDA product is a generic version of Gilead Science's (GILD) Letairis, which is a treatment for pulmonary arterial hypertension. Gilead Sciences and Royalty Pharma Collection Trust filed suit against Actavis on April 1, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent number RE42,462. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Letairis and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending December 31, Letairis had global sales of approximately $595M, according to Gilead.
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