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June 22, 2014
20:56 EDTABBV, SHPGAbbVie looks to diversify product mix with Shire offer, Bloomberg says
With AbbVie's (ABBV) $46.5B bid for Dublin based for Shire (SHPG), Richard Gonzalez, the AbbVie CEO is looking to diversify his company's product mix which is currently largely dependent on arthritis medicine Humira, says Bloomberg. Reference Link
News For ABBV;SHPG From The Last 14 Days
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October 13, 2015
16:18 EDTSHPGShire initiated with an Outperform at Northland
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07:21 EDTSHPGRadius Health 'on radar' of Shire, FT Alphaville says
In a "Market's Live" chat on FT Alphaville, Paul Murphy said he was "reliably informed" from a "NY source with good form" that Radius Health (RDUS) is "on Shire's (SHPG) radar." Shares of Radius Health, which fell $2.53 to close at $55.27 yesterday is up about 12% to trade above $62 per share in early pre-market trading. Reference Link
07:12 EDTSHPGShire granted fast track by FDA for investigation of Cinryze
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October 12, 2015
10:54 EDTSHPGAnalyst says Radius Health osteoporosis drug data should satisfy FDA
Shares of Radius Health (RDUS) were fractionally higher in morning trading after rising over 4% earlier after the company said a Phase 3 trial of its osteoporosis therapy abaloparatide lowered bone fractures by 70% in an 18-month period. WHAT'S NEW: On Saturday, Radius Health announced top-line data from the Phase 3 ACTIVE trial of its osteoporosis therapy abaloparatide, or ABL, in women with postmenopausal osteoporosis at the American Society for Bone and Mineral Research 2015 Annual Meeting. The data showed that patients who received 18 months of daily ABL injections saw a 70% reduction in the incidence of major osteoporotic fractures compared to placebo, the company said. "The Phase 3 ACTIVE trial found that women who were taking abaloparatide experienced an early risk reduction for major osteoporotic fractures," said Lorraine Fitzpatrick, chief medical officer at Radius Health. "These data could be important to patients who have increased skeletal fragility and greater risk of additional fractures." WHAT'S NOTABLE: Radius said it is also developing a transdermal patch for ABL as a separate option from the injection and that it also presented "positive" pharmacokinetic results from a study evaluating the patch's efficacy at the same Annual Meeting. Separately, on September 29, Ben Harrington of the Betaville blog said during an appearance on Tip TV that he heard that "something will be happening" with reference to mergers and acquisitions involving Radius Health over the "next few weeks." He mentioned that the company could be a takeover target for Shire (SHPG) should it abandon its attempt to acquire Baxalta (BXLT). STREET RESEARCH: Canaccord analyst John Newman said this morning that he thinks that the U.S. Food and Drug Administration will be satisfied with the duration of continuous abaloparatide treatment after looking over the full data package starting at year-end 2015. Newman said he is awaiting further details moving forward related to the ABL transdermal patch since photographs of the patch were not allowed at the meeting. The analyst reiterated a Buy rating and $85 price target on Radius Health's shares. Looking ahead, Newman sees FDA approval for abaloparatide subcutaneous formulation in the third quarter of 2016, positive data by year-end 2015 for RAD-1901 and "successful" formulation of the patch formulation. PRICE ACTION: In morning trading, Radius Health gained 0.48% to $58.08.
October 9, 2015
08:33 EDTSHPGAmerican Society for Bone & Mineral Research to hold annual meeting
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October 8, 2015
06:24 EDTABBVBiogen and AbbVie's Zinbryta for MS improved cognitive results in Phase 3 study
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October 7, 2015
07:36 EDTABBVInfectious Diseases Society of America to hold a conference
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07:23 EDTABBVEuropean Committee Treatment & Research in Multiple Sclerosis holds meeting
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October 6, 2015
07:23 EDTSHPGAmerican Society of Human Genetics to hold annual meeting
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October 2, 2015
10:50 EDTSHPGAmicus plunges after saying unlikely to submit migalastat NDA by year end
Shares of Amicus Therapeutics (FOLD) fell dramatically in morning trading after the company said it is unlikely to submit a New Drug Application for its Fabry disease treatment to the U.S. Food and Drug Administration by the end of the year. WHAT'S NEW: Amicus said this morning that it does not expect to be in the position to submit a New Drug Application for migalastat monotherapy, a treatment of Fabry disease, in the United States by the end of 2015 as a result of additional regulatory guidance from the FDA. The company said it received final FDA minutes from its September pre-NDA meeting and has had more follow-up meetings with the agency this week. Amicus said it plans to further evaluate several U.S. pathways to support submission requesting full approval, including gathering additional data. The FDA requested further integration of extant clinical data across studies, which requires more time to complete, the company said. WHAT'S NOTABLE: On September 15, Amicus Therapeutics said that, following a pre-NDA meeting with the FDA, it was still on track to submit an NDA for migalastat in the fourth quarter of 2015 under Accelerated Approval, which is only available to therapies for severe and life-threatening conditions that address "significant" unmet medical needs. In addition to the NDA submission, Amicus said it would submit for review the protocol for the Phase 4 study confirming "positive" effects of migalastat on gastrointestinal symptoms in patients. ANALYST OPINION: On September 16, Chardan analyst Gbola Amusa downgraded Amicus to Neutral from Buy, citing valuation and the stock's outperformance relative to the NASDAQ Biotechnology Index. At the time, Amusa said that Amicus' shares were near all-time highs and that he saw less scope for outperformance in the near-term. Amusa noted that, ahead of the Committee for Medicinal Products for Human Use's opinion on Amicus' Galafold, he thinks Amicus would be an "interesting" M&A target for Sanofi (SNY) and Shire (SHPG). Amusa said he sees a positive CHMP on Galafold by November or December, at which time the chances of Amicus getting acquired could increase. PRICE ACTION: Amicus Therapeutics dropped 32.07% to $9.28 in morning trading.
07:53 EDTSHPGShire has conference call hosted by JPMorgan
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October 1, 2015
13:14 EDTABBVEnanta says 34 abstracts from AbbVie chronic hep C program to be presented
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13:04 EDTABBVAbbVie to present 34 abstracts from hep C program at The Liver Meeting 2015
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September 30, 2015
10:00 EDTSHPGOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Analog Devices (ADI) upgraded to Buy from Neutral at Citi... Asbury Automotive (ABG) upgraded to Neutral from Underperform at BofA/Merrill... Brookfield (BAM) upgraded to Outperform from Market Perform at BMO Capital... CNOOC (CEO) upgraded to Buy from Hold at Jefferies... Canadian Pacific (CP) upgraded to Buy from Neutral at Goldman... Citizens Financial (CFG) upgraded to Buy from Neutral at UBS... Esperion (ESPR) upgraded to Neutral from Sell at Chardan... HSBC (HSBC) upgraded to Buy from Neutral at UBS... Hecla Mining (HL) upgraded to Outperformer from Sector Performer at CIBC... Johnson Controls (JCI) upgraded to Outperform from Market Perform at William Blair... Level 3 (LVLT) upgraded to Buy from Neutral at UBS... Madison Square Garden (MSG) upgraded on asset value, share buyback outlook at Stifel... Medivation (MDVN) upgraded to Market Perform from Underperform at Cowen... PHH Corp. (PHH) upgraded to Buy from Neutral at Compass Point... Post Holdings (POST) upgraded to Buy from Neutral at SunTrust... Ralph Lauren (RL) upgraded to Buy from Neutral at UBS... Regions Financial (RF) upgraded to Buy from Hold at Sandler O'Neill... Shire (SHPG) upgraded to Hold from Reduce at HSBC... Sinopec (SNP) upgraded to Buy from Hold at Jefferies... Verifone (PAY) upgraded to Buy from Hold at Argus.
09:12 EDTABBVInfinity Pharma reaches $130M milestone payment from AbbVie for duvelisib
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07:11 EDTSHPGLeerink to hold a roundtable
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06:14 EDTSHPGShire upgraded to Hold from Reduce at HSBC
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