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Stock Market & Financial Investment News

News Breaks
March 21, 2014
08:26 EDTACT, RHHBYCHMP adopts positive opinion on Actavis generic version of Roche's Tamiflu
The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ebilfumin 30 mg, 45 mg and 75 mg, hard capsules intended for the treatment and prevention of influenza. The applicant for this medicinal product is Actavis (ACT). Ebilfumin is a generic of Roche's (RHHBY) Tamiflu.
News For ACT;RHHBY From The Last 14 Days
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October 16, 2014
08:08 EDTACTActavis confirms generic Quillivant XR patent challenge
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08:02 EDTACTIronwood announces initiation of Phase II linaclotide trial
Ironwood Pharmaceuticals (IRWD) announced the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc (ACT), Ironwood’s co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Linaclotide is not currently approved for the treatment of OIC. The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.
05:58 EDTRHHBYRoche sees FY14 core EPS targeted to grow ahead of sales
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05:56 EDTRHHBYRoche reports 9 month revenue CHF34.76B vs. CHF34.87B last year
Roche CEO Severin Schwan said: “Demand for our products is strong in both divisions and we are well on track to reach our full-year targets. We have had positive news from our product pipeline, including study results for Perjeta in breast cancer and a new combination therapy with Zelboraf in melanoma. The InterMune acquisition has also strengthened our portfolio with a new medicine, Esbriet for idiopathic pulmonary fibrosis, which has now been approved by the FDA. In Diagnostics, growth continues to be driven by the immunodiagnostics business and we have strengthened our molecular diagnostics portfolio with a new generation of testing systems.”
October 15, 2014
15:45 EDTRHHBYFDA approves Esbriet to treat idiopathic pulmonary fibrosis
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October 14, 2014
11:23 EDTRHHBYBIND Therapeutics and The Conference Forum hold a conference
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07:46 EDTACTActavis should be able to mitigate Irish tax downside, says Leerink
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06:03 EDTACTMarket overreacted to new Irish tax rules, says BMO Capital
BMO Capital believes the market may have overreacted yesterday to the report that Ireland is eliminating the "Double Irish" tax loophole. The firm says Allergan (AGN) confirmed that it incorporated potential changes to Irish tax law in its recently raised earnings guidance while Mallinckrodt (MNK) said it does expect the new tax structure to have an immediate impact. BMO views yesterday's pullback in shares of Allergan, Mallinckrodt and Actavis (ACT) as an overreaction.
October 13, 2014
15:12 EDTACTActavis may see modest negative impact from Irish tax change, says BMO Capital
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October 10, 2014
10:20 EDTACTFidelity supports potential merger between Actavis and Allergan, Reuters reports
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07:37 EDTACTActavis more likely partner than Valeant if Allergan merges, says UBS
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October 9, 2014
12:28 EDTACTAllergan price target raised to $230 from $210 at BTIG
BTIG said it expected Allergan to beat the consensus forecast for Q3 EPS, but not by as much as it did, and the firm did not expect the company to raise its future EPS outlook yet again. BTIG feels the stock's move higher indicates Valeant (VRX) or Actavis (ACT) would need to bid above $200 if they hope to buy the company. BTIG maintains its Buy rating on Allergan and raised its price target on the stock to $230 from $210.
11:14 EDTACTAllergan raises outlook again as Valeant pursuit continues
Drug maker Allergan (AGN) this morning preannounced stronger than expected results and again raised its fiscal year profit guidance. The beat and raise results come after The Wall Street Journal reported on Tuesday that drug maker Valeant (VRX) and hedge fund Pershing Square intend to raise their previous bid for Allergan by $15 per share to about $191. Meanwhile, also on Tuesday, Reuters said that drug maker Actavis (ACT) plans to make a new merger offer to Allergan, and sources indicated to the news service that Allergan may be willing to consider an offer from Actavis if the bid is for more than $200 per share. WHAT'S NEW: Allergan estimated that its third quarter earnings per share would come in at $1.76-$1.78, versus analysts' consensus estimate of $1.48. The drug maker had previously provided Q3 EPS guidance of $1.44-$1.47. Allergan raised its fiscal 2014 EPS guidance to $6.20-$6.25 from $5.74-$5.80. Analysts' consensus estimate was $5.81. This is the fourth time that Allergan has raised its guidance this year. Allergan said that its markets have been strong around the world, while it is gaining market share in most categories. ANALYST REACTION: In a note to investors today, Wells Fargo analyst Larry Biegelsen wrote that, in the wake of Allergan's guidance increase, the company's price to earnings multiple could expand to 22x its estimated 2016 earnings, up from its current multiple of 19x. In addition to the raised guidance, a potential accretive acquisition by Allergan and the possibility that it will be acquired make such an increase in the multiple "quite possible," Biegelsen contended. He kept an Outperform rating on the stock. WHAT'S NOTABLE: Allergan has reportedly held advanced talks about acquiring another company in the sector, Salix (SLXP), although CNBC's David Faber on October 2 reported that the talks between the two companies about a merger had "cooled considerably." PRICE ACTION: In late morning trading, Allergan rose fractionally to $191.06 while Valeant slid 1.5% to $124.08.
08:50 EDTACTAllergan shares have further upside, says Wells Fargo
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October 8, 2014
11:31 EDTRHHBYFDA grants priority review for Genentech's Lucentis
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7M Americans. The FDA confirmed action date is February 6, 2015. The sBLA was submitted August 7 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by the FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients. The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections. Benefits of Lucentis treatment were maintained during year three of treatment. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.
10:55 EDTRHHBYLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
08:42 EDTACTSalix shares should be bought on weakness, says Sterne Agee
After Reuters yesterday afternoon reported that Actavis (ACT) plans to make a new merger approach to Allergan (AGN), Sterne Agee believes that Salix's standalone value is $162. The firm expects the shares to reach that level following approval of its Xifaxan IBS-D drug after the February 2015 PDUFA date.
07:19 EDTRHHBYCBI to hold a conference
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06:47 EDTACTLawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
06:23 EDTACTActavis more inclined to pursue Allergan over Salix, says Citigroup
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