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March 5, 2014
08:37 EDTTEVA, VRX, ACT, AGN, SHPGRussia actions could disrupt specialty pharmaceutical sales, says Susquehanna
Susquehanna notes that Russia has been a growth market for specialty pharmaceutical companies such as Teva (TEVA), Valeant (VRX), Actavis (ACT), Allergan (AGN), and Shire (SHPG). The firm factored the sensitivity of a 10% sales impact would translate into roughly 1.0% or less of earnings. The firm said Teva and Valeant have the most sales exposure and that currency could create incremental top line pressure.
News For TEVA;VRX;ACT;AGN;SHPG From The Last 14 Days
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September 15, 2014
07:27 EDTACTPfizer acquisition could drive shares higher, says JPMorgan
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September 12, 2014
10:32 EDTACTPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
09:01 EDTTEVATeva to present Copaxone gene expression analysis
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08:06 EDTTEVATeva presents new clinical safety data in RRMS patients treated with Laquinimod
Teva (TEVA) and Active Biotech (ACTI) announced new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis, or RRMS, who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment. In the pooled safety analysis, rates of adverse events, or AEs, and serious AEs were lower in the open-label extensions than in the core studies and less than three percent of patients discontinued treatment due to AEs during these extensions. Additionally, shifts to potentially significant laboratory values were considerably lower in patients exposed to at least two years of laquinimod.
08:03 EDTTEVATeva, Active Biotech present laquinimod follow-up data
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08:02 EDTVRX, AGNPershing submits special meeting requests totaling 35% of Allergan shares
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05:09 EDTVRX, AGNAllergan comments on Pershing Square delivery of additional requests
Allergan (AGN) commented on Pershing Square Capital Management delivery of additional requests from stockholders owning 1.5% of Allergan’s shares to call a Special Meeting of Stockholders. Allergan will review these requests in addition to the requests from stockholders owning 2.8% of Allergan’s shares that were delivered on September 3. The company issued the following statement: Notwithstanding Pershing Square and Valeant Pharmaceuticals (VRX) efforts to change the subject, Allergan recognizes that what actually matters is value, and that’s what the company is focusing on delivering to stockholders. In that regard, Allergan’s current strategic plan is expected to deliver a compounded annual growth rate of greater than 20% EPS growth, including estimated 2016 EPS at approximately $10.00. Allergan has already scheduled the Special Meeting for December 18. As such, the delivery of additional requests for the Special Meeting by Pershing Square is not a meaningful development. The lawsuit in California is seeking an order barring Valeant, Pershing Square, Ackman, and entities affiliated with them from voting shares that Allergan believes were acquired in violation of the federal securities laws, including insider trading. If Allergan’s motion for a preliminary injunction is granted, it would prevent Valeant, Pershing Square, and Ackman from voting their shares at any meeting of stockholders.
September 11, 2014
11:08 EDTAGNAllergan shareholders owning 35% to ask for meeting, Reuters says
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09:52 EDTVRX, AGNValeant to submit consent from 35% of Allergan holders, CNBC reports
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09:31 EDTTEVATeva announces new data from Phase IIIb GLACIER study
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03:27 EDTTEVATeva Canada announces launch of generic version of Cipralex
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September 10, 2014
14:25 EDTTEVATeva Canada announces launch of generic version of Cipralex
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09:02 EDTACTActavis won't see serious long-term impact from rejection, says Sterne Agee
After the FDA's Cardiovascular and Renal Drugs Advisory Committee voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension, Sterne Agee does not thinks the vote is very meaningful to the company's longer-term growth and earnings potential. The firm says that removing the product from its revenue outlook causes its 2018 EPS estimate for the company to drop by less than 1%. The firm still thinks the company can easily reach its 2017 EPS target of about $20. Sterne Agee keeps a $272 price target and Buy rating on the shares.
08:56 EDTACTFDA advisors recommend against approval of Actavis' nebivolol/valsartan combo
Actavis last night confirmed that the FDA's Cardiovascular and Renal Drugs Advisory Committee has voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. The committee vote was six to four recommending against approval. The committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for the fixed-dose combination of nebivolol and valsartan by the fourth quarter of 2014. Actavis' Senior VP, Global Brands Research and Development, David Nicholson, said, "Although we are disappointed in the Committee's recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension. We remain confident in the safety and efficacy of the combination of these two widely used and well-tolerated treatments, and we look forward to working with the FDA as it completes its review." Shares of Actavis are down more than 2% in pre-market trading following yesterday's committee recommendation.
08:37 EDTSHPGMedgenics appoints Scott Applebaum as Chief Legal Officer
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07:06 EDTSHPGSangamo plans to submit IND application for hemophilia B in 2Q15
Sangamo BioSciences (SGMO) plans to submit an Investigational New Drug application for the treatment of hemophilia B in Q2 2015. This program, partnered with Shire (SHPG), is the first therapeutic application of Sangamo's zinc finger nuclease-mediated In Vivo Protein Replacement Platform. Sangamo is developing the IVPRP as a generally applicable strategy to provide a one-time, permanent genetic cure for monogenic diseases that are currently managed by protein replacement therapy, which involves costly repeat infusions over the lifetime of the patient.
September 9, 2014
17:06 EDTACTFDA panel votes against Actavis blood pressure pill, Bloomberg says
FDA advisers said that Actavis's experimental pill that combines two existing drugs to lower high blood pressure doesn’t provide a clinically meaningful benefit over the two drugs alone, says Bloomberg. The advisory panel voted 6 to 4 against recommending the treatment, added Bloomberg. Shares of Actavis are trading down almost 1% in after-hours trading. Reference Link
16:04 EDTAGNPershing Square reports 9.7% stake in Allergan, sends letter to board
Pershing Square Capital Management sent a letter to the board of Allergan that highlights several reasons why Allergan is extremely shareholder unfriendly and why now is the time for Allergan's management team to wake up. In the letter, Pershing Square said: "Since the bid was announced in April, 75% of Allergan’s shareholders have sold all or a portion of their investment including the company’s largest shareholder, which has sold its entire position. These shareholders are sending the board a message. They would not have sold if they believed that Allergan stock was worth more than current values... We note CFO Jeff Edwards recent decision to retire from the company at age 53 for family reasons, and his replacement by an investor relations executive rather than an experienced public company CFO. The notion that Allergan should execute the largest acquisition in its history led by an investor relations executive is a frightening proposition. While we respect an executive’s need to retire from a company for family reasons, Edwards exit also calls into question the company’s forward earnings guidance which shareholders expected him to execute on when the Company presented these projections on July 21st. I had expected that at some point one or more directors would have woken up and smelled the coffee. There is still time for a subset of directors to rescue their reputations by taking over leadership of this process from David Pyott and his handpicked advisors and doing what you are paid $400,000 per year to do on behalf of the company’s owners."
10:18 EDTACTDollar General listed among 5 largest long positions by Jana Partners
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06:42 EDTAGN, VRXLew expects to make decision on combating inversion deals soon, NY Times reports
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