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Stock Market & Financial Investment News

News Breaks
March 18, 2013
10:03 EDTTEVA, ACT, MYLGeneric drug makers fall after Wells analyst downgrades sector
A number of generic drug makers are losing ground after Wells Fargo analyst Michael Tong downgraded the sector to Market Weight from Overweight in a note to investors earlier today. After four years of outperformance, companies in the sector may have to exploit new catalysts in order to advance further, Tong believes. These new catalysts, however, carry more risks than previous drivers of the stock, the analyst contended. Upcoming catalysts for the sector include profitable international expansion, diversified brand portfolio, and biosimilars, Tong wrote. Investors should move out of generic drug stocks and buy the stocks of large drug companies, the analyst recommended. In the same note, Tong downgraded two specific generic drug makers. He dropped Teva (TEVA) to Market Perform from Outperform and lowered Actavis (ACT) to Market Perform from Outperform. Teva is taking longer than expected to implement its turnaround plan and may face increased competition to its Copaxone MS treatment, while Actavis' stock price has risen to the point where the shares accurately reflect the company's long-term outlook, Tong believes. In early trading, Teva fell 1% to $40.35, Actavis gave back 2% to $90, and Mylan (MYL) lost 1% to $30.15.
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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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September 11, 2014
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.
07:02 EDTMYLMylan to acquire U.S. rights to Arixtra injection from Aspen
Mylan's subsidiary Mylan Ireland Limited has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra Injection and the authorized generic of Arixtra from Aspen Global Incorporated. Arixtra is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing hip fracture surgery. Mylan already is selling Arixtra in the U.S. through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.
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
10:18 EDTACTDollar General listed among 5 largest long positions by Jana Partners
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06:42 EDTMYLLew expects to make decision on combating inversion deals soon, NY Times reports
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September 8, 2014
12:40 EDTTEVAFTC sues AbbVie over blocking of AndroGel generics
The Federal Trade Commission has filed a complaint in federal district court charging several pharmaceutical companies with "illegally blocking American consumers’ access to lower-cost versions of the blockbuster drug AndroGel." The FTC's complaint alleges that AbbVie (ABBV) and its partner Besins Healthcare filed baseless patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of the testosterone replacement drug AndroGel. While the lawsuits were pending, AbbVie then entered into an anticompetitive pay-for-delay settlement agreement with Teva Pharmaceuticals (TEVA) to further delay generic drug competition, the FTC claims. Reference Link
11:05 EDTMYLOptions with increasing implied volatility
Options with increasing implied volatility: NPSP GILD VNET AVNR GTAT YHOO RHT VRTX SDRL COV MYL
10:04 EDTMYLMylan calls active on activist investor speculation
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09:57 EDTMYLRumor: Mylan moves up on activist investor speculation
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09:27 EDTMYL, TEVALeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
08:02 EDTTEVATeva completes Reslizumab Phase III program
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07:03 EDTMYLMylan annoucnes court grants summary judgment in favor of company
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