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News Breaks
January 21, 2014
07:06 EDTPATH, ENDP, TEVANuPathe terminates agreement with Endo, to be acquired by Teva
NuPathe (PATH) announced that it has terminated its agreement and plan of merger with Endo Health Solutions (ENDP) and its board has withdrawn its recommendation that stockholders accept Endo's offer to acquire all outstanding shares of NuPathe common stock. NuPathe has also entered into an agreement and plan of merger with Teva Pharmaceutical (TEVA) under which Teva will acquire NuPathe for $3.65 per share in cash. In addition to the upfront cash payment, NuPathe stockholders will receive rights to receive additional cash payments of up to $3.15 per share if specified net sales of NuPathe's migraine treatment, Zecuity, are achieved over time. Under the terms of the agreement, an affiliate of Teva will promptly commence a tender offer to acquire all outstanding shares of NuPathe's common stock for $3.65 per share in cash and the right to receive contingent cash consideration payments of up to $3.15 per share if specified net sales thresholds for NuPathe's Zecuity are achieved. The contingent cash consideration payments, which will not be publicly traded, are as follows: $2.15 per share in cash payable upon net sales of Zecuity of at least $100M in any four consecutive calendar quarters, on or prior to the 60th day following the ninth anniversary of the date of the first commercial sale of Zecuity; and $1.00 per share in cash payable upon net sales of ZECUITY of at least $300 million in any four consecutive calendar quarters, on or prior to the 60th day following the ninth anniversary of the date of the first commercial sale of Zecuity. The transaction is expected to be completed in February.
News For PATH;ENDP;TEVA From The Last 14 Days
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September 2, 2014
10:02 EDTENDPOn The Fly: Analyst Initiation Summary
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08:02 EDTTEVATeva reports statistically significant results in reslizumab trial
Teva Pharmaceutical Industries announced that reslizumab, an investigational anti-IL-5 monoclonal antibody, demonstrated clear levels of efficacy in achieving the primary endpoint of reduction in the frequency of clinical asthma exacerbations compared to placebo in two pivotal Phase III studies in patients with inadequately controlled moderate to severe asthma with elevated levels of blood eosinophils. In both trials, reslizumab treatment showed both clinically relevant and statistically significant reductions in the frequency of CAE compared to placebo. Reslizumab has also demonstrated a positive effect on lung function and asthma control in the Phase III program . The combination of an effect on clinically important exacerbations and on improvements and preservation of lung function suggest that reslizumab may be a uniquely differentiated treatment for patients with moderate to severe asthma with elevated levels of blood eosinophils. This initial set of results shows the adverse event profile of reslizumab was comparable to placebo in both trials. The incidence of common AEs was consistent with those seen in a moderate to severe asthma population, the most frequent being upper respiratory tract infections, asthma and headache. Further analyses of additional efficacy and safety data are ongoing. These new data are from two global Phase III 12-month, randomized, double-blind, placebo-controlled, parallel-group studies, evaluating the efficacy and safety of intravenously administered reslizumab once every four weeks, compared to placebo in asthma patients that are inadequately controlled by standard of care therapy.
06:42 EDTENDPEndo initiated with an Outperform at RBC Capital
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August 28, 2014
11:22 EDTTEVAMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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August 25, 2014
09:26 EDTENDPEndo puts AMS medical-device unit up for sale, WSJ says
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August 21, 2014
15:16 EDTTEVADEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
August 19, 2014
05:11 EDTTEVAGamida Cell announces investment, option agreement with Novartis
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