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Stock Market & Financial Investment News

News Breaks
April 4, 2014
10:45 EDTTEVA, MYL, CELGMylan rises despite Meda rejecting takeover offer
Mylan (MYL) shares are higher this morning following a Financial Times report of its desire to buy Swedish rival Meda. Subsequent to the story being published, Meda confirmed it had been in talks with Mylan but rejected the company's takeover offer. WHAT'S NEW: The Financial Times reported that Mylan was considering buying Meda, a Swedish drugmaker, in a deal that would create a $23B+ pharmaceuticals business. Mylan reportedly hired advisers to put a deal together for Meda, and though the value of a deal was not noted, sources said Mylan was likely to pay a "significant" premium to Meda's market value, which was $4.5B at the end of trading on Thursday. Mylan's market value currently stands at $18.5B. A combination of the drugmakers would create a company with annual revenues of around $9B, the FT said, noting that would be half the size of generic drug rival Teva (TEVA). WHAT'S NOTABLE: Meda's board of directors confirmed that it was contacted by Mylan regarding a proposal to merge the companies, but the board decided to reject the proposal. Meda said all discussions between the company and Mylan have been terminated "without further actions." ANALYST REACTION: Citigroup upgraded Mylan to Buy from Neutral and raised its price target on the stock to $61 from $52 this morning. The firm cited potential operational and tax benefits from an acquisition of Meda, stating that in addition to expanding Mylan's geographic presence, the deal would increase its presence in specialty, OTC and branded generics. OTHER NEWS: Mylan sued Celgene (CELG) to block that company's efforts to keep generic versions of Revlimid and Thalomid off the market, Reuters reported. PRICE ACTION: Mylan shares are up $2.98, or 5.98%, to $52.84 in mid-morning trading.
News For MYL;TEVA;CELG From The Last 14 Days
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February 23, 2015
07:16 EDTMYLMylan signs exclusive agreement with Gilead to distribute Solvaldi, Harvoni
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February 20, 2015
16:03 EDTCELGOptions Update; February 20, 2015
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09:38 EDTCELGActive equity options trading on open
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08:04 EDTTEVATeva to present new respiratory data at AAAAI
Teva Pharmaceutical Industries announced that four company-sponsored abstracts will be presented at the 2015 Annual Meeting of the American Academy of Allergy, Asthma and Immunology, or AAAAI, in Houston, Texas. Data to be presented include two replicate 52-week Phase III global studies of the company’s anti-IL5 monoclonal antibody, reslizumab, in patients with asthma and elevated blood eosinophils who were inadequately controlled on medium-to-high doses of inhaled corticosteroids with or without an additional controller. The data are scheduled for presentation on Monday, February 23 during an oral session titled “Asthma Therapy and Mechanisms.” Also to be presented are two Phase III studies of beclomethasone dipropionate 40mcg, which gained FDA approval in December 2014, and is now available for the treatment of nasal symptoms associated with allergic rhinitis in children 4-11 years of age. In addition, a dose-response study evaluating the safety and efficacy of fluticasone/salmeterol multidose dry-powder inhaler in patients 12 years of age and older with persistent asthma will be presented.
07:08 EDTTEVA, MYLAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
05:27 EDTCELGCelgene Revlimid approved by EC
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February 19, 2015
17:03 EDTTEVATeva to initiate Phase 2b TV-45070 clinical trial
Xenon Pharmaceuticals (XENE) announced that its development and commercialization partner Teva Pharmaceutical (TEVA) will initiate a Phase 2b clinical trial of TV-45070 in patients with post-herpetic neuralgia, or PHN. The Phase 2b clinical trial in PHN will be a randomized, double-blind, placebo controlled, multi-site study to evaluate the efficacy and safety of TV-45070 in patients with PHN. The study will include three treatment groups to receive doses of 4% or 8% of TV-45070 or placebo, dosed twice daily. Approximately 330 patients will be enrolled in the study. Patients will be stratified into treatment groups based on their R1150W status, a genetic pain biomarker believed to be related to pain susceptibility. The primary endpoint of this study is the change from baseline to week 4 in the numeric rating scale, or NRS, scores. Secondary endpoints include additional pain measurement scores at specified daily time points, the percentage of patients with greater than 30% and greater than 50% improvement in pain scores, quality of life measurements and adverse events measurements. The first patient is anticipated to be dosed in March, and the anticipated completion date for the Phase 2b clinical trial is mid-2016.
February 18, 2015
16:00 EDTCELGOptions Update; February 18, 2015
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10:05 EDTCELGOn The Fly: Analyst Initiation Summary
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09:38 EDTCELGCelgene reports FDA expands indication for Revlimid combo
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09:37 EDTCELGOption volume leaders on open
Option volume leaders: AAPL TSLA TWTR CELG APO NFLX AXP APA LNKD C GILD according to Track Data.
08:41 EDTMYLThe Medicines Co. says not giving financial guidance due to Hospira suit
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07:45 EDTTEVAEagle Pharmaceuticals price target raised to $37 from $30 at Cantor
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07:13 EDTTEVAEagle Pharmaceuticals target raised to $43 from $25 at William Blair
William Blair raised its price target for Eagle Pharmaceuticals (EGRX) to $43 saying the company's agreement with Teva (TEVA) removes a major overhang on the stock. William Blair says the deal is a significant positive for Eagle since it removes litigation risk and moves the company immediately into profitability. It keeps an Outperform rating on the stock.
06:47 EDTCELGCelgene initiated with a Buy at Canaccord
Target $156.
February 17, 2015
18:06 EDTMYLPaulson & Co gives quarterly update on stakes
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08:47 EDTTEVABioTime provides update on Cell Cure's product development, partnering
BioTime (BTX) and its subsidiary Cell Cure Neurosciences provided an update on Cell Cure’s product development and partnering activities. On February 16, Cell Cure opened the clinical trial of OpRegen titled “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy” at Hadassah University Medical Center in Jerusalem, Israel. Patient enrollment is expected to begin shortly. OpRegen consists of animal product-free retinal pigment epithelial cells with high purity and potency. On October 31, 2014, the FDA cleared Cell Cure's Investigational New Drug application to initiate the clinical trial of OpRegen in patients with the severe form of age-related macular degeneration with geographic atrophy.The Phase I/IIa clinical trial, will evaluate three different dose regimens of OpRegen. Following transplantation, the patients will be followed for 12 months at specified intervals, to evaluate the safety and tolerability of the product. Following the initial 12 month period, patients will continue to be monitored at longer intervals for an additional period of time. A secondary objective of the clinical trial will be to examine the ability of transplanted OpRegen to engraft, survive, and moderate disease progression in the patients. In addition to thorough characterization of visual function, a battery of ophthalmic imaging modalities will be used to quantify structural changes and rate of GA expansion. Cell Cure also announced that the option granted to Teva (TEVA) under a Research and Exclusive Option Agreement of October 7, 2010 to license-in rights to its OpRegen product has expired without having been exercised by Teva. Cell Cure will therefore be continuing the clinical development of OpRegen on its own and pursuing discussions with other potential strategic partners, including those that have already indicated interest in participating in development and commercialization of the product. Cell Cure also announced that US patent No. 8,956,866 relating to a proprietary method of manufacturing RPE cells is expected to issue on February 17. This patent combined with other patents and patent applications in the BioTime family of companies provides significant patent protection for this novel therapeutic modality for AMD.
08:39 EDTTEVATeva deal small but important, says BMO Capital
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08:35 EDTTEVATeva announces launch of generic Lovenox and Zyvox in U.S.
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07:04 EDTTEVATeva, Eagle enter license agreement for EP-3102
Teva Pharmaceutical Industries (TEVA) and Eagle Pharmaceuticals (EGRX) announce that the companies have entered into an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride rapid infusion product for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva. As part of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which should allow the product to come to market more quickly. Under the terms of the exclusive license agreement, Eagle will receive an upfront cash payment of $30M and is eligible to receive up to $90M in additional milestone payments. In addition, Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval. The companies will also settle the pending patent infringement action between them.
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