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Stock Market & Financial Investment News

News Breaks
January 8, 2014
07:28 EDTENDP, TEVA, PATHNuPathe says Teva proposal 'reasonably expected' to lead to 'superior proposal'
NuPathe (PATH) disclosed Teva (TEVA) offered to purchase any and all of the shares of NuPathe, at a price per Share of $3.65 per share, net to the seller in cash, plus contractual rights to receive up to an additional $3.15 per share in contingent cash consideration payments payable in the future upon achievement of certain milestones related to ZECUITY. Further, Teva indicated it is prepared to loan the company funds to cover both the company’s ongoing operations pending closing of a transaction and to pay any termination fee due under the existing merger agreement NuPathe has entered with Endo Health Solutions (ENDP). Teva further stated that the Teva proposal will not require additional due diligence, that the Teva offer was unanimously approved by the Teva board of directors, and that there are no financing contingencies with the Teva proposal. NuPathe's board determined that the Teva proposal is :reasonably expected" to lead to a "Superior Proposal," but that pursuant to the terms of the existing merger agreement, NuPathe will continue to recommend that the company’s stockholders tender their shares in the offer by Endo.
News For PATH;TEVA;ENDP From The Last 14 Days
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February 24, 2015
09:02 EDTTEVATeva announces phase 2b study of TEV-48125 achieved endpoints
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February 23, 2015
15:04 EDTTEVATeva announces publication of data on Phase III trials of reslizumab
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12:53 EDTENDPAnalysts debate potential for competing Salix takeover bid
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09:02 EDTENDPAcceptance of NDA for Belbuca triggers $10M milestone payment to BDSI
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07:31 EDTENDPEndo, BioDelivery Sciences announce acceptance of NDA for Belbuca
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February 22, 2015
15:59 EDTENDPValeant to buy Salix for $10.1B, FT says
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February 20, 2015
09:17 EDTENDPEndo price target raised to $101 from $86 at Goldman
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08:21 EDTENDPSummer Street still feels Endo could acquire BioDelivery Sciences
Summer Street reiterated its belief that Endo (ENDP) could acquire BioDelivery Sciences (BDSI), its partner on multiple products. The firm says scripts for BioDelivery's Bunavail continue to trend in the right direction. It reiterates a Buy rating on the stock with a $25 price target.
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 EDTTEVAAmerican 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.
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.
16:34 EDTENDPAmerican Medical Systems enrolls 1,000th patient in PROPPER registry
American Medical Systems, or AMS, a subsidiary of Endo International, announced the enrollment of the 1,000th patient in the largest prospective, multi-year, global registry study of penile prosthetic outcomes in the world. The study, entitled PROPPER, or Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration, is sponsored by AMS and is being conducted by a team of experienced urologists at 11 North American sites. It aims to better characterize real-world patient satisfaction and other outcomes among men who are receiving prosthetic implants to treat their erectile dysfunction. All patients enrolled in the registry will be implanted with penile implants manufactured by AMS, the majority of whom will receive the three piece inflatable penile prosthesis, the AMS 700.
06:13 EDTENDPEndo resumed with a Buy at Citigroup
Price target raised to $98 from $87.
February 18, 2015
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.
February 17, 2015
17:02 EDTENDPSoros Fund Management 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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