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Stock Market & Financial Investment News

News Breaks
March 31, 2014
10:28 EDTMNTA, NVS, TEVA, MYLSupreme Court agrees to hear Teva appeal related to Copaxone generic
An order posted to the Supreme Court website shows that the high court granted Teva Pharmaceuticals' (TEVA) petition for a writ of certiorari, meaning the court will hear an appeal filed by Teva. The review is a setback to drugmakers that were planning to offer generic versions of Teva's multiple-sclerosis drug Copaxone, including Mylan (MYL) and Momenta Pharmaceuticals (MNTA), which has developed a version with Novartis' (NVS) Sandoz unit. Reference Link
News For TEVA;MNTA;MYL;NVS From The Last 14 Days
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February 25, 2015
08:07 EDTNVSNovartis' Farydak myeloma drug approved by FDA, to be distributed by Diplomat
Novartis' (NVS) drug Farydak for the treatment of patients with multiple myeloma Diplomat Pharmacy has been approved by the FDA. The drug is now a treatment option for patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. Farydak will be distributed by Diplomat Pharmacy (DPLO).
08:05 EDTTEVATeva says FDA accepts CEP-33237 NDA for review
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February 24, 2015
16:19 EDTNVSAratana Therapeutics to pay Elanco up to $3M to regains rights to AT-004
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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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15:00 EDTNVSFDA approves Farydak for treatment of multiple myeloma
The FDA approved Farydak for the treatment of patients with multiple myeloma, a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication. Farydak is marketed by Novartis.
13:40 EDTNVSAnalysts clash on Spectrum outlook after patent suit setback
Two research firms had divergent views on Spectrum Pharmaceuticals (SPPI) after a judge ruled that a drug which could compete with the company's Fusilev treatment does not infringe on the company's intellectual property. BACKGROUND: Late Friday, a federal judge ruled that Novartis' (NVS) levoleucovorin, a generic version of Spectrum's Fusilev, does not infringe on Spectrum's intellectual property. Fusilev is indicated after high-dose methotrexate therapy in osteosarcoma, a type of cancer that starts in the bones. It is also used to treat patients with advanced metastatic colorectal cancer. BEARISH TAKE: Roth Capital analyst Joseph Pantginis downgraded Spectrum to Neutral from Buy following the ruling, as he believes the risk to the company's revenue has risen. The company is meaningfully less likely to become profitable again, wrote Pantginis, noting that Fusilev accounted for about 50% of the company's product revenue. According to the analyst, Spectrum is becoming increasingly focused on developing its earlier stage drugs, and he expects those drugs to grow slowly. Pantginis slashed his price target on the shares to $7 from $15. BULLISH TAKE: In a note to investors earlier today, Reni Benjamin, an analyst at research firm H.C. Wainwright, wrote that the stock's plunge after the judge's ruling "creates a table-pounding buying opportunity," noting that Fusilev has been granted exclusivity as a colorectal treatment until 2018. Benjamin does not expect the company's revenue from Fusilev to decline at all until 2018, as a citizen's petition submitted by Spectrum to the FDA, along with an appeal the company is mounting to Friday's ruling, and the difficulty that Novartis will have launching its version of the drug while the appeal is ongoing, will help prevent Spectrum's revenue from dropping. Also likely to protect Spectrum's revenue are the strong relationships that the company has developed with hospitals and community doctors, the analyst stated. He kept a $15 price target and Buy rating on the shares. PRICE ACTION: In mid-afternoon trading, Spectrum tumbled $1.44, or 19.3% to $6.02.
12:21 EDTNVSOn The Fly: Midday Wrap
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11:17 EDTNVSFTC puts conditions on Novartis's proposed acquisition of GSK oncology drugs
According to the FTC, Global pharmaceutical company Novartis (NVS) has agreed to divest all assets related to its BRAF and MEK inhibitor drugs, currently in development, to Boulder, Colorado-based Array BioPharma (ARRY) to settle charges that Novartis’s $16B acquisition of GlaxoSmithKline’s (GSK) portfolio of cancer-treatment drugs would likely be anticompetitive...If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. For that reason, Novartis’s acquisition of GSK’s portfolio of cancer-treatment drugs would likely cause significant competitive harm in the U.S. markets for both the BRAF and MEK inhibitors, ultimately raising prices for consumers and depriving them of potentially superior products. Under the terms of the proposed consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. Reference Link
07:16 EDTMYLMylan signs exclusive agreement with Gilead to distribute Solvaldi, Harvoni
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07:14 EDTNVSSpectrum says plans to appeal patent suit loss to Novartis unit
Spectrum Pharmaceuticals (SPPI) confirmed in a regulatory filing that on February 20, the U.S. District Court for the District of Nevada ordered that judgment be entered in favor of defendant Sandoz in the matter entitled Spectrum Pharmaceuticals, Inc. et al v. Sandoz Inc. "Spectrum Pharmaceuticals Inc. intends to appeal this decision and the ultimate outcome of this litigation remains uncertain," the company stated. Sandoz is the generic pharmaceuticals division of Novartis (NVS).
06:32 EDTMNTAMomenta enters $75M At-The-Market equity sales agreement with Stifel
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February 20, 2015
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 EDTMYL, TEVA, NVSAmerican 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.
07:12 EDTNVSWharton Health Care Club to hold a conference
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February 18, 2015
08:41 EDTMYLThe Medicines Co. says not giving financial guidance due to Hospira suit
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07:56 EDTMNTAMomenta price target lowered to $15 from $18 at UBS
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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.
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