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Stock Market & Financial Investment News

News Breaks
April 21, 2014
08:18 EDTNVS, TEVA, MNTA, MYLMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
News For MNTA;NVS;MYL;TEVA From The Last 14 Days
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March 23, 2015
09:03 EDTNVSLeerink analysts hold a meeting with a conference call hookup
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08:50 EDTTEVATeva reports TEV-48125 met endpoints in phase 2b study
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March 20, 2015
12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
07:41 EDTNVSAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says
March 18, 2015
16:13 EDTTEVAFibrocell Science appoints Keith Goldan as CFO
Fibrocell Science announced the appointment of Keith Goldan as senior VP and Chief Financial Officer, effective immediately. Prior to joining Fibrocell, Goldan served as CFO of two publicly traded companies. Most recently he served as SVP and CFO of NuPathe, which was acquired by Teva Pharmaceutical (TEVA) in 2014.
11:36 EDTTEVAIgnyta price target raised to $17 from $14 at Leerink
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10:08 EDTTEVAEagle Pharmaceuticals price target increased to $67 from $43 at William Blair
William Blair raised its price target on Eagle Pharmaceuticals to $67 from $43 citing its belief that the company can become profitable and have significant cash flow pending the approval of EP-3102. The company added that it view last week's FDA label change for Teva's (TEVA) Treanda as a positive for EP-3102 and that its new price target assumes 2016 launch and "reasonable" penetration for EP-3102.
07:13 EDTTEVATeva volatility elevated, shares near four year high
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March 17, 2015
19:42 EDTTEVAOn The Fly: After Hours Movers
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16:03 EDTTEVAIgnyta acquires 4 oncology R&D assets from Teva for 1.5M shares of common stock
Teva (TEVA) and Ignyta (RXDX) announced the acquisition by Ignyta of the worldwide rights and assets relating to four targeted oncology development programs in exchange for 1.5M shares of Ignyta’s common stock. Concurrently, Ignyta has entered into stock purchase agreements with Teva, and selected additional healthcare investors, whereby Teva will purchase a further 1.5 million shares of common Ignyta stock at a price of $10 per share in a registered direct offering. The other investors will purchase an additional 2.7M shares at $10 per share, valuing the total offering at approximately $41.6M. Under the terms of the asset purchase agreement with Teva, Ignyta is acquiring all of Teva’s assets and worldwide rights relating to four oncology development programs in exchange for 1.5M shares of Ignyta’s common stock. Teva has agreed not to sell or otherwise transfer any of these shares until March 17, 2016, and Ignyta is required to register the resale of these shares with the SEC prior to such date. Ignyta also assumed all of Teva’s ongoing obligations under certain contracts relating to the purchased programs, including the agreements under which Teva in-licensed rights to the assets.
12:51 EDTNVSNovartis hit with $100M gender discrimination lawsuit, Reuters reports
A proposed class action lawsuit against Novartis claims the drug maker routinely denied female employees equal pay and promotional opportunities, reports Reuters. The $110M lawsuit filed on Tuesday says Novartis' Alcon Laboratories maintains a "boy's club atmosphere" that is hostile to women and bars them from leadership positions. Reference Link
10:26 EDTTEVAOptions with increasing implied volatility
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08:34 EDTMYLInSite Vision announces settlement of lawsuit against Mylan
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05:32 EDTNVSIncyte announces Novartis receives EC approval for Jakavi
Incyte (INCY) announced that Novartis (NVS) received approval from the European Commission for Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Jakafi is approved by the FDA for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
05:30 EDTNVSNovartis receives EU approval for Jakavi in polycythemia vera
Novartis announced that the European Commission has approved Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Jakavi is the only JAK 1/2 inhibitor available to treat PV and is also currently approved in more than 80 countries to treat myelofibrosis.
March 16, 2015
11:40 EDTTEVAEnzo Biochem to request rehearing of court of appeals decision
Enzo Biochem (ENZ) said, acting upon advice of counsel, that it disagrees with the March 16 split 2-to-1 decision of the Court of Appeals sitting in panel for the Federal Circuit that reverses-in-part and vacates-in-part the judgment in Enzo’s favor that Applera Corp., now Life Technologies (LIFE), infringed Enzo’s patents covering pioneering technologies relating to compounds used in DNA sequencing systems to read the genetic code, and remands the case to the District Court as to whether the accused product infringes. Counter to the District Court’s construction of the ‘767 patent as allowing for directly-detectable labels on nucleotides and polynucleotides, and counter to the jury’s verdict that the patent describes such labelling, the Court of Appeals, held such labelling excluded by claim 1 of that patent. Enzo notes also that the Court’s partial vacatur and reversal of the judgment does not end the case, but remands the case back to the District Court to find whether the accused product infringes. Enzo will request rehearing of that decision, both by the original panel and by the full en banc Court. Enzo believes rehearing is warranted by the panel’s failure to give appropriate weight to fact findings, including facts found by the jury, consistent with a broader construction of the patent, as required by the Supreme Court’s recent decision in Teva Pharmaceuticals (TEVA).
10:28 EDTTEVA, MYLOptions with increasing implied volatility
Options with increasing implied volatility: PVA NFLX BMRN DNOW MYL TEVA PEP GE
08:44 EDTTEVAFDA warning on liquid bendamustine may help Eagle's EP-3102, says Piper Jaffray
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