New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
April 3, 2014
05:31 EDTNVSNovartis says data on 19 investigational compounds to be presented
Novartis announced that early stage data on 19 investigational compounds in its oncology pipeline will be presented at the annual meeting of the American Association of Cancer Research. Among the data being presented are single agent and combination studies with key investigational compounds in the Novartis Oncology breast cancer development program, including an early phase study of the CDK4/6 inhibitor LEE011 and PI3K inhibitors BKM120 and BYL719. LEE011 and BKM120 are currently in Phase III and BYL719 is in Phase I trials for the treatment of advanced breast cancer.
News For NVS From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | all recent NVS news | >>
March 3, 2015
11:46 EDTNVSLeerink biotech analyst holds an analyst/industry conference call
Subscribe for More Information
March 2, 2015
08:07 EDTNVSArray BioPharma announces completion of binimetinib and encorafenib transactions
Array BioPharma (ARRY) announced the completion of both the binimetinib and encorafenib definitive agreements with Novartis. Along with global ownership of both assets, Array will receive an upfront payment of $85M from Novartis (NVS). Effective March 2, 2015, Novartis' global, exclusive license to binimetinib terminated with all rights reverting to Array, and Array received global rights to encorafenib. Array will receive an $85M upfront payment from Novartis and reimbursement for certain transaction-related expenses. Novartis will provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array patent and other intellectual property rights it owns to the extent they relate to binimetinib and encorafenib. Other than a de minimis payment to Novartis from Array, there are no milestone payments or royalties payable between the parties under the encorafenib agreement. As part of the transactions, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Array entered into a third party agreement necessary to complete the transactions. Net consideration Array agreed to pay amounts to $25M. This payment is consistent with the earnings guidance provided on the quarterly conference call held on February 3, 2015. Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs associated with MILO, which Array will continue to conduct. For NEMO and all other ongoing and planned clinical trials for binimetinib (other than COLUMBUS, as described above), Novartis will conduct and solely fund each trial, until a mutually agreed-upon transition date to Array. Following this transition, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs required to complete these studies. Novartis will remain responsible for conducting and funding development of the NRAS melanoma companion diagnostic until Premarket Approval is received from the U.S. Food and Drug Administration. Following approval, Novartis will transfer the product and Premarket Approval to a diagnostic vendor of Array's designation. Novartis also retains binimetinib and encorafenib supply obligations for all clinical and commercial needs for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of binimetinib and encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib and binimetinib.
07:31 EDTNVSIncyte appoints Steven Stein as Chief Medical Officer
Subscribe for More Information
February 27, 2015
11:33 EDTNVSNovartis says phase II data highlights benefits of Alcon RTH258 in wet AMD
Novartis reports Alcon presented positive results from its second Phase II clinical study of RTH258 during the 38th Annual Macula Society Meeting. This study evaluated the efficacy and safety of the compound versus aflibercept in patients with neovascular age-related macular degeneration, or wet AMD. The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients. Patients treated every three months with RTH258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden. A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity, from Baseline to Week 12. Secondary endpoints included the change assessment in BCVA and central subfield foveal thickness as measured by spectral domain optical coherence tomography. Both RTH258 and aflibercept were well tolerated and no new safety signal was reported during the study.
07:50 EDTNVSNovartis holders approve dividend increase to CHF 2.60
Subscribe for More Information
07:25 EDTNVSNovartis lung cancer drug Zykadia recommended for EU approval
Subscribe for More Information
07:16 EDTNVSZykadia recommended by EMA for approval in advanced NSCLC
The European Medicines Agency has recommended granting a conditional marketing authorization for Zykadia. Zykadia is recommended for the treatment of adult patients with a type of lung cancer called anaplastic lymphoma kinase positive non-small cell lung cancer, or NSCLC, when the disease is advanced and has already been treated with crizotinib. The applicant for Zykadia is Novartis Europharm.
February 26, 2015
09:05 EDTNVSFDA grants Sandoz tentative approval of Fusilev generic
The FDA posted on its website that it granted Novartis's Sandoz tentative approval for levoleucovorin calcium, a generic of Spectrum's (SPPI) colon cancer drug Fusilev. Reference Link
February 25, 2015
14:10 EDTNVSPharmacyclics downgraded to Hold on lack of upside at Deutsche Bank
Subscribe for More Information
12:54 EDTNVSPharmacyclics exploring options including sale, Bloomberg reports
According to sources, Pharmacyclics (PCYC), which develops cancer treatments, is currently exploring options, Bloomberg reports. One option may include a sale of the company, and the sources say Johnson & Johnson (JNJ) and Novartis (NVS) have expressed interest in the company. Pharmacyclics could fetch $17B-$18B in a sale, the sources add. Reference Link
12:53 EDTNVSPharmacyclics weighing sale to U.S. drugmaker, Bloomberg reports
Subscribe for More Information
12:13 EDTNVSGlaxoSmithKline sees Novartis transaction closing next week
Subscribe for More Information
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).
February 24, 2015
16:19 EDTNVSAratana Therapeutics to pay Elanco up to $3M to regains rights to AT-004
Subscribe for More Information
February 23, 2015
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
Subscribe for More Information
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
07:14 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).
February 20, 2015
07:08 EDTNVSAmerican 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.
1 | 2 | all recent NVS news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use