Thu, Apr. 21, 6:14 AM
Thu, Apr. 21, 4:08 AM
- Ericsson (NASDAQ:ERIC) -8.8% premarket after announcing a major management shakeup and missing expectations in the first quarter, citing weakness in Europe and some emerging markets.
- A struggling eyecare business and lackluster heart medicine sales led Novartis' (NYSE:NVS) core net income to fall 13% to $2.79B, but the drugmaker confirmed its outlook for 2016.
- SABMiller (OTCPK:SBMRY) reported a gain in Q4 beer shipments, led by growth in Africa and Latin America, in spite of economic volatility and the potential distraction of AB InBev's takeover offer.
Wed, Apr. 20, 5:30 PM
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Tue, Apr. 19, 9:42 AM
- Pfizer (PFE +0.9%) announces positive top-line results from a Phase 3 study, PALOMA-2, assessing cancer med IBRANCE (palbociclib), in combination with letrozole [Novartis' (NVS +0.5%) FEMARA], in systemic treatment-naive post-menopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. First-line treatment with the combination showed a statistically significant improvement in progression-free survival (PFS), the primary endpoint, compared to treatment with letrozole and placebo. Full results will be presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting in Chicago, June 3-7. The data will support global regulatory applications.
- IBRANCE was first approved by the FDA in February 2015, in combination with letrozole, for the treatment of hormone receptor-positive (HR+), HER2- postmenopausal women who had letrozole as initial endocrine therapy. It was approved for the treatment of HR+, HER2- breast cancer, in combination with AstraZeneca's (AZN +0.2%) FASLODEX (fulvestrant), following endocrine therapy in February.
- Read now Pfizer: Master Of Diversity
Fri, Apr. 8, 11:05 AM
- MacroGenics (MGNX +3.1%) initiated with Buy rating and $35 price target by BTIG Research.
- Viking Therapeutics (VKTX -39.4%) initiated with Buy rating and $6 price target by H.C. Wainwright.
- Pfizer (PFE -0.3%) initiated with an Overweight rating and $38 price target by JP Morgan.
- Medivation (MDVN -0.1%) initiated with Buy rating and $56 price target by SunTrust Robinson Humphrey.
- Eyegate Pharmaceuticals (EYEG +6.5%) initiated with Buy rating and $10 price target by Noble Financial.
- Eiger Biopharmaceuticals (EIGR +0.5%) initiated with Buy rating and $35 price target by Jefferies.
- Vertex Pharmaceuticals (VRTX +0.3%) initiated with Market Perform rating and a $90 price target by BMO Capital.
- SocGen has been busy with initiations on six large cap pharmas: Buy: Merck (MRK +0.1%); Hold: Johnson & Johnson (JNJ -0.4%), Eli Lilly (LLY -0.3%) and Pfizer; Sell: Bristol-Myers Squibb (BMY -0.4%) and AbbVie (ABBV -0.9%).
- Tokai Pharmaceuticals (TKAI -6.7%) initiated with Buy rating and $16 price target by Bank of America. Initiated with Buy rating by Janney Capital.
- Cellectis (CLLS -0.1%) initiated with Buy rating and $45 price target by Ladenburg Thalmann.
- Novartis (NVS +0.5%) initiated with Hold rating by Argus Research.
- TherapeuticsMD (TXMD) initiated with Buy rating and $10 price target by Goldman Sachs.
- Protalix (PLX -4.2%) initiated with Buy rating and $3.50 price target by Rodman & Renshaw.
- Raptor Pharmaceuticals (RPTP -0.4%) upgraded to Outperform from Market Perform by JMP Securities.
- Ironwood Pharmaceuticals (IRWD -0.6%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $16 from $12.
- Intercept Pharmaceuticals (ICPT -6%) upgraded to Outperform from Market Perform by Wells Fargo.
- Edwards Lifesciences (EW -0.1%) upgraded to Buy from Neutral with $115 price target by BTIG Research.
- Express Scripts (ESRX +0.7%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $80 from $76.
- BIND Therapeutics (BIND -7%) downgraded to Market Perform from Outperform by Cowen & Company.
- Allergan (AGN -0.5%) downgraded to Neutral from Buy by Mizuho Securities. Downgraded to Neutral from Positive by Susquehanna. Price target lowered to $275 from $345.
- Bruker (BRKR +0.2%) downgraded to Market Perform from Outperform by Leerink Swann. Price target is $27.
Wed, Apr. 6, 8:32 AM
- Incyte (NASDAQ:INCY) and Eli Lilly (LLY) amend their 2009 License Agreement to enable Incyte to develop and commercialize Jakafi (ruxolitinib) for the treatment of graft-versus-host disease (GVHD). Incyte, in turn, has amended its Collaboration and License Agreement with Novartis (NYSE:NVS) granting it exclusive rights to develop ruxolitinib for GVHD outside the U.S.
- Incyte will make an upfront payment of $35M to Lilly and undisclosed regulatory milestones. Novartis will make undisclosed development and regulatory milestones to Incyte as well pay royalties on commercial sales ex-U.S.
- GVHD is a condition in which donated bone marrow or stem cells view the recipient's body as foreign and attack it. If acute, it can be life-threatening.
- Jakafi is a JAK1/JAK2 inhibitor cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
- Lilly secured global rights to ruxolitinib from Incyte in December 2009 in a deal that included a $90M upfront payment and up to $665M in milestones.
Fri, Apr. 1, 11:25 AM
- Cepheid (CPHD +6%) upgraded to Buy from Neutral by BTIG Research. Price target set at $42 (19% upside).
- Cardiovascular Systems (CSII +28.1%) upgraded to Buy from Underperform by Needham. Price target set at $16 (20% upside).
- United Health Services (UHS -0.6%) upgraded to Outperform from Market Perform by Wells Fargo.
- PRA Health Services (PRAH +1.4%) upgraded to Buy from Neutral by SunTrust Robinson Humphrey. Price target raised to $51 (17% upside) from $47.
- Dimension Therapeutics (DMTX +3.1%) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $10 (25% upside) from $12.
- Novartis (NVS -2%) downgraded to Neutral from Buy by UBS. Price target lowered to CHF72 (3% upside) from CHF100. Downgraded to Neutral from Buy by Citigroup.
- Intuitive Surgical (ISRG -0.2%) downgraded to Neutral from Buy by BTIG Research.
- ATyr Pharma (LIFE -1%) downgraded to Market Perform from Outperform by William Blair. Price target lowered to $8 (106% upside) from $42.
- Achaogen (AKAO -1.4%) downgraded to Market Perform from Outperform by Cowen & Co.
- Portola Pharmaceuticals (PTLA +4.1%) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $30 (40% upside) from $65.
- Quintiles Transnational Holdings (Q +1.9%) downgraded to Neutral from Buy by SunTrust Robinson Humphrey.
Fri, Apr. 1, 10:00 AM
- Array BioPharma (ARRY -3.7%) slumps on increased volume in response to its announcement that it has terminated its Phase 3 study, MILO, assessing binimetinib in low-grade ovarian cancer due to lack of efficacy. Detailed results will be shared with the scientific community at a later date.
- Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a certain cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. It is being investigated in BRAF-positive (COLUMBUS study) and NRAS-positive (NEMO study) melanoma.
- Array licensed binimetinib to Novartis (NVS -2.3%) in 2010 but reacquired the rights after Novartis acquired GlaxoSmithKline's (GSK -1.7%) oncology business in early 2015.
- Now read Earnings Peek: Array BioPharma Has A Lot Going On And A Lot of Money
Fri, Apr. 1, 3:50 AM
- UBS cuts Novartis (NYSE:NVS) to Neutral from Buy.
- Drops price target to CHF72 from CHF100. Implied upside 6%.
- Cuts core EPS estimates by 7-17% for 2016-20, citing reduced Entresto sales and higher marketing spend, and weaker expectations for oncology business and non-Pharma divisions.
- Notes that earnings momentum has been negative since 2Q15 results.
- Says significant acceleration of Entresto U.S. script trends may not materialize before mid-2017, and therefore cuts Entresto 2020 sales estimates to $4.6B vs $8.3B.
- NVS -2.5% this morning in Zurich.
- Now read Entresto Is A Growth Driver For Novartis »
Thu, Mar. 31, 1:33 PM
- Thinly traded micro cap Aclaris Therapeutics (ACRS +16.5%) breaks out today on modestly higher volume. Shares have climbed almost 22% since Monday when the company announced that it acquired global rights to certain Janus Kinase (JAK) inhibitors for the treatment of hair loss and other dermatological conditions via its acquisition of Vixen Pharmaceuticals who licensed the intellectual property from Columbia University.
- The deal included an upfront payment, future milestones and royalties on commercial sales. No specific financial details were disclosed.
- JAK inhibition is an approach used to treat cancer and inflammatory diseases. Examples of approved JAK inhibitors are Pfizer's (PFE -0.3%) XELJANZ (tofacitinib citrate) for rheumatoid arthritis and Novartis' (NVS +0.2%) Jakafi (ruxolitinib) for polycythemia vera and myelofibrosis. Researchers at Columbia discovered the link between JAK inhibition and hair loss.
- Now read Aclaris Therapeutics: A Sizable Market There For The Taking
Wed, Mar. 30, 4:46 AM
- An anonymous whistleblower has accused the Swiss drugmaker of paying bribes in Turkey through a consulting firm to secure business advantages worth an estimated $85M.
- The alleged benefits include getting medicines added to drug lists approved for prescription in government-run hospitals, and avoiding price cuts in other countries by changing the names of two drugs.
- Last week, the U.S. asked Novartis (NYSE:NVS) for records of 80K "sham" doctor events.
Sun, Mar. 27, 12:07 PM
- In a filing Friday, the Manhattan U.S. Attorney said it needs Novartis (NYSE:NVS) to provide information about a decade's worth of doctor events that the US AG claims were shams.
- The government claims Novratis provided illegal kickbacks to health-care providers through bogus educational programs at high-end restaurants and sports bars where the drugs were barely discussed.
- “The requested documents go to the core issues in this case: whether educational materials were provided at these events; which doctors actually attended the events; how much money was spent on meals and honoraria; and indeed, most fundamentally, whether the underlying documentation shows that a particular event actually took place,” it said in its filing.
- Last year Novartis agreed to pay $390M to settle a lawsuit in which the U.S. government claimed it paid kickbacks to pharmacies to boost sales of some of its prescription drugs.
- Now read New Catalysts, New High For Novartis? »
Thu, Mar. 24, 4:05 PM
- Accelerate Diagnostics (AXDX +12.7%) initiated with Overweight rating and $17 (26% upside) price target by JP Morgan.
- Inogen (INGN -2.1%) initiated with Neutral rating with a $46 (15% upside) price target by Piper Jaffray.
- Incyte (INCY +3.3%) initiated with Overweight rating and $85 (21% upside) price target by Morgan Stanley.
- West Pharmaceutical Services (WST -0.1%) initiated with Outperform rating with a $69 (6% upside) price target by Wells Fargo.
- Ironwood Pharmaceuticals (IRWD +1%) initiated with Neutral rating and $14 (35% upside) price target by Goldman Sachs.
- HeartWare International (HTWR -0.4%) upgraded to Buy from Neutral by Bank of America.
- WebMD (WBMD +0.4%) upgraded to 3.5 stars from 3.0 stars (out of 5.0) by top raters at Vetr community. Price target is $62.50 (7% upside).
- Tandem Diabetes (TNDM -15.7%) downgraded to Underperform from Neutral by Bank of America.
- EndoChoice (GI -9.1%) downgraded to Underperform from Buy with a $10 price target by Bank of America.
- DENTSPLY (XRAY -1.6%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target is $65 (9% upside).
- Novartis (NVS -0.8%) downgraded to Market Perform from Outperform by Leerink. Price target lowered to $85 (16% upside) from $98.
- Infinity Pharmaceuticals (INFI -4.3%) downgraded to Underperform from Neutral by Wedbush. Price target lowered to $3 (40% downside risk) from $8.
- Valeant Pharmaceuticals (VRX -7%) downgraded to Equal Weight with $34 (10% upside) price target by Barclays. Downgraded to Underperform from Neutral by Mizuho. Price target lowered to $18 (42% downside risk) from $70.
Wed, Mar. 23, 7:00 PM
- The SEC says Novartis (NVS -0.7%) has settled civil charges of committing bribery in China and agreed to pay $25M to the government.
- Violations happened from 2009 to 2013, the SEC says; Novartis' settlement means that it doesn't admit or deny the charges, and it says the allegations largely predate compliance measures that are now in place.
- According to the SEC, Novartis bribed healthcare professionals in China to boost its sales there, and tried to hide the bribes (which it says included entertainment, gifts, travel, and meals) by recording them as legitimate expenses. The agency also said Novartis failed to devise and maintain effective internal accounting controls.
- Novartis, meanwhile, cooperated with the probe and disciplined or terminated employees along with suspending some vendor relationships.
Mon, Mar. 21, 12:32 PM
- Endo International (ENDP -3.1%) eases on increased volume in response to the news that the FDA has approved a generic version of Voltaren Gel (diclofenac sodium topical gel) 1%, a topical non-steroidal anti-inflammatory medication for the treatment of arthritis pain, a product that accounted for more than 6% of company's 2015 sales ($207.2M/3268.7M).
- The company says its 2016 guidance issued last month anticipated that the appearance of a generic competitor would not materially impact Voltaren Gel sales until the end of the year. Should the market launch commence soon, management will update its guidance no later than its Q1 earning presentation in early May. It has the option of launching its own generic under its December 2015 license agreement with Novartis (NVS +1.1%) and its Sandoz unit.
- Endo also says it has no plans to reduce its pain salesforce as it is in the midst of launching BELBUCA (buprenorphine HCl buccal film), cleared by the FDA in October 2015.
Sat, Feb. 27, 12:11 PM
- The FDA approves the use of Novartis' (NYSE:NVS) Afinitor (everolimus) for the treatment of adults with nonfunctional, unresectable, locally advanced or metastatic neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin.
- The data supporting the indication was generated in the RADIANT-4 study which showed Afinitor reduced the risk of progression in patients with progressive, well-differentiated, nonfunctional NET of GI or lung origin by 52% (p<0.001).
- NET is a rare type of cancer that originates in the hormone-producing cells of the body's neuroendocrine system. It affects ~10K Americans each year. Patients with advanced NET have limited treatment options.
- Afinitor, a kinase inhibitor, is currently cleared for the treatment of a certain type of breast cancer, advanced kidney cancer, renal angiomyolipoma, subependymal giant cell astrocytoma and advanced pancreatic NET. It was originally cleared by the FDA in March 2009.
- Previously: Novartis' Afinitor successful in Phase 3 NET-GI/Lung origin study (June 4, 2015)
Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers... More
Industry: Drug Manufacturers - Major
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