Novo Nordisk A/SNYSE
Mon, Dec. 5, 11:57 AM
- Novo Nordisk (NVO +1.2%) submits a New Drug Application (NDA) to the FDA seeking approval of semaglutide for the treatment of adults with type 2 diabetes (T2D).
- The data supporting the filing was generated in the eight-study SUSTAIN program which showed semaglutide, in combination with basal insulin and oral anti-diabetic agents was effective in sustaining blood glucose control compared to placebo, short-acting insulin, sitagliptin and exenatide extended-release. SUSTAIN 6 also showed that treatment with semaglutide lowered cardiovascular risk in at-risk patients.
- Semaglutide is a GLP-1 analogue that is administered via a once-weekly injection.
Fri, Dec. 2, 1:26 PM
- The FDA approves Eli Lilly (LLY +2.8%) and development partner Boehringer Ingelheim's Jardiance (empagliflozin) to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes and CV disease.
- The data supporting the new claim was generated in a large-scale post-marketing study involving more than 7,000 patients.
- The approval is a big win for the companies considering the close Ad Comm vote (12 - 11 in favor) in June.
- Novo Nordisk (NVO +0.7%) is close behind. It filed marketing applications in the US. and Europe in late October seeking approval of the same claim for Victoza (liraglutide).
- Previously: FDA Ad Comm to review Boehringer Ingelheim's applications for CV risk claims for diabetes meds (June 27)
Wed, Nov. 30, 7:29 AM
- Results from a long-term study, DEVOTE, evaluating the safety of Novo Nordisk's (NYSE:NVO) Tresiba (insulin degludec injection) compared to insulin glargine U100 when added to standard of care achieved the primary endpoint of demonstrating non-inferiority in terms of major cardiovascular events (MACE). The final results confirmed the interim data Novo submitted to the FDA in March 2015.
- The study involved 7,500 type 2 diabetics at high risk of MACE who were treated for ~two years. The primary endpoint was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Participants receiving Tresiba experienced a 9% lower risk of MACE (hazard ratio = 0.91) compared to insulin glargine. There was no statistical difference between the two treatments. The reductions in HbA1c from baseline were also similar.
- Fewer patients (27%) in Tresiba group experienced an episode of severe hypoglycemia and there was a 54% relative reduction in the rate of nocturnal severe hypoglycemia. The differences were statistically significant.
- Detailed results from DEVOTE will be presented at a future scientific conference. The data will be submitted to regulatory authorities in H1 2017.
- Shares are up 3% premarket on average volume.
Mon, Nov. 21, 8:28 PM
- The FDA approves Novo Nordisk's (NYSE:NVO) Xultophy 100/3.6 (insulin degludec and liraglutide injection), a once-daily combination of Tresiba (insulin degludec injection) and Victoza (liraglutide), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on less than 50 units of basal insulin or equal to 1.8 mg of liraglutide per day.
- Commercial launch will commence in H1 2017.
Mon, Nov. 21, 12:26 PM
- 52-week highs on 3x or more normal volume:
- Banco Santander Brasil (BSBR +5.8%) - now up 120% YTD
- Energy Transfer Equity (ETE +3.4%) - Energy Transfer Partners being acquired
- Arista Networks (ANET +6.1%)
- Hillenbrand (HI +1.3%)
- International Game Technology (IGT -4.3%) - strong results, but now reversing
- Lexmark International (LXK +0.5%)
- 52-week lows on just modestly higher than normal volume:
- CubeSmart (CUBE -0.9%)
- Extra Space Storage (EXR -0.9%)
- PLDT (PHI -1.9%)
- 58.com (WUBA -1%)
- Infosys (INFY)
- Novo Nordisk (NVO -0.5%)
- Grupo Televisa (TV -0.4%)
Fri, Nov. 18, 12:34 PM
- In no surprise given the market's one-way street upwards for some time, the list of 52-week highs in large- and mid-cap stocks is too long to list. Suffice it to say, if you own a financial name and it's not at a 52-week high, call management.
- Of far more interest given the major bull run, which names are making 52-week lows?
- Anheuser-Busch (BUD -1.6%)
- Fomento Economico Mexicano (FMX -2.8%)
- National Grid (NGG -0.8%)
- Novo Nordisk (NVO -1%)
- Grupo Televisa (TV -3.3%)
- Unilever (UL -1%)
- CubeSmart (CUBE -1.4%)
- Extra Space Storage (EXR -0.4%)
Thu, Nov. 17, 12:18 PM
- In no surprise, the list is dominated by the ripping financial sector:
- Allstate (ALL +1.4%)
- Ameriprise (AMP +0.2%)
- TD Ameritrade (AMTD +1.6%)
- BB&T (BBT +2.1%)
- Citigroup (C +2.4%)
- Citizens Financial (CFG +2%)
- Comerica (CMA +1.5%)
- CNA Financial (CNA +0.6%)
- Loews Corp. (L +0.9%)
- Marsh & McLennan (MMC +1.9%)
- PNC Financial (PNC +2.6%)
- Royal Bank of Canada (RY +0.7%)
- U.S. Bancorp (USB +1.9%)
- Aetna (AET +1.5%)
- Best Buy (BBY +10.4%)
- CBS (CBS +0.6%)
- Celanese (CE +0.1%)
- Comcast (CMCSA +1.5%)
- Dell Technologies (DVMT +1.1%)
- The Gap (GPS +0.4%)
- Humana (HUM +1.4%)
- KLA-Tencor (KLAC +2.7%)
- Liberty Media (LMCA +1.6%)
- Lam Research (LRCX +1.9%)
- Micron (MU +5.3%)
- Nvidia (NVDA +2.7%)
- Rockwell (ROK -0.5%)
- Teck Resources (TCK +0.5%)
- Texas Instruments (TXN +1.1%)
- New lows:
- Novo Nordisk (NVO +0.3%)
Mon, Nov. 14, 7:10 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Novo Nordisk's (NYSE:NVO) Fiasp (fast-acting insulin aspart) for the treatment of adults with type 1 and type 2 diabetes.
- Fiasp is indicated as the bolus component of basal-bolus therapy in combination with basal insulin and for continuous subcutaneous insulin infusion via an insulin pump. It is designed as mealtime insulin with a greater glucose-lowering effect than NovoRapid (insulin aspart).
- A final decision from the European Commission usually takes ~60 days.
Thu, Nov. 10, 11:05 AM
- Novo Nordisk (NVO -1.9%) submits a type 2 variation application to the European Medicines Agency (EMA) seeking approval to add data from two late-stage studies to the label of long-acting diabetes med Tresiba (insulin degludec injection).
- The first, SWITCH 1, showed type 1 diabetics receiving Tresiba, in combination with insulin aspart, experienced 11% fewer hypoglycemic episodes, 36% fewer episodes of nocturnal hypoglycemia and 35% fewer episodes of severe hypoglycemia than those receiving the combination of insulin glargine and insulin aspart.
- The second, SWITCH 2, showed type 2 diabetics treated with Tresiba plus oral antidiabetic drugs (OADs) experienced 30% fewer episodes of hypoglycemia, 42% fewer episodes of nocturnal hypoglycemia and 46% fewer episodes of severe hypoglycemia compared to insulin glargine plus OADs. The reduction in episodes of severe hypoglycemia was not statistically significant, though.
- The studies also showed that Tresiba was non-inferior to insulin glargine as measured by HbA1c reduction.
Fri, Nov. 4, 8:16 AM
- Almost Family (NASDAQ:AFAM) upgraded to Outperform from Neutral by Baird. Price target raised to $55 (35% upside) from $44.
- Gilead Sciences (NASDAQ:GILD) upgraded to Outperform from Market Perform by BMO Capital. Price target lowered to $84 (17% upside) from $98.
- Dentsply Sirona (NASDAQ:XRAY) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $69 (16% upside) from $65.
- Zimmer Biomet Holdings (NYSE:ZBH) upgraded to Strong Buy from Buy by Needham. Price target lowered to $148 (44% upside) from $150.
- Stryker (NYSE:SYK) upgraded to Market Perform from Underperform with a $125 (8% upside) price target by BMO Capital.
- Teva Pharmaceutical Industries (NASDAQ:TEVA) upgraded to Outperform from Neutral by Credit Suisse. Price target lowered to $52 (33% upside) from $59.
- Cempra (NASDAQ:CEMP) downgraded to Hold from Buy by Stifel Nicolaus. Price target lowered to $8 (6% upside) from $37. Downgraded to Neutral from Overweight by JPMorgan. Price target lowered to $6 (21% downside risk) from $25. Downgraded to Underperform from Outperform by Baird. Price target lowered to $6 (21% downside risk) from $33.
- Diplomat Pharmacy (NYSE:DPLO) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $18 (39% upside) from $35. Downgraded to Market Perform by Citigroup and Avondale Partners.
- WebMD (NASDAQ:WBMD) downgraded to Neutral from Buy by Mizuho Securities. Price target lowered to $52 (5% upside) from $63.
- Pfizer (NYSE:PFE) downgraded to Market Perform from Outperform by BMO Capital. Price target lowered to $33 (10% upside) from $40. Downgraded to Hold from Buy by Argus.
- Adeptus Health (NYSE:ADPT) downgraded to Underperform from Buy by Bank of America. Downgraded to Hold from Buy by Jefferies. Price target lowered to $13 (48% upside) from $77.
- Sangamo BioSciences (NASDAQ:SGMO) downgraded to Neutral from Overweight by Wedbush and Piper Jaffray. Price targets lowered to $4 (25% upside) from $30 and $5 (56% upside) from $9, respectively.
- Novo Nordisk (NYSE:NVO) downgraded to Neutral from Buy by Citigroup and to Hold from Buy by DNB Markets.
- AbbVie (NYSE:ABBV) downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $60 (7% upside) from $70.
Mon, Oct. 31, 11:36 AM
- Shire plc (SHPG -3.3%) slumps in early trading on increased volume in apparent response to comments made by Express Scripts (ESRX +2.6%) Chief Medical Officer Steven Miller during a phone interview. He said the company is mulling ways to manage the rising costs of hemophilia medicines without forcing patients to switch treatments. Shire is a major player in the space after its merger with Baxalta. Hemophilia products accounted for over 46% of Baxalta's business in 2015.
- Related tickers: (OTCPK:BAYRY -0.7%)(PFE -0.2%)(NVO -0.4%)(BMRN -0.6%)(BAX +0.9%)(BIIB -0.4%)(SGMO +1.4%)
Fri, Oct. 28, 11:12 AM
- Merck (MRK -2.6%) eases on modestly higher volume in apparent sympathy with insulin leader Novo Nordisk (NVO -15.3%).
- Novo released Q3 results earlier today that included a cut in its long-term profit growth objective from 10% to 5% due principally to pricing pressure in the U.S.
- Merck's Januvia/Janumet accounted for ~15% of its Q3 sales.
Fri, Oct. 28, 11:01 AM
Fri, Oct. 28, 9:20 AM
Fri, Oct. 28, 8:47 AM
- Novo Nordisk (NYSE:NVO) Q3 results ($M): Net Sales: 4,130 (+3.5%); Diabetes and Obesity Care: 1,480 (+9.4%); Biopharmaceuticals: 383 (-11.1%).
- Modern Insulin: 1,765 (-5.2%); Victoza: 766 (+9.9%); Human Insulin: 414 (+0.2%); New-Generation Insulin: 171 (+205.4%).
- Net Income: 1,470 (+17.7%); Earnings/ADR: 0.58 (+20.8%); CF Ops: 2,277 (+26.4%).
- 2016 Guidance: Sales Growth: 5 - 6% from 5 - 7%; Adjusted Operating Profit: 5 - 7% from 5 - 8%.
- 2017 Guidance will be released on February 2.
- Long-term financial targets: Operating profit growth: 5% from 10%; Operating profit after tax/operating assets: 125% (unch); Cash to earnings: 90% (unch).
- Consensus view was earnings/ADR of $0.56 on revenues of $4.1B.
- Shares are down 13% premarket on robust volume.
Fri, Oct. 28, 6:27 AM