Today, 5:37 PM
Fri, Jul. 10, 9:12 AM
Mon, Jul. 6, 10:39 AM
- Thinly traded small cap Versartis (VSAR +19.5%) jumps on average volume in response to its announcement that the FDA removed the partial clinical hold on its 136-subject Phase 3 trial, called VELOCITY, assessing its lead product candidate, VRS-317, in pediatric patients with growth hormone deficiency. Patient recruitment can now proceed.
- Interim six-month height velocity data are expected by the end of 2016. Top-line data on 12-month mean height velocity are expected by mid-2017. If all goes well, FDA clearance could happen by late 2018.
- The primary endpoint of the study is non-inferiority of VRS-317 administered twice monthly to daily doses of Pfizer's (PFE +0.5%) Genotropin (somatropin [rDNA origin]) and Novo Nordisk's (NVO -0.3%) Norditropin (somatropin [rDNA origin]) as measured by 12-month mean height velocity.
Fri, Feb. 20, 9:16 AM
Oct. 28, 2014, 9:13 AM
Oct. 28, 2014, 7:31 AM
- Sanofi (NYSE:SNY) (OTCQB:SNYNF) is off 8% premarket on moderately higher volume in response to its announcement that sales of its diabetes products will be flat next year due to increased competition in the U.S. CEO Chris Viehbacher says that the firm had to discount Lantus last quarter in order to get on U.S. drug benefit managers' reimbursement lists along with its competitors including Novo Nordisk A/S (NYSE:NVO).
May 1, 2014, 4:28 AM
- Novo Nordisk's (NVO) Q1 net profit increased 8% to 6.46B Danish kroner ($1.2B).
- Sales +2% to 20.34B kroner, slightly missing consensus.
- Excluding the impact of forex fluctuations, sales +7% in local currencies.
- Novo Nordisk lowered its FY sales-growth guidance in local currencies to 7-10% from a prior forecast of 8-11%. The insulin company maintained its outlook for operating-profit growth of 10%.
- Earnings were hampered by Express Scripts excluding Novo's Victoza and NovoLog diabetes treatments from its "preferred drug" list in January.
- Share are -3.2% in Copenhagen. (PR)
Mar. 7, 2014, 5:37 PM
Feb. 5, 2014, 2:19 PM
- Novo Nordisk (NVO +3.8%) moves up after it signs a license agreement with Zosano Pharma to develop a new transdermal presentation of semaglutide, NVO's proprietary human GLP-1 analogue for the treatment of type 2 diabetes, using ZOSN's microneedle patch system.
- In exchange for granting NVO a worldwide, exclusive license to develop and commercialize products, Zosano will receive royalties on sales, plus potential milestone payments.
Jan. 31, 2014, 7:40 AM
- Sanofi (SNY) has sued Eli Lilly (LLY) over the alleged infringement of patents related to the French company's top-selling Lantus diabetes treatment.
- Sanofi's action comes a month after Lilly filed for FDA approval to sell a biosimilar version of Lantus and questioned the validity of several of its patents.
- Sanofi's suit has triggered an automatic 30-month stay of approval by the FDA, which means Lilly won't be able to market its biosimilar drug until mid-2016, over a year later than previously expected.
- Lantus generates worldwide revenue of $7B but is due to lose patent protection in the U.S. in February 2015.
- Sanofi's shares were -1.7% premarket, while those of Novo Nordisk (NVO), another major provider of insulin products, were +3.3%.
Jan. 28, 2014, 9:35 AM
- TherapeuticsMD's (TXMD) Estradiol VagiCap vaginal capsule for the treatment of vulvar vaginal atrophy (VVA) in post-menopausal women performed well in two trials when compared with NovoNordisks (NVO) Vagifem.
- The results of the studies showed substantially lower systemic exposure to the estradiol hormone of the VagiCap - also known as TX 12-004-HR - vs Vagifem.
- VVA affects up to 50% of postmenopausal women and is a result of a decrease in estrogen.
- TherapeuticsMD's shares are +7.8%. (PR)
Jan. 9, 2014, 12:50 PM
Jan. 8, 2014, 11:02 AM
- Aegis figures now is a good time to hike the price target on Oramed Pharmaceuticals (ORMP +20.1%) to $30 from $25 as "positive proof-of-concept data has been generated in animals for both ORMD-0801 [and] ORMD-0901."
- Here's analyst Ram Selvaraju, commenting: "Positive Phase 2b data [in ORMD-0801] could set the scene for a transformative licensing transaction or an acquisition by an established diabetes focused firm like AstraZeneca (AZN), Novartis (NVS), Novo Nordisk (NVO), or Sanofi (SNY)."
- The shares are up 222% since the company reported successful results with its oral insulin capsule last month.
Oct. 31, 2013, 9:13 AM
Oct. 31, 2013, 4:39 AM
- Novo Nordisk's (NVO) Q3 net profit increased 13% to 6.42B ($1.18B) Danish kroner but missed estimates of DKK6.52B.
- Sales rose 3.4% to DKK20.51B, below consensus of DKK21.09B.
- Novo Nordisk slightly reduced its guidance for growth in sales and operating profit, due to forex fluctuations.
- Shares -3.65% in Copenhagen. (PR)
Mar. 18, 2013, 9:10 AM
NVO vs. ETF Alternatives
Novo-Nordisk A/Sis a healthcare company that is engaged in the discovery, development, manufacturing and marketing of pharmaceutical products. The Company has two business segments: diabetes care and biopharmaceuticals.
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