New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
August 11, 2014
11:58 EDTNVO, SNY, LLY, MNKDMannKind rallies after inking licensing agreement with Sanofi
Shares of MannKind (MNKD), a development-stage biopharmaceutical company, are rallying after the company announced that it has formed an exclusive licensing agreement for the development and commercialization of Afrezza inhaled insulin with drug giant Sanofi (SNY). WHAT'S NEW: MannKind and Sanofi this morning said they would develop and commercialize Afrezza for adults with diabetes. The companies plan to launch Afrezza in the United States in the first quarter of 2015. Under the terms of the agreement, MannKind will receive an upfront payment of $150M and potential milestone payments of up to $775M. Sanofi will be responsible for global commercial, regulatory and development activities, while MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Connecticut. The companies are also planning to collaborate to expand manufacturing capacity to meet global demand as necessary. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi has agreed to advance to MannKind its share of the collaboration's expenses up to a limit of $175M, the companies said. WHAT'S NOTABLE: MannKind also reported its second quarter earnings this morning. Second quarter losses per share were (19c), missing analysts' consensus expectation of (12c). Total operating expenses for the quarter were $69.8M versus $41.6M in the year-ago period and research and development expenses increased by $10.2M to $37.3M compared to the same quarter in 2013. ANALYST REACTION: Piper Jaffray, which has a Neutral rating on MannKind shares, views the Sanofi partnership as "impressive" given the "meaningful" upfront payment, shared economics and an advance of expenses. Piper believes investors will view the partnership and terms favorably. PRICE ACTION: Near noon, MannKind shares were up 91c, or 11%, to $9.04, while Sanofi shares were up 7c, or 0.1%, to $52.39. OTHERS TO WATCH: Novo Nordisk (NVO) and Eli Lilly (LLY) also make fast-acting insulin.
News For MNKD;SNY;NVO;LLY 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 news | >>
March 2, 2015
08:53 EDTMNKD, NVO, SNY, LLYNon-profit gives lukewarm review to MannKind inhaled insulin, TheStreet says
Subscribe for More Information
06:05 EDTMNKDStocks with implied volatility movement; MNKD MRVL
Subscribe for More Information
February 27, 2015
10:32 EDTMNKDOptions with decreasing implied volatility
Subscribe for More Information
07:22 EDTSNYSanofi reports positive opinion from CHMP for Toujeo
Sanofi announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has issued a positive opinion recommending the approval of Toujeo, a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus with low within-individual, within-day blood sugar variability. The European Commission is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the FDA and is under review by other regulatory authorities around the world. Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 insulin units, and it has a maximum single injection dose of 80 IU.
February 26, 2015
18:44 EDTNVONovo Nordisk receives Health Canada approval for Saxenda
Subscribe for More Information
05:32 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
Sanofi announced that the FDA approved Toujeo, a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations.
February 25, 2015
20:05 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
Subscribe for More Information
05:52 EDTMNKDStocks with implied volatility movement; MNKD NE
Stocks with implied volatility movement; MannKind (MNKD) 79, Noble Corp. (NE) 52 according to iVolatility.
February 24, 2015
16:48 EDTMNKDMannKind reports Q4 EPS (9c), consensus (9c)
Subscribe for More Information
06:34 EDTLLYEli Lilly CEO states company is not for sale, Financial Times says
Subscribe for More Information
February 23, 2015
15:06 EDTMNKDMannKind volatility increases into Q4 and outlook
MannKind February weekly call option implied volatility is at 103, March is at 63, April is at 60. May is at 55; compared to its 26-week average of 70 according to Track Data, suggests large near term price movement into the expected release into the expected release of Q4 result on February 24.
08:31 EDTLLYEli Lilly announces delay in submission of basal insulin peglispro beyond Q1
Subscribe for More Information
07:06 EDTLLYEli Lilly and Incyte announces positive results for baricitinib
Subscribe for More Information
February 20, 2015
12:02 EDTNVOEmisphere says Novo Nordisk completes Phase 2 OG217SC trial
Emisphere Technologies (EMIS) highlighted positive Phase 2 data from Eligen licensee Novo Nordisk (NVO) pertaining to OG217SC, the oral formulation of semaglutide, a long-acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. OG217SC is provided in a tablet formulation with an absorption-enhancing excipient, SNAC. SNAC is included in the Eligen Carrier Concept. Novo Nordisk announced that it has successfully completed the phase 2 trial for OG217SC, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 people with type 2 diabetes treated for 26 weeks. Results of the study are available on Novo Nordisk's website. Based on these results, Novo Nordisk announced that it will initiate consultations with regulatory authorities subsequent to which a decision of whether to progress OG217SC into phase 3 development will be made. Under its GLP-1 License Agreement, Novo Nordisk is working to develop and commercialize oral formulations of its proprietary GLP-1 receptor agonists in combination with Emisphere carriers. Under the GLP-1 License Agreement, Emisphere could receive additional contingent product development and sales milestone payments and would also be entitled to receive royalties in the event Novo Nordisk commercializes products developed under such Agreement. Under the GLP-1 License Agreement, Novo Nordisk is responsible for the development and commercialization of the products.
07:08 EDTSNYAmerican 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.
February 19, 2015
16:50 EDTSNYSanofi appoints Olivier Brandicourt CEO
Subscribe for More Information
09:59 EDTSNYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Altisource Residential (RESI) upgraded to Neutral from Sell at Compass Point... Angie's List (ANGI) upgraded to Overweight from Equal-Weight at First Analysis... Barrick Gold (ABX) upgraded to Buy from Hold at TD Securities... British Land (BTLCY) upgraded to Buy from Hold at Societe Generale... Coach (COH) upgraded to Buy from Hold at Topeka... Fiat Chrysler (FCAU) upgraded to Outperform from Neutral at Exane BNP Paribas... Garmin (GRMN) upgraded at BofA/Merrill... Hologic (HOLX) upgraded to Buy from Hold at Canaccord... Iberdrola (IBDRY) upgraded to Neutral from Underweight at HSBC... KPN (KKPNY) upgraded to Neutral from Underperform at Exane BNP Paribas... Monster Worldwide (MWW) upgraded at Evercore ISI... Pharmacyclics (PCYC) upgraded to Buy from Neutral at Nomura... RPC, Inc. (RES) upgraded to Equal Weight from Underweight at Morgan Stanley... Sanofi (SNY) upgraded to Buy from Neutral at BofA/Merrill... Sasol (SSL) upgraded to Neutral from Underweight at HSBC... Tractor Supply (TSCO) upgraded at Oppenheimer... Valero (VLO) upgraded to Buy from Hold at Deutsche Bank... Weingarten Realty (WRI) upgraded to Neutral from Sell at UBS... Werner (WERN) upgraded on improving freight fundamentals at RBC Capital... diaDexus (DDXS) upgraded to Buy from Neutral at Ladenburg,
08:04 EDTLLYEli Lilly extends Evacetrapib Phase 3 trial by six months
Subscribe for More Information
06:21 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
05:31 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
1 | 2 | all recent 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