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Stock Market & Financial Investment News

News Breaks
August 11, 2014
11:58 EDTSNY, LLY, MNKD, NVOMannKind 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
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March 20, 2015
09:57 EDTLLYLeerink major pharma analyst holds an analyst/industry conference call
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09:01 EDTLLYEli Lilly up 2% to $75.75 in pre-market trading
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08:01 EDTLLYEli Lilly and Innovent Biologics announce strategic alliance
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07:41 EDTLLYAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
11:07 EDTNVONovo Nordisk management to meet with Jefferies
Meeting to be held in Connecticut on March 24 hosted by Jefferies.
08:08 EDTLLYEli Lilly and Hanmi sign license and collaboration agreement
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07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
12:48 EDTLLYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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09:32 EDTMNKD, SNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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07:46 EDTLLYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
March 17, 2015
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink
March 16, 2015
11:20 EDTMNKDStocks with call strike movement; MNKD BBRY
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08:23 EDTSNYPCSK9 data continues to impress, says Leerink
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07:27 EDTLLYBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.
07:16 EDTSNYRegeneron Sanofi dupilumab drug can generate $6B+ in revenue, says Bernstein
Bernstein believes that dupilumab, a drug made by Regeneron and Sanofi, has shown strong efficacy in patients with severe atopic dermatitis. The firm notes that the drug is currently in pivotal trials involving patients with severe levels of other common diseases. The firm thinks the drug can generate $1.5B of revenue by 2018 and $3.8B by 2020. Bernstein keeps a $500 price target and Outperform rating on Regeneron.
06:40 EDTSNYPCSK9 studies show potential improvement in heart health, WSJ says
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